Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity of Michigan

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • HELP
  • FAM-HELP

Treatment groups

1,900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

Hebrew SeniorLife

Collaborator

MaineHealth

Collaborator

University of Pennsylvania

Collaborator

West Penn Allegheny Health System

Collaborator

UnityPoint Health - Meriter Hospital

Collaborator

University of Utah

Collaborator

MemorialCare Saddleback Medical Center

Collaborator

Brandeis University

Collaborator

Indiana University

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator