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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04933812

Enrollment

Registered

2021-06-22

Start date

2021-06-21

Completion date

2022-10-14

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief summary

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

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.

Interventions

BEHAVIORALFacebook discussions and Virtual group meetings

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Intervention Arm

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points	up to 12 weeks after delivery (approximately 1 year)	Intervention sustainability based on continued engagement from the participants
Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session	up to 12 weeks after delivery (approximately 1 year)	—
Number of Sessions Attended by Each Participant	up to 12 weeks after delivery (approximately 1 year)	As a measure of effectiveness
Implementation as Measured by the Number of Sessions Including Each Topic	up to 12 weeks after delivery (approximately 1 year)	—
Engagement as Measured by Number of Participants Who Attended More Than One Session	up to 12 weeks after delivery (approximately 1 year)	Intervention sustainability based on continued engagement from the participants

Secondary

Measure	Time frame	Description
IP3 Knowledge Questionnaire	at intake	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
Pregnancy-specific Anxiety (PSA)	At intake and at gestational age 20-28 weeks	The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. On a Likert scale of 1 to 5, higher scores indicate greater anxiety.
Interpersonal Processes of Care (IPC)	at intake	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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.
Maternal Social Support Scale (MSSS)	At intake, gestational age 20-28 weeks, and gestational age >=30 weeks	The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. On a Likert scale of 1 to 5, higher scores indicate greater social support.
Number of Participants Who Were Adherent to the IP3 Plan	Post delivery (up to approximately 40 weeks)	Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group Social Support Meetings and Facebook Group 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. Facebook discussions and Virtual group meetings: 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	29
Total	29

Arm

Count

Group Social Support Meetings and Facebook Group

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. Facebook discussions and Virtual group meetings: 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

Total

Baseline characteristics

Characteristic	Group Social Support Meetings and Facebook Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	29 Participants
Age, Continuous	33.3 years STANDARD_DEVIATION 6
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	29 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	29 Participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 31
other Total, other adverse events	0 / 31
serious Total, serious adverse events	1 / 31