PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

Detailed Description
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Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

Official Title
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PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

Conditions
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Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy, Patient Engagement, Patient Empowerment, Parenting, Chronic Conditions, Multiple

Intervention / Treatment
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* Behavioral: PREEMIE PROGRESS
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking parents Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA) Parents who had a singleton or twin birth Parents 18 years of age or older Exclusion Criteria: Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent Infants with imminent or probable death based on the healthcare team's judgement

Ages Eligible for Study
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Minimum Age: 18 Years

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREEMIE PROGRESS<br>PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. | Behavioral: PREEMIE PROGRESS<br>* PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).<br>|
| Active Comparator: Attention Control<br>To maintain their attention, control parents will view Welcome Videos that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. | Behavioral: Attention Control<br>* usual care and welcome videos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Self-Rating of Depression | Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: Scored 0-32. | 2 weeks after baseline visit | 
| Parent Self-Rating of Anxiety | Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: Scored 0-32. | 2 weeks after baseline visit | 
| Receipt of mother's human milk | (exclusive, partial, none) | Category determined at 36 weeks corrected gestional age | 
| Z score of weight gain at 36 weeks corrected gestational age | Z-score method | Caculated for the date that infant is 36 weeks corrected gestational age | 
| NICU Length of Stay | Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU) | Date of NICU discharge will be assessed until study completion, with maximum of 1 year | 
| Self -Report of Hospital readmissions & ER visits | Raw count w/in 30 days of discharge (self-report by phone) | Readmisssions/ER visits counted within 30 days of discharge will be assessed date of NICU discharge will be assessed until study completion, with maximum of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal intensive care unit, prematurity, family management, self-management, patient education