Hybrid Implementation-effectiveness Study Research Articles

Commentary With Study Protocol: Implementation and Effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an Adjunct to Methadone Treatment for Opioid Use Disorder (IMPOWR-MORE).

Traditional methadone treatment (MT) for opioid use disorder (OUD) fails to systematically address the physical pain, emotion dysregulation, and reward processing deficits that co-occur with OUD, and novel interventions that address these issues are needed to improve MT outcomes. Mindfulness-Oriented Recovery Enhancement (MORE) remediates the hedonic dysregulation in brain reward systems that is associated with OUD. Our pilot and phase 2 randomized controlled trials of MORE were the first to demonstrate MORE's feasibility, acceptability, and efficacy as delivered in MT clinics; MORE significantly reduced drug use (eg, benzodiazepines, barbiturates, cocaine, marijuana, opioids, and other drugs), craving, depression, anxiety, and pain among people with OUD. However, uptake of novel, efficacious interventions like MORE may be slow in MT because time and resources are often limited. Therefore, to best address potential implementation issues and to optimize future MORE implementation and dissemination, in this study, we will utilize a Type 2, Hybrid Implementation-Effectiveness study design. We will not only evaluate MORE's effectiveness but also assess barriers and facilitators to integrating MORE into MT. MT clinicians will receive training in (1) a higher intensity MORE implementation strategy consisting of training in the full MORE treatment manual or (2) a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training. We aim to: (1) using a Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, examine barriers and facilitators to implementation of MORE and SMP in MT, and evaluate strategies for optimizing training, fidelity, and engagement, (2) optimize existing MORE and SMP training and implementation toolkits, including adaptable resources that can accelerate the translation of evidence into practice, and (3) compared to usual MT, evaluate the relative effectiveness of MORE plus MT or SMP plus MT (N = 450).

Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study

BackgroundDuring adolescence, behaviours are initiated that will have substantial impacts on the individual’s short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available...

Addressing the challenges of integrating care for perinatal depression in primary care in Nigeria.

This report provides the results of a task-shared approach for integrating care for perinatal depression (PND) within primary maternal and child healthcare (PMCH), including the factors that may facilitate or impede the process. This hybrid implementation-effectiveness study guided by the Replicating Effective Programmes framework was conducted in 27 PMCH clinics in Ibadan, Nigeria. The primary implementation outcome was change in the identification rates of PND by primary health care workers (PHCW) while the primary effectiveness outcome was the difference in symptom remission (EPDS score ≤ 5) 6months postpartum. Outcome measures were compared between two cohorts of pregnant women, one recruited before and the other after training PHCW to identify and treat PND. Barriers and facilitators were explored in qualitative interviews. Identification of PND improved from 1.4% before to 17.4% after training; post-training rate was significantly higher in clinics where PHCW routinely screened using the 2-item patient health questionnaire (24.8%) compared to non-screening clinics (5.6%). At 6-months postpartum, 60% of cohort one experienced remission from depression, compared to 56.5% cohort two [OR-0.9 (95%CI-0.6, 1.3) p = 0.58]. Identified facilitators for successful integration included existence of policy specifying mental health as a component of PHC, use of screening to aid identification and supportive supervision, while barriers included language and cultural attitudes towards mental health and human resource constraints. PHCW were able to make adaptations to address these barriers. Successful implementation of task-shared care for perinatal depression requires addressing staff shortages and adopting strategies that can improve identification by non-specialist providers. This study was retrospectively registered 03 Dec 2019. https://doi.org/10.1186/ISRCTN94230307 .

Evaluating Multidisciplinary Bone Marrow Failure Care (EMBRACE) - a Hybrid Implementation-Effectiveness Study

The bone marrow failure syndromes (BMFS) are clinically diverse, with both inherited and acquired etiologies. Patients with BMFS may present unique, complex management issues and frequently experience poor outcomes due to multiple factors, including the rarity of the individual conditions. The Evaluating Multidisciplinary Bone maRrow fAilure CarE (EMBRACE) study is a multi-stage hybrid implementation-effectiveness study that aims to address these challenges by understanding the nature and scale of issues faced by these patients and their physicians, and then developing, implementing, and evaluating a comprehensive 10-component model of care (MoC10). Herein we report the results of the first stage of the EMBRACE study of issue identification and MoC10 development. To identify barriers to optimal care, we performed structured interviews with patients with BMFS and patient advocate groups, followed by a nation-wide physician survey. Thematic analysis of interviews (n = 9) revealed multiple challenges with patient care, including (i) a lack of access to genomic testing to provide a definitive diagnosis, (ii) widespread difficulty in accessing genetic counselling and fertility advice, (iii) a lack of disease-specific patient information at the time of diagnosis, and (iv) perceived failings in care when transitioning from pediatric to adult services. Patients also described anxiety resulting from frequent encounters with health professionals unfamiliar with their disease, leading to significant anxiety and demonstrating a clear need for education both at the time of initial presentation, in considering whether an underlying inherited condition could be present and also following diagnosis, permitting relevant disease specific surveillance and care. As part of this patient-facing analysis, there was a desire on behalf of patients and patient advocates for the opportunity to participate in research and clinical trials. A nation-wide physician survey was then performed targeting clinicians that treat patients with BMFS which received 74 responses across hematologists, oncologists, pediatricians and geneticists who cared for 267 patients with BMFS. The median number of patients cared for per physician was 2 (range 0 - 25), demonstrating a wide range of subspecialty experience and non-centralized care. Responses indicated a desire for affordable access to genomic testing, assistance with result interpretation and genetic counselling/cascade testing of extended kindred, a forum for complex case discussion and advice regarding patient management strategies. Responses from patients, patient advocates and physicians, along with existing evidence-based and best-practice guidelines, were then used to develop a MoC. The MoC10 (Figure 1) incorporates 10 pillars directed at optimising care for patients with BMFS including funded access to genomic testing, access to expert genetic and fertility counselling, standardized hematological and solid organ cancer surveillance, and opportunity for multidisciplinary case discussion including expert opinion regarding allogeneic stem cell transplant. In addition, uncertain and novel germline variants are presented alongside de-identified case presentations at a national forum attended by physicians, scientists, and researchers to promote education, collaboration and information sharing with treating teams. After institutional approval, the MoC10 has been implemented and is undergoing structured evaluation to determine patient and physician acceptability and adherence. Embracing the well-known ‘Plan, Do, Study, Act’ cycle, our implementation approach facilitates iterative learning for continuous improvement. In summary, after extensive stakeholder engagement, we have developed an evidence based comprehensive MoC addressing the current challenges facing patients with BMFS and their care teams. This comprehensive care program continues to undergo evaluation and audit consistent with the principles of an implementation-effectiveness study to determine both patient and physician satisfaction with the model, and iterative refinement in order to provide optimum care.

Transforming Team Performance Through Reimplementation of the Surgical Safety Checklist

Patient safety interventions, like the World Health Organization Surgical Safety Checklist, require effective implementation strategies to achieve meaningful results. Institutions with underperforming checklists require evidence-based guidance for reimplementing these practices to maximize their impact on patient safety. To assess the ability of a comprehensive system of safety checklist reimplementation to change behavior, enhance safety culture, and improve outcomes for surgical patients. This prospective type 2 hybrid implementation-effectiveness study took place at 2 large academic referral centers in Singapore. All operations performed at either hospital were eligible for observation. Surveys were distributed to all operating room staff. The study team developed a comprehensive surgical safety checklist reimplementation package based on the Exploration, Preparation, Implementation, Sustainment framework. Best practices from implementation science and human factors engineering were combined to redesign the checklist. The revised instrument was reimplemented in November 2021. Implementation outcomes included penetration and fidelity. The primary effectiveness outcome was team performance, assessed by trained observers using the Oxford Non-Technical Skills (NOTECH) system before and after reimplementation. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to assess safety culture and observers tracked device-related interruptions (DRIs). Patient safety events, near-miss events, 30-day mortality, and serious complications were tracked for exploratory analyses. Observers captured 252 cases (161 baseline and 91 end point). Penetration of the checklist was excellent at both time points, but there were significant improvements in all measures of fidelity after reimplementation. Mean NOTECHS scores increased from 37.1 to 42.4 points (4.3 point adjusted increase; 95% CI, 2.9-5.7; P < .001). DRIs decreased by 86.5% (95% CI, -22.1% to -97.8%; P = .03). Significant improvements were noted in 9 of 12 composite areas on culture of safety surveys. Exploratory analyses suggested reductions in patient safety events, mortality, and serious complications. Comprehensive reimplementation of an established checklist intervention can meaningfully improve team behavior, safety culture, patient safety, and patient outcomes. Future efforts will expand the reach of this system by testing a structured guidebook coupled with light-touch implementation guidance in a variety of settings.

Evaluating the implementation of a dynamic digital application to enable community-based decentralisation of rheumatic heart disease case management in Uganda: protocol for a hybrid type III effectiveness-implementation study

IntroductionRheumatic heart disease (RHD) affects over 39 million people worldwide, the majority in low-income and middle-income countries. Secondary antibiotic prophylaxis (SAP), given every 3–4 weeks can improve outcomes, provided more...

Implementation intensification to disseminate a skills-based caregiver training program: protocol for a type III effectiveness-implementation hybrid trial

BackgroundFamily caregiver training decreases caregiver psychological burden and improves caregiver depressive symptoms and health-related quality of life. Caregivers FIRST is an evidence-based group skills training curriculum for family caregivers and was announced for national dissemination in partnership with the Veterans Health Administration (VHA) National Caregiver Support Program (CSP). Previous evaluations of Caregivers FIRST implementation highlighted that varying support was needed to successfully implement the program, ranging from minimal technical assistance to intensive assistance and support. However, we do not know the optimal level of support needed to inform cost-effective national scaling of the program. We describe a protocol for randomizing 24 non-adopting VA medical centers 1:1 to a tailored, high-touch implementation support or a standard, low-touch implementation support to test the primary hypothesis that high-touch support increases Caregivers FIRST penetration, fidelity, and adoption. Additionally, we describe the methods for evaluating the effect of Caregivers FIRST participation on Veteran outcomes using a quasi-experimental design and the methods for a business case analysis to examine cost of delivery differences among sites assigned to a low or high-touch implementation support.MethodsWe use a type III hybrid implementation-effectiveness study design enrolling VA medical centers that do not meet Caregivers FIRST adoption benchmarks following the announcement of the program as mandated within the CSP. Eligible medical centers will be randomized to receive a standard low-touch implementation support based on Replicating Effective Programs (REP) only or to an enhanced REP (high-touch) implementation support consisting of facilitation and tailored technical assistance. Implementation outcomes include penetration (primary), fidelity, and adoption at 12 months. Mixed methods will explore sites’ perceptions and experiences of the high-touch intensification strategy. Additional analyses will include a patient-level effectiveness outcome (Veteran days at home and not in an institution) and a business case analysis using staffing and labor cost data.DiscussionThis pragmatic trial will lead to the development and refinement of implementation tools to support VA in spreading and sustaining Caregivers FIRST in the most efficient means possible.Trial registrationThis study was registered on April 8, 2022, at ClinicalTrials.gov (identifier NCT05319535).

Study protocol for type II hybrid implementation-effectiveness trial of strategies for depression care task-sharing in community health stations in Vietnam: DEP Project

BackgroundIt is not clear what the most effective implementation strategies are for supporting the enactment and sustainment of depression care services in primary care settings. This type-II Hybrid Implementation-Effectiveness study will compare the effectiveness of three system-level strategies for implementing depression care programs at 36 community health stations (CHSs) across 2 provinces in Vietnam.MethodsIn this cluster-randomized controlled trial, CHSs will be randomly assigned to one of three implementation conditions: (1) Usual Implementation (UI), which consists of training workshops and toolkits; (2) Enhanced Supervision (ES), which includes UI combined with bi-weekly/monthly supervision; and (3) Community-Engaged Learning Collaborative (CELC), which includes all components of ES, combined with bi-monthly province-wide learning collaborative meetings, during which cross-site learning and continuous quality improvement (QI) strategies are implemented to achieve better implementation outcomes. The primary outcome will be measured based on the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation quality, and Maintenance) using indicators on implementation, provider, and client factors. The secondary outcome examines factors associated with barriers and facilitators of quality implementation, while the tertiary outcome evaluates the incremental cost-effectiveness ratio of services provided in the ES and CELC conditions, relative to UI condition for depression care. A total of 1,296 clients receiving depression care at CHSs will be surveyed at baseline and 6-month follow-up to assess mental health and psychosocial outcomes (e.g., depression and anxiety severity, health function, quality of life). Additionally, 180 CHS staff and 180 non-CHS staff will complete pre- and post-training evaluation and surveys at baseline, 6, 12, and 24 months.DiscussionWe hypothesize that the additional implementation supports will make mental health service implementation superior in the ES and CELC arms compared to the UI arm. The findings of this project could identify effective implementation models and assess the added value of specific QI strategies for implementing depression care in primary care settings in Vietnam, with implications and recommendations for other low- and middle-income settings. More importantly, this study will provide evidence for key stakeholders and policymakers to consider policies that disseminate, scale up, and advance quality mental health care in Vietnam.Trial registrationNCT04491045 on Clinicaltrials.gov. Registered July 29, 2020.

A sequential, multiple assignment randomized trial comparing web-based education to mobile video interpreter access for improving provider interpreter use in primary care clinics: the mVOCAL hybrid type 3 study protocol

BackgroundIndividuals who use a language other than English for medical care are at risk for disparities related to healthcare safety, patient-centered care, and quality. Professional interpreter use decreases these disparities but remains underutilized, despite widespread access and legal mandates. In this study, we compare two discrete implementation strategies for improving interpreter use: (1) enhanced education targeting intrapersonal barriers to use delivered in a scalable format (interactive web-based educational modules) and (2) a strategy targeting system barriers to use in which mobile video interpreting is enabled on providers’ own mobile devices.MethodsWe will conduct a type 3 hybrid implementation-effectiveness study in 3–5 primary care organizations, using a sequential multiple assignment randomized trial (SMART) design. Our primary implementation outcome is interpreter use, calculated by matching clinic visits to interpreter invoices. Our secondary effectiveness outcome is patient comprehension, determined by comparing patient-reported to provider-documented visit diagnosis. Enrolled providers (n = 55) will be randomized to mobile video interpreting or educational modules, plus standard interpreter access. After 9 months, providers with high interpreter use will continue as assigned; those with lower use will be randomized to continue as before or add the alternative strategy. After another 9 months, both strategies will be available to enrolled providers for 9 more months. Providers will complete 2 surveys (beginning and end) and 3 in-depth interviews (beginning, middle, and end) to understand barriers to interpreter use, based on the Theoretical Domains Framework. Patients who use a language other than English will be surveyed (n = 648) and interviewed (n = 75) following visits with enrolled providers to understand their experiences with communication. Visits will be video recorded (n = 100) to assess fidelity to assigned strategies. We will explore strategy mechanism activation to refine causal pathway models using a quantitative plus qualitative approach. We will also determine the incremental cost-effectiveness of each implementation strategy from a healthcare organization perspective, using administrative and provider survey data.DiscussionDetermining how these two scalable strategies, alone and in sequence, perform for improving interpreter use, the mechanisms by which they do so, and at what cost, will provide critical insights for addressing a persistent cause of healthcare disparities.Trial registrationNCT05591586.

A Novel Process to Recruit and Select Community Partners for a Hybrid Implementation-Effectiveness Study.

Creating strong partnerships with community organizations is essential to test implementation of evidence-based interventions. However, partners are often chosen based on convenience rather than capacity or diversity. Streamlined processes are needed to identify qualified, diverse, and invested partners to conduct community-based research. There is a gap in the literature on effective and efficient processes for recruiting partners. This paper aims to fill that gap by describing a novel approach for identifying a diverse group of community organizations to participate in research. We used a Request for Partners (RFP) approach to recruit partners to participate in a hybrid implementation-effectiveness study of the Veggie Van mobile market model. The process included formative work to inform RFP development, creation of an external advisory committee, an intent-to-apply round, a full application round, and an inperson training and selection process. Data was collected to characterize applicant size, location, and experience; pre-post surveys were conducted to understand the training's utility. We received 59 intent-to-apply submissions and invited 28 organizations to apply: 17 submitted applications and 12 organizations were chosen as finalists. The process took approximately 8 months to recruit 9 organizations and 32 community sites across 5 states and increased understanding of the intervention and partner responsibilities. An RFP process is familiar to many community organizations that compete for grant funding but may not have prior research experience. This process streamlined recruitment timelines, increased diversity, and cultivated community among organizations. It may also improve research transparency, study completion, and intervention fidelity.

Scale-up of the Internet-based Professional Learning to help teachers promote Activity in Youth (iPLAY) intervention: a hybrid type 3 implementation-effectiveness trial

BackgroundWhole-of-school programs have demonstrated success in improving student physical activity levels, but few have progressed beyond efficacy testing to implementation at-scale. The purpose of our study was to evaluate the scale-up of the ‘Internet-based Professional Learning to help teachers promote Activity in Youth’ (iPLAY) intervention in primary schools using the RE-AIM framework.MethodsWe conducted a type 3 hybrid implementation-effectiveness study and collected data between April 2016 and June 2021, in New South Wales (NSW), Australia. RE-AIM was operationalised as: (i) Reach: Number and representativeness of students exposed to iPLAY; (ii) Effectiveness: Impact of iPLAY in a sub-sample of students (n = 5,959); (iii) Adoption: Number and representativeness of schools that received iPLAY; (iv) Implementation: Extent to which the three curricular and three non-curricular components of iPLAY were delivered as intended; (v) Maintenance: Extent to which iPLAY was sustained in schools. We conducted 43 semi-structured interviews with teachers (n = 14), leaders (n = 19), and principals (n = 10) from 18 schools (11 from urban and 7 from rural locations) to determine program maintenance.ResultsReach: iPLAY reached ~ 31,000 students from a variety of socio-economic strata (35% of students were in the bottom quartile, almost half in the middle two quartiles, and 20% in the top quartile). Effectiveness: We observed small positive intervention effects for enjoyment of PE/sport (0.12 units, 95% CI: 0.05 to 0.20, d = 0.17), perceptions of need support from teachers (0.26 units, 95% CI: 0.16 to 0.53, d = 0.40), physical activity participation (0.28 units, 95% CI: 0.10 to 0.47, d = 0.14), and subjective well-being (0.82 units, 95% CI: 0.32 to 1.32, d = 0.12) at 24-months. Adoption: 115 schools received iPLAY. Implementation: Most schools implemented the curricular (59%) and non-curricular (55%) strategies as intended. Maintenance: Based on our qualitative data, changes in teacher practices and school culture resulting from iPLAY were sustained.ConclusionsiPLAY had extensive reach and adoption in NSW primary schools. Most of the schools implemented iPLAY as intended and effectiveness data suggest the positive effects observed in our cluster RCT were sustained when the intervention was delivered at-scale.Trial registrationACTRN12621001132831.

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study

Outcomes from a hybrid implementation-effectiveness study of the living well during pregnancy Tele-coaching program for women at high risk of excessive gestational weight gain

BackgroundExcess gestational weight gain (GWG) is associated with short-term perinatal complications and longer term cardiometabolic risks for mothers and their babies. Dietitian counselling and weight gain monitoring for women at risk of high pregnancy weight gain is recommended by clinical practice guidelines. However, face-to-face appointments, during a time with high appointment burden, can introduce barriers to engaging with care. Telephone counselling may offer a solution. The Living Well during Pregnancy (LWdP) program is a dietitian-delivered telephone coaching program implemented within routine antenatal care for women at risk of excess GWG. This program evaluation used a hybrid implementation-effectiveness design guided by the RE-AIM framework to report on the primary outcomes (reach, adoption, implementation, maintenance) and secondary outcomes (effectiveness) of the LWdP intervention.MethodsThe LWdP program evaluation compared data from women participating in the LWdP program with a historical comparison group (pregnant women receiving dietetic counselling for GWG in the 12 months prior to the study). The primary outcomes were described for the LWdP program. Between group comparisons were used to determine effectiveness of achieving appropriate GWG and pre and post intervention comparisons of LWdP participants was used to determine changes to dietary intake and physical activity.ResultsThe LWdP intervention group (n = 142) were compared with women in the historical comparison group (n = 49). Women in the LWdP intervention group attended 3.4 (95% CI 2.9–3.8) appointments compared with 1.9 (95% CI, 1.6–2.2) in the historical comparison group. GWG was similar between the two groups, including the proportion of women gaining weight above the Institute of Medicine recommendations (70% vs 73%, p = 0.69). Within group comparison showed that total diet quality, intake of fruit and vegetables and weekly physical activity were all significantly improved from baseline to follow-up for the women in LWdP, while consumption of discretionary food and time spent being sedentary decreased (all p < 0.05).ConclusionThe LWdP program resulted in more women accessing care and positive improvements in diet quality, intuitive eating behaviours and physical activity. It was as effective as face-to-face appointments for GWG, though more research is required to identify how to engage women earlier in pregnancy and reduce appointment burden.

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study.

PurposeTo evaluate the implementation and effectiveness of the Carolina Heart Alliance Networking for Greater Equity (CHANGE) Program, an adapted evidence-based cardiovascular disease risk reduction intervention delivered by Community Health Workers (CHW) to rural adults.DesignHybrid implementation-effectiveness study with a pre–post design.SettingNorth Carolina Federally Qualified Health Center and local health department in a rural, medically underserved area.SampleParticipants (n = 255) included 87% Non-Hispanic Black with a mean age of 57 years; 84% had diagnosed hypertension, 55% had diabetes, and 65% had hypercholesterolemia.InterventionA CHW-delivered, low-intensity, 4-month behavioral lifestyle intervention promoting a southern-style Mediterranean dietary pattern and physical activity.MeasuresWe measured number and representativeness of participants reached and retained, intervention delivery fidelity, weight, blood pressure, and self-reported dietary and physical activity behaviors.AnalysisPre–post changes at 4 months were analyzed using paired t-tests.ResultsStudy participants completed 90% of planned intervention contacts; 87% were retained. Intervention delivery fidelity measures showed participants receiving a mean of 3.5 counseling visits, 2.7 booster calls, and on average completing 1.7 modules, setting 1.8 goals, and receiving 1.3 referrals per visit. There were significant mean reductions in systolic (−2.5 mmHg, P < .05) and diastolic blood pressure (−2.1 mmHg, P < .01); the proportion of participants with systolic blood pressure <130 increased by 7 % points (P = .05), and diastolic pressure <80 by 9 percentage points (P < .01). Dietary behaviors improved significantly with average weekly servings of nuts increased by .5 serving (P < .0001), and fruits and vegetables by .8 daily serving (P < .0001). Physical activity also increased on average by 45 min./week (P < .001). Weight did not change significantly.ConclusionsThe CHANGE program showed both implementation and program effectiveness and adds to the evidence supporting CHW-delivered lifestyle interventions to reduce CVD risk among rural, Non-Hispanic Black, and medically underserved populations.

Implementing Shared Decision-Making for Lung Cancer Screening across a Veterans Health Administration Hospital Network: A Hybrid Effectiveness-Implementation Study Protocol.

Shared decision-making (SDM) for lung cancer screening (LCS) is recommended by multiple organizations, reflecting a larger movement toward patient-centered care. Yet SDM for LCS does not routinely occur owing to barriers at multiple levels. Moreover, how best to implement SDM into routine clinical practice remains unknown. There is a need for a novel approach to overcome multilevel barriers and ensure high-quality SDM for LCS is integrated into routine practice. We present the protocol for our U.S. Department of Veterans Affairs (VA)-funded study. Our protocol is designed to implement and evaluate a multilevel, tailored approach to SDM for LCS in routine clinical practice within the VA New England Health Care Network, comprising eight medical centers. In this prospective, pragmatic hybrid implementation-effectiveness study, we will first conduct a formative evaluation of barriers to SDM for LCS at each level of the socioecological model, which will inform our tailored implementation plan. We will then sequentially introduce components of our tailored, multilevel approach to implementing SDM for LCS across VA New England. Finally, using mixed methods, we will evaluate the implementation and its impact on effectiveness (primary outcome, defined as patient-centeredness of SDM), as well as implementation outcomes informed by the RE-AIM implementation science framework (i.e., reach to patients, adoption by providers, implementation fidelity). Tailored implementation will address identified challenges to achieving policy recommendations for SDM for LCS in VA New England, inform nationwide implementation of SDM for LCS, and address stakeholder interests in promoting more patient-centered interactions across the VA.

A Randomized Trial of Specialty Mental Health Probation: Measuring Implementation and Effectiveness Outcomes.

Although the research on specialty mental health probation (SMHP) is promising, there have been no randomized controlled trials (RCT) of the prototypical model advanced in the research literature and little focus on SMHP implementation. This study assesses the adoption of SMHP in two counties and examines its impact on mental health and criminal justice outcomes. Researchers conducted a RCT within a hybrid implementation-effectiveness study to examine intervention adoption as well as mental health treatment engagement and criminal justice outcomes for 100 individuals with serious mental illnesses on probation in one rural and one urban county in a southeastern state. Randomization produced equivalent treatment (n = 47) and control (n = 53) groups with no statistically significant differences between groups on demographic or background characteristics. Compared to standard probation officers, SMHP officers addressed the mental health needs of individuals with serious mental illness (i.e., adoption) at higher rates (p < 0.001). Compared to individuals on standard caseloads, individuals on SMHP had a higher rate of mental health engagement (e.g., mental health assessment, attending treatment appointment; p < 0.050); however, more individuals on SMHP caseloads had a new crime violation during follow-up compared with individuals on standard caseloads (p < 0.01). In conclusions, results suggest successful adoption of the intervention and increased mental health engagement among those on SMHP caseloads. Results are consistent with the mixed findings on the impact of SMHP on improving criminal justice outcomes.

Patient and clinician perceptions of a digital patient monitoring program in the community oncology setting: Findings from the Texas Two-Step Study.

189 Background: Digital monitoring strategies that include electronic patient reported outcomes (ePRO) measures to monitor symptoms among cancer patients have been shown to be effective in improving patient outcomes in a large academic setting and across several smaller multi-center trials. However, demonstration of clinical utility in the real-world setting must incorporate patient and provider perspectives of ePRO programs to ensure successful implementation. We sought to understand perceptions among patients and clinicians in ePRO digital symptom monitoring program. Methods: Texas Two-Step is an ongoing hybrid implementation-effectiveness study of Navigating Cancer’s ePRO digital monitoring program at Texas Oncology. Patients initiating new systemic therapy for their cancer diagnosis were introduced to the program by their oncologist and enrolled in the program by nursing staff for weekly reporting of symptoms based on a modified version of NCI’s PRO-CTCAE instrument. Feedback surveys were administered to both patients and clinic staff after 6 months of implementation of the program to evaluate the overall experience with the program. Results: 1040 (23.5%) patients and 215 (12.4%) clinicians completed the feedback survey. Of the patient responders, 90% found the program very or somewhat easy for reporting symptoms, 85% moderately-extremely beneficial for having symptoms addressed, and 84% moderately-extremely interested in utilizing the program for future treatments. Of the clinician responders, 73% indicated that that they had a good understanding of the benefit of the program; 70.6% felt confident in their ability to interpret patients’ ePRO responses; 80.3% felt confident in their ability to discuss the program with patients; 71.2% confident in their ability to counsel patients based on ePRO responses; and 55.3% felt the program enhanced communication with patients. Additionally, 59% of clinicians felt the program was beneficial for patients. Conclusions: Patients have a more favorable perception of the benefit of the ePRO program than clinicians. Methods to reduce staff burden and reinforcement of program benefits during training and implementation are imperative to improve clinical utility and will be studied further as the program is optimized. As implementation occurred during the COVID-19 pandemic, this may impact perceptions regarding the tool.

