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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study

Conditions
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Preterm Birth

Intervention / Treatment
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* Behavioral: Intervention Arm Weekly IP3 text messages
* Other: Active Control Arm General pregnancy text messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Arm vs. Active Control Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Arm: Weekly IP3 text messages<br>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<br>* 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.<br>|
| Active Comparator: Control Arm: General pregnancy text messages<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | baseline, 28 weeks | 
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | 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). | protocol completion (approximately 1 year) | 
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | 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). | protocol completion (approximately 1 year) | 
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | 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). | protocol completion (approximately 1 year) | 
| Change in Maternal Social Support Scale (MSSS) | 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. | baseline to protocol completion (approximately 1 year) | 
| Gestational Age at Delivery in Weeks |  | approximately 40 weeks | 
| Birth Weight in Grams |  | approximately 40 weeks | 
| Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) |  | approximately 40 weeks | 
| Length of Delivery Hospital Admission in Days |  | approximately 40 weeks |