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1.  Fidelity and moderating factors in complex interventions: a case study of a continuum of care program for frail elderly people in health and social care 
Prior studies measuring fidelity of complex interventions have mainly evaluated adherence, and not taken factors affecting adherence into consideration. A need for studies that clarify the concept of fidelity and the function of factors moderating fidelity has been emphasized. The aim of the study was to systematically evaluate implementation fidelity and possible factors influencing fidelity of a complex care continuum intervention for frail elderly people.
The intervention was a systematization of the collaboration between a nurse with geriatric expertise situated at the emergency department, the hospital ward staff, and a multi-professional team with a case manager in the municipal care services for older people. Implementation was evaluated between September 2008 and May 2010 with observations of work practices, stakeholder interviews, and document analysis according to a modified version of The Conceptual Framework for Implementation Fidelity.
A total of 16 of the 18 intervention components were to a great extent delivered as planned, while some new components were added to the model. No changes in the frequency or duration of the 18 components were observed, but the dose of the added components varied over time. Changes in fidelity were caused in a complex, interrelated fashion by all the moderating factors in the framework, i.e., context, staff and participant responsiveness, facilitation, recruitment, and complexity.
The Conceptual Framework for Implementation Fidelity was empirically useful and included comprehensive measures of factors affecting fidelity. Future studies should focus on developing the framework with regard to how to investigate relationships between the moderating factors and fidelity over time.
Trial registration, NCT01260493.
PMCID: PMC3342887  PMID: 22436121
Adherence; Adaptation; Process evaluation; Complex intervention; Implementation; Care chain; Elderly
2.  The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework 
The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework.
The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets.
A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes.
This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.
Trial registration
ISRCTN18046709 - Peri-operative Implementation Study Evaluation (PoISE).
PMCID: PMC3636004  PMID: 23497438
3.  Factors influencing performance of health workers in the management of seriously sick children at a Kenyan tertiary hospital - participatory action research 
Implementation of World Health Organization case management guidelines for serious childhood illnesses remains a challenge in hospitals in low-income countries. Facilitators of and barriers to implementation of locally adapted clinical practice guidelines (CPGs) have not been explored.
This ethnographic study based on the theory of participatory action research (PAR) was conducted in Kenyatta National Hospital, Kenya’s largest teaching hospital. The primary intervention consisted of dissemination of locally adapted CPGs. The PRECEDE-PROCEED health education model was used as the conceptual framework to guide and examine further reinforcement activities to improve the uptake of the CPGs. Activities focussed on introduction of routine clinical audits and tailored educational sessions. Data were collected by a participant observer who also facilitated the PAR over an eighteen-month period. Naturalistic inquiry was utilized to obtain information from all hospital staff encountered while theoretical sampling allowed in-depth exploration of emerging issues. Data were analysed using interpretive description.
Relevance of the CPGs to routine work and emergence of a champion of change facilitated uptake of best-practices. Mobilization of basic resources was relatively easily undertaken while activities that required real intellectual and professional engagement of the senior staff were a challenge. Accomplishments of the PAR were largely with the passive rather than active involvement of the hospital management. Barriers to implementation of best-practices included i) mismatch between the hospital’s vision and reality, ii) poor communication, iii) lack of objective mechanisms for monitoring and evaluating quality of clinical care, iv) limited capacity for planning strategic change, v) limited management skills to introduce and manage change, vi) hierarchical relationships, and vii) inadequate adaptation of the interventions to the local context.
Educational interventions, often regarded as ‘quick-fixes’ to improve care in low-income countries, may be necessary but are unlikely to be sufficient to deliver improved services. We propose that an understanding of organizational issues that influence the behaviour of individual health professionals should guide and inform the implementation of best-practices.
PMCID: PMC3942276  PMID: 24507629
Clinical audits; Clinical practice guidelines; Continuous medical educational sessions; ETAT+; Ethnographic study; Implementation of best-practices; Interpretive description; Participatory action research; Participant observer; Performance of health workers
4.  Is the process of delivery of an individually tailored lifestyle intervention associated with improvements in LDL cholesterol and multiple lifestyle behaviours in people with Familial Hypercholesterolemia? 
BMC Public Health  2012;12:348.
More insight in the association between reach, dose and fidelity of intervention components and effects is needed. In the current study, we aimed to evaluate reach, dose and fidelity of an individually tailored lifestyle intervention in people with Familial Hypercholesterolemia (FH) and the association between intervention dose and changes in LDL-Cholesterol (LDL-C), and multiple lifestyle behaviours at 12-months follow-up.
Participants (n = 181) randomly allocated to the intervention group received the PRO-FIT intervention consisting of computer-tailored lifestyle advice (PRO-FIT*advice) and counselling (face-to-face and telephone booster calls) using Motivational Interviewing (MI). According to a process evaluation plan, intervention reach, dose delivered and received, and MI fidelity were assessed using the recruitment database, website/counselling logs and the Motivational Interviewing Treatment Integrity (MITI 3.1.1.) code. Regression analyses were conducted to explore differences between participant and non-participant characteristics, and the association between intervention dose and change in LDL-C, and multiple lifestyle behaviours.
A 34% (n = 181) representative proportion of the intended intervention group was reached during the recruitment phase; participants did not differ from non-participants (n = 623) on age, gender and LDL-C levels. Of the participants, 95% received a PRO-FIT*advice log on account, of which 49% actually logged on and completed at least one advice module. Nearly all participants received a face-to-face counselling session and on average, 4.2 telephone booster calls were delivered. None of the face-to-face sessions were implemented according to MI guidelines. Overall, weak non-significant positive associations were found between intervention dose and LDL-C and lifestyle behaviours.
Implementation of the PRO-FIT intervention in practice appears feasible, particularly PRO-FIT*advice, since it can be relative easily implemented with a high dose delivered. However, only less than half of the intervention group received the complete intervention-package as intended. Strategies to let participants optimally engage in using web-based computer-tailored interventions like PRO-FIT*advice are needed. Further, more emphasis should be put on more extensive MI training and monitoring/supervision.
Trial registration
NTR1899 at
PMCID: PMC3487747  PMID: 22583789
Counselling; Computer tailoring; Cholesterol; Lifestyle behaviours; Dose; Fidelity; Motivational interviewing; Process evaluation; Efficacy
5.  DiAlert: a prevention program for overweight first degree relatives of type 2 diabetes patients: results of a pilot study to test feasibility and acceptability 
Trials  2012;13:178.
Prevalence of type 2 diabetes mellitus is increasing due to lifestyle changes, particularly affecting those genetically at risk. We developed DiAlert as a targeted group-based intervention aimed to promote intrinsic motivation and action planning for lifestyle changes and weight loss in first degree relatives of patients with type 2 diabetes mellitus.
The main objective of the pilot of the DiAlert intervention was to assess fidelity, feasibility and acceptability prior to starting the randomized controlled trial.
Individuals with a family history of type 2 diabetes mellitus were self-identified and screened for eligibility. DiAlert consists of two group sessions. Feasibility, fidelity, acceptability and self-reported perceptions and behavioral determinants were evaluated in a pre-post study using questionnaires and observations. Determinants of behavior change were analyzed using paired-samples t tests and Wilcoxon signed rank tests.
DiAlert was delivered to two groups of first degree relatives of patients with type 2 diabetes mellitus (N = 9 and N = 12). Feasibility and fidelity were confirmed. Overall, the DiAlert group sessions were positively evaluated (8.0 on a scale of 1 to 10) by participants. The intervention did not impact perceived susceptibility or worry about personal diabetes risk. Action planning with regard to changing diet and physical activity increased.
DiAlert proved feasible and was well-accepted by participants. Positive trends in action planning indicate increased likelihood of actual behavior change following DiAlert. Testing the effectiveness in a randomized controlled trial is imperative.
Trial registration
Netherlands National Trial Register (NTR): NTR2036
PMCID: PMC3543339  PMID: 23013843
6.  Process evaluation of a sport-for-health intervention to prevent smoking amongst primary school children: SmokeFree Sports 
BMC Public Health  2015;15:347.
SmokeFree Sports (SFS) was a multi-component sport-for-health intervention aiming at preventing smoking among nine to ten year old primary school children from North West England. The purpose of this study was to evaluate the process and implementation of SFS, examining intervention reach, dose, fidelity, acceptability and sustainability, in order to understand the feasibility and challenges of delivering such interventions and inform interpretations of intervention effectiveness.
Process measures included: booking logs, 18 focus groups with children (n = 95), semi-structured interviews with teachers (n = 20) and SFS coaches (n = 7), intervention evaluation questionnaires (completed by children, n = 1097; teachers, n = 50), as well direct observations (by researchers, n = 50 observations) and self-evaluations (completed by teachers, n = 125) of intervention delivery (e.g. length of sessions, implementation of activities as intended, children’s engagement and barriers). Descriptive statistics and thematic analysis were applied to quantitative and qualitative data, respectively.
Overall, SFS reached 30.8% of eligible schools, with 1073 children participating in the intervention (across 32 schools). Thirty-one schools completed the intervention in full. Thirty-three teachers (55% female) and 11 SFS coaches (82% male) attended a bespoke SFS training workshop. Disparities in intervention duration (range = 126 to 201 days), uptake (only 25% of classes received optional intervention components in full), and the extent to which core (mean fidelity score of coaching sessions = 58%) and optional components (no adaptions made = 51% of sessions) were delivered as intended, were apparent. Barriers to intervention delivery included the school setting and children’s behaviour and knowledge. SFS was viewed positively (85% and 82% of children and teachers, respectively, rated SFS five out of five) and recommendations to increase school engagement were provided.
SFS was considered acceptable to children, teachers and coaches. Nevertheless, efforts to enhance intervention reach (at the school level), teachers’ engagement and sustainability must be considered. Variations in dose and fidelity likely reflect challenges associated with complex intervention delivery within school settings and thus a flexible design may be necessary. This study adds to the limited scientific evidence base surrounding sport-for-health interventions and their implementation, and suggests that such interventions offer a promising tool for engaging children in activities which promote their health.
PMCID: PMC4428003  PMID: 25886027
Smoking; Children; School; Intervention; Sport; Process evaluation; Implementation
7.  Tool for evaluating research implementation challenges: A sense-making protocol for addressing implementation challenges in complex research settings 
Many challenges arise in complex organizational interventions that threaten research integrity. This article describes a Tool for Evaluating Research Implementation Challenges (TECH), developed using a complexity science framework to assist research teams in assessing and managing these challenges.
During the implementation of a multi-site, randomized controlled trial (RCT) of organizational interventions to reduce resident falls in eight nursing homes, we inductively developed, and later codified the TECH. The TECH was developed through processes that emerged from interactions among research team members and nursing home staff participants, including a purposive use of complexity science principles.
The TECH provided a structure to assess challenges systematically, consider their potential impact on intervention feasibility and fidelity, and determine actions to take. We codified the process into an algorithm that can be adopted or adapted for other research projects. We present selected examples of the use of the TECH that are relevant to many complex interventions.
Complexity theory provides a useful lens through which research procedures can be developed to address implementation challenges that emerge from complex organizations and research designs. Sense-making is a group process in which diverse members interpret challenges when available information is ambiguous; the groups’ interpretations provide cues for taking action. Sense-making facilitates the creation of safe environments for generating innovative solutions that balance research integrity and practical issues. The challenges encountered during implementation of complex interventions are often unpredictable; however, adoption of a systematic process will allow investigators to address them in a consistent yet flexible manner, protecting fidelity. Research integrity is also protected by allowing for appropriate adaptations to intervention protocols that preserve the feasibility of ‘real world’ interventions.
PMCID: PMC3598718  PMID: 23281623
Long-term care; Complexity science; Nursing homes; Implementation research; Intervention research; Research design; Staff intervention; Sense-making; Research fidelity
8.  Evaluation of the fidelity of an interactive face-to-face educational intervention to improve general practitioner management of back pain 
BMJ Open  2015;5(7):e007886.
Implementation intervention effects can only be fully realised and understood if they are faithfully delivered. However the evaluation of implementation intervention fidelity is not commonly undertaken. The IMPLEMENT intervention was designed to improve the management of low back pain by general medical practitioners. It consisted of a two-session interactive workshop, including didactic presentations and small group discussions by trained facilitators. This study aimed to evaluate the fidelity of the IMPLEMENT intervention by assessing: (1) observed facilitator adherence to planned behaviour change techniques (BCTs); (2) comparison of observed and self-reported adherence to planned BCTs and (3) variation across different facilitators and different BCTs.
The study compared planned and actual, and observed versus self-assessed delivery of BCTs during the IMPLEMENT workshops.
Workshop sessions were audiorecorded and transcribed verbatim. Observed adherence of facilitators to the planned intervention was assessed by analysing the workshop transcripts in terms of BCTs delivered. Self-reported adherence was measured using a checklist completed at the end of each workshop session and was compared with the ‘gold standard’ of observed adherence using sensitivity and specificity analyses.
The overall observed adherence to planned BCTs was 79%, representing moderate-to-high intervention fidelity. There was no significant difference in adherence to BCTs between the facilitators. Sensitivity of self-reported adherence was 95% (95% CI 88 to 98) and specificity was 30% (95% CI 11 to 60).
The findings suggest that the IMPLEMENT intervention was delivered with high levels of adherence to the planned intervention protocol.
Trial registration number
The IMPLEMENT trial was registered in the Australian New Zealand Clinical Trials Registry, ACTRN012606000098538 (
PMCID: PMC4499726  PMID: 26155819
9.  An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers 
One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers.
Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators.
Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers.
Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.
PMCID: PMC4106217  PMID: 25008457
Substance use disorders treatment; Abstinence incentive intervention; Implementation; Process evaluation; Hybrid design
10.  Implementation of multidimensional knowledge translation strategies to improve procedural pain in hospitalized children 
Despite extensive research, institutional policies, and practice guidelines, procedural pain remains undertreated in hospitalized children. Knowledge translation (KT) strategies have been employed to bridge the research to practice gap with varying success. The most effective single or combination of KT strategies has not been found. A multifaceted KT intervention, Evidence-based Practice for Improving Quality (EPIQ), that included tailored KT strategies was effective in improving pain practices and clinical outcomes at the unit level in a prospective comparative cohort study in 32 hospital units (16 EPIQ intervention and 16 Standard Care), in eight pediatric hospitals in Canada.
In a study of the 16 EPIQ units (two at each hospital) only, the objectives were to: determine the effectiveness of evidence-based KT strategies implemented to achieve unit aims; describe the KT strategies implemented and their influence on pain assessment and management across unit types; and identify facilitators and barriers to their implementation.
Data were collected from each EPIQ intervention unit on targeted pain practices and KT strategies implemented, through chart review and a process evaluation checklist, following four intervention cycles over a 15-month period.
Following the completion of the four cycle intervention, 78% of 23 targeted pain practice aims across units were achieved within 80% of the stated aims. A statistically significant improvement was found in the proportion of children receiving pain assessment and management, regardless of pre-determined aims (p < 0.001). The median number of KT strategies implemented was 35 and included reminders, educational outreach and materials, and audit and feedback. Units successful in achieving their aims implemented more KT strategies than units that did not. No specific type of single or combination of KT strategies was more effective in improving pain assessment and management outcomes. Tailoring KT strategies to unit context, support from unit leadership, staff engagement, and dedicated time and resources were identified as facilitating effective implementation of the strategies.
Further research is required to better understand implementation outcomes, such as feasibility and fidelity, how context influences the effectiveness of multifaceted KT strategies, and the sustainability of improved pain practices and outcomes over time.
PMCID: PMC4263210  PMID: 25928349
Pediatric procedural pain; Knowledge translation strategies; Tailored interventions; Quality improvement
11.  Intervention for control of hypertension in Catalonia, Spain (INCOTECA Project): results of a multicentric, non-randomised, quasi-experimental controlled intervention study 
BMJ Open  2012;2(2):e000507.
The purpose of this study was to assess the effectiveness of a quality improvement (QI) plan aimed at primary healthcare teams (PHCTs) to optimise hypertension control and to compare it with standard clinical care.
Design Multicentric, non-randomised, quasi-experimental controlled intervention study.
Setting 5 PHCTs in the intervention and 13 in the standard care group in the province of Barcelona, Catalonia, Spain.
Participants This is a population-based study in which all patients over 18 years of age with a diagnosis of hypertension before 1 January 2006 were included (n=9877 in the intervention group and n=21 704 in the control group).
Intervention A QI plan that targeted primary care professionals. The plan included training sessions, implementation of recommended clinical practice guidelines for the management of hypertensive patients and audit and feedback to health professionals.
Main outcome measure Prevalence of hypertensive patients with an adequate blood pressure (BP) control.
The adjusted difference between intervention and standard care groups in the odds of BP control was 1.3 (95% CI 1.1 to 1.6, p=0.003). Results of the mixed model on repeated measures showed that, on average, an individual in the intervention group had an increase of 92% in the odds of BP control (OR 1.9, 95% CI 1.7 to 2.1).
The implementation of a QI plan can improve BP control. This strategy is potentially feasible for up-scaling within the existing PHCTs.
Trial registration MS: 1998275938244441.
Article summary
Article focus
To assess the effectiveness of a QI programme targeting health professionals to optimise BP control in hypertensive patients. Other factors associated with BP control were analysed.
Key messages
The QI plan aimed at PHCTs (doctors, nurses and administrative staff) implemented in our study has proven effective to improve hypertension control.
A history of a cardiovascular event has a positive effect in BP control.
The addition of different antihypertensive drugs to the management of hypertensive patients without considering other aggravating factors does not guarantee a better BP control.
Strengths and limitations of this study
The population-based design and mixed-effects modelling on repeated measures were the main strengths of this study.
The mixed models approach is a powerful method for analysing data from longitudinal studies, which include multiple measurements on each participant.
Most of the intervention effort in this study was implemented with few additional resources.
The duration of the study can be considered the main limitation of this investigation. Longer term studies that include unmeasured factors are needed to determine the effectiveness and cost-effectiveness of this measure and the impact of a reduction in BP values on cardiovascular morbimortality in the hypertensive population.
PMCID: PMC3332244  PMID: 22514242
12.  Adoption and sustainability of decision support for patients facing health decisions: an implementation case study in nursing 
Effective interventions prepare patients for making values-sensitive health decisions by helping them become informed and clarifying their values for each of the options. However, patient decision support interventions have not been widely implemented and little is known about effective models for delivering them to patients. The purpose of this study was to describe call centre nurses' adoption of a decision support protocol into practice following exposure to an implementation intervention and to identify factors influencing sustainable nursing practice changes.
Exploratory case study at a Canadian province-wide call centre guided by the Ottawa Model of Research Use. Data sources included a survey of nurses who participated in an implementation intervention (n = 31), 2 focus groups with nurses, interviews with 4 administrators, and a document review.
Twenty-five of 31 nurses responded to the survey measuring adoption of decision support in practice. Of the 25 nurses, 11 had used the decision support protocol in their practice within one month of the intervention. Twenty-two of the 25 intended to use it within the next three months. Although some nurses found it challenging to begin using the protocol, most nurses reported that it: a) helped them recognize callers needing decision support; b) changed their approach to handling these calls; and c) was a positive enhancement to their practice. Strategies identified to promote sustainability of practice changes included integration of the decision support protocol in the call centre database, streamlining the patient decision aids for easier use via telephone, clarifying the administrative direction for the call centre's program, creating a call length guideline specific for these calls, incorporating decision support training in the staff development plan, and informing the public of this enhanced service.
Although most nurses adopted the decision support protocol for coaching callers facing values-sensitive decisions, to sustain practice changes, interventions are required to manage barriers in the practice environment and integrate decision support into the organization's policies, resources, and routine activities.
PMCID: PMC1564029  PMID: 16930476
13.  CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes 
Quality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures.
Sixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention. Analysis will use a three-level mixed model.
By focusing on improving local interactions, CONNECT is expected to maximize staff's ability to implement content learned in a falls QI program and integrate it into knowledge and action. Our previous pilot work shows that CONNECT is feasible, acceptable and appropriate.
Trial Registration NCT00636675
PMCID: PMC3310735  PMID: 22376375
14.  A Primary Care Nurse-Delivered Walking Intervention in Older Adults: PACE (Pedometer Accelerometer Consultation Evaluation)-Lift Cluster Randomised Controlled Trial 
PLoS Medicine  2015;12(2):e1001783.
Brisk walking in older people can increase step-counts and moderate to vigorous intensity physical activity (MVPA) in ≥10-minute bouts, as advised in World Health Organization guidelines. Previous interventions have reported step-count increases, but not change in objectively measured MVPA in older people. We assessed whether a primary care nurse-delivered complex intervention increased objectively measured step-counts and MVPA.
Methods and Findings
A total of 988 60–75 year olds, able to increase walking and randomly selected from three UK family practices, were invited to participate in a parallel two-arm cluster randomised trial; randomisation was by household. Two-hundred-ninety-eight people from 250 households were randomised between 2011 and 2012; 150 individuals to the intervention group, 148 to the usual care control group. Intervention participants received four primary care nurse physical activity (PA) consultations over 3 months, incorporating behaviour change techniques, pedometer step-count and accelerometer PA intensity feedback, and an individual PA diary and plan. Assessors were not blinded to group status, but statistical analyses were conducted blind. The primary outcome was change in accelerometry assessed average daily step-counts between baseline and 3 months, with change at 12 months a secondary outcome. Other secondary outcomes were change from baseline in time in MVPA weekly in ≥10-minute bouts, accelerometer counts, and counts/minute at 3 months and 12 months. Other outcomes were adverse events, anthropometric measures, mood, and pain. Qualitative evaluations of intervention participants and practice nurses assessed the intervention’s acceptability. At 3 months, eight participants had withdrawn or were lost to follow-up, 280 (94%) individuals provided primary outcome data. At 3 months changes in both average daily step-counts and weekly MVPA in ≥10-minute bouts were significantly higher in the intervention than control group: by 1,037 (95% CI 513–1,560) steps/day and 63 (95% CI 40–87) minutes/week, respectively. At 12 months corresponding differences were 609 (95% CI 104–1,115) steps/day and 40 (95% CI 17–63) minutes/week. Counts and counts/minute showed similar effects to steps and MVPA. Adverse events, anthropometry, mood, and pain were similar in the two groups. Participants and practice nurses found the intervention acceptable and enjoyable.
The PACE-Lift trial increased both step-counts and objectively measured MVPA in ≥10-minute bouts in 60–75 year olds at 3 and 12 months, with no effect on adverse events. To our knowledge, this is the first trial in this age group to demonstrate objective MVPA increases and highlights the value of individualised support incorporating objective PA assessment in a primary care setting.
Trial Registration ISRCTN42122561
In this cluster randomized controlled trial, Tess Harris and colleagues investigate whether a program delivered by primary care nurses to older adults can increase bouts of moderate to vigorous physical activity.
Editors’ Summary
Worldwide, people are becoming increasingly sedentary. They are sitting at desks instead of doing manual labor; they are driving to work instead of walking; and they are participating in fewer leisure time physical activities. But the human body needs regular exercise to stay healthy. Physical activity helps to maintain a healthy weight and prevents or delays heart disease, type 2 diabetes, and some cancers. Moreover, physically active people feel better and live longer than physically inactive people. The World Health Organization recommends that adults should be active daily and should do at least 150 minutes of moderate- to vigorous-intensity physical activity (MVPA) every week in bouts that each last at least 10 minutes. Moderate-intensity physical activities (for example, brisk walking) require a moderate amount of effort and noticeably increase the heart rate; vigorous-intensity physical activities (for example, running) require a large amount of effort and cause rapid breathing and a substantial heart rate increase.
