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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Qualitative Summary of Barriers to Implementation of A-STAC
研究概览
简要总结
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •(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
研究组 & 干预措施
STAC-CAB Members
Staying Healthy After Childbirth - Community Advisory Board members (8-12 members)
Lived Experience Group Members
Lived Experience Group members (8-12 members)
PDSA Cycle Participants and CBO Staff
Black pregnant or postpartum persons and Community Based Organization Staff
干预措施: PDSA Cycles (Other)
结局指标
主要结局
Qualitative Summary of Barriers to Implementation of A-STAC
时间窗: up to 4 weeks
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.
Qualitative Summary of Facilitators to Implementation of A-STAC
时间窗: up to 4 weeks
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.
Qualitative Summary of Adaptations to STAC
时间窗: up to 8 weeks
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.
The Acceptability of Intervention Measure (AIM)
时间窗: up to 8 weeks
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.
The Intervention Appropriateness Measure (IAM)
时间窗: up to 8 weeks
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.
The Feasibility of Intervention Measure (FIM)
时间窗: up to 8 weeks
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.
次要结局
未报告次要终点
