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1.  The design of the Dutch EASYcare study: a randomised controlled trial on the effectiveness of a problem-based community intervention model for frail elderly people [NCT00105378] 
Because of their complex clinical presentations and needs frail elderly people require another approach than people who age without many complications. Several inpatient geriatric health services have proven effectiveness in frail persons. However, the wish to live independently and policies that promote independent living as an answer to population aging call for community intervention models for frail elderly people. Maybe models such as preventive home visits, comprehensive geriatric assessment, and intermediate care qualify, but their efficacy is controversial, especially in frail elderly persons living in the community. With the Dutch EASYcare Study Geriatric Intervention Programme (DGIP) we developed a model to study effectiveness of problem based community intervention models in frail elderly people.
DGIP is a community intervention model for frail elderly persons where the GP refers elderly patients with a problem in cognition, mood, behaviour, mobility, and nutrition. A geriatric specialist nurse applies a guideline-based intervention with a limited number of follow up visits. The intervention starts with the application of the EASYcare instrument for geriatric screening. The EASYcare instrument assesses (instrumental) activities of daily life, cognition, mood, and includes a goal setting item. During the intervention the nurse regularly consults the referring GP and a geriatrician. Effects on functional performance (Groningen Activity Restriction Scale), health related quality of life (MOS-20), and carer burden (Zarit Burden Interview) are studied in an observer blinded randomised controlled trial. 151 participants were randomised over two treatment arms – DGIP and regular care – using pseudo cluster randomisation. We are currently performing the follow up visits. These visits are planned three and six months after inclusion. Process measures and cost measures will be recorded. Intention to treat analyses will focus on post intervention differences between treatment groups.
The design of a trial evaluating the effects of a community intervention model for frail elderly people was presented. The problem-based participant selection procedure satisfied; few patients that the GP referred did not meet our eligibility criteria. The use of standard terminology makes detailed insight into the contents of our intervention possible using terminology others can understand well.
PMCID: PMC1298295  PMID: 16207382
2.  Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS) 
PLoS ONE  2015;10(5):e0121340.
Poor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period.
To examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care.
Economic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained.
We undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold).
The specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed.
Trial Registration
ISRCTN registry ISRCTN21800480
PMCID: PMC4420253  PMID: 25942421
3.  Feasibility and impact of a post–discharge geriatric evaluation and management service for patients from residential care: the Residential Care Intervention Program in the Elderly (RECIPE) 
BMC Geriatrics  2014;14:48.
Geriatric evaluation and management has become standard care for community dwelling older adults following an acute admission to hospital. It is unclear whether this approach is beneficial for the frailest older adults living in permanent residential care. This study was undertaken to evaluate (1) the feasibility and consumer satisfaction with a geriatrician-led supported discharge service for older adults living in residential care facilities (RCF) and (2) its impact on the uptake of Advanced Care Planning (ACP) and acute health care service utilisation.
In 2002–4 a randomised controlled trial was conducted in Melbourne, Australia comparing the geriatrician–led outreach service to usual care for RCF residents. Patients were recruited during their acute hospital stay and followed up at the RCF for six months. The intervention group received a post-discharge home visit within 96 hours, at which a comprehensive geriatric assessment was performed and a care plan developed. Participants and their families were also offered further meetings to discuss ACPs and document Advanced Directives (AD). Additional reviews were made available for assessment and management of intercurrent illness within the RCF. Consumer satisfaction was surveyed using a postal questionnaire.
The study included 116 participants (57 intervention and 59 controls) with comparable baseline characteristics. The service was well received by consumers demonstrated by higher satisfaction with care in the intervention group compared to controls (95% versus 58%, p = 0.006).
AD were completed by 67% of participants/proxy decision makers in the intervention group compared to 13% of RCF residents prior to service commencement. At six months there was a significant reduction in outpatient visits (intervention 21 (37%) versus controls 45 (76%), (p < 0.001), but no difference in readmissions rates (39% intervention versus 34% control, p = 0.6). There was a trend towards reduced hospital bed-day utilisation (intervention 271 versus controls 372 days).
It is feasible to provide a supported discharge service that includes geriatrician assessment and care planning within a RCF. By expanding the service there is the potential for acute health care cost savings by decreasing the demand for outpatient consultation and further reducing acute care bed-days.
PMCID: PMC3998217  PMID: 24735110
Residential aged care facilities; Geriatric assessment; Advance care plans; Acute health care utilisation
4.  Reactions to caregiving during an intervention targeting frailty in community living older people 
BMC Geriatrics  2012;12:66.
The demands and consequences of caregiving are considerable. However, such outcomes are not commonly investigated in the evaluation of interventions targeting frailty. This study aims to explore family carers’ reactions to caregiving during an intervention targeting frailty in community living older people.
A study of carers (n=119) embedded in a 12 month randomised controlled intervention targeting frailty in people 70 years or older, compared to usual care. Reactions to caregiving were measured in the domains of health, finance, self-esteem, family support and daily schedule. Anxiety and depression levels were also evaluated. Carer outcomes were measured at baseline, 6 months and 12 months and at 3 months post frailty intervention.
Carers of frail older people in the intervention group showed a sustained improvement in health scores during the intervention targeting frailty, while health scores for carers of the frail older people in the control group, decreased and therefore their health worsened (F=2.956, p=0.034). The carers of the frail older people in the intervention group reported overall better health (F=5.303, p=0.023) and self-esteem (F=4.158, p=0.044), and co-resident carers reported higher self-esteem (F=4.088, p=0.046). Anxiety levels increased for carers in both intervention and control groups (F=2.819, p=0.04).
The inclusion of carers in trials targeting frail older people may assist in the identification of at-risk carers and facilitate the provision of information and support that will assist them to continue providing care. Further research that explores the features of frailty interventions that impact on the caregiving experience is recommended.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12608000565347
PMCID: PMC3571864  PMID: 23095644
Carers; Frailty; Caregiving; Older persons; Assessment
5.  Aged Residential Care Health Utilisation Study (ARCHUS): a randomised controlled trial to reduce acute hospitalisations from residential aged care 
BMC Geriatrics  2012;12:54.
For residents of long term care, hospitalisations can cause distress and disruption, and often result in further medical complications. Multi-disciplinary team interventions have been shown to improve the health of Residential Aged Care (RAC) residents, decreasing the need for acute hospitalisation, yet there are few randomised controlled trials of these complex interventions. This paper describes a randomised controlled trial of a structured multi-disciplinary team and gerontology nurse specialist (GNS) intervention aiming to reduce residents’ avoidable hospitalisations.
