Novel Healthcare Approaches for Delirium in Elders

(ENHANCE Trial)

Recruiting at 7 trial locations

Overseen By Eva Schmitt, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Delirium, Coma, Advanced dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 14 days

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to prevent delirium in older patients during hospital stays. One method involves the Hospital Elder Life Program (HELP), which uses various strategies to reduce delirium risk. The other method, called FAM-HELP (Family-Augmented Hospital Elder Life Program), includes family members or care partners to provide additional support. The researchers aim to determine which method more effectively reduces delirium and improves outcomes for patients and their families. This trial suits patients aged 70 or older who expect to stay in the hospital for at least three days and have a family member available to assist. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance hospital care for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these programs are safe for elders?

Research has shown that both the Hospital Elder Life Program (HELP) and its family-augmented version, FAM-HELP, are generally safe. These programs do not use drugs; instead, they employ methods to prevent confusion and disorientation in older patients during hospital stays.

HELP, in use for over 20 years, focuses on reducing confusion and falls. Studies indicate it is effective and easy for patients to manage, with no major negative side effects reported. The program aims to keep patients' minds clear and improve their overall hospital experience.

FAM-HELP builds on HELP by involving family members or caregivers, providing extra support. This addition is well-received, and no evidence suggests any safety concerns with including family in the program.

Overall, both HELP and FAM-HELP appear safe, with no major safety issues reported in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Novel Healthcare Approaches for Delirium in Elders because it explores innovative methods to reduce delirium using non-drug strategies. The Hospital Elder Life Program (HELP) is unique because it focuses on non-pharmacologic strategies that target delirium risk factors to maintain cognitive function during hospitalization. What makes the Family-Augmented Hospital Elder Life Program (FAM-HELP) particularly exciting is its inclusion of family members or care partners, who provide bedside support and emotional care, potentially enhancing the effectiveness of existing protocols. These approaches could offer a safer, more holistic alternative to traditional delirium treatments that rely heavily on medication.

What evidence suggests that this trial's treatments could be effective for preventing delirium in elders?

Research has shown that the Hospital Elder Life Program (HELP), one of the treatment arms in this trial, effectively reduces delirium in older adults. Studies have found that HELP can lower delirium cases by about 40%. In addition to reducing delirium, HELP helps prevent falls and may shorten hospital stays. The Family-Augmented Hospital Elder Life Program (FAM-HELP), another treatment arm in this trial, builds on HELP by involving family members in the care process. Early findings suggest that family support could further improve outcomes by providing extra emotional and social support. Both HELP and FAM-HELP aim to make hospital stays safer and more comfortable for older patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Sharon K Inouye, MD

Principal Investigator

Hebrew SeniorLife

Phillip E Vlisides, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people aged 70 or older who are hospitalized and expected to stay at least 72 hours. They must have a family member available to help, be able to give consent, and have at least one risk factor for delirium but not already be delirious upon admission.

Inclusion Criteria

I am 70 years old or older.

Family member or care partner available to be on-site in the hospital

Provision of informed consent

Exclusion Criteria

I cannot speak due to my current health condition.

Staff safety concerns (e.g., violent behavior)

I am not able to fully participate in treatments due to a severe condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the HELP or FAM-HELP program to prevent delirium during hospitalization

Up to 14 days

Daily in-hospital visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive function and delirium burden

30 days

1-2 follow-up visits (in-person or virtual)

Long-term Follow-up

Participants are monitored for hospital readmission and persistent delirium

30 days after discharge

What Are the Treatments Tested in This Trial?

Interventions

• FAM-HELP
• HELP

Trial Overview The study compares two programs: HELP, which supports elderly patients in hospitals, and FAM-HELP, which includes family in the care process. It aims to see if involving families can better prevent or reduce the severity of delirium.

How Is the Trial Designed?

Group I: Hospital Elder Life Program (HELP) Active Control 1 Intervention

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.

Group II: Family-Augmented Hospital Elder Life Program (FAM-HELP) Active Control 1 Intervention

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.

FAM-HELP is already approved in United States, Canada for the following indications:

Approved in United States as FAM-HELP for:

• Prevention of delirium in older hospitalized adults

Approved in Canada as FAM-HELP for:

• Prevention of delirium in older hospitalized adults

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

UnityPoint Health - Meriter Hospital

Collaborator

Trials

1

Recruited

3,000+

West Penn Allegheny Health System

Collaborator

Trials

36

Recruited

6,000+

MemorialCare Saddleback Medical Center

Collaborator

Trials

1

Recruited

3,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Published Research Related to This Trial

The Hospital Elder Life Program (HELP) effectively prevents delirium in older hospitalized adults, which is crucial given the high risks associated with this condition.

After transitioning to a web-based model, 72% of surveyed sites utilized HELP resources for implementing the program, with many also applying these resources to develop other delirium prevention initiatives and educational efforts for healthcare professionals and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Elder Life Program in the real world: the many uses of the Hospital Elder Life Program website. Chen, P., Dowal, S., Schmitt, E., et al.[2021]

The Hospital Elder Life Program adapted for long-term care (HELP-LTC) did not significantly prevent delirium or reduce its severity in nursing home residents, despite targeting key risk factors like cognitive impairment and immobility.

