Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

Study Overview
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Brief Summary
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The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is an RCT comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to ACOG prematurity patient education handouts.

Detailed Description
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This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making. Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age. At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.

Official Title
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Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education

Conditions
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Premature Birth, Decision Making, Prenatal Care, Resuscitation, Infant, Premature

Intervention / Treatment
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* Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention
* Other: ACOG links


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman or her partner At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications. Gestational age of 16-21 weeks at recruitment. Owns a smartphone. Able to speak English Exclusion Criteria: • Pregnancies with known significant birth defects.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preemie Prep for Parents (P3) Outpatient Mobile Intervention<br>The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants. | Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention<br>* The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.<br>|
| Active Comparator: ACOG links<br>Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists. | Other: ACOG links<br>* Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prematurity Knowledge | Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge. | Assessed at participant's 25th week of pregnancy. | 
| Prematurity Knowledge | Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge. | Assessed at participant's 30th week of pregnancy. | 
| Prematurity Knowledge | Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge. | Assessed at participant's 34th week of pregnancy. | 
| Parental preparation for decision-making | Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision. | Assessed at participant's 25th week of pregnancy. | 
| Parental preparation for decision-making | Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision. | Assessed at participant's 30th week of pregnancy. | 
| Parental preparation for decision-making | Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision. | Assessed at participant's 34th week of pregnancy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Self-Efficacy | Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44. A score of 44 would represent maximum decision self-efficacy. | Assessed at baseline and at 34 weeks of pregnancy. | 
| Anxiety | PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting. | Assessed at baseline and participant's 25th week of pregnancy. | 
| Anxiety | PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting. | Assessed at baseline and participant's 30th week of pregnancy. | 
| Anxiety | PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting. | Assessed at baseline and participant's 34th week of pregnancy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation