Prospective Home-Based Palliative Care and Hospice Study

NCT06362239 | Enrolling By Invitation

• 1 other identifier: STUDY00003853
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone.

Conditions

Pediatric Palliative Care

Outcome Measures

Primary Outcomes (1)

• Hospital Utilization Differences

  Hospital utilization including ICU days, inpatient hospital days, ED visits, quality of life

  At enrollment and every three months for a two year period for a maximum of 24 months

Secondary Outcomes (2)

• Demographic Differences

  Identified at time of study enrollment and does not require ongoing measurement.

• Location of death differences

  From date of enrollment to date of death (if occurred) over study enrollment for a maximum period of 24 months.

Study Arms (2)

High-access home-based hospice and palliative care (HBHPC)

Patients with high-access to home-based hospice and palliative care (HBHPC) enrolled from three sites: Nationwide Children's Hospital, Columbus, OH (NCH); Akron Children's Hospital, Akron, OH (ACH); and Medical University of South Carolina, Charleston, SC (MUSC).

Other: Study Surveys

Low-access home-based hospice and palliative care (HBHPC)

Patients with low-access to home-based hospice and palliative care (HBHPC) (i.e., primarily or exclusively hospital-based services) enrolled from two sites: Nemours Children's Hospital, Wilmington, DE (Nemours); and Texas Children's Hospital, Houston, TX (TCH).

Other: Study Surveys

Interventions

Study Surveys OTHER

Participants will complete study surveys as their participation in the research study. Study staff will collect clinical and demographic information from the electronic medical records. The enrollment in this intervention will not be decided by research enrollment, but would naturally occur regardless of enrollment in the study.

High-access home-based hospice and palliative care (HBHPC); Low-access home-based hospice and palliative care (HBHPC)

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and young adults between the ages of 0-19 years old. One cohort of those that receive HBHPC combined with inpatient/clinic based palliative care and the other cohort will be those that receive only inpatient/clinic based palliative care. The cohorts will not be random in assignment and will be determined by accessibility to HBHPC. The study will include three sites with high access to HBHPC and two sites with limited access to HBHPC. Patients will be allowed to transition between arms should they gain access to HBHPC.

You may qualify if:

• Patients aged 0-19
• Patients seen as new referral or follow up visit by PPC (Pediatric Palliative Care) team in either the inpatient or clinic context and expected to require at least twice-annual palliative care visits

You may not qualify if:

• Followed by PPC regardless of context for \>6 months prior to enrollment
• Patient no longer clinically needs long term PPC follow up
• Child / young adult is in custody of state or county

Sponsors & Collaborators

• Steven Smith: lead
• Akron Children's Hospital: collaborator
• Medical University of South Carolina: collaborator
• Nemours Children's Hospital: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43082, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 12, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)