EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

Study Overview
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Brief Summary
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The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.

Detailed Description
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Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB), delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor intensive with requirements ranging from daily medications, weekly clinic visits, painful injections or invasive ultrasounds. Given the increased rate so of PTB among NHB women and some suggestion of decreased adherence in this population1, we previously conducted qualitative studies with NHB women to uncover patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with prior preterm birth felt that stress and lack of support were key barriers to preterm birth prevention adherence. Stress and limited support made women feel isolated from their peers and community. Based on these data we worked with a stakeholder group to develop a patient-centered, community-involved intervention that will increased adherence to an individualized prematurity prevention plan using community-level social supports. The resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led group social support.

Official Title
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EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3)

Conditions
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Preterm Birth

Intervention / Treatment
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* Behavioral: Facebook discussions and Virtual group meetings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self describe race as Non-hispanic black history of prior singleton preterm delivery (before 37 weeks gestation current singleton gestation, with Individualized Prematurity Prevention (IP3) plan. Exclusion Criteria: women with anomalous fetuses age below 18 years non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group Social Support Meetings and Facebook Group<br>Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. | Behavioral: Facebook discussions and Virtual group meetings<br>* Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach or Participation Rate | Percent of eligible participants who are successfully recruited and attend at least one group session | 1 year | 
| Effectiveness | Retention rate in the intervention measured by the number of sessions each participant | 1 year | 
| Implementation | Fidelity to the intervention protocol by observer at each group session recording the topics | 1 year | 
| Maintenance | Intervention sustainability based on continued engagement from the participants | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IP3 knowledge questionnaire | Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct | monthly until delivery | 
| Pregnancy-specific anxiety (PSA) | The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. higher scores are negative, four questions answered on a 1 to 5 Likert scare | monthly until delivery | 
| Interpersonal Processes of Care (IPC) | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All domains are measured 1 to 5 on a Likert scale | monthly until delivery | 
| Maternal Social Support Scale (MSSS) | The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. Higher scores better - 1 to 5 Likert scale | monthly until delivery | 
| IP3 Adherence Data | We will gather data on adherence to the IP3 based on both participant report and EHR chart review. Higher is better, dichotomized as adherent or not adherent | monthly until delivery | 
| Tobacco Use PRAMS Questionnaire | A single question regarding tobacco use | monthly until delivery |