ACTIVE_NOT_RECRUITING

Multi-component Family Support Tool Intervention (FST)

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

The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that. Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.

Official Title

Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults

Quick Facts

Study Start:2021-11-11
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05019261

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  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

Douglas B White, MD, MAS
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Baystate Medical Center
Springfield, Massachusetts, 01199
United States
NYC Health + Hospitals/Lincoln Hospital
New York, New York, 10451
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27710
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, 15240
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Douglas B White, MD, MAS, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2021-11-11
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2021-11-11
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Patient centeredness of care
  • Psychological Distress
  • End of Life Care
  • Critical Illness
  • Surrogate Decision Making
  • Goal Concordant Care

Additional Relevant MeSH Terms

  • Critical Illness