Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease

Sponsor
Boston Children's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05285345
Collaborator
Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other)
50
10

Study Details

Study Description

Brief Summary

The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction/feedback with implementation of these guidelines.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Premature infants with bronchopulmonary dysplasia (BPD) have complex care needs around discharge. BPD affects up to 40% of former preterm infants born at <28 weeks gestation, with about 10,000 new cases of BPD in the United States every year. Healthcare utilization in this population in the first two years of life is high, with increased hospitalizations, visits, and medication usage. Coordinated follow-up programs may help improve outcomes and reduce rates of hospitalization in this population. However, guidelines do not exist to identify which infants discharging from the NICU should be targeted for specialty follow-up for their respiratory disease, the time frame and format that this should occur, and which evaluations should be performed routinely around discharge.

    This will be an implementation study, measuring outcomes 3 months prior and 3 months after enactment of a discharge bundle for preterm infants with BPD at local NICUs (Brigham and Women's Hospital, Beth Israel Deaconess Medical Center) who will be followed by Boston Children's Hospital.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Pre-Guideline Implementation

    Participants in this group will be recruited during the first 3 months of the study and the time will be used for baseline data collection with existing standards of care around discharge practices of infants with BPD

    Post-Guideline Implementation

    After 3 months, the discharge bundle developed from consensus from the Delphi process will be introduced to both NICUs using Quality Improvement principles. Participants will be recruited after the introduction of the discharge bundle.

    Outcome Measures

    Primary Outcome Measures

    1. Healthcare Utilization [8 months]

      Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.

    Secondary Outcome Measures

    1. Rates of pulmonary follow-up and use of telemedicine in follow-up [8 months]

      Review of medical record

    2. Completion of recommended evaluations and testing [8 months]

      Review of medical record

    3. Medication use [8 months]

      Review of medical record

    4. Home oxygen use [8 months]

      Review of medical record

    5. Feeding [8 months]

      Review of medical record

    6. Family satisfaction with care for respiratory symptoms around and after discharge [8 months]

      Assessed by surveys

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 1 Year
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Preterm infants born <32 weeks with at least mild BPD, defined as 28 days of respiratory support after birth.

    • Efforts will be made to include a mix of infants with mild, moderate, and severe BPD, including infants discharged on oxygen.

    Exclusion Criteria:
    • Discharge to a location other than home.

    • Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boston Children's Hospital
    • Beth Israel Deaconess Medical Center
    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Jonathan Levin, MD, Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan Levin, Instructor of Pediatrics, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05285345
    Other Study ID Numbers:
    • IRB-P00039393
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jonathan Levin, Instructor of Pediatrics, Boston Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022