Boosting Resources for Tracheostomy Care at Home

Part of paid clinical trials in La Jolla, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT06283953
Status
Enrolling By Invitation

Conditions

  • Caregiver Burden
  • Tracheostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trach Plus — BEHAVIORAL
    The Trach Plus program includes education, social support, and outreach to outpatient care team.
  • Trach Me Home — BEHAVIORAL
    The Trach Me Home discharge program includes caregiver education, skills training and case management.

Study Details

The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are: * What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home? * How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge? Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

Key Dates

Start date
May 16, 2024
Status verified
Oct 2025
Primary completion
Dec 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Active Comparator Caregivers
    TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers
  • Experimental: Intervention Caregivers
    Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.
  • Active Comparator: Active Comparator Physicians
    Primary care physicians' of the enrolled participant's child receiving discharge communication
  • Experimental: Intervention Physicians
    Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge

Primary Outcome Measure

Caregiver Burden [ Time Frame: 4 weeks post-discharge ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of San Diego Rady Children's HospitalLa JollaCalifornia92093-
Children's National Medical Center, Children's Research InstituteSilver SpringMaryland20910-
Massachusetts General HospitalBostonMassachusetts02114-
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesota55404-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146-

Find similar trials in La Jolla, CA

By research site
University of San Diego Rady Children's Hospital· La Jolla, CAChildren's National Medical Center, Children's Research Institute· Silver Spring, MDMassachusetts General Hospital· Boston, MAChildren's Hospitals and Clinics of Minnesota· Minneapolis, MNCincinnati Children's Hospital Medical Center· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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