This Aged Residential Care Healthcare Utilisation Study (ARCHUS) is a cluster- randomised controlled trial (n = 1700 residents) of a complex multi-disciplinary team intervention in long-term care facilities. Eligible facilities certified for residential care were selected from those identified as at moderate or higher risk of resident potentially avoidable hospitalisations by statistical modelling. The facilities were all located in the Auckland region, New Zealand and were stratified by District Health Board (DHB).
The intervention provided a structured GNS intervention including a baseline facility needs assessment, quality indicator benchmarking, a staff education programme and care coordination. Alongside this, three multi-disciplinary team (MDT) meetings were held involving a geriatrician, facility GP, pharmacist, GNS and senior nursing staff.
Hospitalisations are recorded from routinely-collected acute admissions during the 9-month intervention period followed by a 5-month follow-up period. ICD diagnosis codes are used in a pre-specified definition of potentially reducible admissions.
This randomised-controlled trial will evaluate a complex intervention to increase early identification and intervention to improve the health of residents of long term care. The results of this trial are expected in early 2013.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN 12611000187943
PMCID: PMC3489701  PMID: 22974314
6.  Effects of case management in community aged care on client and carer outcomes: a systematic review of randomized trials and comparative observational studies 
Case management has been applied in community aged care to meet frail older people’s holistic needs and promote cost-effectiveness. This systematic review aims to evaluate the effects of case management in community aged care on client and carer outcomes.
We searched Web of Science, Scopus, Medline, CINAHL (EBSCO) and PsycINFO (CSA) from inception to 2011 July. Inclusion criteria were: no restriction on date, English language, community-dwelling older people and/or carers, case management in community aged care, published in refereed journals, randomized control trials (RCTs) or comparative observational studies, examining client or carer outcomes. Quality of studies was assessed by using such indicators as quality control, randomization, comparability, follow-up rate, dropout, blinding assessors, and intention-to-treat analysis. Two reviewers independently screened potentially relevant studies, extracted information and assessed study quality. A narrative summary of findings were presented.
Ten RCTs and five comparative observational studies were identified. One RCT was rated high quality. Client outcomes included mortality (7 studies), physical or cognitive functioning (6 studies), medical conditions (2 studies), behavioral problems (2 studies) , unmet service needs (3 studies), psychological health or well-being (7 studies) , and satisfaction with care (4 studies), while carer outcomes included stress or burden (6 studies), satisfaction with care (2 studies), psychological health or well-being (5 studies), and social consequences (such as social support and relationships with clients) (2 studies). Five of the seven studies reported that case management in community aged care interventions significantly improved psychological health or well-being in the intervention group, while all the three studies consistently reported fewer unmet service needs among the intervention participants. In contrast, available studies reported mixed results regarding client physical or cognitive functioning and carer stress or burden. There was also limited evidence indicating significant effects of the interventions on the other client and carer outcomes as described above.
Available evidence showed that case management in community aged care can improve client psychological health or well-being and unmet service needs. Future studies should investigate what specific components of case management are crucial in improving clients and their carers’ outcomes.
PMCID: PMC3508812  PMID: 23151143
Case management; Community aged care; Effects; Systematic review
7.  Care in specialist medical and mental health unit compared with standard care for older people with cognitive impairment admitted to general hospital: randomised controlled trial (NIHR TEAM trial) 
Objective To develop and evaluate a best practice model of general hospital acute medical care for older people with cognitive impairment.
Design Randomised controlled trial, adapted to take account of constraints imposed by a busy acute medical admission system.
Setting Large acute general hospital in the United Kingdom.
Participants 600 patients aged over 65 admitted for acute medical care, identified as “confused” on admission.
Interventions Participants were randomised to a specialist medical and mental health unit, designed to deliver best practice care for people with delirium or dementia, or to standard care (acute geriatric or general medical wards). Features of the specialist unit included joint staffing by medical and mental health professionals; enhanced staff training in delirium, dementia, and person centred dementia care; provision of organised purposeful activity; environmental modification to meet the needs of those with cognitive impairment; delirium prevention; and a proactive and inclusive approach to family carers.
Main outcome measures Primary outcome: number of days spent at home over the 90 days after randomisation. Secondary outcomes: structured non-participant observations to ascertain patients’ experiences; satisfaction of family carers with hospital care. When possible, outcome assessment was blind to allocation.
Results There was no significant difference in days spent at home between the specialist unit and standard care groups (median 51 v 45 days, 95% confidence interval for difference −12 to 24; P=0.3). Median index hospital stay was 11 versus 11 days, mortality 22% versus 25% (−9% to 4%), readmission 32% versus 35% (−10% to 5%), and new admission to care home 20% versus 28% (−16% to 0) for the specialist unit and standard care groups, respectively. Patients returning home spent a median of 70.5 versus 71.0 days at home (−6.0 to 6.5). Patients on the specialist unit spent significantly more time with positive mood or engagement (79% v 68%, 2% to 20%; P=0.03) and experienced more staff interactions that met emotional and psychological needs (median 4 v 1 per observation; P<0.001). More family carers were satisfied with care (overall 91% v 83%, 2% to 15%; P=0.004), and severe dissatisfaction was reduced (5% v 10%, −10% to 0%; P=0.05).
Conclusions Specialist care for people with delirium and dementia improved the experience of patients and satisfaction of carers, but there were no convincing benefits in health status or service use. Patients’ experience and carers’ satisfaction might be more appropriate measures of success for frail older people approaching the end of life.
Trial registration Clinical Trials NCT01136148
PMCID: PMC3698942  PMID: 23819964
8.  Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial 
Trials  2015;16:106.
Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process.
This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence.
The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study.
Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool.
The primary outcome is ‘informed choice’ after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey). Secondary outcomes include decisional conflict, adherence to immunotherapy decisions, autonomy preference, planned behaviour, coping self-efficacy, and perceived involvement in coaching and decisional encounters. Safety outcomes are comprised of anxiety and depression and disease-specific quality of life.
This trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany.
Trial registration
Current Controlled Trials (identifier: ISRCTN37929939), May 27, 2014.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0611-7) contains supplementary material, which is available to authorized users.
