Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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 |
Behavioral: Intervention Arm Weekly IP3 text messages
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.
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| Active Comparator: 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 |
Other: Active Control Arm General pregnancy text messages
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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility as measured by number of participants enrolled [1 year]
Target enrollment reached.
- Acceptability as measured by number of participants who completed the study [1 year]
Secondary Outcome Measures
- IP3 Adherence as measured by patient and EMR report of medication compliance [baseline, and weekly thereafter during pregnancy]
Compare adherence to the IP3 schedule in women randomized to the intervention compared to the active control.
Eligibility Criteria
Criteria
Inclusion Criteria:
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self described race as Non-Hispanic Black
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history of prior singleton preterm delivery (before 37 weeks gestation
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current singleton gestation
Exclusion Criteria:
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women with anomalous fetuses
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age below 18]
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non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Sarahn Wheeler, MD, Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00103922