Community-based Implementation of Adapted STAC

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).

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Pregnancy Related; Blood Pressure; Health Equity
• Intervention / Treatment: Other: PDSA Cycles

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Knutson Sinaise, MS, ACSM-CEP; Phone Number: 608-556-9708; Email: mknutson2@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: STAC-CAB Members; Staying Healthy After Childbirth - Community Advisory Board members (8-12 members)
No Intervention: Lived Experience Group Members; Lived Experience Group members (8-12 members)
Experimental: PDSA Cycle Participants and CBO Staff; Black pregnant or postpartum persons and Community Based Organization Staff	Other: PDSA Cycles; Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Summary of Barriers to Implementation of A-STAC	Barriers to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding barriers will be coded for themes summarized by participant count.	up to 4 weeks
Qualitative Summary of Facilitators to Implementation of A-STAC	Facilitators to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding facilitators will be coded for themes summarized by participant count.	up to 4 weeks
Qualitative Summary of Adaptations to STAC	Adaptations to STAC will be analyzed from patient participant interviews and CBO staff participants post-PDSA cycles. Interviews will be coded for themes summarized by count.	up to 8 weeks
The Acceptability of Intervention Measure (AIM)	The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.	up to 8 weeks
The Intervention Appropriateness Measure (IAM)	The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.	up to 8 weeks
The Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.	up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Kara Hoppe, DO, PhD, University of Wisconsin, Madison; Principal Investigator: Andrew Garbacz, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• STAC Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Blood Pressure; Post Partum; Prenatal; Hypertensive Disorders of Pregnancy; Remote Patient Monitoring; Community-Based Participation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2024-1594; U48DP006793 (U.S. NIH Grant/Contract); Protocol Approved 5/14/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No