Implementation strategies in suicide prevention: a scoping review.

BACKGROUND: Implementation strategies can be a vital leveraging point for enhancing the implementation and dissemination of evidence-based suicide prevention interventions and programming. However, much remains unknown about which implementation strategies are commonly used and effective for supporting suicide prevention efforts. METHODS: In light of the limited available literature, a scoping review was conducted to evaluate implementation strategies present in current suicide prevention studies. We identified studies that were published between 2013 and 2022 that focused on suicide prevention and incorporated at least one implementation strategy. Studies were coded by two independent coders who showed strong inter-rater reliability. Data were synthesized using descriptive statistics and a narrative synthesis of findings. RESULTS: Overall, we found that studies most commonly utilized strategies related to iterative evaluation, training, and education. The majority of studies did not include direct measurement of suicide behavior outcomes, and there were few studies that directly tested implementation strategy effectiveness. CONCLUSION: Implementation science strategies remain an important component for improving suicide prevention and intervention implementation. Future research should consider the incorporation of more type 3 hybrid designs as well as increased systematic documentation of implementation strategies. TRIAL REGISTRATION: < de-identified > .

Maintaining Implementation through Dynamic Adaptations (MIDAS): protocol for a cluster-randomized trial of implementation strategies to optimize and sustain use of evidence-based practices in Veteran Health Administration (VHA) patients.

BACKGROUND: The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: (1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; (2) appropriate dosing and drug selection of direct oral anticoagulants (DOACs); and (3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies. METHODS: For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act. PROCESS: (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 18 months post-baseline. Each trial will also be analyzed independently. DISCUSSION: MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.

The LEAP Program: Quality Improvement Training to Address Team Readiness Gaps Identified by Implementation Science Findings.

BACKGROUND: Integrating evidence-based innovations (EBIs) into sustained use is challenging; most implementations in health systems fail. Increasing frontline teams' quality improvement (QI) capability may increase the implementation readiness and success of EBI implementation. OBJECTIVES: Develop a QI training program ("Learn. Engage. Act. Process." (LEAP)) and evaluate its impact on frontline obesity treatment teams to improve treatment delivered within the Veterans Health Administration (VHA). DESIGN: This was a pre-post evaluation of the LEAP program. MOVE! coordinators (N = 68) were invited to participate in LEAP; 24 were randomly assigned to four starting times. MOVE! coordinators formed teams to work on improvement aims. Pre-post surveys assessed team organizational readiness for implementing change and self-rated QI skills. Program satisfaction, assignment completion, and aim achievement were also evaluated. PARTICIPANTS: VHA facility-based MOVE! teams. INTERVENTIONS: LEAP is a 21-week QI training program. Core components include audit and feedback reports, structured curriculum, coaching and learning community, and online platform. MAIN MEASURES: Organizational readiness for implementing change (ORIC); self-rated QI skills before and after LEAP; assignment completion and aim achievement; program satisfaction. KEY RESULTS: Seventeen of 24 randomized teams participated in LEAP. Participants' self-ratings across six categories of QI skills increased after completing LEAP (p< 0.0001). The ORIC measure showed no statistically significant change overall; the change efficacy subscale marginally improved (p < 0.08), and the change commitment subscale remained the same (p = 0.66). Depending on the assignment, 35 to 100% of teams completed the assignment. Nine teams achieved their aim. Most team members were satisfied or very satisfied (81-89%) with the LEAP components, 74% intended to continue using QI methods, and 81% planned to continue improvement work. CONCLUSIONS: LEAP is scalable and does not require travel or time away from clinical responsibilities. While QI skills improved among participating teams and most completed the work, they struggled to do so amid competing clinical priorities.

The "State of Implementation" Progress Report (SIPREP): a pilot demonstration of a navigation system for implementation.

BACKGROUND: Implementation of new clinical programs across diverse facilities in national healthcare systems like the Veterans Health Administration (VHA) can be extraordinarily complex. Implementation is a dynamic process, influenced heavily by local organizational context and the individual staff at each medical center. It is not always clear in the midst of implementation what issues are most important to whom or how to address them. In recognition of these challenges, implementation researchers within VHA developed a new systemic approach to map the implementation work required at different stages and provide ongoing, detailed, and nuanced feedback about implementation progress. METHODS: This observational pilot demonstration project details how a novel approach to monitoring implementation progress was applied across two different national VHA initiatives. Stage-specific grids organized the implementation work into columns, rows, and cells, identifying specific implementation activities at the site level to be completed along with who was responsible for completing each implementation activity. As implementation advanced, item-level checkboxes were crossed off and cells changed colors, offering a visual representation of implementation progress within and across sites across the various stages of implementation. RESULTS: Applied across two different national initiatives, the SIPREP provided a novel navigation system to guide and inform ongoing implementation within and across facilities. The SIPREP addressed different needs of different audiences, both described and explained how to implement the program, made ample use of visualizations, and revealed both what was happening and not happening within and across sites. The final SIPREP product spanned distinct stages of implementation. CONCLUSIONS: The SIPREP made the work of implementation explicit at the facility level (i.e., who does what, and when) and provided a new common way for all stakeholders to monitor implementation progress and to help keep implementation moving forward. This approach could be adapted to a wide range of settings and interventions and is planned to be integrated into the national deployment of two additional VHA initiatives within the next 12 months.

Quality Improvement and Personalization for Statins: the QUIPS Quality Improvement Randomized Trial of Veterans' Primary Care Statin Use.

BACKGROUND: Implementation of new practice guidelines for statin use was very poor. OBJECTIVE: To test a multi-component quality improvement intervention to encourage use of new guidelines for statin use. DESIGN: Cluster-randomized, usual-care controlled trial. PARTICIPANTS: The study population was primary care visits for patients who were recommended statins by the 2013 guidelines, but were not receiving them. We excluded patients who were over 75 years old, or had an ICD9 or ICD10 code for end-stage renal disease, muscle pain, pregnancy, or in vitro fertilization in the 2 years prior to the study visit. INTERVENTIONS: A novel quality improvement intervention consisting of a personalized decision support tool, an educational program, a performance measure, and an audit and feedback system. Randomization was at the level of the primary care team. MAIN MEASURES: Our primary outcome was prescription of a medium- or high-strength statin. We studied how receiving the intervention changed care during the quality improvement intervention compared to before it and if that change continued after the intervention. KEY RESULTS: Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR 3.0, 95% CI 1.8-4.9), though the effect resolved after the personalized decision support ended (OR 1.7, 95% CI 0.99-2.77). CONCLUSIONS: A simple, personalized quality improvement intervention is promising for enabling the adoption of new guidelines. CLINICALTRIALS. GOV IDENTIFIER: NCT02820870.

The Phased Implementation of a National Telehealth Weight Management Program for Veterans: Mixed-Methods Program Evaluation.

BACKGROUND: The burden of obesity is high among US veterans, yet many face barriers to engaging in in-person, facility-based treatment programs. To improve access to weight-management services, the Veterans Health Administration (VHA) developed TeleMOVE, a home-based, 82-day curriculum that utilizes in-home messaging devices to promote weight loss in VHA patients facing barriers to accessing facility-based services. OBJECTIVE: The primary aim was to establish preliminary evidence for the program by comparing outcomes for TeleMOVE with standard, facility-based MOVE weight-management services (group, individual modalities) over the evaluation period based on the number of patients enrolled per site and the program's clinical effectiveness, as demonstrated by average weight lost per patient. The secondary aim was to understand factors influencing TeleMOVE implementation variability across demonstration sites to develop recommendations to improve national program dissemination. METHODS: We employed a formative mixed-methods design to evaluate the phased implementation of TeleMOVE at 9 demonstration sites and compare patient- and site-level measures of program uptake. Data were collected between October 1, 2009 and September 30, 2011. Patient-level program outcomes were extracted from VHA patient care databases to evaluate program enrollment rates and clinical outcomes. To assess preliminary clinical effectiveness, weight loss outcomes for veterans who enrolled in TeleMOVE were compared with outcomes for veterans enrolled in standard MOVE! at each demonstration site, as well as with national averages during the first 2 years of program implementation. For the secondary aim, we invited program stakeholders to participate in 2 rounds of semistructured interviews about aspects of TeleMOVE implementation processes, site-level contextual factors, and program delivery. Twenty-eight stakeholders participated in audio-recorded interviews. RESULTS: Although stakeholders at 3 sites declined to be interviewed, objective program uptake was high at 2 sites, delayed-high at 2 sites, and low at 5 sites. At 6 months post enrollment, the mean weight loss was comparable for TeleMOVE (n=417) and MOVE! (n=1543) participants at -5.2 lb (SD 14.4) and -5.1 lb (SD 12.2), respectively (P=.91). All sites reported high program complexity because TeleMOVE required more staff time per participant than MOVE! due to logistical and technical assistance issues related to the devices. High-uptake sites overcame implementation challenges by leveraging communication networks with stakeholders, adapting the program to patient needs whenever possible, setting programmatic goals and monitoring feedback of results, and taking time to reflect and evaluate on delivery to foster incremental delivery improvements, whereas low-uptake sites reported less leadership support and effective communication among stakeholders. CONCLUSIONS: This implementation evaluation of a clinical telehealth program demonstrated the value of partnership-based research in which researchers not only provided operational leaders with feedback regarding the effectiveness of a new program but also relevant feedback into contextual factors related to program implementation to enable adaptations for national deployment efforts.

Comprehensive process model of clinical information interaction in primary care: results of a "best-fit" framework synthesis.

Objective: To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. Materials and Methods: We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. Results: The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. Discussion: The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. Conclusion: The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.

Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial.

BACKGROUND: Small Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term. OBJECTIVE: The purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs. DESIGN: Following participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs. PARTICIPANTS: Three hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year. MAIN MEASURES: Twenty-four-month weight change (kg). KEY RESULTS: Twenty-four months after baseline, participants in all three groups had modest weight loss (-1.40 kg [-2.61 to -0.18] in the ASPIRE-Group, -2.13 kg [-3.43 to -0.83] in ASPIRE-Phone, and -1.78 kg [-3.07 to -0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (-2.6 kg [-4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92-4.69]) compared to those without diabetes. CONCLUSIONS: Participants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.

A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies.

PURPOSE: Walking programs improve health outcomes in adults at risk for cardiovascular disease and self-monitoring strategies can improve adherence to such programs. The objective of this study was to determine if a six-month internet-based walking program using web-enhanced pedometers results in more weight loss than walking programs based on time or simple pedometer-step count goals in adults with or at risk for cardiovascular disease (CVD). METHODS: This was a multi-site, randomized controlled trial of 255 male Veterans who were ambulatory, insufficiently active, BMI ≥ 28, and who reported 1 ≥ CVD risk factors. Participants were randomized to one of three self-monitoring strategies to increase walking: (1) time-based walking goals; (2) simple pedometer-based walking goals; and (3) web-enhanced pedometer feedback goals with Internet-mediated feedback. All participants also attended five individual weight loss sessions with a dietitian. The main outcome measure was change in weight at six months (kg) and secondary outcomes were change in accelerometer-measured physical activity (min) and change in health-related quality of life at six months. RESULTS: The 255 participants had a mean age of 56.3 years (SD = 10.0), BMI=36.3 (SD = 5.3) with a mean of 5.2 (SD = 2.3) medical comorbidities. Dropouts were distributed evenly across the three groups and 72% of participants completed the program. At six months, participants in the web-enhanced pedometer arm lost significantly more weight (-1.9 kg, 95% CI=-2.7, -1.1) than those in the time-based group (-0.7 kg, 95% CI=-1.5, 0.0; p = 0.04) and simple pedometer group (-0.6 kg, 95% CI=-1.4, 0.2; p = 0.02). CONCLUSION: Internet-enhanced pedometers result in greater weight loss in Veterans than walking programs using time-based walking goals or simple pedometers.

Small-changes obesity treatment among veterans: 12-month outcomes.

BACKGROUND: Weight-loss trials tend to recruit highly selective, non-representative samples. Effective weight-loss approaches are needed for real-world challenging populations. PURPOSE: To test whether a small-changes intervention, delivered in groups or via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-2012 and analyzed in 2013. DESIGN: A three-arm, 12-month randomized pragmatic effectiveness trial. SETTING/PARTICIPANTS: Four-hundred eighty-one overweight/obese participants from two Midwestern Veterans Affairs (VA) Medical Centers were randomly assigned to one of three programs: the 12-month Aspiring to Lifelong Health (ASPIRE) weight-loss program delivered (1) individually over the phone (ASPIRE-Phone) or (2) in-person group sessions (ASPIRE-Group); compared to (3) VA's standard weight-loss program (MOVE!). INTERVENTION: Twenty-eight sessions with a non-clinician coach via telephone or in-person groups using a small-changes obesity treatment approach compared to a 15-30-session standard VA program. MAIN OUTCOME MEASURES: Twelve-month change in weight (kilograms). RESULTS: Participants in all three arms lost significant (p<0.01) weight at 12 months. Participants in the ASPIRE-Group arm lost significantly more weight at 12 months than those in the other two treatment arms (-2.8 kg, 95% CI=-3.8, -1.9, in ASPIRE-Group vs -1.4 kg, 95% CI=-2.4, -0.5, in ASPIRE-Phone and -1.4 kg, 95% CI=-2.3, -0.4) in MOVE!(®). ASPIRE-Group resulted in greater improvements in all other anthropometric measures compared to MOVE! at 12 months (p<0.05) and for all (p<0.05) but waist circumference (p=0.23) compared to ASPIRE-Phone. CONCLUSIONS: Group-based delivery of the ASPIRE weight management program is more effective than MOVE! and the phone-based version of ASPIRE at promoting sustained weight loss in a predominantly male population with multiple comorbidities. The incremental benefits of group-based ASPIRE over the current MOVE! program could yield significant population-level benefits if implemented on a large scale.

Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR).

BACKGROUND: In the United States, as in many other parts of the world, the prevalence of overweight/obesity is at epidemic proportions in the adult population and even higher among Veterans. To address the high prevalence of overweight/obesity among Veterans, the MOVE!(®) weight management program was disseminated nationally to Veteran Affairs (VA) medical centers. The objective of this paper is two-fold: to describe factors that explain the wide variation in implementation of MOVE!; and to illustrate, step-by-step, how to apply a theory-based framework using qualitative data. METHODS: Five VA facilities were selected to maximize variation in implementation effectiveness and geographic location. Twenty-four key stakeholders were interviewed about their experiences in implementing MOVE!. The Consolidated Framework for Implementation Research (CFIR) was used to guide collection and analysis of qualitative data. Constructs that most strongly influence implementation effectiveness were identified through a cross-case comparison of ratings. RESULTS: Of the 31 CFIR constructs assessed, ten constructs strongly distinguished between facilities with low versus high program implementation effectiveness. The majority (six) were related to the inner setting: networks and communications; tension for change; relative priority; goals and feedback; learning climate; and leadership engagement. One construct each, from intervention characteristics (relative advantage) and outer setting (patient needs and resources), plus two from process (executing and reflecting) also strongly distinguished between high and low implementation. Two additional constructs weakly distinguished, 16 were mixed, three constructs had insufficient data to assess, and one was not applicable. Detailed descriptions of how each distinguishing construct manifested in study facilities and a table of recommendations is provided. CONCLUSIONS: This paper presents an approach for using the CFIR to code and rate qualitative data in a way that will facilitate comparisons across studies. An online Wiki resource (http://www.wiki.cfirwiki.net) is available, in addition to the information presented here, that contains much of the published information about the CFIR and its constructs and sub-constructs. We hope that the described approach and open access to the CFIR will generate wide use and encourage dialogue and continued refinement of both the framework and approaches for applying it.

Nurse practitioners as primary care providers within the VA.

We examined the perceptions of nurse practitioners (NPs) and physicians regarding NPs' roles as primary care providers within the Department of Veterans Affairs, thus suggesting possible reasons for the variation of NPs use. NPs and physicians from 7 Veterans Affairs hospitals were surveyed regarding perceptions and concerns about NPs' responsibilities. Quality of care was verified through outpatient services, laboratory results, and medications prescribed for 104,226 hypertensive or diabetic patients. Clinical findings suggest primary care for diabetic and hypertensive patients was comparable. Survey findings suggest physicians tended to underestimate what NPs do on their own for acute patients. Both groups expressed some concerns about expectations for NPs. To successfully integrate NPs into the primary care environment, health systems need to pay increased attention to differences in role perceptions among primary care providers.

A systematic exploration of differences in contextual factors related to implementing the MOVE! weight management program in VA: a mixed methods study.

BACKGROUND: In January 2006, Veterans Affairs (VA) disseminated the MOVE!® Weight Management Program to VA medical centers to address the high prevalence of overweight/obesity. In its second year, MOVE! implementation varied widely across facilities. The objective of this study was to understand contextual factors that facilitated or impeded implementation of MOVE! in VA medical centers in the second year after its dissemination. METHODS: We used an embedded mixed methods cross-sectional study design. Qualitative and quantitative data were collected simultaneously with the primary purpose to explore contextual factors most likely to influence MOVE! implementation effectiveness at five purposively selected facilities. Facilities were selected to maximize variation with respect to participation in MOVE! by candidate Veterans. Semi-structured phone interviews were conducted with 24 staff across the five facilities. Quantitative responses were elicited followed by open-ended questions. The quantitative measures were adapted from a published implementation model. Qualitative analysis was conducted using rigorous content analysis methods. RESULTS: Qualitative and quantitative data converged to strengthen findings that point to several recommendations. Management support can help increase visibility of the program, commit needed resources, and communicate the importance of implementation efforts. Establishing a receptive implementation climate can be accomplished by emphasizing the important role that weight management may have in reducing incidence and severity of obesity-related chronic conditions. Coalescing highly functioning multi-disciplinary teams was an essential step for more effective implementation of MOVE!. In some situations, local champions can overcome challenging barriers in facilities that lack sufficient management support. CONCLUSIONS: Key organizational factors at local VA medical centers were strongly associated with MOVE! implementation. Results pointed to recommendations that can help accelerate large-scale dissemination of complex weight management programs.

A quick measure to guide allocation of chaplains' time with hospitalized veterans.

Assessing veterans' desire to see a chaplain can be difficult. Due to alleged personal weakness associated with seeing a chaplain while on active duty, veterans may still be reluctant to admit a need. Additionally chaplains may be challenged with multiple time demands. We devised and correlated with known instruments a single item containing four graded responses. One correlation was strong, suggesting the question's potential for serving as a useful tool for allocation of chaplains' time.

Using Electronic Health Record Systems in Diabetes Care: Emerging Practices.

While there has been considerable attention devoted to the deployment of electronic health record (EHR) systems, there has been far less attention given to their appropriation for use in clinical encounters - particularly in the context of complex, chronic illness. The Department of Veterans' Affairs (VA) has been at the forefront of EHR adoption and, as such, provides a unique opportunity to examine a mature EHR system in widespread use. Moreover, with a high prevalence of diabetes in its patient population, the VA provides a useful platform for examining EHR use in the context of chronic disease care. We conducted a sequential, exploratory qualitative study at two VA Medical Centers in the Midwest. First, we conducted observations of 64 clinical consultations with diabetes patients. These observations involved 31 different health care providers. Second, using insights from these observations, we conducted in-depth, semi-structured interviews with 39 health care providers focusing on their use of information in diabetes patient care. Field notes and interview transcripts were analyzed using a grounded theory approach. Our analysis generated several categories of EHR use in clinical encounters: priming, structuring, assessing, informing, and continuing. We also outline some mismatches between EHR system design and VA diabetes care practices. We conclude by discussing implications of these emergent system uses for improving the software design of EHRs to better support chronic disease care, as well as for our understanding of the integration of technologies in health care.

A small-change approach delivered via telephone promotes weight loss in veterans: results from the ASPIRE-VA pilot study.

OBJECTIVE: High rates of overweight and obesity (70%) among US veterans pose a significant threat of obesity-related chronic disease and disability. The purpose of this pilot study was to demonstrate feasibility and impact of a phone-based small-change weight loss intervention (ASPIRE-VA) with veterans. METHODS: Participants received a pedometer, food log book, and treatment manual outlining the small change program. Participants then scheduled weekly phone calls with a lifestyle coach, during which they reviewed the prior week's goals and developed new goals for the following week. Primary outcome was weight loss measured at 12 weeks, compared to baseline. RESULTS: Fourteen sedentary (4471+/-2315 steps per day), obese (37.0+/-4.2 BMI), middle aged (53.8+/-12.5) male (64%) and female (36%) participants were enrolled. At 12 weeks participants exhibited significant weight loss (-3.8+/-3.6 kg; p=.002) and increased intake of fruits and vegetables (+2.2+/-3.1 daily servings; p=.03); though no change in walking (+786+/-2288 daily steps; p=.24). CONCLUSION: Results suggest that a phone-based small change program is feasible and beneficial for promoting weight loss in overweight/obese veterans. PRACTICE IMPLICATIONS: This telephone-based program has the potential to reduce rates of overweight and obesity among veterans and thus prevent and improve prognosis of associated chronic conditions.

Fidelity of implementation: development and testing of a measure.

BACKGROUND: Along with the increasing prevalence of chronic illness has been an increase in interventions, such as nurse case management programs, to improve outcomes for patients with chronic illness. Evidence supports the effectiveness of such interventions in reducing patient morbidity, mortality, and resource utilization, but other studies have produced equivocal results. Often, little is known about how implementation of an intervention actually occurs in clinical practice. While studies often assume that interventions are used in clinical practice exactly as originally designed, this may not be the case. Thus, fidelity of an intervention's implementation reflects how an intervention is, or is not, used in clinical practice and is an important factor in understanding intervention effectiveness and in replicating the intervention in dissemination efforts. The purpose of this paper is to contribute to the understanding of implementation science by (a) proposing a methodology for measuring fidelity of implementation (FOI) and (b) testing the measure by examining the association between FOI and intervention effectiveness. METHODS: We define and measure FOI based on organizational members' level of commitment to using the distinct components that make up an intervention as they were designed. Semistructured interviews were conducted among 18 organizational members in four medical centers, and the interviews were analyzed qualitatively to assess three dimensions of commitment to use--satisfaction, consistency, and quality--and to develop an overall rating of FOI. Mixed methods were used to explore the association between FOI and intervention effectiveness (inpatient resource utilization and mortality). RESULTS: Predictive validity of the FOI measure was supported based on the statistical significance of FOI as a predictor of intervention effectiveness. The strongest relationship between FOI and intervention effectiveness was found when an alternative measure of FOI was utilized based on individual intervention components that had the greatest variation across medical centers. CONCLUSIONS: In addition to contextual factors, implementation research needs to consider FOI as an important factor in influencing intervention effectiveness. Our proposed methodology offers a systematic means for understanding organizational members' use of distinct intervention components, assessing the reasons for variation in use across components and organizations, and evaluating the impact of FOI on intervention effectiveness.

Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.

BACKGROUND: Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. METHODS: We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. RESULTS: The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. CONCLUSION: The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

Prospective analysis of long-term psychosocial outcomes in breast reconstruction: two-year postoperative results from the Michigan Breast Reconstruction Outcomes Study.

OBJECTIVE: To prospectively evaluate the psychosocial outcomes and body image of patients 2 years postmastectomy reconstruction using a multicenter, multisurgeon approach. BACKGROUND: Although breast reconstruction has been shown to confer significant psychosocial benefits in breast cancer patients at year 1 postreconstruction, we considered the possibility that psychosocial outcomes may remain in a state of flux for years after surgery. METHODS: Patients were recruited as part of the Michigan Breast Reconstruction Outcome Study, a 12 center, 23 surgeon prospective cohort study of mastectomy reconstruction patients. Two-sided paired sample t tests were used to compare change scores for the various psychosocial subscales. Multiple regression analysis was used to determine whether the magnitude of the change score varied by procedure type. RESULTS: Preoperative and postoperative year 2 surveys were received from 173 patients; 116 with immediate and 57 with delayed reconstruction. For the immediate reconstruction cohort, significant improvements were observed in all psychosocial subscales except for body image. This occurred essentially independent of procedure type. In the cohort with delayed reconstruction, significant change scores were observed only in body image. Women with transverse rectus abdominis musculocutaneous flaps had significantly greater gains in body image scores (P = 0.003 and P = 0.034, respectively) when compared with expander/implants. CONCLUSIONS: General psychosocial benefits and body image gains continued to manifest at 2 years postmastectomy reconstruction. In addition, procedure type had a surprisingly limited effect on psychosocial well being. With outcomes evolving beyond year 1, these data support the need for additional longitudinal breast reconstruction outcome studies.