Novel Healthcare Approaches for Delirium in Elders
(ENHANCE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment FAM-HELP for delirium in elders?
Is the Hospital Elder Life Program (HELP) safe for older adults?
The Hospital Elder Life Program (HELP) is generally considered safe for older adults, as it has been successfully implemented in various settings to prevent delirium without reported safety concerns. It is well-received by patients, families, and healthcare staff, and has been shown to improve patient satisfaction and reduce hospital costs.12467
How is the FAM-HELP treatment different from other treatments for delirium in elders?
FAM-HELP is unique because it combines the Hospital Elder Life Program (HELP) with family support to prevent delirium in older adults. This approach is novel as it involves family members in the care process, enhancing the traditional HELP model, which focuses on non-drug interventions like orientation, cognitive activities, and sleep promotion.12489
What is the purpose of this trial?
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.
Research Team
Phillip E Vlisides, MD
Principal Investigator
University of Michigan
Sharon K Inouye, MD
Principal Investigator
Hebrew SeniorLife
Eligibility Criteria
This trial is for people aged 70 or older who are hospitalized and expected to stay at least 72 hours. They must have a family member available to help, be able to give consent, and have at least one risk factor for delirium but not already be delirious upon admission.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the HELP or FAM-HELP program to prevent delirium during hospitalization
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive function and delirium burden
Long-term Follow-up
Participants are monitored for hospital readmission and persistent delirium
Treatment Details
Interventions
- FAM-HELP
- HELP
FAM-HELP is already approved in United States, Canada for the following indications:
- Prevention of delirium in older hospitalized adults
- Prevention of delirium in older hospitalized adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
University of Utah
Collaborator
Indiana University
Collaborator
UnityPoint Health - Meriter Hospital
Collaborator
West Penn Allegheny Health System
Collaborator
MemorialCare Saddleback Medical Center
Collaborator
University of Pennsylvania
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Hebrew SeniorLife
Collaborator
MaineHealth
Collaborator