Implementation research and practice最新文献

Background: Substance use disorders (SUDs) result in individual and societal burden. However, most individuals with SUD receive no treatment. Implementing SUD interventions in primary care could address this population's treatment needs. In the USA, reSET^® and reSET-O^® were the first prescription digital therapeutics (PDTs) for SUDs and opioid use disorder (OUD), respectively. The Digital Treatments for Substance Use Disorder (DIGITS) study tested the effectiveness of practice facilitation and health coaching strategies to support reSET and reSET-O implementation into primary care. A formative evaluation was conducted to monitor implementation, inform adaptations, and learn what promotes PDT sustainment.

Method: The Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies guided the evaluation. Using rapid qualitative methods, we collected and analyzed observational fieldnotes, key informant interviews, and document sources (e.g., meeting minutes) for synthesis and dissemination to clinical partners and the study team via formative reports. We analyzed the reports to generate evaluation results.

Results: Twenty-four primary care clinics participated. Evaluation data included 98 observational fieldnotes, 16 interviews, and 253 document sources. We produced nine formative reports. The study encountered barriers and facilitators in each DSF domain (ecological system, practice setting, and intervention). In the ecological system, the PDT vendor enabled the study, but the COVID-19 pandemic, laws, regulations, and contracting delayed implementation. In the practice setting, staff shortages and low clinic capacity were implementation challenges, while electronic health record capabilities were both barriers and facilitators. At the intervention level, non-routine workflows, clinician burden, and low patient engagement were barriers despite clinicians' efforts.

Conclusions: Digital therapeutics are promising SUD and OUD treatments, but integration into primary care requires conducive laws and regulations, organizational capacity, and patient and clinician engagement. Formative evaluation identified important lessons for future PDT implementation.

Background: The outcomes of planned implementation efforts have been mixed, with some applications failing to achieve the desired change or impact. While reasons for mixed findings in implementation research are multifaceted (e.g., Damschroder et al., 2009, 2022), how the implementation strategy (IS) was deployed (i.e., integrity) and its impact on the implementation outcomes of evidence-based innovations (EBIs) is under-studied and warrants further clarification.

Method: This article builds on the IS fidelity and mechanisms of change literature to create the Implementation Strategy Integrity Framework (ISIF). The ISIF was developed by a set of implementation science researchers in the Justice Community Opioid Innovation Network seeking to document the role of implementation strategies in influencing EBI outcomes.

Results: The authors identified four areas of documentation and measurement to examine the role of IS integrity on EBI outcomes. (a) Implementation Strategy Rigor (i.e., adherence, dose, and quality) requires those implementing the strategy/strategies to specify them, document adherence to the planned strategies, quality of execution, and any adaptations made. (b) Target User Responsiveness documents the extent and quality of targeted users' participation in IS activities and how well the target users perform their roles in conducting actions intended by the implementation strategies. (c) Target Mechanism Activation notes to what degree the implementation strategies achieved the intended impact(s) on targeted factors that facilitate EBI use. Finally, (d) these three areas are combined with selected Inner and Outer Context variables to explain IS integrity's potential moderating and mediating effects on EBI outcomes.

Conclusions: A framework that can define the integrity of an IS and allow for its subsequent use as an explanatory variable in EBI outcomes is necessary for better elucidating mechanisms of action. The ISIF offers a structured approach to operationalize, measure, and evaluate the application and related impacts of implementation strategies.

Background: There is a growing need for mental health and psychosocial support (MHPSS) interventions that can feasibly be provided to larger groups of people, particularly in humanitarian settings. However, scaling up mental health interventions is notoriously difficult. There are therefore growing calls for integrating mental health outside traditional health structures, both to increase reach and to address social determinants of mental health. The objective of this study is to explore barriers and facilitators of Self-Help Plus (SH+), an MHPSS innovation implemented through multisectoral integration. We explore delivery and uptake at the scale of SH+ and aim to understand intervention adaptation needs when integrating SH+ within other health and non-health sectors in Uganda.

Method: We conducted a qualitative study using in-depth interviews in two phases: first for a needs and resource assessment, and second for a process evaluation. We conducted 50 in-depth interviews with BRAC Uganda and MoH partner staff, intervention facilitators, and target impact group members between July and December 2022. A thematic network analysis process was used to identify barriers and facilitators of SH+ delivery and uptake at scale in Uganda.

Results: We identified five major factors that should be considered when scaling through multisectoral integration, namely: (1) adaptivity, (2) funding mechanisms, (3) social capital, (4) participation, and (5) sustainability. Within these factors, there were varying degrees to which a factor was a facilitator or barrier, depending on participants' perceptions of the intervention.

Conclusions: Our findings suggest that multisectoral integration of SH+ into sectors both inside and outside of health may be a viable means to scale SH+ and increase reach. However, funding, partnerships, co-creation, and adaptability need to be further explored to facilitate better and more sustainable integration.

Background: Technology-enabled services (TESs) have the potential to increase access to mental healthcare. However, little research has focused on how TESs can be integrated into publicly funded service settings. As part of the state-wide Help@Hand project, Marin County conducted a pilot implementation of myStrength, a digital cognitive behavioral therapy platform, to explore its potential to reduce loneliness among isolated older adults. We evaluated the pilot impact using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Method: A single-site 6-month pilot implementation recruited English (n = 15) and Spanish-speaking (n = 15) isolated older adults who received a digital literacy course followed by 8 weeks of myStrength access and human support. We evaluated factors related to reach, effectiveness, adoption, and implementation using the perspectives of users and County staff. Descriptive statistics were used to examine reach, adoption, and implementation. Nonparametric tests, including Friedman and Wilcoxon signed-rank, were used to examine effectiveness.

Results: Reach: Compared to overall county demographics, platform users were majority female (93.1% vs. 50.5%), ethnoracialized (62.1% vs. 24.2%), and of lower socioeconomic status (Mdn = $35,000 vs. $131,008). Effectiveness: Users reported a significant (z = -2.62, p < .001) decrease in loneliness. Adoption: Users logged into myStrength an average of 10 times and completed 33 activities during the 8 weeks of myStrength use. Implementation: Each pilot staff (N = 20) spent an average of 19.8 hr (SD = 16.51) supporting users' use of myStrength during the pilot. Pilot staff reported several adaptations to meet the needs of users.

Conclusions: Successes included reaching the target population, reducing loneliness, and user adoption. However, pilot staff invested significant time to support those with lower digital literacy skills. As such, although TESs may address unmet needs, their use with underserved populations may require upfront and ongoing support provided by the settings where they are implemented.

Plain language summary title: Testing a New Digital Therapy Tool for Isolated Older Adults in County Mental Health Services.

Background: Despite the ubiquity of multilevel sampling, design, and analysis in mental health implementation trials, few resources are available that provide reference values of design parameters (e.g., effect size, intraclass correlation coefficient [ICC], and proportion of variance explained by covariates [covariate R ²]) needed to accurately determine sample size. The aim of this study was to provide empirical reference values for these parameters by aggregating data on implementation and clinical outcomes from multilevel implementation trials, including cluster randomized trials and individually randomized repeated measures trials, in mental health. The compendium of design parameters presented here represents plausible values that implementation scientists can use to guide sample size calculations for future trials.

Method: We searched NIH RePORTER for all federally funded, multilevel implementation trials addressing mental health populations and settings from 2010 to 2020. For all continuous and binary implementation and clinical outcomes included in eligible trials, we generated values of effect size, ICC, and covariate R² at each level via secondary analysis of trial data or via extraction of estimates from analyses in published research reports. Effect sizes were calculated as Cohen d; ICCs were generated via one-way random effects ANOVAs; covariate R² estimates were calculated using the reduction in variance approach.

Results: Seventeen trials were eligible, reporting on 53 implementation and clinical outcomes and 81 contrasts between implementation conditions. Tables of effect size, ICC, and covariate R² are provided to guide implementation researchers in power analyses for designing multilevel implementation trials in mental health settings, including two- and three-level cluster randomized designs and unit-randomized repeated-measures designs.

Conclusions: Researchers can use the empirical reference values reported in this study to develop meaningful sample size determinations for multilevel implementation trials in mental health. Discussion focuses on the application of the reference values reported in this study.

Background: Shifting organizational priorities can negatively affect the sustainment of innovations in community settings. Shifting priorities can present barriers to conducting clinical research in schools if a misalignment occurs between school district priorities and the aims of the study. Often this misalignment occurs due to a shift during the period between when the study is submitted for funding and when research activities begin. Participatory research approaches can be employed to restore alignment between study processes and school district priorities. The purpose of the study is to describe data from a shared process with district partners. The shared process resulted in modifications to the main study's implementation processes and strategies in order to restore alignment with evolving school priorities while remaining faithful to the aims of the study.

Method: Data originated from qualitative interviews conducted with 20 school district and school personnel in a large urban school district. Qualitative themes were organized into categories based on a social-ecological school implementation framework. Data from team meetings, meetings with school district administrators, and emails served to supplement and verify findings from interview analyses.

Results: Themes included barriers and facilitators at the macro-, school-, individual-, team-, and implementation quality levels. Adaptations were made to address barriers and facilitators and restore alignment with school district priorities. Most adaptations to study processes and implementation strategies focused on re-training and providing more information to school district coaches and school-based staff. New procedures were created, and resources were re-allocated for the larger study.

Conclusions: Findings were discussed in relation to the implementation literature in schools. Recommendations for sustaining strong collaboration among researchers and school partners are provided.

Background: There is a growing interest in practice-based implementation research, yet too often research prioritizes and is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites.

Method: To better understand needed supports for implementation trial participation, we conducted exit interviews (n = 5) with key staff at these community sites. Interview transcripts were double-coded and analyzed using Rapid Assessment Process. Qualitative themes were iteratively reviewed by the study team.

Results: Three themes emerged characterizing challenges for community sites, including that: (1) research threatens sites' most precious resource-staff; (2) staff lack comfort with and skills for research; and (3) research participation in its current form does not offer a clear return on investment.

