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Search / Trial NCT05929703

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Launched by UNIVERSITY OF MICHIGAN · Jun 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Delirium Clinical Trial Comparative Effectiveness Research Implementation Science

ClinConnect Summary

This clinical trial is studying two different programs aimed at helping older patients in the hospital avoid delirium, which is a sudden change in mental status that can cause confusion and disorientation. The trial compares the standard Hospital Elder Life Program (HELP) with a new version called Family-Augmented HELP (FAM-HELP), which includes family members or caregivers to provide additional support. The main goals are to see which program is better at preventing delirium and improving the experiences of both patients and their families during hospital stays.

To be eligible for this trial, participants must be at least 70 years old, expect to stay in the hospital for at least three days, and have a family member or caregiver who can be present in the hospital. They should also have at least one factor that makes them at risk for delirium, such as memory problems or dehydration. However, those who are already experiencing delirium when they arrive at the hospital or cannot communicate will not be included. If you join the study, you can expect to receive either the standard HELP or the FAM-HELP program, both designed to enhance your care and support during your hospital stay.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Provision of informed consent
  • At least 70 years of age
  • Anticipated length of hospital stay at least 72 hours
  • Family member or care partner available to be on-site in the hospital
  • At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment)
  • Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment)
  • Exclusion Criteria:
  • Delirium on admission
  • Unable to communicate verbally (e.g., coma, mechanical ventilation)
  • Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)
  • Staff safety concerns (e.g., violent behavior)
  • Cardiac or intracranial surgery (due to competing causes of delirium)

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Philadelphia, Pennsylvania, United States

Madison, Wisconsin, United States

Pittsburgh, Pennsylvania, United States

Salt Lake City, Utah, United States

Pittsburg, Pennsylvania, United States

Ann Arbor, Michigan, United States

Orange, California, United States

Portland, Maine, United States

Patients applied

0 patients applied

Trial Officials

Sharon K Inouye, MD

Principal Investigator

Hebrew SeniorLife

Phillip E Vlisides, MD

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported