NCT05929703 · University of Michigan
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
(ENHANCE)
What this study is about
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.
View original scientific 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.
Interventions
BEHAVIORAL
HELP
This is usual (standard) care across hospitals in this trial. A multidisciplinary team of nurse specialists, social workers, and volunteers implement daily protocols focused on orientation, cognitive stimulation, early mobilization, sleep enhancement, support with visual and hearing aids, mealtime assistance, hydration, reduction in polypharmacy, and nursing-based delirium prevention protocols.
BEHAVIORAL
FAM-HELP
Family members and care partners will provide daily emotional and social support during hospitalization. Additionally, family members and care partners will engage in HELP-based protocols throughout the day. The rationale for this protocol augmentation is two-fold: (1) HELP may not consistently have available volunteers (e.g., short-staffing) during a hospital stay, and (2) patients may be more likely to engage in therapeutic activities with a family member given the connection and comfort level.
Primary outcome measures
Delirium Incidence
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), supplemented by a validated chart review approach for delirium.
Delirium Severity
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Delirium severity will be scored using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium). Score derived from the same CAM instrument and items used for delirium incidence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Orange, California
- Portland, Maine
- Ann Arbor, Michigan
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Salt Lake City, Utah
- Madison, Wisconsin
Collaborators
Hebrew SeniorLife, MaineHealth, University of Pennsylvania, West Penn Allegheny Health System, UnityPoint Health - Meriter Hospital, University of Utah, MemorialCare Saddleback Medical Center, Brandeis University, Indiana University, Patient-Centered Outcomes Research Institute
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations