Hybrid Effectiveness-implementation Trial Research Articles

Concurrent Hospice and Dialysis Care: Considerations for Implementation.

Hospice positively impacts care at the end of life for patients and their families. However, compared to the general Medicare population, patients on dialysis are half as likely to receive hospice. Concurrent hospice and dialysis care offers an opportunity to improve care for people living with end-stage kidney disease (ESKD). We sought to (1) develop a conceptual model of the Program and (2) identify key components, resources, and considerations for further implementation. We conducted a template analysis of qualitative interviews and convened a community advisory panel (CAP) to get feedback on current concurrent care design and considerations for dissemination and implementation. Thirty-nine patients with late-stage chronic kidney disease (CKD), family caregivers, bereaved family caregivers, hospice clinicians, nephrology clinicians, administrators, and policy experts participated in interviews. A purposive subset of 19 interviewees composed the CAP. Qualitative feedback on concurrent care design refinements, implementation, and resources. Participants identified four themes that define an effective model of concurrent hospice and dialysis: it requires (1) timely goals-of-care conversations and (2) an interdisciplinary approach; (3) clear guidelines ensure smooth transitions for patients and families; and (4) hospice payment policy must support concurrent care. CAP participants provided feedback on the phases of an effective model of concurrent hospice and dialysis, and resources, including written and interactive educational materials, communication tools, workflow processes, and order sets. We developed a conceptual model for concurrent hospice and dialysis care and a corresponding resource list. In addition to policy changes, clinical implementation and educational resources can facilitate scalable and equitable dissemination of concurrent care. Concurrent hospice and dialysis care must be systematically evaluated via a hybrid implementation-effectiveness trial that includes the resources outlined herein, based on our conceptual model of concurrent care delivery.

Physiotherapy-led telehealth and exercise intervention to improve mobility in older people receiving aged care services (TOP UP): protocol for a randomised controlled type 1 hybrid effectiveness-implementation trial

IntroductionDeteriorating mobility and falls reduce independence and quality of life for older people receiving aged care services. This trial aims to establish effectiveness on the mobility of older people, and...

Very brief intervention for physical activity behaviour change in cardiac rehabilitation: protocol for the ‘Measure It!’ effectiveness–implementation hybrid trial

IntroductionPhysical inactivity is a risk factor for repeat cardiac events and all-cause mortality in coronary heart disease (CHD). Cardiac rehabilitation, a secondary prevention programme, aims to increase physical activity levels...

Sudden gains in PTSD symptoms and social functioning in cognitive processing therapy for posttraumatic stress disorder

ABSTRACT Objective: Sudden gains (SGs) are rapid symptom improvements between two consecutive therapy sessions that predict treatment outcomes. This study investigated SGs in posttraumatic stress disorder (PTSD) symptoms, interpersonal relationship functioning, and social role functioning in Cognitive Processing Therapy (CPT). Method: Participants were 121 patients and 81 therapists involved in a parent randomized controlled hybrid implementation-effectiveness trial of CPT. Descriptive analyses examined the frequency and timing of different forms of SGs. Multilevel modeling examined the impact of the three SGs on outcomes. Results: PTSD SGs occurred more often and at different sessions than SGs in facets of social functioning. Most individuals experienced only one form of SG and there were no significant clinical or demographic differences in those who had PTSD only SGs, social functioning only SGs, or both SGs. PTSD SGs and interpersonal relationship functioning SGs both predicted changes in PTSD symptoms and interpersonal difficulties over time, but not changes in social role functioning. SGs in social role functioning predicted all three forms of outcomes. Conclusions: The findings suggest that there are multiple forms of SGs in CPT beyond primary symptom changes that are predictive of patient outcomes. Clinicians should highlight various SGs that patients experience to further enhance outcomes.

Scale-up of the Australian Fans in Training (Aussie-FIT) men’s health behaviour change program: a protocol for a randomised controlled hybrid effectiveness–implementation trial

IntroductionImproving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health...

Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers

IntroductionTo end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for...

Scaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: protocol for the TransformUs hybrid effectiveness–implementation trial

IntroductionEfficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children’s (5–12 years) physical activity...

Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial

BackgroundContingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim).MethodsUtilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2–3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints.DiscussionBetween planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol.Trial registrationThis study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.

Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial.

The authors examined whether brief cognitive-behavioral therapy (bCBT) for depression, delivered by mental health providers in community-based outpatient clinics (CBOCs) of the Veterans Health Administration, improved depression outcomes and was feasible and acceptable in clinical settings. The authors used a type-2 hybrid effectiveness-implementation, patient-randomized trial to compare bCBT with enhanced usual care. Participants (N=189) with moderate symptoms of depression (Patient Health Questionnaire-9 [PHQ-9] score ≥10) were enrolled from CBOCs in the southern United States. bCBT (N=109) consisted of three to six sessions, delivered by mental health providers (N=17) as part of routine clinic practices. Providers received comprehensive training and support to facilitate bCBT delivery. Recipients of enhanced usual care (N=80) were given educational materials and encouraged to discuss treatment options with their primary care provider. The primary effectiveness outcome was PHQ-9-assessed depression symptoms posttreatment (4 months after baseline) and at 8- and 12-month follow-ups. Implementation outcomes focused on bCBT dose received, provider fidelity, and satisfaction with bCBT training and support. bCBT improved depression symptoms (Cohen's d=0.55, p<0.01) relative to enhanced usual care posttreatment, and the improvement was maintained at 8- and 12-month follow-ups (p=0.004). bCBT participants received a mean±SD of 3.7±2.7 sessions (range 0-9), and 64% completed treatment (≥3 sessions). Providers delivered bCBT with fidelity and reported that bCBT training and support were feasible and effective. bCBT had a modest treatment footprint of approximately four sessions, was acceptable to participants and providers, was feasible for delivery in CBOCs, and produced meaningful sustained improvements in depression.

An innovative sequential mixed-methods approach to evaluating clinician acceptability during implementation of a standardized labor induction protocol

BackgroundImplementation outcomes, including acceptability, are of critical importance in both implementation research and practice. The gold standard measure of acceptability, Acceptability of Intervention Measure (AIM), skews positively with a limited range. In an ongoing hybrid effectiveness-implementation trial, we aimed to evaluate clinician acceptability of induction standardization. Here, we describe an innovative mixed-methods approach to maximize the interpretability of the AIM using a case study in maternal health.MethodsIn this explanatory sequential mixed methods study, we distributed the validated, 4-question AIM (total 4–20) to labor and delivery clinicians 6 months post-implementation at 2 sites (Site 1: 3/2021; Site 2: 6/2021). Respondents were grouped by total score into tertiles. The top (“High” Acceptability) and bottom (“Low” Acceptability) tertiles were invited to participate in a 30-minute semi-structured qualitative interview from 6/2021 to 10/2021 until thematic saturation was reached in each acceptability group. Participants were purposively sampled by role and site. Interviews were coded using an integrated approach, incorporating a priori attributes (Consolidated Framework for Implementation Research constructs) into a modified content analysis approach.Results104 clinicians completed the initial survey; 24 were interviewed (12 “High” and 12 “Low” Acceptability). Median total AIM scores were 20/20 IQR[20–20] in the High and 12.5/20 IQR[11–14] in the Low Acceptability groups. In both groups, clinicians were enthusiastic about efforts to standardize labor induction, believing it reduces inter-clinician variability and improves equitable, evidence-based care. In the Low Acceptability group, clinicians stated the need for flexibility and consideration for patient uniqueness. Rarely, clinicians felt labor induction could not or should not be standardized, citing discomfort with medicalization of labor, and concerns with “bulldozing” the patient with interventions. Suggested strategies for overcoming negative sentiment included comprehensive clinician education, as well as involving patients as active participants in the protocol prenatally.ConclusionsThis study utilized AIM in an innovative sequential mixed-methods approach to characterize clinician acceptability, which may be generalizable across implementation endeavors. By performing this work during a hybrid trial, implementation strategies to improve acceptability emerged (clinician education focusing on respect for flexibility; involving patients as active participants prenatally) for year 2, which will inform future multi-site work.

A pragmatic clinical effectiveness trial of a novel alternative to punishment for school-based substance use infractions: study protocol for the iDECIDE curriculum.

Adolescents who use alcohol and other drugs on school campuses are at heightened risk for adverse consequences to their health and wellbeing. Schools have historically turned to punitive approaches as a first-line response to substance use. However, punishment is an ineffective deterrent for substance use and may cause harm and increase inequities. iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) was developed as a scalable and youth-centered drug education and diversion program that can be used as a skills-based alternative to punishment. We aim to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punishment (ATP) for school-based substance use infractions in the context of a large pragmatic clinical effectiveness study. We will conduct a Type 1, hybrid effectiveness-implementation trial. Using a stepped wedge design with approximately 90 middle and high schools in Massachusetts, we will randomly allocate the timing of implementation of the iDECIDE curriculum compared to standard disciplinary response over approximately 36 months. We will test the overarching hypothesis that student-level outcomes (knowledge of drug effects and attitudes about substance use; frequency of substance use; school connectedness) improve over time as schools transition from a standard disciplinary response to having access to iDECIDE. The secondary aims of this trial are to (1) explore whether change in student-level outcomes vary according to baseline substance use, number of peers who use alcohol or other drugs, age, gender, and school urbanicity, and (2) determine the acceptability and feasibility of the iDECIDE curriculum through qualitative stakeholder interviews. Substance use continues to be a major and rapidly evolving problem in schools. The importance of moving away from punishment to more restorative approaches is widely accepted; however, scalable alternatives have not yet been identified. This will be the first study to our knowledge to systematically evaluate an ATP for students who violate the school substance use policy and is well poised to have important implications for policy making.

Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression symptoms

BackgroundIn studies of the general population and of military veterans, many primary care patients with hazardous drinking and PTSD and/or depression (abbreviated here as HD +) do not initiate or engage with alcohol-related care. To address this gap in care, we identified and will pilot test a promising evidence-based intervention, Connect To Care (C2C). C2C is a strengths-based approach, delivered by a Care Coach by telephone and/or video, with four components: (1) identifying and leveraging patient strengths to facilitate care initiation, (2) collaborative decision-making around a menu of care options, (3) identifying and resolving barriers to care, and (4) monitoring and facilitating progress toward care initiation by, for example, checking on barriers, identifying solutions, and revisiting care options.Methods/DesignAim 1 will involve adapting C2C for use in Veterans Affairs’ (VA) primary care. We will use an iterative process that includes focus groups and semi-structured interviews with key stakeholders (patients, primary care providers, and VA national policy leaders). In Aim 2, we will conduct a two-site, pilot randomized controlled trial to determine the feasibility of conducting a larger scale trial to test C2C’s effectiveness, ascertain the acceptability of C2C among primary care patients with HD + , and explore the efficacy of C2C to improve veteran patients’ initiation of and engagement in alcohol care, and their alcohol and mental health (PTSD, depression) outcomes, at 3-month follow-up. We will explore explanatory mechanisms by which C2C is effective.DiscussionStudy findings are likely to have implications for clinical practice to enhance current approaches to linking patients with HD + to alcohol care by applying a practical intervention such as C2C. The results may improve treatment outcomes for people with HD + by drawing on patients’ strengths to problem-solve barriers to care following a process of shared decision-making with a coach. In addition to possibly accelerating the translation of C2C into practice, study findings will also support additional research in terms of a planned effectiveness-implementation hybrid trial, adding to this study’s potential for high impact.Trial registration: ClinicalTrials.gov Identifier: NCT05023317.

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).

Acceptability, appropriateness, and feasibility of Rural School Support Strategies for behavioral interventions: a mixed methods evaluation over two years of a hybrid type 3 implementation-effectiveness trial

BackgroundPositive Behavioral Interventions and Supports (PBIS) is a framework for implementing evidence-based interventions for preventing behavioral issues and improving climate in schools. The implementation of school-wide PBIS with fidelity is complex, requiring leadership commitment, teaming, and coordination of systems for tracking behaviors and consequences. Putting these components in place while ensuring alignment with the values and needs of the school community can be difficult for schools with fewer resources, such as rural schools. Implementation supports are needed, including strategies such as technical assistance, but it is unclear whether lower-cost modalities such as virtual support are acceptable, appropriate, and feasible and whether perceptions vary throughout the implementation process.MethodsA type 3 hybrid implementation-effectiveness trial is taking place in 40 Idaho schools, testing a bundle of implementation supports selected to meet the needs of schools in rural areas. Supports include technical assistance from an implementation support practitioner (ISP), didactic trainings, virtual learning sessions, and an online resource portal. Surveys and interviews in the first 2 years of implementation (fall 2019 to spring 2021) explored outcomes of acceptability, appropriateness, and feasibility regarding the implementation supports among more than 150 school stakeholders.ResultsEvaluations showed high acceptability and appropriateness of the PBIS concepts and training. The 20 schools receiving additional implementation support rated the technical assistance and support from the project’s ISPs as the most acceptable and appropriate resource. Reasons for acceptability were the relationship built with the ISP, the ISP’s expertise, and being a “neutral party.” Although in-person support from the ISP was preferred, remote support was acceptable and increased feasibility of attendance. Virtual learning sessions were acceptable for learning and collaboration, particularly in the second year of implementation, once ISPs had developed closer relationships with school teams.ConclusionsSchool staff found training, technical assistance, and virtual learning sessions to be acceptable and appropriate. Virtual formats of training and technical assistance decreased in acceptability but increased feasibility of attendance. In-person support was preferred during initial implementation, and virtual support was more acceptable thereafter.Trial registrationThis trial was prospectively registered on ClinicalTrials.gov (NCT03736395), on November 9, 2018.

Veteran Cultural Competence Training: Initial Effectiveness and National-Level Implementation.

Because service professionals often lack cultural competence in working with veterans, veterans often perceive such professionals as "not understanding." The authors developed, evaluated, and implemented Veteran Cultural Competence Training (VCCT), combining educational and experiential components in an in-person training focused on building awareness, knowledge, and skills to better work with veterans. Study 1 was a type 1 effectiveness-implementation hybrid trial examining VCCT effectiveness in a sample of social service professionals (N=41) compared with a matched comparison group (N=41) via the Multicultural Counseling Self-Efficacy Scale-Veteran Form (MCSE-V) instrument. In study 2, the authors used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to conduct a type 2 effectiveness-implementation hybrid trial and implemented VCCT with an expanded population (N=312) during eight training sessions in three U.S. states. Results from study 1 indicated that VCCT significantly increased self-efficacy of trainees in veteran cultural competence compared with the matched group (p<0.001). In study 2, the RE-AIM framework highlighted the importance of building coalitions and utilizing implementation facilitation to maintain fidelity. The within-group effectiveness of VCCT was statistically significant and maintained across settings and professions (p<0.001), and trainees were satisfied with VCCT. Maintenance analysis revealed expansion of VCCT after implementation in terms of the number of training sessions (N=9), regions hosting the training (N=5), staff hired (N=13), and trainee applications (N=1,018). VCCT effectively increases self-efficacy in veteran cultural competence. Gains appeared across different professions, demographic characteristics, and locations. Participation in VCCT may increase professionals' competence in understanding veteran culture, thereby potentially improving veteran services.

A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial

BackgroundMedical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, “SMARThealth Pregnancy,” to improve health during pregnancy and the first year after birth.MethodsA pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire).DiscussionEngaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women’s lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world.Trial registrationClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.

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.

Community-based family peer navigator programme to facilitate linkage to coordinated specialty care for early psychosis among Black families in the USA: A protocol for a hybrid type I feasibility study

BackgroundApproximately 70% of Black/African American family members report no contact with mental health providers prior to initial diagnosis and the receipt of services for early psychosis. Black families often encounter...