Why Was This Study Done?
When physical activity is objectively measured using an accelerometer (a movement monitor that is usually worn on the waist; unlike pedometers, which simply count the number of steps a person takes, accelerometers record both step-counts and the intensity of physical activity), fewer than 5% of older people achieve the recommended weekly levels of MVPA. These levels could be reached by taking regular brisk walks but how can older people be persuaded to make such walks part of their daily lives? In this cluster randomized controlled trial—the PACE (Pedometer Accelerometer Consultation Evaluation)-Lift trial—the researchers assess whether an intervention to increase walking comprising pedometer and accelerometer feedback combined with physical activity consultations provided by practice nurses can lead to sustained increases in physical activity in 60–75 year olds. Cluster randomized trials compare outcomes in groups of people (here, husbands and wives living in one household) assigned through the play of chance to receive a test or a control intervention.
What Did the Researchers Do and Find?
The researchers assigned 298 people from 250 households to receive the intervention or usual care and determined the participants’ physical activity at baseline, 3 months, and 12 months by asking them to wear an accelerometer for 7 days. Intervention group participants received four physical activity consultations with a primary care nurse over 3 months. At the first consultation, the nurse gave each participant a pedometer to measure step-counts, a physical activity diary in which to record their goals and progress, and the PACE-Lift patient handbook. At each consultation, the nurse used behavior change techniques (for example, goal setting) to encourage the participant to walk regularly, gave the participant visual feedback from their accelerometer readings, and devised a personal walking plan. Control group participants received normal care only from the practice. At 3 months and 12 months, both the average daily step-count and the weekly MVPA level had decreased from baseline in the control group but increased in the intervention group. At 3 months, compared to the control group, the average step-count in the intervention group was 1,037 steps/day higher and the MVPA in bouts of more than 10 minutes in the intervention group was 63 minutes/week higher. At 12 months, the corresponding differences were 609 steps/day and 40 minutes/week. There were no significant differences in adverse events (for example, pain), body fat, or other measured health-related outcomes between the groups.
What Do These Findings Mean?
These findings show that the complex intervention tested in the PACE-Lift trial increased both step-counts and objectively measured MPVA among 60–75 year olds for at least 12 months. Importantly, all the participants and practice nurses were positive and enthusiastic about the intervention. Moreover, the observed increase in physical activity is estimated to reduce the participants’ risk of heart disease and type 2 diabetes by an estimated 5.5% and 9.1%, respectively. Further trials are needed to determine which aspects of the intervention were responsible for increasing physical activity, to determine whether the intervention’s effects will persist for longer than 12 months, and to test the intervention in socio-economically diverse populations (all the PACE-Lift participants came from an affluent, non-ethnically diverse area). However, these findings highlight the value of family practices providing older individuals with individualized support that incorporates objective assessment of physical activity to help them become more physically active.
Additional Information
Please access these websites via the online version of this summary at
The US Centers for Disease Control and Prevention provides information on all aspects of healthy living; its Physical Activity for Everyone web pages include guidelines for older people, instructional videos, and personal success stories (some information in English and Spanish)
The World Health Organization provides information about physical activity and health (in several languages); its Global Recommendations on Physical Activity for Health are available in several languages
The UK National Health Service information source Choices explains the benefits of regular physical activity, provides recommendations for older people, and includes tips for exercising and some personal stories
MedlinePlus has links to other resources about exercise and physical fitness (in English and Spanish)
More information about the PACE-Lift trial protocol is available
PMCID: PMC4331517  PMID: 25689364
15.  The Prevention and Reactivation Care Program: intervention fidelity matters 
The Prevention and Reactivation Care Program (PReCaP) entails an innovative multidisciplinary, integrated and goal oriented approach aimed at reducing hospital related functional decline among elderly patients. Despite calls for process evaluation as an essential component of clinical trials in the geriatric care field, studies assessing fidelity lag behind the number of effect studies. The threefold purpose of this study was (1) to systematically assess intervention fidelity of the hospital phase of the PReCaP in the first year of the intervention delivery; (2) to improve our understanding of the moderating factors and modifications affecting intervention fidelity; and (3) to explore the feasibility of the PReCaP fidelity assessment in view of the modifications.
Based on the PReCaP description we developed a fidelity instrument incorporating nineteen (n=19) intervention components. A combination of data collection methods was utilized, i.e. data collection from patient records and individual Goal Attainment Scaling care plans, in-depth interviews with stakeholders, and non-participant observations. Descriptive analysis was performed to obtain levels of fidelity of each of the nineteen PReCaP components. Moderating factors were identified by using the Conceptual Framework for Implementation Fidelity.
Ten of the nineteen intervention components were always or often delivered to the group of twenty elderly patients. Moderating factors, such as facilitating strategies and context were useful in explaining the non- or low-adherence of particular intervention components.
Fidelity assessment was carried out to evaluate the adherence to the PReCaP in the Vlietland Ziekenhuis in the Netherlands. Given that the fidelity was assessed in the first year of PReCaP implementation it was commendable that ten of the nineteen intervention components were performed always or often. The adequate delivery of the intervention components strongly depended on various moderating factors. Since the intervention is still developing and undergoing continuous modifications, it has been concluded that the fidelity criteria should evolve with the modified intervention. Furthermore, repeated intervention fidelity assessments will be necessary to ensure a valid and reliable fidelity assessment of the PReCaP.
Trial registration
The Netherlands National Trial Register: NTR2317
PMCID: PMC3566920  PMID: 23351355
Geriatric care intervention; Intervention fidelity; Moderating factors
16.  Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e001039.
To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.
Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.
A postnatal ward in Scotland.
Women initiating breast feeding and living in disadvantaged areas.
Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.
Main outcome measures
Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.
A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff–team–woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.
Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.
Trial registration
ISRCTN27207603. The study protocol and final report is available on request.
