Literature Collection

BACKGROUND: Implementation of evidence-based practices into routine clinical care within a health system remains a challenge. Rigorous evaluation of clinical implementation efforts with data collection guided by an implementation science framework can provide significant insight into variation in outcomes across the health system as well as learnings related to contextual factors that may contribute to both clinical and implementation outcomes. We describe the protocols for two implementation projects, each of which aims to implement into routine practice previously published research findings of a care delivery innovation addressing management of a chronic disease within primary care settings. METHODS: The two implementation projects include Implementation of Intensive Lifestyle Treatment for Weight Loss in Primary Care Settings and Implementation of Effective Hypertension Management Approaches, each funded through the Patient-Centered Outcomes Research Institute Health Systems Implementation Initiative (PCORI HSII) program. Both care delivery innovations will be implemented in 56 primary care practices (suburban, urban, rural) in one health system in Northeast Ohio and will involve alignment of clinical, operational, and evaluation teams. For the weight loss project, we will build on our health system model of shared medical appointments led by multidisciplinary teams to deliver a group visit intervention for patients with obesity (body mass index >/=30 kg/m2). The primary outcome will be change in body weight. For the hypertension project, we will implement an intensive home blood pressure management program for patients with uncontrolled blood pressure (>150/95 mmHg) with follow-up every 2-4 weeks with a pharmacist or advanced practice provider. The primary outcome will be change in systolic blood pressure. Each care model will be implemented in primary care practices utilizing a randomized stepped-wedge design. Specific implementation strategies will be utilized, and implementation outcomes collected utilizing an implementation framework. Adaptations at the practice group level will be documented. DISCUSSION: The two implementation projects described have the potential to significantly improve treatment for both obesity and uncontrolled hypertension in primary care practices in one health system. Clinical effectiveness and implementation outcomes will be collected and will inform scale-up of the programs as well as need for tailoring of future health system implementation efforts. TRIAL REGISTRATION: NCT07268417(Initial Release Date 11/13/2025): Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices (ACTIVATE OC) NCT07232017(Initial Release Date 11/14/2025): Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic (IN-HOME BP).

BACKGROUND: Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN: We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION: The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.

BACKGROUND: Contingency management (CM), a behavioral intervention that provides incentives for achieving treatment goals, is an evidence-based adjunct to medication to treat opioid use disorder. Unfortunately, many front-line treatment providers do not utilize CM, likely due to contextual barriers that limit effective training and ongoing support for evidence-based practices. This study applied user-informed approaches to adapt a multi-level implementation strategy called the Science to Service Laboratory (SSL) to support CM implementation. METHODS: Leaders and treatment providers working in community-based opioid treatment programs (OTPs; N = 43) completed qualitative interviews inquiring about their preferences for training and support implementation strategies (didactic training, performance feedback, and external facilitation). Our team coded interviews using a reflexive team approach to identify common a priori and emergent themes. RESULTS: Leaders and providers expressed a preference for brief training that included case examples and research data, along with experiential learning strategies. They reported a desire for performance feedback from internal supervisors, patients, and clinical experts. Providers and leaders had mixed feelings about audio-recording sessions but were open to the use of rating sheets to evaluate CM performance. Finally, participants desired both on-call and regularly scheduled external facilitation to support their continued use of CM. CONCLUSIONS: This study provides an exemplar of a user-informed approach to adapt the SSL implementation support strategies for CM scale-up in community OTPs. Study findings highlight the need for user-informed approaches to training, performance feedback, and facilitation to support sustained CM use in this setting.

INTRODUCTION: Cognitive behavioural therapy (CBT) is an evidence-based approach for perinatal mental health, yet its integration into perinatal primary care remains limited. Midwifery-led CBT-based interventions may enhance continuity, accessibility, and acceptability within primary healthcare. To address the gap between evidence and practice, this scoping review mapped existing research on midwifery-led CBT-based interventions and synthesised implementation-relevant characteristics that facilitate their integration into primary care settings. METHODS: We conducted a scoping review following the Arksey and O'Malley framework and PRISMA-ScR guidelines. Five databases, MEDLINE, CINAHL Complete, EMBASE, Web of Science, and Scopus, were searched for studies published between 2004 and 2024. We synthesised data narratively across three domains: contextual, provider-related, and intervention-specific characteristics. Study quality was appraised using the SIGN checklist. RESULTS: Ten studies met the inclusion criteria. Recurring implementation-relevant characteristics were observed in target population selection, intervention timing, provider configuration, and delivery formats, while substantial heterogeneity was observed in baseline symptom severity, intervention intensity, and evaluation approaches across contexts. DISCUSSION: The recurring patterns identified across studies are likely to reflect pragmatic considerations related to feasibility within routine maternity care settings. In contrast, heterogeneity across the literature appears to reflect differences in intervention aims and care contexts, particularly preventive versus treatment-oriented approaches. CONCLUSION: This review provides a foundation for future research to support the integration of midwifery-led CBT-based interventions into perinatal primary care. It highlights the importance of clearly defining intervention intent, developing feasibility-informed implementation strategies, and improving reporting practices to enhance interpretability and comparability across studies.

INTRODUCTION: Co-production is a key principle of the Women's Health Strategy for England, yet there are limited published examples of its application at system level. This article describes the development of a co-produced women's health programme within an integrated care system in England. METHODS: A service improvement approach was used, involving a multidisciplinary advisory group of over 160 members, including people with lived experience. The group co-designed methods to identify local priorities and support programme development. RESULTS: A survey of 1238 respondents identified gaps in access to and integration of women's health services. These findings informed the design and implementation of five prioritised women's health service models, each with defined objectives and built-in evaluation to support quality and sustainability. DISCUSSION: This study demonstrates how community co-production can inform the design of locally responsive women's health services. Integrating lived experience with professional expertise supported equitable service development, though challenges included limited long-term funding and sustaining broad engagement. CONCLUSION: System-level co-production can support the development of women's health programmes aligned with national strategy. This model illustrates a co-production approach that may inform the development of women's health services in other local settings. PATIENT AND PUBLIC CONTRIBUTION: People with lived experience of women's health services were involved throughout, including identifying priorities, co-designing solutions and shaping programme development.

Opioid agonist medication, including methadone, is considered the first-line treatment for opioid use disorder. Methadone, when taken daily, reduces the risk of fatal overdose; however, overdose risk increases following medication cessation. Amid an overdose epidemic accelerated by the proliferation of fentanyl, ensuring continuity of methadone treatment during the COVID-19 pandemic is a vital public health priority. (Am J Public Health. 2021;111(12):2115-2117. https://doi.org/10.2105/AJPH.2021.306523).