Adaptive Designs in Implementation Science and Practice: Their Promise and the Need for Greater Understanding and Improved Communication.

The promise of adaptation and adaptive designs in implementation science has been hindered by the lack of clarity and precision in defining what it means to adapt, especially regarding the distinction between adaptive study designs and adaptive implementation strategies. To ensure a common language for science and practice, authors reviewed the implementation science literature and found that the term adaptive was used to describe interventions, implementation strategies, and trial designs. To provide clarity and offer recommendations for reporting and strengthening study design, we propose a taxonomy that describes fixed versus adaptive implementation strategies and implementation trial designs. To improve impact, (a) future implementation studies should prespecify implementation strategy core functions that in turn can be taught to and replicated by health system/community partners, (b) funders should support exploratory studies that refine and specify implementation strategies, and (c) investigators should systematically address design requirements and ethical considerations (e.g., randomization, blinding/masking) with health system/community partners. Expected final online publication date for the Annual Review of Public Health, Volume 45 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Core implementation strategies for improving cirrhosis care in the Veterans Health Administration.

BACKGROUND AND AIMS: The Veterans Health Administration (VHA) provides care for more than 80,000 veterans with cirrhosis. This longitudinal, multimethod evaluation of a cirrhosis care quality improvement program aimed to (1) identify implementation strategies associated with evidence-based, guideline-concordant cirrhosis care over time, and (2) use qualitative interviews to operationalize strategies for a manualized intervention. APPROACH AND RESULTS: VHA providers were surveyed annually about the use of 73 implementation strategies to improve cirrhosis care in fiscal years 2018 (FY18) and 2019 (FY19). Implementation strategies linked to guideline-concordant cirrhosis care were identified using bivariate statistics and comparative configurational methods. Semistructured interviews were conducted with 12 facilities in the highest quartile of cirrhosis care to specify the successful implementation strategies and their mechanisms of change. A total of 106 VHA facilities (82%) responded at least once over the 2-year period (FY18, n = 63; FY19, n = 100). Facilities reported using a median of 12 (interquartile range [IQR] 20) implementation strategies in FY18 and 10 (IQR 19) in FY19. Of the 73 strategies, 35 (48%) were positively correlated with provision of evidence-based cirrhosis care. Configurational analysis identified multiple strategy pathways directly linked to more guideline-concordant cirrhosis care. Across both methods, a subset of eight strategies was determined to be core to cirrhosis care improvement and specified using qualitative interviews. CONCLUSIONS: In a national cirrhosis care improvement initiative, a multimethod approach identified a core subset of successful implementation strategy combinations. This process of empirically identifying and specifying implementation strategies may be applicable to other implementation challenges in hepatology.

Barriers and Enablers to Implementing Peer Specialists in Veterans Health Administration Primary Care: a Qualitative Study.

BACKGROUND: Peer specialists (PSs) are increasingly deployed in a variety of settings to provide patient-centered care. In the Veterans Health Administration (VHA), efforts are underway to integrate PSs into primary care settings. Little is known about the barriers and enablers to implementing PS services in primary care. OBJECTIVE: To characterize barriers and enablers to implementing PSs in primary care. DESIGN: Qualitative study using semi-structured interviews. PARTICIPANTS: PSs and their supervisors from 25 VHA primary care settings. APPROACH: PSs and supervisors were interviewed about their experiences integrating PSs in primary care. Rapid analysis was conducted to identify barriers and enablers to PS integration, as well as to examine the role of external facilitation in implementation experiences. KEY RESULTS: Fifty-two interviews were completed (25 PSs from 19 sites and 27 supervisors from 24 sites). Barriers and enablers to PS integration in VHA primary care settings included PS role clarity and constraints, provider buy-in, supervision, leadership support, and primary care culture. The barriers and enablers were consistent across both external facilitation and control sites. CONCLUSIONS: Results describe how the characteristics of the innovation, the recipients, and the context impact successful implementation of PSs in primary care settings. The identification of barriers and enablers holds promise for improving future efforts to embed PSs in primary care. TRIAL REGISTRATION: This project is registered at ClinicalTrials.gov with number NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 ).

Integrating stakeholder feedback into the design of a peer-delivered primary care wellness program: A rapid qualitative study.

BACKGROUND: Individuals seen in Primary Care with behavioral health concerns who decline behavioral health treatment may benefit from the support of peers (consumers in recovery from behavioral health concerns employed to support other consumers). Whole Health STEPS is a new intervention for Veterans in Primary Care with behavioral health concerns which combines essential elements of peers' role and the Whole Health model using a stepped-care design. We incorporated stakeholder feedback in the Whole Health STEPS design to improve fit with Veterans, peers, and primary care settings. METHODS: We conducted semi-structured qualitative interviews with VA staff using questions derived from the Consolidated Framework for Implementation Research (CFIR). Participants were recruited via a maximum variation strategy across a national sample and interviewed between January 2021-April 2021. The analytic design was a rapid qualitative analysis. Interviews addressed design decisions and potential barriers and facilitators to future implementation. Then, we made adaptations to Whole Health STEPS and catalogued changes using the Framework for Adaptations and Modifications-Enhanced (FRAME). A VA peer conducted the interviews, participated in analyses, assisted with design modifications, and co-wrote this paper. RESULTS: Sixteen staff members from 9 VA primary care peer programs participated (8 peers and 8 supervisors/administrators). Feedback themes included: capitalizing on peer skills (e.g., navigation), ensuring patient-centered and flexible design, and making it easy and efficient (e.g., reducing session length). Understanding the structure of primary care peers' roles and their interactions with other programs helped us identify role conflicts (e.g., overlap with Whole Health Coaches and Health Behavior Coordinators), which led to design modifications to carve out a unique role for Whole Health STEPS. Staff also made recommendations about marketing materials and training tools to support Whole Health STEPS roll out. CONCLUSIONS: Feedback from frontline staff, including peers, in the design process was crucial to identifying essential modifications that would not have been possible after initial trials without re-evaluating efficacy due to the extent of the changes. Whole Health STEPS was adapted to fit within a range of program structures, emphasize peers' unique contributions, and streamline delivery. Lessons learned can be applied to other interventions.

Improving Sexual Assault and Sexual Harassment Prevention from the Bottom-up: a Pilot of Getting To Outcomes in the US Military.

While the Department of Defense (DoD) has given increased attention and priority to preventing sexual assault and sexual harassment (SA/SH), it remains a problem. To build its prevention capacity, DoD piloted Getting To Outcomes® (GTO®) from 2019 to 2022 at 10 military installations. GTO is an evidence-based planning and implementation support that has been used in many civilian contexts but has only recently been adapted for military SA/SH. The purpose of this study was to describe GTO use, identify its benefits and challenges, and discuss lessons the GTO effort yielded for prevention more broadly using a framework of organizational and program-level capacities needed for successful prevention in the military context, called the Prevention Evaluation Framework (PEF). GTO was piloted with 10 military installations ("sites") representing all Military Services, plus the Coast Guard and National Guard. GTO is comprised of a written guide, training, and ongoing coaching. The pilot's goal was for each site to use GTO to implement a SA/SH prevention program twice. Participants from each site were interviewed and data was collected on GTO steps completed, whether GTO spurred new evaluation activities and collaborations, and the degree of leadership support for GTO. Most sites completed all GTO steps at least once. Interviews showed that DoD participants believe GTO improved prevention understanding, planning, and evaluation capacity; strengthened confidence in chosen programs; and helped sites tailor programs to the military context. Barriers were the complexity of GTO, DoD personnel turnover, and the disruption that the COVID pandemic caused in sexual assault prevention program delivery. Many respondents were unsure if they would continue all of GTO after the coaching ended, but many believed they would continue at least some parts. According to the PEF, the GTO pilot revealed several additional prevention system gaps (e.g., need for leadership support) and changes needed to GTO (e.g., stronger leader and champion engagement), to support quality prevention. The military and other large organizations will need to focus on these issues to ensure prevention implementation and evaluation are conducted with quality.

Development and Pilot Test of the Competency Assessment for Sexual Assault Prevention Practitioners.

Sexual assault is a preventable problem that is widespread and particularly prevalent for certain populations (e.g., female college students, Native American women). Despite the gravity of this public health priority, most individuals tasked with the primary prevention of sexual assault are not adequately trained for the job (e.g., professionals often trained solely in sexual assault response). To achieve optimal outcomes, professionals responsible for implementing sexual assault prevention must possess certain core competencies, or knowledge and skills essential for job performance, which include those needed for any primary prevention effort in addition to those specific to sexual assault prevention. The purpose of this study was to develop and assess the construct validity of a competency assessment tool for sexual assault prevention practitioners. An existing assessment tool, which was designed for injury and violence prevention practitioners, was tailored to reflect competencies needed by sexual assault prevention practitioners as informed by the literature. The newly tailored measure was pilot tested with 33 individuals with varying levels of expertise with sexual assault prevention. These individuals were categorized into three groups based on self-rated sexual assault prevention expertise (low, medium, or high) to assess group differences. As expected, the high expertise group rated higher knowledge in all the competencies than the medium and low expertise groups (except for the competency pertaining to developing and maintaining competency). Data collection and analyses were conducted in 2020. Implications for how the assessment tool can be used to identify gaps among individual practitioners and teams of practitioners are discussed.

Implementing Peer Specialists in Suicide Prevention Efforts in the Veterans Health Administration.

OBJECTIVE: The Veterans Health Administration (VHA) recognizes peer support as an underused intervention in suicide prevention. PREVAIL is a peer-based suicide prevention intervention that was designed and piloted with non-veteran patients recently hospitalized for suicidal thoughts or behaviors. The purpose of this study was to elicit veteran and stakeholder feedback to inform the adaptation of PREVAIL for piloting with veterans flagged for high suicide risk. METHODS: Semi-structured interviews were conducted with multiple stakeholders from a VHA medical center in the northeast. Interviews focused on the perceived benefits and concerns of peer specialists directly addressing suicide risk with veterans. Interviews were recorded, transcribed, and analyzed using rapid qualitative analysis. RESULTS: Interviewees included clinical directors (n = 3), suicide prevention coordinators (n = 1), outpatient psychologists (n = 2), peer specialists (n = 1), and high-risk veterans (n = 2). Overall, peer specialists were viewed as possessing many distinct strengths in engaging and helping high-risk veterans as part of a team approach. Concerns included liability, adequate training, clinical supervision and support, and self-care for peer specialists. CONCLUSIONS: Findings indicated support and confidence that peer support specialists would be a valuable addition and could help fill existing gap in VHA's suicide prevention efforts.

Using Intervention Mapping to Develop a Novel Pain Self-Management Intervention for People with Cirrhosis.

BACKGROUND: Chronic pain is common among patients with cirrhosis and is challenging to treat. While promising, pain self-management (PSM) interventions have not been tailored to this population's needs. AIMS: To design a PSM intervention for patients with cirrhosis. METHODS: Semi-structured interviews with 17 patients with cirrhosis, 12 hepatologists, and 6 administrators from two medical centers were conducted to inform a rigorous, structured intervention mapping (IM) process. Qualitative content analysis was guided by social cognitive theory (SCT) and the Consolidated Framework for Implementation Research (CFIR) and incorporated into intervention development. A planning group met regularly throughout the intervention, to reach consensus about how to use data and theory to develop the intervention through IM. RESULTS: Participants described barriers to PSM behaviors, including the absence of simple, evidence-based interventions for pain for patients with cirrhosis, inadequate provider knowledge, time, and training, and lack of champions, funding, and communication. Patients described high motivation to treat pain using behavioral methods including meditation, prayer, and exercise. The intervention was designed to address barriers to PSM behaviors for patients with cirrhosis, using behavior change methods that address knowledge, self-efficacy, and outcome expectations. The LEAP (Liver Education About Pain) intervention is a 12-week, modular intervention delivered by phone via individual and group sessions with a health coach. CONCLUSIONS: People with cirrhosis, hepatologists, and administrators informed this theory-driven, tailored PSM intervention, which was designed to be implementable in the real world.

"What We Have Here, Is a Failure to [Replicate]": Ways to Solve a Replication Crisis in Implementation Science.

Adapting the classic line from the 1967 film Cool Hand Luke, the title is meant to convey that implementation science (IS), like other fields, has not been embracing replication studies, which is a key component to the open science movement. The purpose of this article is to review what is known about replication of implementation trials and identify the gaps and next steps to continue increasing the transparency, openness, and replicability of implementation research. After presenting an overview of study replication and how it is a key component of open science, the article will examine how replication of implementation studies has (or more accurately has not) been approached in IS. As will be discussed, replication in IS shares some challenges with studies that attempt to replicate interventions, but also presents unique challenges. This article discusses different types of replications (e.g., direct vs. conceptual) and how they can benefit the field of IS. The article then presents a specific example of an implementation strategy called Getting To Outcomes© to describe how to design a replication study and interpret the results. The article ends with multiple options implementation scientists could consider to improve the likelihood and quality of replication studies. The discussion also envisions how implementation science can enable researchers and practitioners to work together in real-world contexts to encourage wide replication of implementation studies and advance the goal of improving public health.

Explaining Service Use and Residential Stability in Supported Housing: Problems, Preferences, Peers.

BACKGROUND: The behavioral model of health service use identified health needs, service preferences (predispositions), and service availability (enabling factors) as important predictors, but research has not conceptualized consistently each type of influence nor identified their separate effects on use of substance abuse and mental health services or their value in predicting service outcomes. OBJECTIVES: To test hypotheses predicting use of substance abuse and mental health services and residential stability and evaluate peer specialists' impact. RESEARCH DESIGN: Randomized trial of peer support added to standard case management in VA-supported housing program (Housing and Urban Development-VA Supportive Housing program). SUBJECTS: One hundred sixty-six dually diagnosed Veterans in Housing and Urban Development-VA Supportive Housing program in 2 cities. MEASURES: Average VA service episodes for substance abuse and mental illness; residential instability; preferences for alcohol, drug, and psychological services; extent of alcohol, drug, and psychological problems; availability of a peer specialist. RESULTS: Self-assessed health needs, mediated by service preferences, and assignment to a peer specialist predicted use of VA behavioral health services and residential stability, as did chronic medical problems, sex, and race. CONCLUSIONS: The behavioral model identifies major predictors of health service use and residential stability, but must recognize the mediating role of service preferences, the differing effects of alcohol and drug use, the unique influences of social background, and the importance of clinical judgment in needs assessment. Service availability and residential stability can be increased by proactive efforts involving peer specialists even in a health care system that provides services without a financial barrier.

Mapping the road to elimination: a 5-year evaluation of implementation strategies associated with hepatitis C treatment in the veterans health administration.

BACKGROUND: While few countries and healthcare systems are on track to meet the World Health Organization's hepatitis C virus (HCV) elimination goals, the US Veterans Health Administration (VHA) has been a leader in these efforts. We aimed to determine which implementation strategies were associated with successful national viral elimination implementation within the VHA. METHODS: We conducted a five-year, longitudinal cohort study of the VHA Hepatic Innovation Team (HIT) Collaborative between October 2015 and September 2019. Participants from 130 VHA medical centers treating HCV were sent annual electronic surveys about their use of 73 implementation strategies, organized into nine clusters as described by the Expert Recommendations for Implementing Change taxonomy. Descriptive and nonparametric analyses assessed strategy use over time, strategy attribution to the HIT, and strategy associations with site HCV treatment volume and rate of adoption, following the Theory of Diffusion of Innovations. RESULTS: Between 58 and 109 medical centers provided responses in each year, including 127 (98%) responding at least once, and 54 (42%) responding in all four implementation years. A median of 13-27 strategies were endorsed per year, and 8-36 individual strategies were significantly associated with treatment volume per year. Data warehousing, tailoring, and patient-facing strategies were most commonly endorsed. One strategy-"identify early adopters to learn from their experiences"-was significantly associated with HCV treatment volume in each year. Peak implementation year was associated with revising professional roles, providing local technical assistance, using data warehousing (i.e., dashboard population management), and identifying and preparing champions. Many of the strategies were driven by a national learning collaborative, which was instrumental in successful HCV elimination. CONCLUSIONS: VHA's tremendous success in rapidly treating nearly all Veterans with HCV can provide a roadmap for other HCV elimination initiatives.

Health service preferences among veterans in supported housing in relation to needs expressed and services used.

BACKGROUND: Understanding consumer service preferences is important for recovery-oriented care. AIMS: To test the influence of perceived service needs on importance attached to treatment for alcohol, drug, mental health, and physical health problems and identify the influence of service needs and preferences on service use. METHODS: Formerly homeless dually diagnosed Veterans in supported housing were surveyed in three waves for 1 year, with measures of treatment interests, health problems, social support, clinician-assessed risk of housing loss, and sociodemographics. Multiple regression analysis was used to identify independent influences on preferences in each wave. Different health services at the VA were distinguished in administrative records and baseline predictors for services used throughout the project were identified with multiple regression analysis. RESULTS: Self-assessed problem severity was associated with the importance of treatment for alcohol, drug, mental health, and physical health problems. Social support also had some association with treatment interest for alcohol abuse, as did baseline clinician risk rating at the project's end. Preferences, but not perceived problem severity, predicted the use of the corresponding health services. CONCLUSIONS: The health beliefs model of service interests was supported, but more integrated service delivery models may be needed to strengthen the association of health needs with service use.

Pre-implementation Evaluation of PARTNER-MH: A Mental Healthcare Disparity Intervention for Minority Veterans in the VHA.

To design PARTNER-MH, a peer-led, patient navigation program for implementation in Veterans Health Administration (VHA) mental health care settings, we conducted a pre-implementation evaluation during intervention development to assess stakeholders' views of the intervention and to explore implementation factors critical to its future adoption. This is a convergent mixed-methods study that involved qualitative semi-structured interviews and survey data. Data collection was guided by the Consolidated Framework for Implementation Research (CFIR). We interviewed and administered the surveys to 23 peers and 10 supervisors from 12 midwestern VHA facilities. We used deductive and inductive approaches to analyze the qualitative data. We also conducted descriptive analysis and Fisher Exact Test to compare peers and supervisors' survey responses. We triangulated findings to refine the intervention. Overall, participants viewed PARTNER-MH favorably. However, they saw the intervention's focus on minority Veterans and social determinants of health framework as potential barriers, believing this could negatively affect the packaging of the intervention, complicate its delivery process, and impact its adoption. They also viewed clinic structures, available resources, and learning climate as potential barriers. Peers and supervisors' selections and discussions of CFIR items were similar. Our findings informed PARTNER-MH development and helped identify factors that could impact its implementation. This project is responsive to the increasing recognition of the need to incorporate implementation science in healthcare disparities research. Understanding the resistance to the intervention's focus on minority Veterans and the potential barriers presented by contextual factors positions us to adjust the intervention prior to testing, in an effort to maximize implementation success.

Impact of Peer Specialist Services on Residential Stability and Behavioral Health Status Among Formerly Homeless Veterans With Cooccurring Mental Health and Substance Use Conditions.

OBJECTIVES: This study tested the impacts of peer specialists on housing stability, substance abuse, and mental health status for previously homeless Veterans with cooccurring mental health issues and substance abuse. METHODS: Veterans living in the US Housing and Urban Development-Veterans Administration Supported Housing (HUD-VASH) program were randomized to peer specialist services that worked independently from HUD-VASH case managers (ie, not part of a case manager/peer specialist dyad) and to treatment as usual that included case management services. Peer specialist services were community-based, using a structured curriculum for recovery with up to 40 weekly sessions. Standardized self-report measures were collected at 3 timepoints. The intent-to-treat analysis tested treatment effects using a generalized additive mixed-effects model that allows for different nonlinear relationships between outcomes and time for treatment and control groups. A secondary analysis was conducted for Veterans who received services from peer specialists that were adherent to the intervention protocol. RESULTS: Treated Veterans did not spend more days in housing compared with control Veterans during any part of the study at the 95% level of confidence. Veterans assigned to protocol adherent peer specialists showed greater housing stability between about 400 and 800 days postbaseline. Neither analysis detected significant effects for the behavioral health measures. CONCLUSIONS: Some impact of peer specialist services was found for housing stability but not for behavioral health problems. Future studies may need more sensitive measures for early steps in recovery and may need longer time frames to effectively impact this highly challenged population.

Strategy Configurations Directly Linked to Higher Hepatitis C Virus Treatment Starts: An Applied Use of Configurational Comparative Methods.

BACKGROUND: The Department of Veterans Affairs (VA) cares for more patients with hepatitis C virus (HCV) than any other US health care system. We tracked the implementation strategies that VA sites used to implement highly effective new treatments for HCV with the aim of uncovering how combinations of implementation strategies influenced the uptake of the HCV treatment innovation. We applied Configurational Comparative Methods (CCMs) to uncover causal dependencies and identify difference-making strategy configurations, and to distinguish higher from lower HCV treating sites. METHODS: We surveyed providers to assess VA sites' use of 73 implementation strategies to promote HCV treatment in the fiscal year 2015. CCMs were used to identify strategy configurations that uniquely distinguished higher HCV from lower HCV treating sites. RESULTS: From the 73 possible implementation strategies, CCMs identified 5 distinct strategy configurations, or "solution paths." These were comprised of 10 individual strategies that collectively explained 80% of the sites with higher HCV treatment starts with 100% consistency. Using any one of the following 5 solution paths was sufficient to produce higher treatment starts: (1) technical assistance; (2) engaging in a learning collaborative AND designating leaders; (3) site visits AND outreach to patients to promote uptake and adherence; (4) developing resource sharing agreements AND an implementation blueprint; OR (5) creating new clinical teams AND sharing quality improvement knowledge with other sites AND engaging patients. There was equifinality in that the presence of any one of the 5 solution paths was sufficient for higher treatment starts. CONCLUSIONS: Five strategy configurations distinguished higher HCV from lower HCV treating sites with 100% consistency. CCMs represent a methodological advancement that can help inform high-yield implementation strategy selection and increase the efficiency and effectiveness of future implementation efforts.

Cost analysis of a randomized trial of Getting to Outcomes implementation support for a teen pregnancy prevention program offered in Boys and Girls Clubs in Alabama and Georgia.

Implementation support can improve outcomes of evidence-based programs (EBP) for adolescents, but with a cost. To assist in determining whether this cost is worthwhile, this study estimated the cost of adding Getting To Outcomes© (GTO) implementation support to a teen pregnancy and sexually transmitted infection prevention EBP called Making Proud Choices (MPC) in 32 Boys and Girls Clubs (BGCs) in Alabama and Georgia. Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS) was a 2-year, cluster-randomized controlled trial comparing MPC with MPC + GTO. We used micro-costing to estimate costs and captured MPC and GTO time from activity logs completed by GTO staff. Key resource use and cost components were compared between the randomized groups, years, and states (to capture different community site circumstances) using 2-sample t tests. There were no significant differences between randomized groups in attendees per site, resource use, or costs for either year. However, there were significant differences between states. Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama. The higher Alabama cost was due to longer travel distances and to more BGC staff time spent on GTO in that state. GTO also improved adherence, classroom delivery, and condom-use intentions more in Alabama youth. Thus, Alabama's GTO-related BGC staff time costs may be better estimates of effective GTO. If teen childbearing costs taxpayers approximately $20,000 per teen birth, adding GTO to MPC would be worthwhile to society if it prevented one more teen birth per 140 attendees than MPC alone.Trial registration. ClinicalTrials.gov , NCT01818791. Registered March 26, 2013, https://clinicaltrials.gov/ct2/show/NCT01818791?term=NCT01818791&draw=2&rank=1.

Sustaining an Evidence-Based Program Over Time: Moderators of Sustainability and the Role of the Getting to Outcomes® Implementation Support Intervention.

Problematic rates of alcohol, e-cigarette, and other drug use among US adolescents highlight the need for effective implementation of evidence-based programs (EBPs), yet schools and community organizations have great difficulty implementing and sustaining EBPs. Although a growing number of studies show that implementation support interventions can improve EBP implementation, the literature on how to improve sustainability through implementation support is limited. This randomized controlled trial advances the literature by testing the effects of one such implementation intervention-Getting To Outcomes (GTO)-on sustainability of CHOICE, an after-school EBP for preventing substance use among middle-school students. CHOICE implementation was tracked for 2 years after GTO support ended across 29 Boys and Girls Club sites in the greater Los Angeles area. Predictors of sustainability were identified for a set of key tasks targeted by the GTO approach (e.g., goal setting, evaluation, collectively called "GTO performance") and for CHOICE fidelity using a series of path models. One year after GTO support ended, we found no differences between GTO and control sites on CHOICE fidelity. GTO performance was also similar between groups; however, GTO sites were superior in conducting evaluation. Better GTO performance predicted better CHOICE fidelity. Two years after GTO support ended, GTO sites were significantly more likely to sustain CHOICE implementation when compared with control sites. This study suggests that using an implementation support intervention like GTO can help low-resource settings continue to sustain their EBP implementation to help them get the most out of their investment. ClinicalTrials.gov Identifier: NCT02135991.

Cost Analysis of a Randomized Trial of Getting to Outcomes Implementation Support of CHOICE in Boys and Girls Clubs in Southern California.

Costs of supporting prevention program implementation are not well known. This study estimates the societal costs of implementing CHOICE, a voluntary after-school alcohol and other drug prevention program for adolescents, in Boys and Girls Clubs (BGCs) across Southern California with and without an implementation support system called Getting To Outcomes© (GTO). This article uses micro-costing methods to estimate the cost of the CHOICE program and GTO support. Labor and expense data were obtained from logs kept by the BGC staff and by the GTO technical assistance (TA) staff, and staff time was valued based on Bureau of Labor Statistics estimates. From the societal perspective, the cost of implementing CHOICE at BGCs over the 2-year study period was $27 per attendee when CHOICE was offered by itself (all costs incurred by the BGCs) and $177 per attendee when CHOICE was offered with GTO implementation support ($67 cost to the BGCs; $110 to the entity funding GTO). These results were most sensitive to assumptions as to the number of times CHOICE was offered per year. Adding GTO implementation support to CHOICE increased the cost per attendee by approximately $150. For this additional cost, there was evidence that the CHOICE program was offered with more fidelity and offered more often after the 2-year intervention ended. If the long-term benefits of this better and continued implementation are found to exceed these additional costs, GTO could be an attractive structure to support evidence-based substance misuse prevention programs. Trial Registration. This project is registered at ClinicalTrials.gov with number NCT02135991 (URL: https://clinicaltrials.gov/show/NCT02135991). The trial was registered May 12, 2014.

Characteristics of Opioid Prescriptions to Veterans With Cirrhosis.