Article summary
Article focus
To use a participatory approach to design, deliver and implement a feeding support team intervention integrated into routine postnatal ward care and to deliver a pilot randomised controlled trial (RCT) of proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To use a mixed qualitative and quantitative methods process evaluation to assess the study acceptability, feasibility and intervention fidelity from the perspectives of women and National Health Service staff.
To inform the design of a future definitive RCT.
Key messages
Women living in disadvantaged areas are unlikely to initiate calls for help with breast feeding and proactive telephone calls may help to counteract the inverse care law.
Women undervalue both breast feeding and their own needs compared with the needs of others as a reason to ask for help in the context of overstretched maternity services.
A caring, reassuring woman-centred communication style with continuity of care from hospital to home was valued and increased women's confidence.
Strengths and limitations of this study
The participatory approach embedding a rigorous RCT within a before-and-after cohort study with mixed-methods data to evaluate implementation processes and costs are strengths that will enable us to design a feasible and acceptable definitive trial.
The contribution of the personal characteristics and skills of the feeding team to the intervention was important and may be challenging to replicate.
The low number of women who reported having an entire breast feed observed is a limitation and warrants further investigation.
More research is required before feeding teams and proactive calls are widely implemented as there are likely to be unintended consequences to such an organisational change in postnatal care.
PMCID: PMC3341595  PMID: 22535794
17.  Implementation of a culturally tailored diabetes intervention with community health workers in American Samoa 
The Diabetes educator  2013;39(6):761-771.
The examination of implementation process in translation research can inform other interventions’ modifications for different socio-cultural contexts. The purpose of this paper is to answer key implementation questions of a primary-care based, nurse-community health worker (CHW) team intervention to support type 2 diabetes self-management, as part of a randomized trial: 1) How was the evidence-based model adapted? 2) How were CHWs trained and supervised? 3) What was fidelity to protocols? 4) What were intervention costs? Lessons learned during implementation are also discussed.
Descriptive data are given on intervention delivery, CHW visit content, patient safety and intervention costs, along with statistical analyses to examine participant characteristics of higher attendance at visits.
In the intervention sample (n=104), 74% (SD 16) of planned intervention visits occurred, guided by an algorithm-based protocol. Higher risk participants had a significantly lower dose of their weekly assigned visits (66%), than those at moderate (74%) and lower risk (90%). Twenty-eight percent of participants moved to a lower risk group over the year. Estimated intervention cost was $656 per person. Participants with less education were more likely to attend optimal percent of visits.
A nurse-CHW team can deliver a culturally adapted diabetes self-management support intervention with excellent fidelity to the algorithm-based protocols. The team accommodated participants’ needs by meeting them whenever and wherever they could. This study provides an example of adaptation of an evidence-based model to the Samoan cultural context and its resource-poor setting.
PMCID: PMC4062972  PMID: 24052204
community health workers; implementation; fidelity; cultural adaptation; American Samoa
18.  An ongoing struggle: a mixed-method systematic review of interventions, barriers and facilitators to achieving optimal self-care by children and young people with Type 1 Diabetes in educational settings 
BMC Pediatrics  2014;14:228.
Type 1 diabetes occurs more frequently in younger children who are often pre-school age and enter the education system with diabetes-related support needs that evolve over time. It is important that children are supported to optimally manage their diet, exercise, blood glucose monitoring and insulin regime at school. Young people self-manage at college/university.
Theory-informed mixed-method systematic review to determine intervention effectiveness and synthesise child/parent/professional views of barriers and facilitators to achieving optimal diabetes self-care and management for children and young people age 3–25 years in educational settings.
Eleven intervention and 55 views studies were included. Meta-analysis was not possible. Study foci broadly matched school diabetes guidance. Intervention studies were limited to specific contexts with mostly high risk of bias. Views studies were mostly moderate quality with common transferrable findings.
Health plans, and school nurse support (various types) were effective. Telemedicine in school was effective for individual case management. Most educational interventions to increase knowledge and confidence of children or school staff had significant short-term effects but longer follow-up is required. Children, parents and staff said they struggled with many common structural, organisational, educational and attitudinal school barriers. Aspects of school guidance had not been generally implemented (e.g. individual health plans). Children recognized and appreciated school staff who were trained and confident in supporting diabetes management.
Research with college/university students was lacking. Campus-based college/university student support significantly improved knowledge, attitudes and diabetes self-care. Self-management was easier for students who juggled diabetes-management with student lifestyle, such as adopting strategies to manage alcohol consumption.
This novel mixed-method systematic review is the first to integrate intervention effectiveness with views of children/parents/professionals mapped against school diabetes guidelines. Diabetes management could be generally improved by fully implementing and auditing guideline impact. Evidence is limited by quality and there are gaps in knowledge of what works. Telemedicine between healthcare providers and schools, and school nurse support for children is effective in specific contexts, but not all education systems employ onsite nurses. More innovative and sustainable solutions and robust evaluations are required. Comprehensive lifestyle approaches for college/university students warrant further development and evaluation.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2431-14-228) contains supplementary material, which is available to authorized users.
PMCID: PMC4263204  PMID: 25213220
Systematic review; Diabetes Type 1; Children; Adolescent; Young Person; Educational setting; School; University; College; School nurse
19.  A participatory and capacity-building approach to healthy eating and physical activity – SCIP-school: a 2-year controlled trial 
Schools can be effective settings for improving eating habits and physical activity, whereas it is more difficult to prevent obesity. A key challenge is the “implementation gap”. Trade-off must be made between expert-driven programmes on the one hand and contextual relevance, flexibility, participation and capacity building on the other. The aim of the Stockholm County Implementation Programme was to improve eating habits, physical activity, self-esteem, and promote a healthy body weight in children aged 6–16 years. We describe the programme, intervention fidelity, impacts and outcomes after two years of intervention.
Nine out of 18 schools in a middle-class municipality in Sweden agreed to participate whereas the other nine schools served as the comparison group (quasi-experimental study). Tailored action plans were developed by school health teams on the basis of a self-assessment questionnaire called KEY assessing strengths and weaknesses of each school’s health practices and environments. Process evaluation was carried out by the research staff. Impacts at school level were assessed yearly by the KEY. Outcome measures at student level were anthropometry (measured), and health behaviours assessed by a questionnaire, at baseline and after 2 years. All children in grade 2, 4 and 7 were invited to participate (n=1359) of which 59.8% consented. The effect of the intervention on health behaviours, self-esteem, weight status and BMIsds was evaluated by unilevel and multilevel regression analysis adjusted for gender and baseline values.
Programme fidelity was high demonstrating feasibility, but fidelity to school action plans was only 48% after two years. Positive and significant (p<.05) impacts were noted in school health practices and environments after 2 years. At student level no significant intervention effects were seen for the main outcomes.
School staff has the capacity to create their own solutions and make changes at school level on the basis of self-assessment and facilitation by external agents. However these changes were challenging to sustain over time and had little impact on student behaviours or weight status. Better student outcomes could probably be attained by a more focused and evidence-based approach with stepwise implementation of action plans.
PMCID: PMC3545832  PMID: 23245473
Children; Eating habits; Exercise; Fidelity; Health promotion; Obesity prevention; Process evaluation; Quasi-experimental study; Self-esteem
20.  The ENHANCES study—Enhancing Head and Neck Cancer patients’ Experiences of Survivorship: study protocol for a randomized controlled trial 
Trials  2014;15:191.
Few cancers pose greater challenges than head and neck (H&N) cancer. Residual effects following treatment include body image changes, pain, fatigue and difficulties with appetite, swallowing and speech. Depression is a common comorbidity. There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment. In this study, we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer.
This is a preliminary study in which 120 patients will be recruited. A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan (HNCP) involving pre- and post-intervention assessments will be used. Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms: (1) usual care, (2) information in the form of a written resource or (3) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support. The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP, based on principles of chronic disease self-management. Participants will be assessed at baseline, 3 and 6 months. The primary outcome measure is quality of life. The secondary outcome measures include mood, self-efficacy and health-care utilisation. The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses, managers and administrators. Interviews with patients who received the HNCP will explore their perceptions of the HNCP, including factors that assisted them in achieving behavioural change.
In this study, we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment. Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and, if successful, will be a model of care that can be implemented for diverse patient populations.
Trial registration
ACTRN12613000542796 (registered on 15 May 2013)
PMCID: PMC4053405  PMID: 24885486
Head and neck cancer; Self-management; Survivorship
21.  A process evaluation of a worksite vitality intervention among ageing hospital workers 
The process evaluation of the Vital@Work intervention was primary aimed at gaining insight into the context, dose delivered, fidelity, reach, dose received, and participants' attitude. Further, the differences between intervention locations were evaluated.
Eligible for this study were 730 workers, aged ≥ 45 years, from two academic hospitals. Workers randomised to the intervention group (n = 367) received a 6-months intervention consisting a Vitality Exercise Programme (VEP) combined with three visits to a Personal Vitality Coach (PVC), aimed at goal setting, feedback, and problem solving. The VEP consisted of a guided yoga session, a guided workout session, and aerobic exercising without direct face-to-face instruction, all once a week. Data were collected by means of a questionnaire after the intervention, attendance registration forms (i.e. attendance at guided VEP group sessions), and coaching registration forms (filled in by the PVCs).
The dose delivered of the yoga and workout sessions were 72.3% and 96.3%. All PVC visits (100%) were offered. The reach for the yoga sessions, workout sessions and PVC visits was 70.6%, 63.8%, and 89.6%, respectively. When taken these three intervention components together, the reach was 52%. This differed between the two locations (59.2% versus 36.8%). The dose received was for the yoga 10.4 sessions/24 weeks and for the workout 11.1 sessions/24 weeks. The attendance rate, defined as the mean percentage of attended group sessions in relation to the total provided group sessions, for the yoga and workout sessions was 51.7% and 44.8%, respectively. For the yoga sessions this rate was different between the two locations (63.2% versus 46.5%). No differences were found between the locations regarding the workout sessions and PVC visits. Workers attended on average 2.7 PVC visits. Overall, workers were satisfied with the intervention components: 7.5 for yoga sessions, 7.8 for workout sessions, and 6.9 for PVC visits.
The implementation of the intervention was accomplished as planned with respect to the dose delivered. Based on the reach, most workers were willing to attend the guided group sessions and the PVC visits, although there were differences between the locations and between intervention components. Overall, workers were positive about the intervention.
Trial registration
Trial registration NTR1240
PMCID: PMC3127968  PMID: 21663610
process evaluation; ageing workers; vitality; lifestyle intervention
22.  COSMOS—improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial 
Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients’ quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.
COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.
Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff’s knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.
Trial registration NCT02238652
PMCID: PMC4572450  PMID: 26374231
23.  Effect of a Community-Based Nursing Intervention on Mortality in Chronically Ill Older Adults: A Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001265.
Kenneth Coburn and colleagues report findings from a randomized trial evaluating the effects of a complex nursing intervention on mortality risk among older individuals diagnosed with chronic health conditions.
Improving the health of chronically ill older adults is a major challenge facing modern health care systems. A community-based nursing intervention developed by Health Quality Partners (HQP) was one of 15 different models of care coordination tested in randomized controlled trials within the Medicare Coordinated Care Demonstration (MCCD), a national US study. Evaluation of the HQP program began in 2002. The study reported here was designed to evaluate the survival impact of the HQP program versus usual care up to five years post-enrollment.
Methods and Findings
HQP enrolled 1,736 adults aged 65 and over, with one or more eligible chronic conditions (coronary artery disease, heart failure, diabetes, asthma, hypertension, or hyperlipidemia) during the first six years of the study. The intervention group (n = 873) was offered a comprehensive, integrated, and tightly managed system of care coordination, disease management, and preventive services provided by community-based nurse care managers working collaboratively with primary care providers. The control group (n = 863) received usual care. Overall, a 25% lower relative risk of death (hazard ratio [HR] 0.75 [95% CI 0.57–1.00], p = 0.047) was observed among intervention participants with 86 (9.9%) deaths in the intervention group and 111 (12.9%) deaths in the control group during a mean follow-up of 4.2 years. When covariates for sex, age group, primary diagnosis, perceived health, number of medications taken, hospital stays in the past 6 months, and tobacco use were included, the adjusted HR was 0.73 (95% CI 0.55–0.98, p = 0.033). Subgroup analyses did not demonstrate statistically significant interaction effects for any subgroup. No suspected program-related adverse events were identified.
The HQP model of community-based nurse care management appeared to reduce all-cause mortality in chronically ill older adults. Limitations of the study are that few low-income and non-white individuals were enrolled and implementation was in a single geographic region of the US. Additional research to confirm these findings and determine the model's scalability and generalizability is warranted.
Trial Registration NCT01071967
Please see later in the article for the Editors' Summary
Editors' Summary
In almost every country in the world, the proportion of people aged over 60 years is growing faster than any other age group because of increased life expectancy. This demographic change has several implications for public health, especially as older age is a risk factor for many chronic diseases—diseases of long duration and generally slow progression. Chronic diseases, such as heart disease, stroke, cancer, chronic respiratory diseases, and diabetes, are by far the leading cause of death in the world, representing almost two-thirds of all deaths. Therefore in most countries, the challenge of managing increasingly ageing populations who have chronic illnesses demands an urgent response and countries such as the United States are actively researching possible solutions.
Why Was This Study Done?
Some studies suggest that innovations in chronic disease management that are led by nurses may help address the epidemic of chronic diseases by increasing the quality and reducing the cost of care. However, to date, reports of the evaluation of such interventions lack rigor and do not provide evidence of improved long-term health outcomes or reduced health care costs. So in this study, the researchers used the gold standard of research, a randomized controlled trial, to examine the impact of a community-based nurse care management model for older adults with chronic illnesses in the United States as part of a series of studies supported by the Centers for Medicare and Medicaid Services.
What Did the Researchers Do and Find?
The researchers recruited eligible patients aged 65 years and over with heart failure, coronary heart disease, asthma, diabetes, hypertension, and/or hyperlipidemia who received traditional Medicare—a fee for service insurance scheme in which beneficiaries can choose to receive their care from any Medicare provider—from participating primary care practices in Pennsylvania. The researchers then categorized patients according to their risk on the basis of several factors including the number of chronic diseases each individual had before randomizing patients to receive usual care or the nurse-led intervention. The intervention included an individualized plan comprising education, symptom monitoring, medication, counseling for adherence, help identifying, arranging, and monitoring community health and social service referrals in addition to group interventions such as weight loss maintenance and exercise classes. The researchers checked whether any participating patients had died by using the online Social Security Death Master File. Then the researchers used a statistical model to calculate the risk of death in both groups.
Of the 1,736 patients the researchers recruited into the trial, 873 were randomized to receive the intervention and 863 were in the control group (usual care). The researchers found that 86 (9.9%) participants in the intervention group and 111 (12.9%) participants in the control group died during the study period, representing a 25% lower relative risk of death among the intervention group. However, when the researchers considered other factors, such as sex, age group, primary diagnosis, perceived health, number of medications taken, hospital stays in the past 6 months, and tobacco use in their statistical model, this risk was slightly altered—0.73 risk of death in the intervention group.
What Do These Findings Mean?
These findings suggest that that community-based nurse care management is associated with a reduction in all-cause mortality among older adults with chronic illnesses who are beneficiaries of the fee for service Medicare scheme in the United States. These findings also support the important role of nurses in improving health outcomes in this group of patients and show the feasibility of implementing this program in collaboration with primary care practices. Future research is needed to test the adaptability, scalability, and generalizability of this model of care.
Additional Information
Please access these Web sites via the online version of this summary at
This study is further discussed in a PLoS Medicine Perspective by Arlene Bierman
Information about the Centers for Medicare and Medicaid Services is available
The World Health Organization provides statistics on the prevalence of both chronic illness and ageing
Heath Quality Partners provide information about the study
PMCID: PMC3398966  PMID: 22815653
24.  Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study) 
Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked.
211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded.
Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients’ action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group.
It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects.
Trial registration
PMCID: PMC4055947  PMID: 24902481
Fidelity; Implementation; Medication adherence; Behaviour change techniques; Process evaluation
Preliminary studies of body therapy for women in trauma recovery suggest positive results but are not specific to women with post-traumatic stress disorder (PTSD) and chronic pain.
Objective and Participants
To examine the feasibility and acceptability of body-oriented therapy for female veterans with PTSD and chronic pain taking prescription analgesics.
Design and Setting
A 2-group, randomized, repeated-measures design was employed. Female veterans (N=14) were recruited from a Veterans Affairs (VA) healthcare system in the Northwest United States (VA Puget Sound Health Care System, Seattle, Washington). Participants were assigned to either treatment as usual (TAU) or treatment as usual and 8 weekly individual body-oriented therapy sessions (mindful awareness in body-oriented therapy group).
Written questionnaires and interviews were used assess intervention acceptability; reliable and valid measures were administered at 3 time points to evaluate measurement acceptability and performance; and within-treatment process measures and a participant post-intervention questionnaire assessed treatment fidelity.
A body-oriented therapy protocol, “Mindful Awareness in Body-oriented Therapy” (MABT) was used. This is a mind-body approach that incorporates massage, mindfulness, and the emotional processing of psychotherapy.
Over 10 weeks of recruitment, 31 women expressed interest in study participation. The primary reason for exclusion was the lack of prescription analgesic use for chronic pain. Study participants adhered to study procedures, and 100% attended at least 7 of 8 sessions; all completed in-person post-treatment assessment. Written questionnaires about intervention experience suggest increased tools for pain relief/relaxation, increased body/mind connection, and increased trust/safety. Ten of 14 responded to mailed 3-month follow-up. The response-to-process measures indicated the feasibility of implementing the manualized protocol and point to the need for longer sessions and a longer intervention period with this population.
PMCID: PMC3037268  PMID: 17985809

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