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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Other: Active Control Arm General pregnancy text messages; Behavioral: Intervention Arm Weekly IP3 text messages

• Registration Number: NCT04149002
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Study Start: 2020-02-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Results First Submitted: 2022-03-31
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Results First Posted: 2022-11-02
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm: General pregnancy text messages	Active Control Arm General pregnancy text messages	* 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
Intervention Arm: Weekly IP3 text messages	Intervention Arm Weekly IP3 text messages	* 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

Primary Outcome Measures

Name	Time	Method
Acceptability as Measured by Number of Participants Who Completed the Study	study duration (approximately 14 months)	Completion target of 80% participants retained in study protocol.
Feasibility as Measured by Number of Recruited Eligible Patients Enrolled	study duration (approximately 14 months)	Enrollment target of 30% of eligible patients recruited.

Secondary Outcome Measures

Name	Time	Method
IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance	approximately 1 year
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain	protocol completion (approximately 1 year)	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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive).
Change in Maternal Social Support Scale (MSSS)	baseline to protocol completion (approximately 1 year)	The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support.
Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)	approximately 40 weeks
Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain	protocol completion (approximately 1 year)	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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative).
Gestational Age at Delivery in Weeks	approximately 40 weeks
Pregnancy Specific Anxiety (PSA)	baseline, 28 weeks	Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety.
Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain	protocol completion (approximately 1 year)	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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient).
Length of Delivery Hospital Admission in Days	approximately 40 weeks
Birth Weight in Grams	approximately 40 weeks

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States