BACKGROUND & AIMS: Despite increased risks for adverse effects in patients with cirrhosis, little is known about opioid prescriptions for this population. We aimed to assess time trends in opioid prescribing and factors associated with receiving opioids among patients with cirrhosis. METHODS: Among Veterans with cirrhosis, identified using national Veterans Health Administration data (2005-2014), we assessed characteristics of patients and their prescriptions for opioids. We calculated the annual proportion of patients receiving any opioid prescription. Among opioid recipients, we assessed prescriptions that were long-term (>90 days' supply), for high doses (>100 MME/day), or involved combinations of opioids and acetaminophen or benzodiazepine. We evaluated patient characteristics independently associated with long-term and any opioid prescriptions using mixed-effects regression models. RESULTS: Among 127,239 Veterans with cirrhosis, 97,974 (77.0%) received a prescription for an opioid. Annual opioid prescriptions increased from 36% in 2005 to 47% in 2014 (P < .01). Among recipients of opioids, the proportions of those receiving long-term prescriptions increased from 47% in 2005 to 54% in 2014 (P < .01), and19%-21% received prescriptions for high-dose opioids. Prescriptions for combinations of opioids and acetaminophen decreased from 68% in 2005 to 50% in 2014 (P < .01) and for combinations of opioids and benzodiazepines decreased from 24% to 19% over this time (P < .01). Greater probability of long-term opioid prescriptions was independently associated with younger age, female sex, white race, hepatitis C, prior hepatic decompensation, hepatocellular carcinoma, mental health disorders, nicotine use disorders, medical comorbidities, surgery, and pain-related conditions. CONCLUSION: Among Veterans with cirrhosis, 36%-47% were prescribed opioids in each year. Mental health disorders and hepatic decompensation were independently associated with long-term opioid prescriptions.

Influence of an Implementation Support Intervention on Barriers and Facilitators to Delivery of a Substance Use Prevention Program.

Implementation support interventions have helped organizations implement programs with quality and obtain intended outcomes. For example, a recent randomized controlled trial called Preparing to Run Effective Programs (PREP) showed that an implementation support intervention called Getting To Outcomes (GTO) improved implementation of an evidence-based substance use prevention program (CHOICE) run in community-based settings. However, more information is needed on how these interventions affect organizational barriers and facilitators of implementation. This paper aims to identify differences in implementation facilitators and barriers in sites conducting a substance use prevention program with and without GTO. PREP is a cluster-randomized controlled trial testing GTO, a two-year implementation support intervention, in Boys & Girls Clubs. The trial compares 15 Boys & Girls Club sites implementing CHOICE (control group), a five-session evidence-based alcohol and drug prevention program, with 14 Boys & Girls Club sites implementing CHOICE supported by GTO (intervention group). All sites received CHOICE training. Intervention sites also received GTO manuals, training, and onsite technical assistance to help practitioners complete implementation best practices specified by GTO (i.e., GTO steps). During the first year, technical assistance providers helped the intervention group adopt, plan, and deliver CHOICE, and then evaluate and make quality improvements to CHOICE implementation using feedback reports summarizing their data. Following the second year of CHOICE and GTO implementation, all sites participated in semi-structured interviews to identify barriers and facilitators to CHOICE implementation using the Consolidated Framework for Implementation Research (CFIR). This paper assesses the extent to which these facilitators and barriers differed between intervention and control group. Intervention sites had significantly higher average ratings than control sites for two constructs from the CFIR process domain: planning and reflecting and evaluating. At the same time, intervention sites had significantly lower ratings on the culture and available resources constructs. Findings suggest that strong planning, evaluation, and reflection-likely improved with GTO support-can facilitate implementation even in the face of perceptions of a less desirable implementation climate. These findings highlight that implementation support, such as GTO, is likely to help low-resourced community-based organizations improve program delivery through a focus on implementation processes. TRIAL REGISTRATION: This project is registered at ClinicalTrials.gov with number NCT02135991 (URL: https://clinicaltrials.gov/show/NCT02135991). The trial was first registered May 12, 2014.