RECRUITING

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

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 goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Official Title

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

Quick Facts

Study Start:2023-12-04
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05929703

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:70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of informed consent
  2. * At least 70 years of age
  3. * Anticipated length of hospital stay at least 72 hours
  4. * Family member or care partner available to be on-site in the hospital
  5. * At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment)
  1. * Delirium on admission
  2. * Unable to communicate verbally (e.g., coma, mechanical ventilation)
  3. * Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)
  4. * Staff safety concerns (e.g., violent behavior)
  5. * Cardiac or intracranial surgery (due to competing causes of delirium)

Contacts and Locations

Study Contact

Eva Schmitt, PhD
CONTACT
617-971-5390
EvaSchmitt@hsl.harvard.edu

Principal Investigator

Sharon K Inouye, MD
PRINCIPAL_INVESTIGATOR
Hebrew SeniorLife
Phillip E Vlisides, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Saddleback Medical Center
Orange, California, 92868
United States
MaineHealth
Portland, Maine, 04102
United States
Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Meriter Hospital
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Sharon K Inouye, MD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife
  • Phillip E Vlisides, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2023-12-04
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Delirium
  • Clinical Trial
  • Comparative Effectiveness Research
  • Implementation Science

Additional Relevant MeSH Terms

  • Delirium
  • Neurocognitive Disorders
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Aging
  • Family Support
  • Family Members
  • Caregiver Burden
  • Implementation Science
  • Patient Satisfaction