In the UK, the use of care planning and written care plans has been proposed to improve the management of long-term conditions, yet there is limited evidence concerning their uptake and benefits.
To explore the implementation of care plans and care planning in the UK and associations with the process and outcome of care.
Design and setting
A controlled prospective cohort study among two groups of patients with long-term conditions who were similar in demographic and clinical characteristics, but who were registered with general practices varying in their implementation of care plans and care planning.
Implementation of care plans and care planning in general practice was assessed using the 2009–2010 GP Patient Survey, and relationships with patient outcomes (self-management and vitality) were examined using multilevel, mixed effects linear regression modelling.
The study recruited 38 practices and 2439 patients. Practices in the two groups (high and low users of written documents) were similar in structural and population characteristics. Patients in the two groups of practices were similar in demographics and baseline health. Patients did demonstrate significant differences in reported experiences of care planning, although the differences were modest. Very few patients in the cohort reported a written plan that could be confirmed. Analysis of outcomes suggested that most patients show limited change over time in vitality and self-management. Variation in the use of care plans at the practice level was very limited and not related to patient outcomes over time.
The use of written care plans in patients with long-term conditions is uncommon and unlikely to explain a substantive amount of variation in the process and outcome of care. More proactive efforts at implementation may be required to provide a rigorous test of the potential of care plans and care planning.
care plans; care planning; general practice; long-term conditions; UK
Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their own care, there is substantial empirical evidence that the majority of users are not fully involved in the care planning process. Our aim is to evaluate the effectiveness and cost-effectiveness of training for mental health professionals in improving user involvement with the care planning processes.
This is a cluster randomised controlled trial of community mental health teams in NHS Trusts in England allocated either to a training intervention to improve user and carer involvement in care planning or control (no training and care planning as usual).
We will evaluate the effectiveness of the training intervention using a mixed design, including a ‘cluster cohort’ sample, a ‘cluster cross-sectional’ sample and process evaluation. Service users will be recruited from the caseloads of care co-ordinators.
The primary outcome will be change in self-reported involvement in care planning as measured by the validated Health Care Climate Questionnaire. Secondary outcomes include involvement in care planning, satisfaction with services, medication side-effects, recovery and hope, mental health symptoms, alliance/engagement, well-being and quality of life. Cost- effectiveness will also be measured. A process evaluation informed by implementation theory will be undertaken to assess the extent to which the training was implemented and to gauge sustainability beyond the time-frame of the trial.
It is hoped that the trial will generate data to inform mental health care policy and practice on care planning.
Trial Registration Number
ISRCTN16488358 (14 May 2014)
Care planning; Severe mental illness; Service user involvement
Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions.
The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD).
In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61).
Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population.
Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012
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Recruitment; Patient information; Research methodology; Randomised controlled trial; Primary care
An ageing population with multimorbidity is putting pressure on health systems. A popular method of managing this pressure is identification of patients in primary care ‘at-risk’ of hospitalisation, and delivering case management to improve outcomes and avoid admissions. However, the effectiveness of this model has not been subjected to rigorous quantitative synthesis.
Methods and Findings
We carried out a systematic review and meta-analysis of the effectiveness of case management for ‘at-risk’ patients in primary care. Six bibliographic databases were searched using terms for ‘case management’, ‘primary care’, and a methodology filter (Cochrane EPOC group). Effectiveness compared to usual care was measured across a number of relevant outcomes: Health – self-assessed health status, mortality; Cost – total cost of care, healthcare utilisation (primary and non-specialist care and secondary care separately), and; Satisfaction – patient satisfaction. We conducted secondary subgroup analyses to assess whether effectiveness was moderated by the particular model of case management, context, and study design. A total of 15,327 titles and abstracts were screened, 36 unique studies were included. Meta-analyses showed no significant differences in total cost, mortality, utilisation of primary or secondary care. A very small significant effect favouring case management was found for self-reported health status in the short-term (0.07, 95% CI 0.00 to 0.14). A small significant effect favouring case management was found for patient satisfaction in the short- (0.26, 0.16 to 0.36) and long-term (0.35, 0.04 to 0.66). Secondary subgroup analyses suggested the effectiveness of case management may be increased when delivered by a multidisciplinary team, when a social worker was involved, and when delivered in a setting rated as low in initial ‘strength’ of primary care.
This was the first meta-analytic review which examined the effects of case management on a wide range of outcomes and considered also the effects of key moderators. Current results do not support case management as an effective model, especially concerning reduction of secondary care use or total costs. We consider reasons for lack of effect and highlight key research questions for the future.
