Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology (mFI-Care)

The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care. This exploratory two-group comparison study will examine the feasibility, acceptability and effectiveness, providing the first United States (US) information about outcomes of a new NICU care model that better integrates parents into all aspects of their baby's care. The use of mobile technology as part of this new model of care could improve access and equity in family integration for the many US families who face barriers to NICU involvement.

Study Overview

• Status: Completed
• Conditions: Premature Birth of Newborn
• Intervention / Treatment: Behavioral: Family Integrated Care

Detailed Description

Poor growth during neonatal intensive care unit (NICU) hospitalization is a modifiable risk factor contributing to mortality and serious long-term morbidity for many of the nearly 400,000 preterm infants born each year in the United States (US). Active parent involvement in preterm infant caregiving promotes parent-infant attachment and leads to higher breastfeeding rates, earlier discharge, and improved long-term neurodevelopment. Despite decades of evidence of the positive effects of parental involvement, parents remain for the most part passive bystanders in the NICU setting. Even with many NICUs adopting a Family-Centered Care (FCC) approach, parent-infant contact and parenting skills remain well below desired levels.

Family Integrated Care (FI-Care) is a novel intervention that differs from FCC because it formally teaches and supports parents to be primary caregivers for their infants and restructures the relationship between parents and clinicians so that parents are fully integrated into the care team. There is strong evidence from a large, well-designed cluster randomized trial conducted in Canada and Australia that FI-Care improves infant growth and breastfeeding rates and reduces maternal stress. However, these findings cannot be generalized to US NICUs where parents face many barriers to involvement in their infant's NICU care. The research team has developed a secure, HIPAA-compliant, mobile application to capture high quality data about parent involvement in NICU caregiving and to deliver essential elements of the FI-Care program remotely. This mobile-enhanced FI-Care (mFI-Care) may improve involvement of parents who cannot be present in the NICU during daytime hours due to distance, employment or other responsibilities and family commitments. Increasing access and equity in family-integrated care may improve outcomes for US preterm infants.

This exploratory two-group, multi-site comparison study will compare usual FCC with mFI-Care on growth and clinical outcomes of preterm infants < 33 weeks gestational age, as well as the stress, competence and self-efficacy of their parents. The feasibility and acceptability of using mobile technology to gather data about parent involvement in the care of preterm infants receiving FCC or mFICare as well as of the mFI-Care intervention will be evaluated (Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2). This study will provide important new information on innovative approaches to increasing parent involvement in NICU infant caregiving, including the use of a novel mobile application. The findings will be used to develop a future US cluster-randomized trial of mFI-Care with the aim of improving outcomes for preterm infants and their parents.

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93721
      • Community Regional Medical Center
    • La Jolla, California, United States, 92037
      • Jacobs Medical Center, UC San Diego Health
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland
    • San Francisco, California, United States, 94158
      • UCSF Benioff Children's Hospital San Francisco
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente - Santa Clara
    • Santa Monica, California, United States, 90404
      • UCLA Medical Center, Santa Monica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infant ≤ 33 weeks and their parent or guardian

Exclusion Criteria:

• Infant has a life-threatening congenital anomaly, is unlikely to survive or is receiving palliative care
• Parent is not English literate
• Parent < 18 years of age
• Parent does not have access to hand-held computer (smartphone or tablet)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Family Integrated Care (mFI-Care); Parents of infants assigned to the Family Integrated Care (mFI-Care) intervention will be treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches. Parent training on the Canadian FI-Care Parent Curriculum will be provided during small group sessions facilitated by the study team. Parents will receive peer support from mFI-Care-trained alumni parents and can interact with other mFI-Care parents through the We3Health App secure online parent forum. mFI-Care parents will be expected to track time spent with their infant; record infant activity, feeds and output; track learning and skills acquisition; and keep a journal of the NICU experience using the We3Health app.	Behavioral: Family Integrated Care; Parents of infants assigned to mFI-Care will be trained and treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches.
NO_INTERVENTION: Family-Centered Care (FCC); Infants assigned to usual FCC will have NICU nurses as primary caregivers per standard NICU protocol. FCC provides parents with orientation to the NICU; individualized teaching and support; and encouragement to participate in infant care under nursing supervision. Individualized support from social workers, lactation consultants and other specialists will be offered. As part of the study, parents will be asked to use the We3Health mobile app track their time in the NICU, time learning and time spent in infant caregiving activities and to keep of a journal of their NICU experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in infant weight (z-score)	Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups	21 days of age after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of human milk/formula supplementation	number of ml for all breast feeding, breast pumping, bottle feeding, and nasal gastric (NG) feeding will be obtained from the medical record	At study enrollment and at hospital discharge, usually 21 days after admission
Frequency of breastfeeding	Number of feedings for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record	At study enrollment and at hospital discharge, usually 21 days after admission
Breastfeeding rate	Breastfeeding rate will be calculated using amount of Number of feedings and ml for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record	At study enrollment and at hospital discharge, usually 21 days after admission
Length of stay	Number of days of NICU and hospital stay	Number of days of NICU and hospital stay, usually 21 days after admission
Weight gain velocity	number of grams gained from enrollment to specified date divided by the number of days = weight gain velocity	at NICU discharge, usually 21 days after admission
Major morbidities	Nosocomial infection, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and adverse events.	at NICU discharge, usually 21 days after admission
Parent perceived stress	Self- reported survey	at NICU discharge, usually 21 days after admission
Parenting competence	self reported survey	at NICU discharge, usually 21 days after admission
Perceived parenting self-efficacy	self-reported survey	at NICU discharge, usually 21 days after admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in infant weight (z-score)	Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups	3 months post-discharge
Breastfeeding rate	self-reported survey	3 months post-discharge
Breastfeeding frequency	self-reported survey	3 months post-discharge
Hospital readmission rate	self-reported survey	3 months post-discharge
Perceived parenting self-efficacy	self-reported survey	3 months post-discharge

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, San Diego; University of California, Los Angeles; Kaiser Permanente
• Investigators: Principal Investigator: Linda Franck, RN, PhD, Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF

Publications and helpful links

General Publications

• O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.
• Furtak SL, Gay CL, Kriz RM, Bisgaard R, Bolick SC, Lothe B, Cormier DM, Joe P, Sasinski JK, Kim JH, Lin CK, Sun Y, Franck LS. What parents want to know about caring for their preterm infant: A longitudinal descriptive study. Patient Educ Couns. 2021 Nov;104(11):2732-2739. doi: 10.1016/j.pec.2021.04.011. Epub 2021 Apr 17.
• Franck LS, Kriz RM, Bisgaard R, Cormier DM, Joe P, Miller PS, Kim JH, Lin C, Sun Y. Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol. BMC Pediatr. 2019 Dec 2;19(1):469. doi: 10.1186/s12887-019-1838-3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2017
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): February 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Parents; Mobile application; Intensive Care Units, Neonatal
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 16-19542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No