An interventional study of HELP and FAM-HELP in Delirium, Neurocognitive Disorders and Mild Cognitive Impairment, sponsored by University of Michigan. Recruiting at 7 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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:
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: HELP
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.
Behavioral: FAM-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.
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.
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.
Time frame: 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.
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Delirium Duration
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 30 days after hospital discharge
Falls
Proportion of participants in each group (%) experiencing at least one fall
Time frame: Day of trial enrollment through 30 days after hospital discharge
Length of Hospital Stay
Total number of days (n) spent in the hospital
Time frame: 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)
Time frame: Day of hospital discharge through 30 days after discharge
30-Day Readmission
Proportion of participants in each group (%) requiring hospital readmission
Time frame: Day of hospital discharge through 30 days after discharge
Antipsychotic use
Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Restraint use
Proportion of participants in each group (%) requiring restraint use during hospitalization
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Mortality
Incidence (%)
Time frame: Day of trial enrollment through 30 days after discharge
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data package will be transferred to the repository by November 15, 2028, per contractual PCORI milestone.
Access criteria: The data request process and required qualifications are outlined in the PCORI Policy for Data Management and Data Sharing: https://www.pcori.org/sites/default/files/PCORI-Policy-for-Data-Management-and-Data-Sharing.pdf
Data sharing details ↗ · www.pcori.org
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