Back to Trials
NCT06689930NARecruitingAccepts Healthy Volunteers

Community-based Implementation of Adapted STAC

University of Wisconsin, Madison

Start Date

5/22/2025

Completion Date

9/1/2026

Summary

This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).

Detailed Description

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 Community Based Organization (CBO) partners 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 (up to three PDSA cycles total), 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 cycles and follow-up interviews and surveys for patients (3-5 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 additional PDSA cycles (up to 3). Step 5: Finalize A-STAC Intervention.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria (Interviews and Focus Groups): * Belong to the STAC-CAB or Lived Experience Group * Aged 18 or older Inclusion Criteria (CBO Staff): * Staff of CBO participating in PDSA cycle * Aged 18 years or older Inclusion Criteria (PDSA-Cycles): * Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum * Self-Identify as African American or Black * Aged 18 years or older * Capable of providing informed consent in English * Can follow M•care System use instructions in English * Have ownership of a functioning and reliable smartphone to upload and use the M•other App * Interested in preventing or managing blood pressure during pregnancy Exclusion Criteria (PDSA-Cycles): * Persistent second or third trimester bleeding at time of enrollment * Premature rupture of membranes in the current pregnancy at time of enrollment * Known unrepaired maternal congenital heart disease requiring surgical correction * Maternal heart failure * Chronic kidney disease specifically requiring dialysis * On greater than two antihypertensive medications at time of enrollment

Interventions

OTHER

PDSA Cycles

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Blood PressureHypertensionPregnancy RelatedHealth Equity

Locations

University of Wisconsin

Madison, Wisconsin 53792

United States