An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS

BackgroundTobacco use remains the leading cause of preventable disease, disability, and death in the world. Lebanon has an exceptionally high tobacco use burden. The World Health Organization endorses smoking cessation advice integrated into primary care settings as well as easily accessible and free phone-based counseling and low-cost pharmacotherapy as standard of practice for population-level tobacco dependence treatment. Although these interventions can increase access to tobacco treatment and are highly cost-effective compared with other interventions, their evidence base comes primarily from high-income countries, and they have rarely been evaluated in low- and middle-income countries. Recommended interventions are not integrated as a routine part of primary care in Lebanon, as in other low-resource settings. Addressing this evidence-to-practice gap requires research on multi-level interventions and contextual factors for implementing integrated, scalable, and sustainable cessation treatment within low-resource settings.MethodsThe objective of this study is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based tobacco treatment in primary healthcare centers within the Lebanese National Primary Healthcare Network. We will adapt and tailor an existing in-person smoking cessation program to deliver phone-based counseling to smokers in Lebanon. We will then conduct a three-arm group-randomized trial of 1500 patients across 24 clinics comparing (1) ask about tobacco use; advise to quit; assist with brief counseling (AAA) as standard care; (2) ask; advise; connect to phone-based counseling (AAC); and (3) AAC + nicotine replacement therapy (NRT). We will also evaluate the implementation process to measure factors that influence implementation. Our central hypothesis is that connecting patients to phone-based counseling with NRT is the most effective alternative. This study will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, supported by Proctor’s framework for implementation outcomes.DiscussionThe project addresses the evidence-to-practice gap in the provision of tobacco dependence treatment within low-resource settings by developing and testing contextually tailored multi-level interventions while optimizing implementation success and sustainability. This research is significant for its potential to guide the large-scale adoption of cost-effective strategies for implementing tobacco dependence treatment in low-resource settings, thereby reducing tobacco-related morbidity and mortality.Trial registrationClinicalTrials.gov, NCT05628389, Registered 16 November 2022.

MHealth to improve implementation of TB contact investigation: a case study from Uganda

BackgroundImplementation science offers a systematic approach to adapting innovations and delivery strategies to new contexts but has yet to be widely applied in low- and middle-income countries. The Fogarty Center for Global Health Studies is sponsoring a special series, “Global Implementation Science Case Studies,” to address this gap.MethodsWe developed a case study for this series describing our approach and lessons learned while conducting a prospective, multi-modal study to design, implement, and evaluate an implementation strategy for TB contact investigation in Kampala, Uganda. The study included formative, evaluative, and summative phases that allowed us to develop and test an adapted contact investigation intervention involving home-based sample collection for TB and HIV testing. We concurrently developed a multi-component mHealth implementation strategy involving fingerprint scanning, electronic decision support, and automated reporting of test results via text message. We then conducted a household-randomized, hybrid implementation-effectiveness trial comparing the adapted intervention and implementation strategy to usual care. Our assessment included nested quantitative and qualitative studies to understand the strategy’s acceptability, appropriateness, feasibility, fidelity, and costs. Reflecting on this process with a multi-disciplinary team of implementing researchers and local public health partners, we provide commentary on the previously published studies and how the results influenced the adaptation of international TB contact investigation guidelines to fit the local context.ResultsWhile the trial did not show improvements in contact investigation delivery or public health outcomes, our multi-modal evaluation strategy helped us identify which elements of home-based, mHealth-facilitated contact investigation were feasible, acceptable, and appropriate and which elements reduced its fidelity and sustainability, including high costs. We identified a need for better tools for measuring implementation that are simple, quantitative, and repeatable and for greater attention to ethical issues in implementation science.ConclusionsOverall, a theory-informed, community-engaged approach to implementation offered many learnings and actionable insights for delivering TB contact investigation and using implementation science in low-income countries. Future implementation trials, especially those incorporating mHealth strategies, should apply the learnings from this case study to enhance the rigor, equity, and impact of implementation research in global health settings.