The review protocol is available as part of the PROSPERO database (registration number: CRD42014010824).
A limitation of service delivery in primary care in the United Kingdom is that services are often organised to manage discrete long-term conditions, using guidelines related to single conditions, and managed in clinics organised around single conditions. However, many older patients have more than one condition (so called multimorbidity). Qualitative research suggests that these patients experience ‘hassles’ in their care, including multiple appointments, poor co-ordination, and conflicting recommendations. However, there is limited quantitative evidence on the ‘hassles’ that patients with multimorbidity experience, or factors predicting ‘hassles’ in patients with multimorbidity.
We conducted a cross sectional study, mailing questionnaires to 1460 patients with multimorbidity identified from the disease registers of four general practices in the UK. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery. Data were analysed using regression modelling to assess the factors predicting ‘hassles’ in patients with multimorbidity.
In total 33 % (n = 486) of patients responded to the baseline survey. The ‘hassles’ most often reported by patients related to lack of information about conditions and treatment options, poor communication among health professionals, and poor access to specialist care. There was a significant relationship between numbers of conditions, and reports of ‘hassles’. In multivariate analysis, 5 variables predicted more ‘hassles’: more long-term conditions, symptoms of anxiety and depression, younger age, being in paid employment, and not having a discussion with their GP in the last 12 months.
Hassles are frequently reported by patients with multimorbidity in primary care. A priority for future research should be on the development of new models of care that better cater for these patients. This research highlights core hassles that need to be addressed, and the patient groups that are most at risk, which may aid in the design of these new models.
Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge (www.trialforge.org) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.
This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants’ views on the processes in the life of a randomised trial that should be covered by Trial Forge.
General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a ‘go to’ website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.
Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.
Randomised controlled trials; methodology; efficiency; research waste
The ethnic minority population in developed countries is increasing over time. These groups are at higher risk of mental illness and demonstrate lower participation in research. Published evidence suggests that multiple factors like stigma, lack of trust, differences in explanatory models, logistical issues and lack of culturally aware researchers act as barriers to ethnic minority recruitment into mental health research. To reduce inequalities in participation, there is a need to devise innovative and culturally sensitive recruitment strategies. It is important that researchers share their experience of employing these strategies so that ethnic minority participation can be facilitated.
We previously published a systematic review of barriers to recruiting ethnic minority participants into mental health research. The nine papers included in our prior review formed the basis for developing a typology of barriers to recruiting ethnic minorities into mental health research. This typology identified 33 barriers, described under five themes. We further extracted data on the strategies used to overcome these recruitment barriers, as described in the included studies.
The strategies employed by the authors could be matched to all but two barriers (psychopathology/substance misuse and limited resource availability). There was evidence that multiple strategies were employed, and that these depended upon the population, clinical set-up and resources available.
This typology of strategies to overcome barriers to recruiting ethnic minorities provides guidance on achieving higher rates of recruitment. It is important that researchers plan to deploy these strategies well in advance of initiating recruitment. Whilst adopting these strategies, the authors have not been able to quantify the positive impact of these strategies on recruitment. The typology should encourage researchers to employ these strategies in future research, refine them further and quantitatively evaluate their impact.
To assess the effectiveness of self-management support interventions in men with long-term conditions.
A quantitative systematic review with meta-analysis.
The Cochrane Database of Systematic Reviews was searched to identify published reviews of self-management support interventions. Relevant reviews were screened to identify randomised controlled trials (RCTs) of self-management support interventions conducted in men alone, or which analysed the effects of interventions by sex.
Data on relevant outcomes, patient populations, intervention type and study quality were extracted. Quality appraisal was conducted using the Cochrane Risk of Bias Tool. Meta-analysis was conducted to compare the effects of interventions in men, women, and mixed-sex sub-groups.
40 RCTs of self-management support interventions in men, and 20 eligible RCTs where an analysis by sex was reported, were included in the review. Meta-analysis suggested that physical activity, education, and peer support-based interventions have a positive impact on quality of life in men. However, there is currently insufficient evidence to make strong statements about whether self-management support interventions show larger, similar or smaller effects in men compared with women and mixed-sex groups.
Clinicians may wish to consider whether certain types of self-management support (eg, physical activity, education, peer support) are particularly effective in men, although more research is needed to fully determine and explore this.
PRIMARY CARE; PUBLIC HEALTH
Poor adherence to prescribed medication has major consequences. Managing multiple long-term conditions often involves polypharmacy, potentially increasing complexity and the possibility of poor adherence. As a result of the globally recognised problems in supporting adherence to medication, some researchers have proposed the use of reminder charts. The main aim of the research was to explore the need for and perceptions around the ‘Universal Medication Schedule’ (UMS). Looking at ways in which pharmacists and General Practitioners (GPs) could use the UMS in NHS settings.
Semi-structured interviews were carried out with 10 GPs, 10 community pharmacists and 15 patients. Patients were aged 65 years and over, had multiple long-term conditions and were prescribed at least 5 medications. Interviews were recorded and transcribed and thematic analysis was conducted, using a framework approach to manage the data.
Attitudes towards the UMS were mixed with stakeholders seeing benefits and limitations to the chart. Practitioners proposed a number of existing services where they thought the UMS could easily be integrated but there was evidence of role conflict with GPs feeling it may be best placed with pharmacists and vice versa. The potential for the UMS to be used as a tool to aid communication between the different services involved in a patient’s care was a key theme.
The UMS chart provides consolidated medicines information that might help to improve patients’ knowledge and health literacy, which may or may not improve adherence but could help patients in making informed decisions about their treatment. One of the key benefits of using the UMS in practice is that it could be introduced across services. In this way it may aid in medicines reconciliation between healthcare settings to ensure continuity of message, improve patient experience and create more joined up working between services. Further research is needed to test implementation in different services and to assess outcomes on patient understanding and adherence.
Electronic supplementary material
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Medication adherence; Multimorbidity; Comorbidity; Reminder charts; Primary care; Pharmacy
Objective To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions.
Design Cluster randomised controlled trial.
Setting 36 general practices in the north west of England.
Participants 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) long term conditions other than diabetes or heart disease; 240 (62%) were men; 360 (90%) completed the trial.
Interventions Collaborative care included patient preference for behavioural activation, cognitive restructuring, graded exposure, and/or lifestyle advice, management of drug treatment, and prevention of relapse. Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse. Usual care was standard clinical practice provided by general practitioners and practice nurses.
Main outcome measures The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale (SCL-D13) at four months after baseline assessment. Secondary outcomes included anxiety symptoms (generalised anxiety disorder 7), self management (health education impact questionnaire), disability (Sheehan disability scale), and global quality of life (WHOQOL-BREF).
Results 19 general practices were randomised to collaborative care and 20 to usual care; three practices withdrew from the trial before patients were recruited. 191 patients were recruited from practices allocated to collaborative care, and 196 from practices allocated to usual care. After adjustment for baseline depression score, mean depressive scores were 0.23 SCL-D13 points lower (95% confidence interval −0.41 to −0.05) in the collaborative care arm, equal to an adjusted standardised effect size of 0.30. Patients in the intervention arm also reported being better self managers, rated their care as more patient centred, and were more satisfied with their care. There were no significant differences between groups in quality of life, disease specific quality of life, self efficacy, disability, and social support.
Conclusions Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity. The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity.
Trial registration ISRCTN80309252.
There is a need to better understand the mechanisms which lead to poor outcomes in patients with multimorbidity, especially those factors that might be amenable to intervention.
This research aims to explore what factors predict self-management behaviour and health outcomes in patients with multimorbidity in primary care in the UK.
A prospective study design was used. Questionnaires were mailed out to 1460 patients with multimorbidity. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery and outcomes (three measures of self-management: behaviours, Self-monitoring and Insight and medication adherence; and a measure of self-reported health).
In total, 36% (n = 499) of patients responded to the baseline survey and 80% of those respondents completed follow-up. Self-management behaviour at 4 months was predicted by illness perceptions around the consequences of individual conditions. Self-monitoring and Insight at 4 months was predicted by patient experience of ‘Hassles’ in health services. Self-reported medication adherence at 4 months was predicted by health status, Self-monitoring and Insight and ‘Hassles’ in health services. Perceived health status at 4 months was predicted by age and patient experience of multimorbidity.
This research shows that different factors, particularly around patients’ experiences of health care and control over their treatment, impact on various types of self-management. Patient experience of multimorbidity was not a critical predictor of self-management but did predict health status in the short term. The findings can help to develop and target interventions that might improve outcomes in patients with multimorbidity.
Co-existent conditions; health services; primary health care; prospective studies; self-care; self-report.
Primary care clinicians and researchers are growing increasingly aware of the prevalence of multimorbidity among long-term conditions, and the impact on patient experience, health, and utilisation of care. The correspondence paper by Muth et al. entitled ‘The Ariadne principles: how to handle multimorbidity in primary care consultations’ outlines new thinking on a better way to manage the challenges of decision-making in multimorbidity. The paper highlights the importance of shared treatment goals as a fundamental basis for more effective management. Although a welcome contribution to the literature, the principles raise a number of challenges: the complexities of achieving effective patient-centred assessment and goal-setting; how best to encourage implementation of new practices; and the current state of the evidence around multimorbidity and its management.
Please see related article: http://www.biomedcentral.com/1741-7015/12/223.
Assessment; Multimorbidity; Treatment burden; Treatment goals
Improving the quality of care for patients with vascular disease is a priority. Clinical guidance has emphasised the importance of early identification and active management of chronic kidney disease (CKD) in primary care in order to maintain vascular health. However, awareness of stage 3 CKD amongst patients remains limited. We aimed to identify predictors of patient self-report of CKD to inform tailoring of conversations around CKD in primary care for diverse patient populations.
We conducted a cross-sectional analysis of baseline data from 436 patients with stage 3 CKD from 24 GP practices taking part in a randomised controlled trial (RCT) evaluating a complex self-management intervention, which aimed to support the maintenance of vascular health in patients with stage 3 CKD. Potential predictors of patient self-report of CKD included demographics, stage of CKD, cardiovascular risk, self-reported co-morbidities, health status, self-management ability, and health service utilisation.
Around half (52%, n = 227) of patients did not self-report CKD. Self-report rates did not appreciably differ by practice. Multivariate analysis revealed that female patients (p = 0.004), and patients with stage 3b CKD (p < 0.001), and with higher anxiety levels (p < 0.001), were more likely to self-report CKD.
Self-report of kidney problems by patients on CKD registers was variable and patterned by sociodemographic factors. Although it cannot be assumed that failure to self-report indicates a lack of awareness of CKD, our data do suggest the need for greater consistency in discussions around kidney health, with meaningful and relevant clinical dialogue that is aligned with existing clinical encounters to enable shared decision making and minimise anxiety.
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Kidney diseases; Primary health care; Self-report; Awareness; Predictors; Communication; Self-management
Self-management support interventions can improve health outcomes, but their impact is limited by the numbers of people able or willing to access them. Men’s attendance at existing self-management support services appears suboptimal despite their increased risk of developing many of the most serious long term conditions. The aim of this review was to determine whether current self-management support interventions are acceptable and accessible to men with long term conditions, and explore what may act as facilitators and barriers to access of interventions and support activities.
A systematic search for qualitative research was undertaken on CINAHL, EMBASE, MEDLINE, PsycINFO and Social Science Citation Index, in July 2013. Reference lists of relevant articles were also examined. Studies that used a qualitative design to explore men’s experiences of, or perceptions towards, self-management support for one or more long term condition were included. Studies which focused on experiences of living with a long term condition without consideration of self-management support were excluded. Thirty-eight studies met the inclusion criteria. A meta-ethnography approach was employed to synthesise the findings.
Four constructs associated with men’s experience of, and perceptions towards, self-management support were identified: 1) need for purpose; 2) trusted environments; 3) value of peers; and 4) becoming an expert. The synthesis showed that men may feel less comfortable participating in self-management support if it is viewed as incongruous with valued aspects of their identity, particularly when activities are perceived to challenge masculine ideals associated with independence, stoicism, and control. Men may find self-management support more attractive when it is perceived as action-oriented, having a clear purpose, and offering personally meaningful information and practical strategies that can be integrated into daily life.
Self-management support is most likely to be successful in engaging men when it is congruent with key aspects of their masculine identity. In order to overcome barriers to access and fully engage with interventions, some men may need self-management support interventions to be delivered in an environment that offers a sense of shared understanding, connectedness, and normality, and involves and/or is facilitated by men with a shared illness experience.
Electronic supplementary material
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Men’s health; Long term conditions; Self-management; Masculinity
Primary care is increasingly focussed on the care of people with two or more long-term conditions (multimorbidity). The UK Department of Health strategy for long term conditions is to use self-management support for the majority of patients but there is evidence of limited engagement among primary care professionals and patients with multimorbidity. Furthermore, multimorbidity is more common in areas of socioeconomic deprivation but deprivation may act as a barrier to patient engagement in self-management practices.
Effective self-management is considered critical to meet the needs of people living with long term conditions but achieving this is a significant challenge in patients with multimorbidity. This study aimed to explore patient and practitioner views on factors influencing engagement in self-management in the context of multimorbidity.
A qualitative study using individual semi-structured interviews with 20 patients and 20 practitioners drawn from four general practices in Greater Manchester situated in areas of high and low social deprivation.
Patients were purposively sampled on socioeconomic deprivation (defined by Index of Multiple Deprivation (IMD) score), number and type of long term conditions (2 or more of: coronary heart disease, diabetes mellitus, osteoarthritis, chronic obstructive pulmonary disease and depression), age and gender. Practitioners were sampled by deprivation status of the practice area; role (i.e. salaried GP, GP principal, practice nurse); and number of years’ experience. Interviews were audio-recorded and transcribed verbatim. Analysis used a thematic approach based on Framework.
Three main factors were identified as influencing patient engagement in self-management: capacity (access and availability of socio-economic resources and time; knowledge; and emotional and physical energy), responsibility (the degree to which patients and practitioners agreed about the division of labour about chronic disease management, including self-management) and motivation (willingness to take-up types of self-management practices). Socioeconomic deprivation negatively impacted on all three factors. Motivation was especially reduced in the presence of mental and physical multimorbidity.
Full engagement in self-management practices in multimorbidity was only present where patients’ articulated a sense of capacity, responsibility, and motivation. Patient ‘know-how’ or interpretive capacity to self-manage multimorbidity is potentially an important precursor to responsibility and motivation, and might be a critical target for intervention. However, individual and social resources are needed to generate capacity, responsibility, and motivation for self-management, pointing to a balanced role for health services and wider enabling networks.
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Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.
The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.
Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.
The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.
Randomized controlled trial; Recruitment; Primary care; Community; Trial participation; Intervention; Multimedia; Decision support systems; Protocols; Participant information
Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD.
Methods and Findings
In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control.
An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention.
Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions.
In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions.
Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives.
Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.
Electronic supplementary material
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Trials; Recruitment; Retention
Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms) and the process of care (use of anti-depressant medication).
Methods and Findings
Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs) between study level covariates and depressive symptoms and relative risk (95% CI) and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants). Collaborative care that included psychological interventions predicted improvement in depression (β coefficient −0.11, 95% CI −0.20 to −0.01, p = 0.03). Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004) and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02) predicted use of anti-depressant medication.
Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical condition reported improved use of anti-depressant medication. However, these findings are limited by the observational nature of meta-regression, incomplete data reporting, and the use of study aggregates.
This is the protocol for a review and there is no abstract. The objectives are as follows:
To evaluate the effectiveness of interventions that reduce weight in obese pregnant women.
There is increasing interest in the role of ‘self-management’ interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions.
We used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses.
We included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits.
Self-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.
Electronic supplementary material
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Self-management support interventions; Long-term conditions; Health outcomes; Quality of life; Health care utilization; Hospitalizations; Costs; Cost-effectiveness; Systematic review; Meta-analysis
Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention.
Methods and analysis
We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors.
Ethics and dissemination
Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision-making, patient empowerment or other relevant models.
Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking.
To assess the cost-effectiveness of collaborative care in a UK primary care setting.
An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane.
The collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: –0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: –202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual.
Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.
UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help (GSH) to more intensive psychological and pharmacological interventions. Cognitive behavioural therapy (CBT), including exposure and response prevention, is the recommended psychological treatment. However, whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective, a more robust evidence base of their clinical and cost effectiveness and acceptability is required.
Our proposed study will test two different self-help treatments for OCD: 1) computerised CBT (cCBT) using OCFighter, an internet-delivered OCD treatment package; and 2) GSH using a book. Both treatments will be accompanied by email or telephone support from a mental health professional. We will evaluate the effectiveness, cost and patient and health professional acceptability of the treatments.
This study will provide more robust evidence of efficacy, cost effectiveness and acceptability of self-help treatments for OCD. If cCBT and/or GSH prove effective, it will provide additional, more accessible treatment options for people with OCD.
Current Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011
Obsessive compulsive disorder; Guided self-help; Computerised cognitive behaviour therapy; Cognitive behaviour therapy; Exposure and response prevention
Purpose of the study: to examine the costs and cost-effectiveness of ‘second-generation’ telecare, in addition to standard support and care that could include ‘first-generation’ forms of telecare, compared with standard support and care that could include ‘first-generation’ forms of telecare.
Design and methods: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care.
Primary outcome measure: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective.
Results: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY.
Implications: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs.
Trial registration number: ISRCTN 43002091.
telecare; economic evaluation; social care; older people