Clinical trial NCT06689930: Community-based Implementation of Adapted STAC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Hypertension
Pregnancy Related
Health Equity
Keywords: Prenatal
Post Partum
Hypertensive Disorders of Pregnancy
Remote Patient Monitoring
Blood Pressure
Community-Based Participation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is primarily a qualitative study designed to identify implementation strategies for the Adapted Staying Healthy After Childbirth (A-STAC). This pre-implementation phase includes 10 pilot participants and at least 2 CBO staff.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Qualitative Summary of Barriers to Implementation of A-STAC
timeFrame: up to 4 weeks
measure: Qualitative Summary of Facilitators to Implementation of A-STAC
timeFrame: up to 4 weeks
measure: Qualitative Summary of Adaptations to STAC
timeFrame: up to 8 weeks
measure: The Acceptability of Intervention Measure (AIM)
timeFrame: up to 8 weeks
measure: The Intervention Appropriateness Measure (IAM)
timeFrame: up to 8 weeks
measure: The Feasibility of Intervention Measure (FIM)
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kara Hoppe, DO, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Andrew Garbacz, PhD
role: PRINCIPAL_INVESTIGATOR
References: