Clinical trial NCT04149002: Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Official title: Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Arm vs. Active Control Arm
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.

Detailed description: The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index.

The team will collect feedback on the intervention based on an intake questionnaire and an exit interview.

Information will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview.

Eligibility criteria: Inclusion Criteria:

* self described race as Non-Hispanic Black
* history of prior singleton preterm delivery (before 37 weeks gestation)
* current singleton gestation

Exclusion Criteria:

* women with anomalous fetuses
* age below 18\]
* non-English speaking

Primary outcomes:
measure: Feasibility as Measured by Number of Recruited Eligible Patients Enrolled
timeFrame: study duration (approximately 14 months)
measure: Acceptability as Measured by Number of Participants Who Completed the Study
timeFrame: study duration (approximately 14 months)
Secondary outcomes:
measure: IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance
timeFrame: approximately 1 year
measure: Pregnancy Specific Anxiety (PSA)
timeFrame: baseline, 28 weeks
measure: Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
timeFrame: protocol completion (approximately 1 year)
measure: Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain
timeFrame: protocol completion (approximately 1 year)
measure: Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
timeFrame: protocol completion (approximately 1 year)
measure: Change in Maternal Social Support Scale (MSSS)
timeFrame: baseline to protocol completion (approximately 1 year)
measure: Gestational Age at Delivery in Weeks
timeFrame: approximately 40 weeks
measure: Birth Weight in Grams
timeFrame: approximately 40 weeks
measure: Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)
timeFrame: approximately 40 weeks
measure: Length of Delivery Hospital Admission in Days
timeFrame: approximately 40 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarahn Wheeler, MD
role: PRINCIPAL_INVESTIGATOR
References: