Clinical trial NCT03418870: Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
Official title: Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Keywords: Intensive Care Units, Neonatal
Parents
Mobile application
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, San Diego
name: Kaiser Permanente
First posted: 2018-02-01
Enrollment: 347
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 is "usual care" and Phase 2 is the intervention phase.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in infant weight (z-score)
timeFrame: 21 days of age after enrollment
Secondary outcomes:
measure: Amount of human milk/formula supplementation
timeFrame: At study enrollment and at hospital discharge, usually 21 days after admission
measure: Frequency of breastfeeding
timeFrame: At study enrollment and at hospital discharge, usually 21 days after admission
measure: Breastfeeding rate
timeFrame: At study enrollment and at hospital discharge, usually 21 days after admission
measure: Length of stay
timeFrame: Number of days of NICU and hospital stay, usually 21 days after admission
measure: Weight gain velocity
timeFrame: at NICU discharge, usually 21 days after admission
measure: Major morbidities
timeFrame: at NICU discharge, usually 21 days after admission
measure: Parent perceived stress
timeFrame: at NICU discharge, usually 21 days after admission
measure: Parenting competence
timeFrame: at NICU discharge, usually 21 days after admission
measure: Perceived parenting self-efficacy
timeFrame: at NICU discharge, usually 21 days after admission
Other outcomes:
measure: Change in infant weight (z-score)
timeFrame: 3 months post-discharge
measure: Breastfeeding rate
timeFrame: 3 months post-discharge
measure: Breastfeeding frequency
timeFrame: 3 months post-discharge
measure: Hospital readmission rate
timeFrame: 3 months post-discharge
measure: Perceived parenting self-efficacy
timeFrame: 3 months post-discharge
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: La Jolla
country: United States
facility: Jacobs Medical Center, UC San Diego Health
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
Study officials:
affiliation: Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF
name: Linda Franck, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.