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An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

ABSTRACT: BACKGROUND:Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and short visits with inconsistent provisioning of essential services and minimal health promotion, especially for HIV prevention. This study answers WHO's call for the rigorous study of group antenatal care as a transformative model that provides a positive pregnancy experience and improves outcomes. METHODS:Using a hybrid type 1 effectiveness-implementation design, we test the effectiveness of group antenatal care by comparing it to individual care across 6 clinics in Blantyre District, Malawi. Our first aim is to evaluate the effectiveness of group antenatal care through 6?months postpartum. We hypothesize that women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We will test hypotheses using multi-level hierarchical models using data from repeated surveys (four time points) and health records. Guided by the consolidated framework for implementation research, our second aim is to identify contextual factors related to clinic-level degree of implementation success. Analyses use within and across-case matrices. DISCUSSION:This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care. Results will provide rigorous evidence documenting the effectiveness and scalability of group antenatal care. If results are negative, governments will avoid spending on less effective care. If our study shows positive health impacts in Malawi, the results will provide strong evidence and valuable lessons learned for widespread scale-up in other low-resource settings. Positive maternal, neonatal, and HIV-related outcomes will save lives, impact the quality of antenatal care, and influence health policy as governments make decisions about whether to adopt this innovative healthcare model. TRIAL REGISTRATION:ClinicalTrials.gov registration number NCT03673709. Registered on September 17, 2018.

SUBMITTER: Chirwa E

PROVIDER: S-EPMC7008527 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

Chirwa Ellen E Kapito Esnath E Jere Diana L DL Kafulafula Ursula U Chodzaza Elizabeth E Chorwe-Sungani Genesis G Gresh Ashley A Liu Li L Abrams Elizabeth T ET Klima Carrie S CS McCreary Linda L LL Norr Kathleen F KF Patil Crystal L CL

BMC public health 20200210 1

<h4>Background</h4>Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and sh ...[more]

PMID: 32039721

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Project description:BackgroundKnee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT.MethodsIn this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted.DiscussionTo our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT.Trial registrationThis study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).

Project description:BackgroundFor approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children's SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.MethodsThis project uses a blocked randomized cohort design with an active comparison control (ACC) condition. We will recruit and include approximately 276 teachers from 46 schools randomly assigned to BASIS-T or ACC conditions. Aim 1 will evaluate the main effects of BASIS-T on proximal implementation mechanisms (attitudes, subjective norms, self-efficacy, intentions to implement, and maintenance self-efficacy), implementation outcomes (adoption, reach, fidelity, and sustainment), and child outcomes (SEB, attendance, discipline, achievement). Aim 2 will examine how, for whom, under what conditions, and how efficiently BASIS-T works, specifically by testing whether the effects of BASIS-T on child outcomes are (a) mediated via its putative mechanisms of behavior change, (b) moderated by teacher factors or school contextual factors, and (c) cost-effective.DiscussionThis study will provide a rigorous test of BASIS-T-a pragmatic, theory-driven, and generalizable implementation strategy designed to target theoretically-derived motivational mechanisms-to increase the yield of standard EBPP training and support strategies.Trial registrationClinicalTrials.gov ID: NCT05989568. Registered on May 30, 2023.

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Dataset Information

An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

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An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

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