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Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
Hypertensive disorders of pregnancy (HDP) are windows into chronic disease risk. The immediate postpartum (PP) period (6 weeks) is the highest risk and most important period for prevention of serious adverse outcomes with long term consequences. This project focuses on a multicomponent evidence-based intervention, Staying Healthy After Childbirth (STAC) that has been tested in a Midwest academic hospital. The intervention has been shown to be effective at addressing factors associated with health promotion priorities in populations with high levels of health disparities and inequities by increasing access to hypertension (HTN) care in the critical PP window by providing patients a home blood pressure monitor and access to a dedicated healthcare team that provides remote BP surveillance and antihypertensive medication titration. To optimize STAC to prevent and reduce racial disparities in immediate PP morbidity and mortality, deeper engagement with community stakeholders is critical. This is a qualitative investigation designed as pre-implementation of the Adapted Staying Healthy After Childbirth (A-STAC) intervention. STAC-Community Advisory Board (CAB) members and Lived Experience Group members will provide qualitative data through semi-structured interviews regarding implementation factors of STAC, including priorities for adaptation, barriers and facilitators to implementation, and usability. Rapid qualitative analysis will be used to glean themes from the qualitative data. A second round of semi-structured focus groups using the nominal decision-making process will be conducted to address the revisions to implementation strategies and determine priorities for A-STAC. Next, abbreviated study cycles to test implementation (Plan-Do-Study-Act or PDSA cycles) will take place, with a Community Based Organization (CBO) partner and participating Black pregnant persons. After each PDSA cycle, interviews and surveys with patients and staff will be conducted. Rapid qualitative analysis will again be used to gain information about the usability of A-STAC from the focus group; this information will then be used to refine the A-STAC intervention. This process will be repeated for a second PDSA cycle, after which the A-STAC intervention will be finalized for implementation (registered to a separate ClinicalTrials.gov record). Step 1: Conduct interviews with STAC-CAB members (8-12 members) and Lived Experience Group members (8-12 members) to evaluate implementation factors and priorities for adaptation of STAC. Use rapid qualitative analysis process to glean implementation strategies. Step 2: Conduct small focus groups (3-4 participants per group) with STAC-CAB members (8-12 members) and Lived Experience Group members separately using nominal group decision decision making process. Address revisions to implementation strategies and priorities for A-STAC. Step 3: Conduct PDSA cycle and follow-up interviews and surveys for patients (5 participants per cycle, 10 total) and CBO staff (at least 2 staff). Step 4: Incorporate usability data from cycle 1 to refine A-STAC. Repeat steps 3-4 for second PDSA cycle. Step 5: Finalize A-STAC Intervention.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Wisconsin
Madison, Wisconsin, United States
Start Date
May 22, 2025
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2026
Last Updated
January 22, 2026
46
ESTIMATED participants
PDSA Cycles
OTHER
Lead Sponsor
University of Wisconsin, Madison
Collaborators
NCT02417740
NCT07482930
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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