PMCID: PMC4397890  PMID: 25872529
Multiple sclerosis; Coaching; Shared decision-making; Cluster randomised controlled trial; Patient information; Nurses; Self-management; Evidence-based medicine
9.  A randomised controlled trial to prevent hospital readmissions and loss of functional ability in high risk older adults: a study protocol 
Older people have higher rates of hospital admission than the general population and higher rates of readmission due to complications and falls. During hospitalisation, older people experience significant functional decline which impairs their future independence and quality of life. Acute hospital services comprise the largest section of health expenditure in Australia and prevention or delay of disease is known to produce more effective use of services. Current models of discharge planning and follow-up care, however, do not address the need to prevent deconditioning or functional decline. This paper describes the protocol of a randomised controlled trial which aims to evaluate innovative transitional care strategies to reduce unplanned readmissions and improve functional status, independence, and psycho-social well-being of community-based older people at risk of readmission.
The study is a randomised controlled trial. Within 72 hours of hospital admission, a sample of older adults fitting the inclusion/exclusion criteria (aged 65 years and over, admitted with a medical diagnosis, able to walk independently for 3 meters, and at least one risk factor for readmission) are randomised into one of four groups: 1) the usual care control group, 2) the exercise and in-home/telephone follow-up intervention group, 3) the exercise only intervention group, or 4) the in-home/telephone follow-up only intervention group. The usual care control group receive usual discharge planning provided by the health service. In addition to usual care, the exercise and in-home/telephone follow-up intervention group receive an intervention consisting of a tailored exercise program, in-home visit and 24 week telephone follow-up by a gerontic nurse. The exercise only and in-home/telephone follow-up only intervention groups, in addition to usual care receive only the exercise or gerontic nurse components of the intervention respectively. Data collection is undertaken at baseline within 72 hours of hospital admission, 4 weeks following hospital discharge, 12 weeks following hospital discharge, and 24 weeks following hospital discharge. Outcome assessors are blinded to group allocation. Primary outcomes are emergency hospital readmissions and health service use, functional status, psychosocial well-being and cost effectiveness.
The acute hospital sector comprises the largest component of health care system expenditure in developed countries, and older adults are the most frequent consumers. There are few trials to demonstrate effective models of transitional care to prevent emergency readmissions, loss of functional ability and independence in this population following an acute hospital admission. This study aims to address that gap and provide information for future health service planning which meets client needs and lowers the use of acute care services.
Trial Registration No
Australian & New Zealand Clinical Trials Registry ACTRN12608000202369
PMCID: PMC3224378  PMID: 21861920
Older adults; discharge planning; in-home follow-up; telephone follow-up; exercise; randomised control trial
10.  Psychosocial Factors That Shape Patient and Carer Experiences of Dementia Diagnosis and Treatment: A Systematic Review of Qualitative Studies 
PLoS Medicine  2012;9(10):e1001331.
A systematic review of qualitative studies conducted by Frances Bunn and colleagues identifies and describes the experiences of patients and caregivers on receiving and adapting to a diagnosis of dementia.
Early diagnosis and intervention for people with dementia is increasingly considered a priority, but practitioners are concerned with the effects of earlier diagnosis and interventions on patients and caregivers. This systematic review evaluates the qualitative evidence about how people accommodate and adapt to the diagnosis of dementia and its immediate consequences, to guide practice.
Methods and Findings
We systematically reviewed qualitative studies exploring experiences of community-dwelling individuals with dementia, and their carers, around diagnosis and the transition to becoming a person with dementia. We searched PubMed, PsychINFO, Embase, CINAHL, and the British Nursing Index (all searched in May 2010 with no date restrictions; PubMed search updated in February 2012), checked reference lists, and undertook citation searches in PubMed and Google Scholar (ongoing to September 2011). We used thematic synthesis to identify key themes, commonalities, barriers to earlier diagnosis, and support identified as helpful. We identified 126 papers reporting 102 studies including a total of 3,095 participants. Three overarching themes emerged from our analysis: (1) pathways through diagnosis, including its impact on identity, roles, and relationships; (2) resolving conflicts to accommodate a diagnosis, including the acceptability of support, focusing on the present or the future, and the use or avoidance of knowledge; and (3) strategies and support to minimise the impact of dementia. Consistent barriers to diagnosis include stigma, normalisation of symptoms, and lack of knowledge. Studies report a lack of specialist support particularly post-diagnosis.
There is an extensive body of qualitative literature on the experiences of community-dwelling individuals with dementia on receiving and adapting to a diagnosis of dementia. We present a thematic analysis that could be useful to professionals working with people with dementia. We suggest that research emphasis should shift towards the development and evaluation of interventions, particularly those providing support after diagnosis.
Please see later in the article for the Editors' Summary.
Editors' Summary
Dementia is a decline in mental ability severe enough to interfere with daily life. Alzheimer disease is the most common type of dementia. People with dementia usually have problems with two or more cognitive functions—thinking, language, memory, understanding, and judgment. Dementia is rare before the age of 65, but about a quarter of people over 85 have dementia. Because more people live longer these days, the number of patients with dementia is increasing. It is estimated that today between 40 and 50 million people live with dementia worldwide. By 2050, this number is expected to triple.
One way to study what dementia means to patients and their carers (most often spouses or other family members) is through qualitative research. Qualitative research aims to develop an in-depth understanding of individuals' experiences and behavior, as well as the reasons for their feelings and actions. In qualitative studies, researchers interview patients, their families, and doctors. When the studies are published, they usually contain direct quotations from interviews as well as summaries by the scientists who designed the interviews and analyzed the responses.
Why Was This Study Done?
This study was done to better understand the experiences and attitudes of patients and their carers surrounding dementia diagnosis. It focused on patients who lived and were cared for within the community (as opposed to people living in senior care facilities or other institutions). Most cases of dementia are progressive, meaning symptoms get worse over time. Diagnosis often happens at an advanced stage of the disease, and some patients never receive a formal diagnosis. This could have many possible reasons, including unawareness or denial of symptoms by patients and people close to them. The study was also trying to understand barriers to early diagnosis and what type of support is useful for newly diagnosed patients and carers.
What Did the Researchers Do and Find?
The researchers conducted a systematic search for published qualitative research studies that reported on the experience, beliefs, feelings, and attitudes surrounding dementia diagnosis. They identified and reviewed 102 such studies. Among the quotations and summaries of the individual studies, they looked for prominent and recurring themes. They also compared and contrasted the respective experiences of patients and carers.
Overall, they found that the complexity and variety of responses to a diagnosis of dementia means that making the diagnosis and conveying it to patients and carers is challenging. Negative connotations associated with dementia, inconsistent symptoms, and not knowing enough about the signs and symptoms were commonly reported barriers to early dementia diagnosis. It was often the carer who initiated the search for help from a doctor, and among patients, willingness and readiness to receive a diagnosis varied. Being told one had dementia had a big impact on a patient's identity and often caused feelings of loss, anger, fear, and frustration. Spouses had to adjust to increasingly unequal relationships and the transition to a role as carer. The strain associated with this often caused health problems in the carers as well. On the other hand, studies examining the experience of couples often reported that they found ways to continue working together as a team.
