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Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

ABSTRACT: OBJECTIVE:To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS:A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS:The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION:Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.

SUBMITTER: Patil CL

PROVIDER: S-EPMC5673548 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

Patil Crystal L CL Klima Carrie S CS Steffen Alana D AD Leshabari Sebalda C SC Pauls Heather H Norr Kathleen F KF

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 20171010 3

<h4>Objective</h4>To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot.<h4>Methods</h4>A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in ...[more]

PMID: 28905377

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Project description:ObjectiveThis study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities.Study designA pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle.ResultsOf 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms.ConclusionDiabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes.Key points· Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..

Project description:ObjectiveTo determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences.MethodsA multisite randomized controlled trial was conducted at two university-affiliated hospital prenatal clinics. Pregnant women aged 14-25 years (n=1,047) were randomly assigned to either standard or group care. Women with medical conditions requiring individualized care were excluded from randomization. Group participants received care in a group setting with women having the same expected delivery month. Timing and content of visits followed obstetric guidelines from week 18 through delivery. Each 2-hour prenatal care session included physical assessment, education and skills building, and support through facilitated group discussion. Structured interviews were conducted at study entry, during the third trimester, and postpartum.ResultsMean age of participants was 20.4 years; 80% were African American. Using intent-to-treat analyses, women assigned to group care were significantly less likely to have preterm births compared with those in standard care: 9.8% compared with 13.8%, with no differences in age, parity, education, or income between study conditions. This is equivalent to a risk reduction of 33% (odds ratio 0.67, 95% confidence interval 0.44-0.99, P=.045), or 40 per 1,000 births. Effects were strengthened for African-American women: 10.0% compared with 15.8% (odds ratio 0.59, 95% confidence interval 0.38-0.92, P=.02). Women in group sessions were less likely to have suboptimal prenatal care (P<.01), had significantly better prenatal knowledge (P<.001), felt more ready for labor and delivery (P<.001), and had greater satisfaction with care (P<.001). Breastfeeding initiation was higher in group care: 66.5% compared with 54.6%, P<.001. There were no differences in birth weight nor in costs associated with prenatal care or delivery.ConclusionGroup prenatal care resulted in equal or improved perinatal outcomes at no added cost.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00271960Level of evidenceI.

Project description: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.

Project description:BackgroundGroup prenatal care enhances quality of care, improves outcomes, and lowers costs. However, this healthcare innovation is not widely available. Using a case-study approach, our objectives were to (1) examine organizational characteristics that support implementation of Expect With Me group prenatal care and (2) identify key factors influencing adoption and sustainability.MethodsWe studied five clinical sites implementing group prenatal care, collecting qualitative data including focus group discussions with clinicians (n = 4 focus groups, 41 clinicians), key informant interviews (n = 9), and administrative data. We utilized a comparative qualitative case-study approach to characterize clinical sites and explain organizational traits that fostered implementation success. We characterized adopting and non-adopting (unable to sustain group prenatal care) sites in terms of fit for five criteria specified in the Framework for Transformational Change: (1) impetus to transform, (2) leadership commitment to quality, (3) improvement initiatives that engage staff, (4) alignment to achieve organization-wide goals, and (5) integration.ResultsTwo sites were classified as adopters and three as non-adopters based on duration, frequency, and consistency of group prenatal care implementation. Adopters had better fit with the five criteria for transformational change. Adopting organizations were more successful implementing group prenatal care due to alignment between organizational goals and resources, dedicated healthcare providers coordinating group care, space for group prenatal care sessions, and strong commitment from organization leadership.ConclusionsAdopting sites were more likely to integrate group prenatal care when stakeholders achieved alignment across staff on organizational change goals, leadership buy-in, and committed institutional support and dedicated resources to sustain it.Trial registrationThe Expect With Me intervention's design and hypotheses were preregistered: https://clinicaltrials.gov/study/NCT02169024 . Date: June 19, 2014.

Project description:BACKGROUND:In Malawi, early retention in HIV care remains challenging. Depression is strongly associated with reduced anti-retroviral therapy (ART) adherence and viral suppression. Appropriate depression care for people initiating ART is likely to be supportive of early and continued engagement in the HIV care continuum. This paper aims to provide an overview of a task-shifting program that integrates depression screening and treatment into HIV care and the strategy used to evaluate this program, describes the implementation process, and discusses key challenges and lessons learned in the first phase of program implementation. METHODS:We are implementing a program integrating depression screening and treatment into HIV care initiation at two clinics in Lilongwe District, Malawi. The program's effect on patients' depression and HIV outcomes will be evaluated using a multiple baseline pre-post study. In this manuscript, we draw from our experiences as program implementers and some of the quantitative data to describe the process of implementation and key lessons learned. RESULTS:We successfully implemented the screening phase of this program at both clinics; 88.3 and 93.2% of newly diagnosed patients have been screened for depression at each clinic respectively. 25% of enrolled patients reported symptoms of mild-to-severe depression and only 6% reported symptoms of moderate-to-severe depression. Key lessons learned from the process show the importance of utilizing existing processes and infrastructure and focusing on iterative and collaborative learning. We continued to face challenges around establishing a sense of program ownership among providers, developing capacity to diagnose and manage depression, and ensuring the availability of appropriate medication. Our efforts to address these challenges provide insight into the technical and managerial support needed to prepare for, roll out, and sustain integrated models of mental health and HIV care. CONCLUSIONS:This activity demonstrates how a depression screening program can successfully be integrated into HIV care within the public health system in Malawi. While this program focuses on integrating depression management into HIV care, most of the lessons learned could apply to integration of mental health into any non-psychiatric specialist setting. TRIAL REGISTRATION:ClinicalTrials.gov ID [ NCT03555669 ]. Retrospectively registered on 13 June 2018.

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Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

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Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

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