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

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ClinicalTrials.gov Identifier: NCT03418870
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, San Diego
Kaiser Permanente
Information provided by (Responsible Party):
Linda Franck, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Premature Birth of Newborn Behavioral: Family Integrated Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 is "usual care" and Phase 2 is the intervention phase.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

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.



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


Secondary Outcome Measures :
  1. Amount of human milk/formula supplementation [ Time Frame: At study enrollment and at hospital discharge, usually 21 days after admission ]
    number of ml for all breast feeding, breast pumping, bottle feeding, and nasal gastric (NG) feeding will be obtained from the medical record

  2. Frequency of breastfeeding [ Time Frame: At study enrollment and at hospital discharge, usually 21 days after admission ]
    Number of feedings for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record

  3. Breastfeeding rate [ Time Frame: At study enrollment and at hospital discharge, usually 21 days after admission ]
    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

  4. Length of stay [ Time Frame: Number of days of NICU and hospital stay, usually 21 days after admission ]
    Number of days of NICU and hospital stay

  5. Weight gain velocity [ Time Frame: at NICU discharge, usually 21 days after admission ]
    number of grams gained from enrollment to specified date divided by the number of days = weight gain velocity

  6. Major morbidities [ Time Frame: at NICU discharge, usually 21 days after admission ]
    Nosocomial infection, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and adverse events.

  7. Parent perceived stress [ Time Frame: at NICU discharge, usually 21 days after admission ]
    Self- reported survey

  8. Parenting competence [ Time Frame: at NICU discharge, usually 21 days after admission ]
    self reported survey

  9. Perceived parenting self-efficacy [ Time Frame: at NICU discharge, usually 21 days after admission ]
    self-reported survey


Other Outcome Measures:
  1. Change in infant weight (z-score) [ Time Frame: 3 months post-discharge ]
    Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups

  2. Breastfeeding rate [ Time Frame: 3 months post-discharge ]
    self-reported survey

  3. Breastfeeding frequency [ Time Frame: 3 months post-discharge ]
    self-reported survey

  4. Hospital readmission rate [ Time Frame: 3 months post-discharge ]
    self-reported survey

  5. Perceived parenting self-efficacy [ Time Frame: 3 months post-discharge ]
    self-reported survey



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418870


Contacts
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Contact: Rebecca Kriz, MS 925-324-3046 rebecca.kriz@ucsf.edu
Contact: Riya Jacob, BA 415-290-9786 riya.jacob@ucsf.edu

Locations
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United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Contact: Diana Cormier       DCormier@communitymedical.org   
Principal Investigator: Diana Cormier, DNP         
Jacobs Medical Center, UC San Diego Health Not yet recruiting
La Jolla, California, United States, 92037
Contact: Mary Ekno, BSN, RNC-NIC       mekno@ucsd.edu   
Principal Investigator: Jae Kim, MD         
UCSF Benioff Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
Contact: Holly Christenson       HChris@mail.cho.org   
Principal Investigator: Pricilla Joe         
UCSF Benioff Children's Hospital San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Katie Millar       katie.millar@ucsf.edu   
Kaiser Permanente - Santa Clara Not yet recruiting
Santa Clara, California, United States, 95051
Contact: Carol Lin, MD    408-851-7114    Carol.K.Lin@kp.org   
Principal Investigator: Carol Lin, MD         
UCLA Medical Center, Santa Monica Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Valencia Walker, MD         
Principal Investigator: Pamela Miller, PhD, RN         
Sponsors and Collaborators
University of California, San Francisco
University of California, Los Angeles
University of California, San Diego
Kaiser Permanente
Investigators
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Principal Investigator: Linda Franck, RN, PhD Department of Family Care Nursing, California Preterm Birth Initiative, University of California San Francisco
  Study Documents (Full-Text)

Documents provided by Linda Franck, University of California, San Francisco:

Publications:
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Responsible Party: Linda Franck, Professor, Department of Family Health Care Nursing, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03418870     History of Changes
Other Study ID Numbers: 16-19542
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linda Franck, University of California, San Francisco:
Intensive Care Units, Neonatal
Parents
Mobile application

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications