DeliriumENHANCENCT05929703
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
A study testing HELP and FAM-HELP in people with Delirium and Neurocognitive Disorders, run by University of Michigan at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium, Neurocognitive Disorders, Mild Cognitive Impairment
- What is being tested?
- HELP and FAM-HELP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Dec 2023to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
- Active neurologic disease (as primary reason for admission)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Michigan Medicine
Ann Arbor, Michigan, 48109
Jocelyn Wiggins, MD, 734-647-7299, wiggi@med.umich.edu
Shenbagam Dewar, MBBS, 734-647-7299, sdewar@med.umich.edu
- Recruiting
Meriter Hospital
Madison, Wisconsin, 53715
Carrie Bennett, DNP, (608) 417-5724, carrie.bennett@unitypoint.org
- Recruiting
Saddleback Medical Center
Orange, California, 92868
Elizabeth Chassagne, BSN, RN, NE-BC, 949-452-3969, EChassagne@memorialcare.org
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rebecca Trotta, PhD, 215-615-4925, Rebecca.Trotta@pennmedicine.upenn.edu
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Lyn Weinberg, MD, 412-235-5810, Lyn.WEINBERG@ahn.org
- Recruiting
MaineHealth
Portland, Maine, 04102
Emily Carter, MD, 207-662-3157, Emily.Carter1@mainehealth.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Roxanne Weiss, MD, 210-462-6266, Roxanne.Weiss@hsc.utah.edu
About this study
Official title: Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
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:
- To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
- To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
- To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.
Read the detailed description
Delirium is a common complication of hospitalization and major surgery for older adults, and it can lead to loss of independence and substantial healthcare costs. One approach to preventing delirium is through the Hospital Elder Life Program (HELP). HELP personnel work to prevent delirium by providing orienting communication, assisting patients with walking and exercise, providing help with nutrition and fluids, implementing sleep protocols, and helping patients with vision and hearing aids.
However, it is unknown whether involving family members in these activities along with HELP staff (i.e., "FAM-HELP") might be more effective with preventing delirium. The objective of this clinical trial is thus to compare the traditional HELP program with a family-augmented version of HELP (FAM-HELP) to determine which program is more effective with preventing delirium and related complications in older, hospitalized patients.
- Conditions
- Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support
- Being tested
- HELP, FAM-HELP
- Keywords
- Delirium, Clinical Trial, Comparative Effectiveness Research, Implementation Science
- Medical subject headings
- Delirium, Neurocognitive Disorders, Cognitive Dysfunction, Alzheimer Disease, Caregiver Burden, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELPBehavioural
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.
FAM-HELPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital Elder Life Program (HELP) | Active comparator | Hospital Elder Life Program (HELP) is built upon multicomponent, non-pharmacologic strategies that target delirium risk factors to optimize cognitive and clinical function during hospitalization. Receives: Behavioral: HELP |
| Family-Augmented Hospital Elder Life Program (FAM-HELP) | Active comparator | The FAM-HELP program will incorporate a family member and/or care partner, who will play a central role with providing bedside support for delirium risk reduction. Family members and care partners will provide social and emotional support along with augmentation of HELP-based protocols. Receives: Behavioral: FAM-HELP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Incidence
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.
Measured: Day of trial enrollment through day of hospital discharge, up to 14 days
Delirium Severity
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.
Measured: Day of trial enrollment through day of hospital discharge, up to 14 days
Secondary outcomes (13)
Delirium Duration
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants
Measured: Day of trial enrollment through day of hospital discharge, up to 14 days
Persistent Delirium
Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)
Measured: 30 days after hospital discharge
Delirium Burden - Patient
Delirium burden will be calculated using the Patient Delirium Burden Scale (DEL-B-P) (n, 0-40, with higher number indicating more severe burden)
Measured: Day of trial enrollment through 30 days after discharge
Delirium Burden - Family and Care Partners
Delirium burden will be calculated using the Patient Delirium Family Caregiver Scale (DEL-B-C) (n, 0-40, with higher number indicating more severe burden)
Measured: Day of trial enrollment through 30 days after discharge
Caregiving Strain
Strain associated with patient caregiving will be assessed via Modified Caregiver Strain Index (MCSI) (n, 0-26, with higher number indicating more caregiver strain)
Measured: Hospital discharge through 30 days after discharge
Cognitive Function - Subjective Reporting
Subjective reporting of cognitive function will be assessed via PROMIS Cognitive Function - Short Form 6a (n, 6-30, with higher number indicating better subjective cognitive function)
Measured: Hospital discharge through 30 days after discharge
Hospital Experience
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (n, 7-28, with higher score indicating better hospital experience)
Measured: Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Global Health
Assessment of overall physical and mental health via PROMIS Global Health-10. Two separate subscales will be calculated, Global Physical Health (n, 4-20) and Global Mental Health (n, 4-20), with higher scores indicating better health.
Measured: Hospital discharge through 30 days after discharge
Physical Function
Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).
Measured: 30 days after hospital discharge
Falls
Proportion of participants in each group (%) experiencing at least one fall
Measured: Day of trial enrollment through 30 days after hospital discharge
Length of Hospital Stay
Total number of days (n) spent in the hospital
Measured: Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Discharge Disposition
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)
Measured: Day of hospital discharge through 30 days after discharge
30-Day Readmission
Proportion of participants in each group (%) requiring hospital readmission
Measured: Day of hospital discharge through 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start4 Dec 2023
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge, cluster randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Phillip Vlisides, University of Michigan
- Investigators
- Sharon K Inouye, MD, Principal investigator, Hebrew SeniorLifePhillip E Vlisides, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929703
- Sponsor's protocol ID
- HUM00227397
- Other IDs
- DE-2022C1-25666
- Acronym
- ENHANCE
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be in compliance with the PCORI Policy for Data Management and Data Sharing. This will include a deidentified dataset deposited into the Patient-Centered Outcomes Data Repository, housed at the University of Michigan Inter-university Consortium for Political and Social Research (ICPSR).