Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan

Duke University

Status: Completed

Conditions: Preterm Birth

Treatments: Behavioral: Intervention Arm Weekly IP3 text messages; Other: Active Control Arm General pregnancy text messages

Study type: Interventional

Funder types: Other

Identifiers

NCT04149002

Pro00103922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention Arm: Weekly IP3 text messages

Other group

Description:

* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation. * Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers. * Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information * Formal letter of encouragement from provider at 28 weeks gestation

Treatment:

Behavioral: Intervention Arm Weekly IP3 text messages

Control Arm: General pregnancy text messages

Active Comparator group

Description:

* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview

Treatment:

Other: Active Control Arm General pregnancy text messages