Adjusting to a dementia diagnosis is a complex process. Initially, most patients and carers experienced conflicts, for example, between autonomy and safety, between recognizing the need for help but reluctance to accept it, or between living in the present and dealing with anxiety about and preparing for the future. As these were resolved and as the disease progressed, the attitudes of patients and carers towards dementia often became more balanced and accepting. Many patients and their families adopted strategies to cope with the impact of dementia on their lives in order to manage the disease and maintain some sort of normal life. These included practical strategies involving reminders, social strategies such as relying on family support, and emotional strategies such as using humor. At some point many patients and carers reported that they were able to adopt positive mindsets and incorporate dementia in their lives.
The studies also pointed to an urgent need for support from outside the family, both right after diagnosis and subsequently. General practitioners and family physicians have important roles in helping patients and carers to get access to information, social and psychological support, and community care. The need for information was reported to be ongoing and varied, and meeting it required a variety of sources and formats. Key needs for patients and carers mentioned in the studies include information on financial aids and entitlements early on, and continued access to supportive professionals and specialists.
What Do These Findings Mean?
Qualitative studies to date on how patients and carers respond to a diagnosis of dementia provide a fairly detailed picture of their experiences. The summary provided here should help professionals to understand better the challenges patients and carers face around the time of diagnosis as well as their immediate and evolving needs. The results also suggest that future research should focus on the development and evaluation of ways to meet those needs.
Additional Information
Please access these websites via the online version of this summary at
Wikipedia has pages on dementia and qualitative research (note that Wikipedia is a free online encyclopedia that anyone can edit)
Alzheimer Europe, an umbrella organization of 34 Alzheimer associations from 30 countries across Europe, has a page on the different approaches to research
The UK Department of Health has pages on dementia, including guidelines for carers of people with dementia
MedlinePlus also has information about dementia
PMCID: PMC3484131  PMID: 23118618
11.  The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia 
BMC Geriatrics  2012;12:2.
Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers such as a lack of resources impede the implementation of activities in aged care facilities. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care.
We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will be randomly assigned by facility to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive symptoms, and a better quality of life than carers in the waiting list condition.
We hypothesise that training family carers to deliver personalised activities to their relatives in a residential setting will make visits more satisfying and may consequently improve the quality of life for carers and their relatives. These beneficial effects might also reduce nursing staff burden and thus impact positively on residential facilities.
Trial Registration
Australian New Zealand Clinical Trials Registry - ACTRN12611000998943
PMCID: PMC3268081  PMID: 22236064
12.  The impact on carers of individuals with social care needs: the Whole Systems Demonstrator study 
Carers of individuals with social care needs (including frail elderly people, those at risk of falls and those requiring night sitting), are subject to high levels of carer burden, social isolation and poor psychological outcomes. Carers’ worries and concerns include leaving the individual alone; risks of harm to the care-recipient; or household emergencies in their absence. At present there is a lack of research on the impact of telecare interventions on carer outcomes. It is feasible that carers’ anxieties and level of strain may be ameliorated with concomitant increases in quality of life, with the introduction of telecare systems for their care-recipient.
This study investigates the secondary impact of telecare on carers, specifically whether the use of telecare reduces informal carer burden and social isolation and whether it improves carers’ psychological well-being and confidence in leaving the care-recipient alone.
We report on the prospective analysis of a pragmatic controlled trial on carers of telecare users and controls within the WSD evaluation of telecare (a pragmatic cluster randomised controlled trial investigating the effectiveness of telecare for social care recipients).
Carers of individuals with social care needs were identified and recruited to the study via a combination of snowball sampling, light touch visits (to users) and self selection. Over 200 carers completed a questionnaire pack at baseline, and at short and long-term follow-ups; with roughly equal numbers of carers of recipients of telecare and recipients of usual care. The questionnaire pack included measures of quality of life (ICECAP), health related quality of life (SF12, EQ5D), psychosocial well-being (STAI-6, CESD10) and care-giver strain measures (CGSI, Carer confidence and anxiety).
Results and Conclusions
Multi-level modelling of difference in outcomes between carer groups and across time was conducted with appropriate covariates. Specific findings from the Telecare Carers Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571154
carers; telecare; quality of life; carer outcomes; social care needs
13.  Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial 
Trials  2013;14:434.
Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention (‘Coach2Move’) delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined.
The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified ‘get up and go’ test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs.
Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating factor in evaluating a new approach is that it may not be automatically adopted by clinicians. Specific actions are undertaken to optimize implementation of the Coach2Move strategy during the trial. Whether or not these will be sufficient is a matter we will consider subsequently, using quality indicators and process analysis.
Trial Registration
The Netherlands National Trial Register: NTR3527.
PMCID: PMC3878551  PMID: 24345073
Physiotherapy; Frailty; Physical activity; Mobility
14.  Protocol for a randomised controlled trial of an outreach support program for family carers of older people discharged from hospital 
BMC Geriatrics  2015;15:70.
Presentations to hospital of older people receiving family care at home incur substantial costs for patients, families, and the health care system, yet there can be positive carer outcomes when systematically assessing/addressing their support needs, and reductions in older people’s returns to hospital attributed to appropriate discharge planning. This study will trial the Further Enabling Care at Home program, a 2-week telephone outreach initiative for family carers of older people returning home from hospital. Hypotheses are that the program will (a) better prepare families to sustain their caregiving role and (b) reduce patients' re-presentations/readmissions to hospital, and/or their length of stay; also that reduced health system costs attributable to the program will outweigh costs of its implementation.
In this randomised controlled trial, family carers of older patients aged 70+ discharged from a Medical Assessment Unit in a Western Australian tertiary hospital, plus the patients themselves, will be recruited at discharge (N = 180 dyads). Carers will be randomly assigned (block allocation, assessors blinded) to receive usual care (control) or the new program (intervention). The primary outcome is the carer’s self-reported preparedness for caregiving (Preparedness for Caregiving Scale administered within 4 days of discharge, 2–3 weeks post-discharge, 6 weeks post-discharge). To detect a clinically meaningful change of two points with 80 % power, 126 carers need to complete the study. Patients’ returns to hospital and subsequent length of stay will be ascertained for a minimum of 3 months after the index admission. Regression analyses will be used to determine differences in carer and patient outcomes over time associated with the group (intervention or control). Data will be analysed using an Intention to Treat approach. A qualitative exploration will examine patients’ and their family carers’ experiences of the new program (interviews) and explore the hospital staff’s perceptions (focus groups). Process evaluation will identify barriers to, and facilitators of, program implementation. A comprehensive economic evaluation will determine cost consequences.
This study investigates a novel approach to identifying and addressing family carers’ needs following discharge from hospital of the older person receiving care. If successful, the program has potential to be incorporated into routine post-discharge support.
Trial registration
Australian and New Zealand Clinical Trial Registry: ACTRN12614001174673.
PMCID: PMC4479237  PMID: 26108207
15.  The Effectiveness of Mobile-Health Technologies to Improve Health Care Service Delivery Processes: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(1):e1001363.
Caroline Free and colleagues systematically review controlled trials of mobile technology interventions to improve health care delivery processes and show that current interventions give only modest benefits and that high-quality trials measuring clinical outcomes are needed.
Mobile health interventions could have beneficial effects on health care delivery processes. We aimed to conduct a systematic review of controlled trials of mobile technology interventions to improve health care delivery processes.
Methods and Findings
We searched for all controlled trials of mobile technology based health interventions using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990–Sept 2010). Two authors independently extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and we used random effects meta-analysis to give pooled estimates.
We identified 42 trials. None of the trials had low risk of bias. Seven trials of health care provider support reported 25 outcomes regarding appropriate disease management, of which 11 showed statistically significant benefits. One trial reported a statistically significant improvement in nurse/surgeon communication using mobile phones. Two trials reported statistically significant reductions in correct diagnoses using mobile technology photos compared to gold standard. The pooled effect on appointment attendance using text message (short message service or SMS) reminders versus no reminder was increased, with a relative risk (RR) of 1.06 (95% CI 1.05–1.07, I2 = 6%). The pooled effects on the number of cancelled appointments was not significantly increased RR 1.08 (95% CI 0.89–1.30). There was no difference in attendance using SMS reminders versus other reminders (RR 0.98, 95% CI 0.94–1.02, respectively). To address the limitation of the older search, we also reviewed more recent literature.
The results for health care provider support interventions on diagnosis and management outcomes are generally consistent with modest benefits. Trials using mobile technology-based photos reported reductions in correct diagnoses when compared to the gold standard. SMS appointment reminders have modest benefits and may be appropriate for implementation. High quality trials measuring clinical outcomes are needed.
Please see later in the article for the Editors' Summary
Editors’ Summary
Over the past few decades, computing and communication technologies have changed dramatically. Bulky, slow computers have been replaced by portable devices that can complete increasingly complex tasks in less and less time. Similarly, landlines have been replaced by mobile phones and other mobile communication technologies that can connect people anytime and anywhere, and that can transmit text messages (short message service; SMS), photographs, and data at the touch of a button. These advances have led to the development of mobile-health (mHealth)—the use of mobile computing and communication technologies in health care and public health. mHealth has many applications. It can be used to facilitate data collection and to encourage health-care consumers to adopt healthy lifestyles or to self-manage chronic conditions. It can also be used to improve health-care service delivery processes by targeting health-care providers or communication between these providers and their patients. So, for example, mobile technologies can be used to provide clinical management support in settings where there are no specialist clinicians, and they can be used to send patients test results and timely reminders of appointments.
Why Was This Study Done?
Many experts believe that mHealth interventions could greatly improve health-care delivery processes, particularly in resource-poor settings. The results of several controlled trials (studies that compare the outcomes of people who do or do not receive an intervention) of mHealth interventions designed to improve health-care delivery processes have been published. However, these data have not been comprehensively reviewed, and the effectiveness of this type of mHealth intervention has not been quantified. Here, the researchers rectify this situation by undertaking a systematic review and meta-analysis of controlled trials of mobile technology-based interventions designed to improve health-care service delivery processes. A systematic review is a study that uses predefined criteria to identify all the research on a given topic; a meta-analysis is a statistical approach that is used to pool the results of several independent studies.
What Did the Researchers Do and Find?
The researchers identified 42 controlled trials that investigated mobile technology-based interventions designed to improve health-care service delivery processes. None of the trials were of high quality—many had methodological problems likely to affect the accuracy of their findings—and nearly all were undertaken in high-income countries. Thirty-two of the trials tested interventions directed at health-care providers. Of these trials, seven investigated interventions providing health-care provider education, 18 investigated interventions supporting clinical diagnosis and treatment, and seven investigated interventions to facilitate communication between health-care providers. Several of the trials reported that the tested intervention led to statistically significant improvements (improvements unlikely to have happened by chance) in outcomes related to disease management. However, two trials that used mobile phones to transmit photos to off-site clinicians for diagnosis reported significant reductions in correct diagnoses compared to diagnosis by an on-site specialist. Ten of the 42 trials investigated interventions targeting communication between health-care providers and patients. Eight of these trials investigated SMS-based appointment reminders. Meta-analyses of the results of these trials indicated that using SMS appointment reminders significantly but modestly increased patient attendance compared to no reminders. However, SMS reminders were no more effective than postal or phone call reminders, and texting reminders to patients who persistently missed appointments did not significantly change the number of cancelled appointments.
What Do These Findings Mean?
These findings indicate that some mHealth interventions designed to improve health-care service delivery processes are modestly effective, but they also highlight the need for more trials of these interventions. Specifically, these findings show that although some interventions designed to provide support for health-care providers modestly improved some aspects of clinical diagnosis and management, other interventions had deleterious effects—most notably, the use of mobile technology–based photos for diagnosis. In terms of mHealth interventions targeting communication between health-care providers and patients, the finding that SMS appointment reminders have modest benefits suggests that implementation of this intervention should be considered, at least in high-income settings. However, the researchers stress that more trials are needed to robustly establish the ability of mobile technology-based interventions to improve health-care delivery processes. These trials need to be of high quality, they should be undertaken in resource-limited settings as well as in high-income countries, and, ideally, they should consider interventions that combine mHealth and conventional approaches.
Additional Information
Please access these Web sites via the online version of this summary at
A related PLOS Medicine Research Article by Free et al. investigates the effectiveness of mHealth technology-based health behavior change and disease management interventions for health-care consumers
Wikipedia has a page on mHealth (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
mHealth: New horizons for health through mobile technologies is a global survey of mHealth prepared by the World Health Organization’s Global Observatory for eHealth (eHealth is health-care practice supported by electronic processes and communication)
The mHealth in Low-Resource Settings website, which is maintained by the Netherlands Royal Tropical Institute, provides information on the current use, potential, and limitations of mHealth in low-resource settings
The US National Institutes of Health Fogarty International Center provides links to resources and information about mHealth
PMCID: PMC3566926  PMID: 23458994
16.  Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial 
Trials  2013;14:337.
