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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093492
• Other study ID #: PRO00033902
• Secondary ID: R21HD092664
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 31, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Preemie Prep for Parents (P3) Outpatient Mobile Intervention
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.
• ACOG links
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.

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Prematurity Knowledge Questionnaire	Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.	Assessed at participant's 25th week of pregnancy.
Primary	Parent Prematurity Knowledge Questionnaire	Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.	Assessed at participant's 30th week of pregnancy.
Primary	Parent Prematurity Knowledge Questionnaire	Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.	Assessed at participant's 34th week of pregnancy.
Primary	Preparation for Decision Making Scale	Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.	Assessed at participant's 25th week of pregnancy.
Primary	Preparation for Decision Making Scale	Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.	Assessed at participant's 30th week of pregnancy.
Primary	Preparation for Decision Making Scale	Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.	Assessed at participant's 34th week of pregnancy.
Secondary	Anxiety	Patient-Reported Outcomes Measurement Information System (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
Secondary	Anxiety	Patient-Reported Outcomes Measurement Information System (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 participant's 25th week of pregnancy.
Secondary	Anxiety	Patient-Reported Outcomes Measurement Information System (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 participant's 30th week of pregnancy.
Secondary	Anxiety	Patient-Reported Outcomes Measurement Information System (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 participant's 34th week of pregnancy.
Secondary	Decision Self-Efficacy	Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.	Assessed at baseline
Secondary	Decision Self-Efficacy	Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.	Assessed at 34 weeks of pregnancy