Scaling up care for perinatal depression for improved maternal and infant health (SPECTRA): protocol of a hybrid implementation study of the impact of a cascade training of primary maternal care providers in Nigeria

BackgroundThe large treatment gap for mental disorders in low- and middle-income countries (LMIC) necessitates task-sharing approaches in scaling up care for mental disorders. Previous work have shown that primary health care workers (PHCW) can be trained to recognize and respond to common mental disorders but there are lingering questions around sustainable implementation and scale-up in real world settings.MethodThis project is a hybrid implementation-effectiveness study guided by the Replicating Effective Programmes Framework. It will be conducted in four overlapping phases in maternal care clinics (MCC) in 11 local government areas in and around Ibadan metropolis, Nigeria. In Phase I, engagement meetings with relevant stake holders will be held. In phase II, the organizational and clinical profiles of MCC to deliver chronic depression care will be assessed, using interviews and a standardized assessment tool administered to staff and managers of the clinics. To ascertain the current level of care, 167 consecutive women presenting for antenatal care for the first time and who screened positive for depression will be recruited and followed up till 12 months post-partum. In phase III, we will design and implement a cascade training programme for PHCW, to equip them to identify and treat perinatal depression. In phase IV, a second cohort of 334 antenatal women will be recruited and followed up as in Phase I, to ascertain post-training level of care. The primary implementation outcome is change in the identification and treatment of perinatal depression by the PHCW while the primary effectiveness outcome is recovery from depression among the women at 6 months post-partum. A range of mixed-method approaches will be used to explore secondary implementation outcomes, including fidelity and acceptability. Secondary effectiveness outcomes are measures of disability and of infant outcomes.DiscussionThis study represents an attempt to systematically assess and document an implementation strategy that could inform the scaling up of evidence based interventions for perinatal depression using the WHO mhGAP-IG in LMIC.Trial registration This study was registered on 03 December, 2019. https://doi.org/10.1186/ISRCTN94230307.

Trauma-informed care in geriatric inpatient units to improve staff skills and reduce patient distress: a co-designed study protocol

BackgroundGeriatric hospital wards are highly medicalised environments with limited opportunities for choice and control, and can be distressing for older survivors of psychological trauma. While trauma-informed models of care (TIC) are effectively applied across mental health and other settings, the utility of these models in aged care settings has not been assessed. The objective of this study was to examine whether TIC can reduce responsive behaviour, chemical restraint, and improve staff skills and patient experiences in inpatient geriatric settings.MethodsFour wards participated in this type I hybrid implementation-effectiveness study across southern Adelaide, Australia, including 79 beds. Using a co-design method, the principles of TIC were transformed into an implementation strategy including staff training, establishment of highly trained ‘champions’ on each ward, screening for trauma-related needs, and amending ward policies and procedures. Primary outcomes will be examined using an interrupted time-series design and are monthly incidence of responsive behaviour incidents and use of chemical restraint. Process evaluation will be used to examine secondary, implementation outcomes including the acceptability, feasibility, and fidelity to the implementation strategy.DiscussionTrauma-informed care has potential to improve the safety and accessibility of hospital wards for older people who have survived psychologically traumatic events and has an extensive evidence base supporting its effectiveness in other settings. Identifying trauma-related needs and amending care to reduce the risk of re-traumatisation and distress may also reduce the incidence of responsive behaviour change, which has a significant impact on the quality of life of hospital patients and staff and is very costly. The inclusion of a process evaluation will allow us to identify and report changes made on each ward and make recommendations for future implementation efforts.

Outcomes of Implementing in the Real World the Women's Health CoOp Intervention in Cape Town, South Africa

Women in South Africa living with HIV who use alcohol may not adhere to ART, affecting the country’s 90-90-90 targets. The Women’s Health CoOp (WHC), a woman-focused HIV intervention, has shown efficacy in numerous trials with key populations of women in South Africa who use alcohol and drugs. In a hybrid implementation effectiveness study, the WHC was implemented in usual care clinics by healthcare providers in a modified stepped-wedge design. We present the outcomes of alcohol use and ART adherence with 480 women, with a 95% 6-month follow-up rate across 4 implementation cycles. Compared with the first cycle, women in the fourth cycle were significantly less likely (OR = 0.10 [95% CI 0.04, 0.24]) to report alcohol use disorder risk and were 4 times more likely (OR = 4.16 [95% CI 1.05, 16.51]) to report ART adherence at 6-month follow-up. Overall, acceptability and satisfaction were extremely high. The WHC intervention was successful in reaching key populations of women to reduce alcohol use and increase ART adherence, which is essential for South Africa to reach the 90-90-90 goals.