The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades. Improving the self-management skills of patients is a strategy to steer against this burden. This could lead to better outcomes and lower healthcare costs. Health coaching is one method for enhancing the self-management of patients and can be delivered by phone. The effects of telephone-based health coaching are promising, but still inconclusive. Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare. Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany.
The study is a prospective randomized controlled trial comparing the effects of telephone-based health coaching with usual care during a 4-year time period. Data are collected at baseline and after 12, 24 and 36 months. Patients are selected based on one of the following chronic conditions: diabetes, coronary artery disease, asthma, hypertension, heart failure, COPD, chronic depression or schizophrenia. The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance. The frequency and the topics of the health coaching are manual-based but tailored to the patients’ needs and medical condition, following the concepts of motivational interviewing, shared decision-making and evidence-based-medicine. Approximately 12,000 insurants will be enrolled and randomized into intervention and control groups. Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching, assessed by routine data. Secondary outcomes are patient-reported outcomes like changes in quality of life, depression and anxiety and clinical values assessed with questionnaires. Additional secondary outcomes are further economic evaluations like health service use as well as costs and hospital readmission rates. The statistical analyses includes intention-to-treat and as-treated principles. The recruitment will be completed in September 2014.
This study will provide evidence regarding economic and clinical effects of telephone-delivered health coaching. Additionally, this study will show whether health coaching is an adequate option for the German healthcare system to address the growing burden of chronic diseases.
Trial registration
German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00000584.
PMCID: PMC4016132  PMID: 24135027
Chronic conditions; Health coaching; Telephone-based; Economic evaluation; Routine data
17.  Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart'): study protocol. Secondary prevention program for myocardial infarction patients 
Coronary heart disease (CHD) is a significant cause of health and economic burden. Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient, provider, health system and societal-level barriers. As such, there is a need to develop innovative secondary prevention programs to address the treatment gap. Telephone-delivered care is convenient, flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction (MI). This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients (ProActive Heart).
550 adult MI patients have been recruited over a 14 month period (December 2007 to January 2009) through two Brisbane metropolitan hospitals, and randomised to an intervention or control group (n = 225 per group). The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ('health coaches') during up to 10 × 30 minute scripted telephone health coaching sessions. Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions. The intervention focuses on appropriate modification of CHD risk factors, compliance with pharmacological management, and management of psychosocial issues. Data collection occurs at baseline or prior to commencement of the intervention (Time 1), six months follow-up or the completion of the intervention (Time 2), and at 12 months follow-up for longer term outcomes (Time 3). Primary outcome measures include quality of life (Short Form-36) and physical activity (Active Australia Survey). A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.
The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients.
Trial Registration Number
PMCID: PMC2689849  PMID: 19426524
18.  Community-Based Care for the Management of Type 2 Diabetes 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site,,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
The objective of this report is to determine the efficacy of specialized multidisciplinary community care for the management of type 2 diabetes compared to usual care.
Clinical Need: Target Population and Condition
Diabetes (i.e. diabetes mellitus) is a highly prevalent chronic metabolic disorder that interferes with the body’s ability to produce or effectively use insulin. The majority (90%) of diabetes patients have type 2 diabetes. (1) Based on the United Kingdom Prospective Diabetes Study (UKPDS), intensive blood glucose and blood pressure control significantly reduce the risk of microvascular and macrovascular complications in type 2 diabetics. While many studies have documented that patients often do not meet the glycemic control targets specified by national and international guidelines, factors associated with glycemic control are less well studied, one of which is the provider(s) of care.
Multidisciplinary approaches to care may be particularly important for diabetes management. According guidelines from the Canadian Diabetes Association (CDA), the diabetes health care team should be multi-and interdisciplinary. Presently in Ontario, the core diabetes health care team consists of at least a family physician and/or diabetes specialist, and diabetes educators (registered nurse and registered dietician).
Increasing the role played by allied health care professionals in diabetes care and their collaboration with physicians may represent a more cost-effective option for diabetes management. Several systematic reviews and meta-analyses have examined multidisciplinary care programs, but these have either been limited to a specific component of multidisciplinary care (e.g. intensified education programs), or were conducted as part of a broader disease management program, of which not all were multidisciplinary in nature. Most reviews also do not clearly define the intervention(s) of interest, making the evaluation of such multidisciplinary community programs challenging.
Evidence-Based Analysis Methods
Research Questions
What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a registered nurse, registered dietician and physician (primary care and/or specialist) for the management of type 2 diabetes compared to usual care? [Henceforth referred to as Model 1]
What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a pharmacist and a primary care physician for the management of type 2 diabetes compared to usual care? [Henceforth referred to as Model 2]
Inclusion Criteria
English language full-reports
Published between January 1, 2000 and September 28, 2008
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Type 2 diabetic adult population (≥18 years of age)
Total sample size ≥30
Describe specialized multidisciplinary community care defined as ambulatory-based care provided by at least two health care disciplines (of which at least one must be a specialist in diabetes) with integrated communication between the care providers.
Compared to usual care (defined as health care provision by non-specialist(s) in diabetes, such as primary care providers; may include referral to other health care professionals/services as necessary)
≥6 months follow-up
Exclusion Criteria
Studies where discrete results on diabetes cannot be abstracted
Predominantly home-based interventions
Inpatient-based interventions
Outcomes of Interest
The primary outcomes for this review were glycosylated hemoglobin (rHbA1c) levels and systolic blood pressure (SBP).
Search Strategy
A literature search was performed on September 28, 2008 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 1, 2000 and September 28, 2008. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Given the high clinical heterogeneity of the articles that met the inclusion criteria, specific models of specialized multidisciplinary community care were examined based on models of care that are currently being supported in Ontario, models of care that were commonly reported in the literature, as well as suggestions from an Expert Advisory Panel Meeting held on January 21, 2009.
Summary of Findings
The initial search yielded 2,116 unique citations, from which 22 RCTs trials and nine systematic reviews published were identified as meeting the eligibility criteria. Of these, five studies focused on care provided by at least a nurse, dietician, and physician (primary care and/or specialist) model of care (Model 1; see Table ES 1), while three studies focused on care provided by at least a pharmacist and primary care physician (Model 2; see Table ES 2).
Based on moderate quality evidence, specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinically significant reduction in HbA1c of 1.0% compared with usual care. The effects of this model on SBP, however, are uncertain compared with usual care, based on very-low quality evidence. Specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinically significant reduction in both HbA1c of 1.05% (based on high quality evidence) and SBP of 7.13 mm Hg (based on moderate quality evidence) compared to usual care. For both models, the evidence does not suggest a preferred setting of care delivery (i.e., primary care vs. hospital outpatient clinic vs. community clinic).
Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 1
Mean change from baseline to follow-up between intervention and control groups
Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 2
Mean change from baseline to follow-up between intervention and control groups
PMCID: PMC3377524  PMID: 23074528
19.  A systematic review of psychosocial interventions for family carers of palliative care patients 
BMC Palliative Care  2010;9:17.
Being a family carer to a patient nearing the end of their life is a challenging and confronting experience. Studies show that caregiving can have negative consequences on the health of family carers including fatigue, sleep problems, depression, anxiety and burnout. One of the goals of palliative care is to provide psychosocial support to patients and families facing terminal illness. A systematic review of interventions for family carers of cancer and palliative care patients conducted at the start of this millennium demonstrated that there was a dearth of rigorous inquiry on this topic and consequently limited knowledge regarding the types of interventions likely to be effective in meeting the complex needs of family carers. We wanted to discern whether or not the evidence base to support family carers has improved. Furthermore, undertaking this review was acknowledged as one of the priorities for the International Palliative Care Family Carer Research Collaboration
A systematic review was undertaken in order to identify developments in family carer support that have occurred over the last decade. The focus of the review was on interventions that targeted improvements in the psychosocial support of family carers of palliative care patients. Studies were graded to assess their quality.
A total of fourteen studies met the inclusion criteria. The focus of interventions included psycho-education, psychosocial support, carer coping, symptom management, sleep promotion and family meetings. Five studies were randomised controlled trials, three of which met the criteria for the highest quality evidence. There were two prospective studies, five pre-test/post-test projects and two qualitative studies.
The systematic review identified a slight increase in the quality and quantity of psychosocial interventions conducted for family carers in the last decade. More rigorous intervention research is required in order to meet the supportive care needs of family carers of palliative care patients.
PMCID: PMC2924287  PMID: 20687960
20.  Encouraging patients and family caregivers to assert a more active role during care hand-offs: The Care Transitions Intervention™ 
What is the model
During a 4-week program, patients with complex care needs and family caregivers receive specific tools and work with a ‘Transitions Coach,’ to learn self-management skills that will ensure their needs are met during the transition from hospital to home. This is a low-cost, low-intensity intervention comprised of a home visit and three phone calls.
What makes this model unique
In contrast to traditional case management approaches, the Care Transitions Intervention is a self-management model. The Care Transitions Program has modeled national Medicare data sets to demonstrate the frequency with which older adults making care transitions across settings will experience another transition in the near future. In other words, for most of these individuals, there will be a ‘next time’. Using qualitative techniques, the Care Transitions Program worked with older adults to identify the key self-management skills needed to assert a more active role in their care. Next, a Transition Coach was introduced to help impart these skills and help the individual and the family caregiver become more confident in this new role. Although critics are quick to point out that this is only applicable to highly educated or motivated patients, our studies have shown that most patients and family caregivers are able to become engaged and do considerably more for themselves.
In essence, the model involves making an investment in helping patients and family caregivers become more comfortable and competent in participating in their care during care transitions. Five months after the Transition Coach signed off, these patients continued to remain out of the hospital demonstrating a sustained effect from coaching.
The intervention focuses on four conceptual domains referred to as pillars
1. Medication self-management
2. Use of a dynamic patient-centered record, the personal health record
3. Timely primary care/specialty care follow-up
4. Knowledge of red flags that indicate a worsening in their condition and how to respond
What are the key findings
Patients who received this program were significantly less likely to be readmitted to the hospital, and the benefits were sustained for five months after the end of the one-month intervention. Thus, rather than simply managing post-hospital care in a reactive manner, imparting self-management skills pays dividends long after the program ends. Anticipated net cost savings for a typical coach panel of 350 chronically ill adults with an initial hospitalization over 12 months is USD$ 295,594. Patients who received this program were also more likely to achieve self-identified personal goals around symptom management and functional recovery. To date more than 160 organizations have adopted the care transitions intervention.
Project sponsors
The John A. Hartford Foundation and The Robert Wood Johnson Foundation
Where Can I Learn More?
Please visit or email:
PMCID: PMC2807117
care transitions
21.  Cost-effectiveness of a coronary heart disease secondary prevention program in patients with myocardial infarction: results from a randomised controlled trial (ProActive Heart) 
Participation in coronary heart disease (CHD) secondary prevention programs is low. Telephone-delivered CHD secondary prevention programs may overcome the treatment gap. The telephone-based health coaching ProActive Heart trial intervention has previously been shown to be effective for improving health-related quality of life, physical activity, body mass index, diet, alcohol intake and anxiety. As a secondary aim, the current study evaluated the cost-effectiveness of the ProActive Heart intervention compared to usual care.
430 adult myocardial infarction patients were randomised to a six-month CHD secondary prevention ‘health coaching’ intervention or ‘usual care’ control group. Primary outcome variables were health-related quality of life (SF-36) and physical activity (Active Australia Survey). Data were collected at baseline, six-months (post-intervention) and 12 months (six-months post-intervention completion) for longer term effects. Cost-effectiveness data [health utility (SF-6D) and health care utilisation] were collected using self-reported (general practitioner, specialist, other health professionals, health services, and medication) and claims data (hospitalisation rates). Intervention effects are presented as mean differences (95% CI), p-value.
Improvements in health status (SF-6D) were observed in both groups, with no significant difference between the groups at six [0.012 (-0.016, 0.041), p = 0.372] or 12 months [0.011 (-0.028, 0.051) p = 0.738]. Patients in the health coaching group were significantly more likely to be admitted to hospital due to causes unrelated to cardiovascular disease (p = 0.042). The overall cost for the health coaching group was higher ($10,574 vs. $8,534, p = 0.021), mainly due to higher hospitalisation (both CHD and non-CHD) costs ($6,841 vs. $4,984, p = 0.036). The incremental cost-effectiveness ratio was $85,423 per QALY.
There was no intervention effect measured using the SF-36/SF-6D and ProActive Heart resulted in significantly increased costs. The cost per QALY gained from ProActive Heart was high and above acceptable limits compared to usual care.
