Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

September 2, 2026 updated by: Phillip Vlisides, University of Michigan

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Saddleback Medical Center
        • Contact:
    • Maine
      • Portland, Maine, United States, 04102
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Michigan Medicine
        • Contact:
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Wisconsin
      • Madison, Wisconsin, United States, 53715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)
  • Active neurologic disease (as primary reason for admission)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hospital Elder Life Program (HELP)
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
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.
Active Comparator: Family-Augmented Hospital Elder Life Program (FAM-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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day of trial enrollment through day of hospital discharge, up to 14 days
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.
Day of trial enrollment through day of hospital discharge, up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delirium Duration
Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants
Day of trial enrollment through day of hospital discharge, up to 14 days
Persistent Delirium
Time Frame: 30 days after hospital discharge
Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)
30 days after hospital discharge
Delirium Burden - Patient
Time Frame: Day of trial enrollment through 30 days after discharge
Delirium burden will be calculated using the Patient Delirium Burden Scale (DEL-B-P) (n, 0-40, with higher number indicating more severe burden)
Day of trial enrollment through 30 days after discharge
Delirium Burden - Family and Care Partners
Time Frame: Day of trial enrollment through 30 days after discharge
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)
Day of trial enrollment through 30 days after discharge
Caregiving Strain
Time Frame: Hospital discharge through 30 days after discharge
Strain associated with patient caregiving will be assessed via Modified Caregiver Strain Index (MCSI) (n, 0-26, with higher number indicating more caregiver strain)
Hospital discharge through 30 days after discharge
Cognitive Function - Subjective Reporting
Time Frame: Hospital discharge through 30 days after discharge
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)
Hospital discharge through 30 days after discharge
Hospital Experience
Time Frame: Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (n, 7-28, with higher score indicating better hospital experience)
Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Global Health
Time Frame: Hospital discharge through 30 days after discharge
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.
Hospital discharge through 30 days after discharge
Physical Function
Time Frame: 30 days after hospital discharge
Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).
30 days after hospital discharge
Falls
Time Frame: Day of trial enrollment through 30 days after hospital discharge
Proportion of participants in each group (%) experiencing at least one fall
Day of trial enrollment through 30 days after hospital discharge
Length of Hospital Stay
Time Frame: Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Total number of days (n) spent in the hospital
Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Discharge Disposition
Time Frame: Day of hospital discharge through 30 days after discharge
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)
Day of hospital discharge through 30 days after discharge
30-Day Readmission
Time Frame: Day of hospital discharge through 30 days after discharge
Proportion of participants in each group (%) requiring hospital readmission
Day of hospital discharge through 30 days after discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antipsychotic use
Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization
Day of trial enrollment through day of hospital discharge, up to 14 days
Restraint use
Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Proportion of participants in each group (%) requiring restraint use during hospitalization
Day of trial enrollment through day of hospital discharge, up to 14 days
Mortality
Time Frame: Day of trial enrollment through 30 days after discharge
Incidence (%)
Day of trial enrollment through 30 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
University of Pennsylvania
University of Utah
West Penn Allegheny Health System
Indiana University
MaineHealth
Hebrew SeniorLife
Brandeis University
UnityPoint Health - Meriter Hospital
MemorialCare Saddleback Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Phillip E Vlisides, MD, University of Michigan
  • Principal Investigator: Sharon K Inouye, MD, Hebrew SeniorLife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00227397
  • DE-2022C1-25666 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

The data package will be transferred to the repository by November 15, 2028, per contractual PCORI milestone.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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