Both the HELP-LTC and usual care groups showed improvements in delirium symptoms over time, which may have influenced the study's results, highlighting the need for further research to refine interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Elder Life Program in Long-Term Care (HELP-LTC): A Cluster Randomized Controlled Trial. Boockvar, KS., Judon, KM., Eimicke, JP., et al.[2023]

The modified Hospital Elder Life Program (HELP) significantly reduced the incidence of delirium in hospitalized patients aged 70 and older, with rates dropping from 14.71% in the control group to 3.66% in the intervention group.

This study involved 195 participants and demonstrated a strong efficacy of the modified HELP interventions, with an odds ratio of 0.124 indicating a substantial reduction in delirium risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial. Kojaie-Bidgoli, A., Sharifi, F., Maghsoud, F., et al.[2021]

The adaptation of the Hospital Elder Life Program (HELP) at a community hospital, which included enhanced volunteer participation, significantly improved nurse satisfaction from 64% to 91% within two years.

Patient and family satisfaction with HELP was extremely high at 95%, demonstrating that this volunteer-assisted model effectively supports elder care and is a cost-effective way to enhance nursing care for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A volunteer-based Hospital Elder Life Program to reduce delirium. Sandhaus, S., Zalon, ML., Valenti, D., et al.[2019]

A delirium intervention program implemented at Mount Sinai Hospital for older patients with existing delirium resulted in a significant reduction in hospital length of stay by an average of 1.98 days.

The program also led to decreased use of sedative medications, including morphine, diazepam, and quetiapine, indicating a potential for safer management of delirious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-Phase Quality Improvement Initiative for the Treatment of Active Delirium in Older Persons. Friedman, JI., Li, L., Kirpalani, S., et al.[2021]

The Hospital Elder Life Program (HELP) significantly reduced the prevalence of delirium in older patients from 10.9% to 2.5% in a rehabilitation setting, while the usual care group showed no change.

Patients receiving HELP demonstrated greater improvements in cognitive and functional outcomes, including short-term memory and recall, and had a shorter average length of stay compared to those who did not receive the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Hospital Elder Life Program in a rehabilitation setting: a pilot feasibility study. Huson, K., Stolee, P., Pearce, N., et al.[2019]

The Hospital Elder Life Program (HELP) has been successfully implemented and sustained over 7 years in a community teaching hospital, expanding from one to six inpatient units and serving over 7,000 older patients annually, establishing it as the standard of care.

The program has led to significant improvements, including a lower rate of delirium, shorter hospital stays, increased satisfaction among patients and staff, and substantial cost savings of over $7.3 million per year, highlighting its effectiveness in enhancing care for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability and scalability of the hospital elder life program at a community hospital. Rubin, FH., Neal, K., Fenlon, K., et al.[2022]

The Modified and Extended Hospital Elder Life Program (HELP-ME) was successfully implemented at four sites with 106 patients, achieving an overall protocol adherence rate of 82%, which meets the feasibility target of over 75%.

Feedback from focus groups indicated that while the remote intervention was generally well-accepted, a hybrid approach combining in-person and remote strategies may enhance effectiveness and sustainability in preventing delirium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Modified and Extended Hospital Elder Life Program: A remote model of care to expand delirium prevention. Fong, TG., Albaum, JA., Anderson, ML., et al.[2023]

Delirium in older adults can lead to serious cognitive and functional decline, but implementing a comprehensive prevention program like the Hospital Elder Life Program (HELP) can prevent 30-40% of cases.

HELP has been successfully adapted in over 200 hospitals worldwide, including in Germany, focusing on identifying patients at risk and providing tailored interventions such as cognitive activation and mobilization to reduce delirium risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HELP - Hospital Elder Life Program - multimodal delirium prevention in elderly patients]. Singler, K., Thomas, C.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6362826/

Hospital Elder Life Program: Systematic Review and Meta ... The Hospital Elder Life Program is effective in reducing incidence of delirium and rate of falls, with a trend toward decreasing length of stay and preventing ...

2. pcori.org pcori.org/research-results/2022/comparing-two-programs-prevent-delirium-hospitalized-older-adults

Comparing Two Programs To Prevent Delirium in ... This study compares the clinical effectiveness of the Hospital Elder Life Program (HELP) and Family-Augmented-HELP (FAM-HELP) for preventing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05929703?term=AREA%5BBasicSearch%5D(help)&rank=10

Evaluating Novel Healthcare Approaches to Nurturing and ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3588581/

Sustainability and Scalability of the Hospital Elder Life ... Outcomes include reduced rate of incident delirium, reduced length of stay, increased satisfaction by patients, families, and nursing staff, and significantly ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/572155

Evaluating Novel Healthcare Approaches to Nurturing and ... The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), ...