PMCID: PMC3646683  PMID: 23634982
22.  A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial 
Trials  2014;15:124.
Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.
A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the ‘teach-back’ method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients’ physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.
BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.
Trial registration # NCT01360203.
PMCID: PMC3990010  PMID: 24725308
Heart failure; Telemonitoring; Nurse coaching; Readmission; Care coordination; Self-care
23.  Effectiveness of enhanced communication therapy in the first four months after stroke for aphasia and dysarthria: a randomised controlled trial 
Objective To assess the effectiveness of enhanced communication therapy in the first four months after stroke compared with an attention control (unstructured social contact).
Design Externally randomised, pragmatic, parallel, superiority trial with blinded outcome assessment.
Setting Twelve UK hospital and community stroke services.
Participants 170 adults (mean age 70 years) randomised within two weeks of admission to hospital with stroke (December 2006 to January 2010) whom speech and language therapists deemed eligible, and 135 carers.
Interventions Enhanced, agreed best practice, communication therapy specific to aphasia or dysarthria, offered by speech and language therapists according to participants’ needs for up to four months, with continuity from hospital to community. Comparison was with similarly resourced social contact (without communication therapy) from employed visitors.
Outcome measures Primary outcome was blinded, functional communicative ability at six months on the Therapy Outcome Measure (TOM) activity subscale. Secondary outcomes (unblinded, six months): participants’ perceptions on the Communication Outcomes After Stroke scale (COAST); carers’ perceptions of participants from part of the Carer COAST; carers’ wellbeing on Carers of Older People in Europe Index and quality of life items from Carer COAST; and serious adverse events.
Results Therapist and visitor contact both had good uptake from service users. An average 22 contacts (intervention or control) over 13 weeks were accepted by users. Impairment focused therapy was the approach most often used by the speech and language therapists. Visitors most often provided general conversation. In total, 81/85 of the intervention group and 72/85 of the control group completed the primary outcome measure. Both groups improved on the TOM activity subscale. The estimated six months group difference was not statistically significant, with 0.25 (95% CI –0.19 to 0.69) points in favour of therapy. Sensitivity analyses that adjusted for chance baseline imbalance further reduced this difference. Per protocol analyses rejected a possible dilution of treatment effect from controls declining their allocation and receiving usual care. There was no added benefit of therapy on secondary outcome measures, subgroup analyses (such as aphasia), or serious adverse events, although the latter were less common after intervention (odds ratio 0.42 (95% CI 0.16 to 1.1)).
Conclusions Communication therapy had no added benefit beyond that from everyday communication in the first four months after stroke. Future research should evaluate reorganised services that support functional communication practice early in the stroke pathway.
This project was funded by the NIHR Health Technology Assessment programme (project No 02/11/04) and is published in full in Health Technology Assessment 2012;16(26):1-160.
Trial registration ISRCTN78617680
PMCID: PMC3396461  PMID: 22797843
24.  Qualitative process evaluation of a problem-solving guided self-help manual for family carers of young people with first-episode psychosis 
BMC Psychiatry  2014;14:168.
Caring for a young person experiencing first-episode psychosis is challenging and can affect carers’ well-being adversely. While some face-to-face approaches have achieved promising outcomes, they are costly and resource-intensive to provide, restricting their reach and penetration. Guided self-help in book-form (or bibliotherapy) is an alternative but untested approach in these circumstances. In this study, we aimed to evaluate carers’ beliefs about the usefulness of problem-solving guided self-help manual for primary carers of young people with first-episode psychosis.
A qualitative process evaluation nested in a randomised controlled trial, conducted across two early intervention psychosis services in Melbourne, Australia. 124 carers were randomised to problem-solving guided self-help intervention or treatment as usual. We also undertook a qualitative process evaluation, using individual interviews, with a random sample of 24 of the intervention group. A thematic analysis of the qualitative data was undertaken, which is the subject of this paper. Interviews were conducted between January 2009 and September 2010.
Three themes were abstracted from the data, reflecting carers’ beliefs about the usefulness of the manual: promoting carers’ well-being, increasing carers’ understanding of and support for the young person with first-episode psychosis, and accessibility and delivery modes of the programme.
This process evaluation highlights that guided self-help is useful in informing and supporting carers of affected young people. While there is scope for broadening the delivery modes, the approach is easy to use and accessible, and can be used as a cost-effective adjunct to standard support provided to carers, by community mental health nurses and other clinicians.
Trial registration
PMCID: PMC4064108  PMID: 24906392
Bibliotherapy; Clinicians; First-episode psychosis; Guided self-help; Nurses; Primary carers; Problem-solving; Process evaluation; Qualitative research; Randomised controlled trial; Self-help manual
25.  Palliative care in advanced dementia; A mixed methods approach for the development of a complex intervention 
There is increasing interest in improving the quality of care that patients with advanced dementia receive when they are dying. Our understanding of the palliative care needs of these patients and the natural history of advanced disease is limited. Many people with advanced dementia have unplanned emergency admissions to the acute hospital; this is a critical event: half will die within 6 months. These patients have complex needs but often lack capacity to express their wishes. Often carers are expected to make decisions. Advance care planning discussions are rarely performed, despite potential benefits such more consistent supportive healthcare, a reduction in emergency admissions to the acute hospital and better resolution of carer bereavement.
We have used the MRC complex interventions framework, a "bottom-up" methodology, to develop an intervention for patients with advanced dementia and their carers aiming to 1) define end of life care needs for both patients and carers, 2) pilot a palliative care intervention and 3) produce a framework for advance care planning for patients.
The results of qualitative phase 1 work, which involved interviews with carers, hospital and primary care staff from a range of disciplines, have been used to identify key barriers and challenges. For the exploratory trial, 40 patients will be recruited to each of the control and intervention groups. The intervention will be delivered by a nurse specialist. We shall investigate and develop methodology for a phase 3 randomised controlled trial. For example we shall explore the feasibility of randomisation, how best to optimise recruitment, decide on appropriate outcomes and obtain data for power calculations. We will evaluate whether the intervention is pragmatic, feasible and deliverable on acute hospital wards and test model fidelity and its acceptability to carers, patients and staff.
Results of qualitative phase 1 work suggested that carers and staff were keen to discuss these issues and guided the development of the intervention and choice of outcomes. This will be vital in moving to a phase III trial that is pragmatic and feasible for these complex patients within the NHS
Trial registration
PMCID: PMC2475530  PMID: 18620567

Results 1-25 (1236043)