Conclusions: Learnings from this work illuminate some of the barriers community sites face when trying to participate in multisite implementation research. An undercurrent of participant perspectives was the belief that community sites like theirs are just not set up to successfully participate in clinical trial research, including population-based implementation trials. Future implementation trials should consider strategies that disrupt traditional approaches, increasing the equitable inclusion of diverse practice settings in implementation research.

Preventing and treating mental health and substance use problems requires effective, affordable, scalable, and efficient interventions. The multiphase optimization strategy (MOST) framework guides researchers through a phased and systematic process of developing optimized interventions. However, new methods of systematically incorporating information about implementation constraints across MOST phases are needed. We propose that early and sustained integration of community-engaged methods within MOST is a promising strategy for enhancing an optimized intervention's potential for implementation. In this article, we outline the advantages of using community-engaged methods throughout the intervention optimization process, with a focus on the Preparation and Optimization Phases of MOST. We discuss the role of experimental designs in optimization research and highlight potential challenges in conducting rigorous experiments in community settings. We then demonstrate how relying on the resource management principle to select experimental designs across MOST phases is a promising strategy for maintaining both experimental rigor and community responsiveness. We end with an applied example illustrating a community-engaged approach to optimize an intervention to reduce the risk for mental health problems and substance use problems among children with incarcerated parents.

Background: This study examined the implementation determinants of a culturally grounded, school-based drug prevention curriculum in rural Hawai'i. Test development and validation procedures were used to examine the impact of implementation barriers and facilitators of the curriculum in public or charter middle/intermediate schools on Hawai'i Island.

Method: A five-phase, mixed-methods approach toward test development and validation was used. These phases included item generation (Phase 1), item refinement and selection (Phase 2), item reduction (Phase 3), reliability testing (Phase 4), and validity testing (Phase 5). Educational administrators, teachers, and staff employed by the Hawai'i State Department of Education (HIDOE) participated in the study.

Results: Phases 1 and 2 yielded 50 implementation barriers and 27 implementation facilitators that were evaluated by 204 HIDOE administrators, teachers, and staff. Factor analysis of the barrier items indicated a four-factor solution: (1) Innovation Barriers, (2) HIDOE State-Level Barriers, (3) Teacher-Level Barriers, and (4) Administrator-Level Barriers. Mean comparisons indicated that several barrier and facilitator items differentiated teachers from administrators in the sample.

Conclusions: This study contributes to the implementation measurement literature, specifically in the areas of mental health and substance use. It also highlights the importance of addressing multiple contextual levels in the implementation of culturally focused prevention interventions.

Plain language summary title: Examining Implementation Barriers and Facilitators for School-Based Prevention in Hawai'i. Plain Language Summary Compared with other major ethnic groups, Native Hawaiian and Pacific Islander (NHPI) youth have substantially higher rates of substance use and higher adverse mental and physical health effects related to their use. Despite these disparities, educational and community-based practitioners have long struggled with implementing and sustaining promising substance use interventions for NHPI youth. This study contributes to our understanding of measuring implementation barriers and facilitators for substance use prevention for NHPI youth in rural school settings. It contributes to the field of health disparities and health equity promotion, by addressing calls for research to understand factors affecting successful implementation of prevention programs. This is critical toward achieving health equity for underrepresented and vulnerable populations, such as NHPI and rural youth.

Background: Sustained delivery of evidence-based treatments (EBTs) is essential to addressing the public health impacts of youth mental health problems, but is complicated by the limited and fragmented funding available to youth mental health service agencies. Supports are needed that can guide service agencies in accessing sustainable funding for EBTs. We conducted a pilot evaluation of the Fiscal Mapping Process, an Excel-based strategic planning tool that helps service agency leaders identify and coordinate financing strategies for their EBT programs.

Method: Pilot testing of the Fiscal Mapping Process was completed with 10 youth mental health service agencies over a 12-month period, using trauma-focused cognitive-behavioral therapy or parent-child interaction therapy programs. Service agency representatives received initial training and monthly coaching in using the tool. We used case study methods to synthesize all available data (surveys, focus groups, coaching notes, document review) and contrast agency experiences to identify key findings through explanation building.

Results: Key evaluation findings related to the process and outcomes of using the Fiscal Mapping Process, as well as contextual influences. Process evaluation findings helped clarify the primary use case for the tool and identified the importance-and challenges-of engaging external collaborators. Outcome evaluation findings documented the impacts of the Fiscal Mapping Process on agency-reported sustainment capacities (strategic planning, funding stability), which fully explained reported improvements in outcomes (extent and likelihood)-although these impacts were incremental. Findings on contextual factors documented the influence of environmental and organizational capacities on engagement with the tool and concerns about equitable impacts, but also the view that the process could usefully generalize to other EBTs.

Conclusions: Our pilot evaluation of the Fiscal Mapping Process was promising. In future work, we plan to integrate the tool into EBT implementation initiatives and test its impact on long-term sustainment outcomes across various EBTs, while increasing attention to equity considerations.