COMPLETED

Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.

Official Title

Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial

Quick Facts

Study Start:2024-10-17
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06629142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years of age or older; AND
  2. * Predicted 1-year mortality risk of 60% or greater; AND
  3. * Admitted to a study hospital.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Katherine Courtright, MD, MS
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Scott Halpern, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Kaiser Permanente Southern California
Pasadena, California, 91101
United States
Trinity Health
Livonia, Michigan, 48152
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Katherine Courtright, MD, MS, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Scott Halpern, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-10-17
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • Palliative

Additional Relevant MeSH Terms

  • Seriously Ill Hospitalized Patients