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

NCT04149002 | Completed Results

• 1 other identifier: Pro00103922
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• Feasibility as Measured by Number of Recruited Eligible Patients Enrolled

  Enrollment target of 30% of eligible patients recruited.

  study duration (approximately 14 months)

• Acceptability as Measured by Number of Participants Who Completed the Study

  Completion target of 80% participants retained in study protocol.

  study duration (approximately 14 months)

Secondary Outcomes (10)

• IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance

  approximately 1 year

• Pregnancy Specific Anxiety (PSA)

  baseline, 28 weeks

• Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain

  protocol completion (approximately 1 year)

• Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain

  protocol completion (approximately 1 year)

• Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain

  protocol completion (approximately 1 year)

Study Arms (2)

Intervention Arm: Weekly IP3 text messages

OTHER

* 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

Behavioral: Intervention Arm Weekly IP3 text messages

Control Arm: General pregnancy text messages

ACTIVE COMPARATOR

* 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

Other: Active Control Arm General pregnancy text messages

Interventions

Intervention Arm Weekly IP3 text messages BEHAVIORAL

Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.

Intervention Arm: Weekly IP3 text messages

Active Control Arm General pregnancy text messages OTHER

Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.

Control Arm: General pregnancy text messages

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Sarahn M. Wheeler, MD
• Organization: Duke University

sarahn.wheeler@duke.edu

(919) 684-6327

Study Officials

• Sarahn Wheeler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Arm vs. Active Control Arm

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 4, 2019
• Study Start: February 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 2, 2022
• Results First Posted: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)