Novel Healthcare Approaches for Delirium in Elders

(ENHANCE Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Phillip E Vlisides, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Disqualifiers: Delirium, Coma, Advanced dementia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment FAM-HELP for delirium in elders?

The Hospital Elder Life Program (HELP), which FAM-HELP is based on, has been shown to effectively prevent delirium in older hospitalized adults, leading to lower rates of delirium, shorter hospital stays, and greater satisfaction among patients and families.

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Is the Hospital Elder Life Program (HELP) safe for older adults?

The Hospital Elder Life Program (HELP) is generally considered safe for older adults, as it has been successfully implemented in various settings to prevent delirium without reported safety concerns. It is well-received by patients, families, and healthcare staff, and has been shown to improve patient satisfaction and reduce hospital costs.

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How is the FAM-HELP treatment different from other treatments for delirium in elders?

FAM-HELP is unique because it combines the Hospital Elder Life Program (HELP) with family support to prevent delirium in older adults. This approach is novel as it involves family members in the care process, enhancing the traditional HELP model, which focuses on non-drug interventions like orientation, cognitive activities, and sleep promotion.

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Eligibility Criteria

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.

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

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

Trial Timeline

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

Participant Groups

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.

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, Australia 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

🇦🇺 Approved in Australia as FAM-HELP for:

• Prevention of delirium in older hospitalized adults

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MaineHealth Portland, ME

Meriter Hospital Madison, WI

Allegheny General Hospital Pittsburg, PA

Michigan Medicine Ann Arbor, MI

More Trial Locations

Who Is Running the Clinical Trial?

University of Michigan Lead Sponsor

University of Utah Collaborator

Indiana University Collaborator

UnityPoint Health - Meriter Hospital Collaborator

West Penn Allegheny Health System Collaborator

MemorialCare Saddleback Medical Center Collaborator

University of Pennsylvania Collaborator

Patient-Centered Outcomes Research Institute Collaborator

Hebrew SeniorLife Collaborator

MaineHealth Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Sustainability and scalability of the hospital elder life program at a community hospital. [2022] The Hospital Elder Life Program (HELP), an effective intervention to prevent delirium in older hospitalized adults, has been successfully replicated in a community teaching hospital as a quality improvement project. This article reports on successfully sustaining the program over 7 years and expanding its scale from one to six inpatient units at the same hospital. The program currently serves more than 7,000 older patients annually and is accepted as the standard of care throughout the hospital. Innovations that enhanced scalability and widespread implementation included ensuring dedicated staffing for the program, local adaptations to streamline protocols, continuous recruitment of volunteers, and more-efficient data collection. Outcomes include a lower rate of incident delirium; shorter length of stay (LOS); greater satisfaction of patients, families, and nursing staff; and significantly lower costs for the hospital. The financial return of the program, estimated at more than $7.3 million per year during 2008, comprises cost savings from delirium prevention and revenue generated from freeing up hospital beds (shorter LOS of HELP patients with and without delirium). Delirium poses a major challenge for hospital quality of care, patient safety, Medicare no-pay conditions, and costs of hospital care for older persons. Faced with rising numbers of elderly patients, hospitals can use HELP to improve the quality and cost-effectiveness of care.

2. United States pubmed.ncbi.nlm.nih.gov

The Modified and Extended Hospital Elder Life Program: A remote model of care to expand delirium prevention. [2023] Delirium is a common complication of hospitalization and is associated with poor outcomes. Multicomponent delirium prevention strategies such as the Hospital Elder Life Program (HELP) have proven effective but rely on face-to-face intervention protocols and volunteer staff, which was not possible due to restrictions during the COVID-19 pandemic. We developed the Modified and Extended Hospital Elder Life Program (HELP-ME), an innovative adaptation of HELP for remote and/or physically distanced applications.

3. England pubmed.ncbi.nlm.nih.gov

Examining the Hospital Elder Life Program in a rehabilitation setting: a pilot feasibility study. [2019] The Hospital Elder Life Program (HELP) has been shown to effectively prevent delirium and functional decline in older patients in acute care, but has not been examined in a rehabilitation setting. This pilot study examined potential successes and implementation factors of the HELP in a post-acute rehabilitation hospital setting.

4. United States pubmed.ncbi.nlm.nih.gov

Hospital Elder Life Program in the real world: the many uses of the Hospital Elder Life Program website. [2021] The Hospital Elder Life Program (HELP) can prevent delirium, a common condition in older hospitalized adults associated with substantial morbidity, mortality, and healthcare costs. In 2011, HELP transitioned to a web-based dissemination model to provide accessible resources, including implementation materials; information for healthcare professionals, patients, and families; and a searchable reference database. It was hypothesized that, although intended to assist sites to establish HELP, the resources that the HELP website offer might have broader applications. An e-mail was sent to all HELP website registrants from September 10, 2012, to March 15, 2013, requesting participation in an online survey to examine uses of the resources on the website and to evaluate knowledge diffusion related to these resources. Of 102 responding sites, 73 (72%) completed the survey. Thirty-nine (53%) had implemented and maintained an active HELP model. Twenty-six (35%) sites had used the HELP website resources to plan for implementation of the HELP model and 35 (50%) sites to implement and support the program during and after launch. Sites also used the resources for the development of non-HELP delirium prevention programs and guidelines. Forty-five sites (61%) used the website resources for educational purposes, targeting healthcare professionals, patients, families, or volunteers. The results demonstrated that HELP resources were used for implementation of HELP and other delirium prevention programs and were also disseminated broadly in innovative educational efforts across the professional and lay communities.

5. England 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. [2021] Hospital Elder Life Program (HELP) provides protocols based on factors for reducing delirium. Due to the lack of geriatric wards and aged care teams in Iran, it seems that some of the original HELP interventions need to be modified through a trial study. Hence, this study was conducted to determine whether the Iranian modified HELP could reduce delirium in geriatric hospitalized patients.

6. United States pubmed.ncbi.nlm.nih.gov

Hospital Elder Life Program in Long-Term Care (HELP-LTC): A Cluster Randomized Controlled Trial. [2023] The Hospital Elder Life Program (HELP) has been shown to prevent delirium in hospitalized older adults. The objective of this study was to test the efficacy of HELP adapted to long-term care (HELP-LTC).

7. United States pubmed.ncbi.nlm.nih.gov

A volunteer-based Hospital Elder Life Program to reduce delirium. [2019] A community hospital with nearly 50% of its admitted patients 70 years or older adapted the well-established Hospital Elder Life Program (HELP). The primary adaptation entailed an enhanced participation of trained volunteers in HELP interventions designed to prevent and reduce delirium. Integral program elements include detailed volunteer training, required demonstration of competencies, and regular evaluation and feedback of volunteers provided by program staff. Nurse satisfaction with HELP increased from 64% to 91% in the second year of implementation, and a survey of patients and families indicated that 95% were satisfied with HELP. This innovative volunteer-assisted model of elder care support was positively embraced by patients, their families, and the nursing staff and supported by nursing administration. The use of volunteers is a cost-effective method of enhancing the nursing care of vulnerable elders during hospitalization.

8. Germany pubmed.ncbi.nlm.nih.gov

[HELP - Hospital Elder Life Program - multimodal delirium prevention in elderly patients]. [2019] Delirium in older adults is associated with an increased risk for cognitive and functional decline. Multiple risk factors, such as underlying dementia, multiple comorbidities, anticholinergic medication or visual and hearing impairment foster the incidence of delirium. By identification of patients at risk and the initiation of a multiple component delirium prevention program delirium is preventable in 30-40% of all cases. There is broad evidence for comprehensive multicomponent delirium prevention strategies in patient care, but their implementation is still lacking in many hospitals. The Hospital Elder Life Program (HELP), designed in 1999 by S.K. Inouye, is a comprehensive protocol for hospitalized elderly patients and has been implemented successfully in more than 200 hospitals worldwide. In German hospitals, positive experiences with HELP, with minor modifications, have been made. The core of the HELP concept is the identification of a patient's delirium risk profile and an individually assigned intervention protocol consisting of (re-)orientation, cognitive activation, simple mobilization or meal companionship and nonpharmacological sleep promotion. Many strategies for the prevention of delirium in elders integrate substantial elements of HELP; however, a measurable preventive effect requires the modification of multiple predisposing and precipitating factors. The article reviews the original Hospital Elder Life Program and its implementation in German hospitals.

9. United States pubmed.ncbi.nlm.nih.gov

A Multi-Phase Quality Improvement Initiative for the Treatment of Active Delirium in Older Persons. [2021] The Hospital Elder Life Program emerged 20 years ago as the reference model for delirium prevention in hospitalized older patients. However, implementation has been achieved at only 200 hospitals worldwide over the last 20 years. Among the barriers to implementation for some institutions is an unwillingness of hospital administration to assume the costs associated with implementing programs that service all hospitalized older patients at risk for delirium. Facing such a situation, we implemented a unique and self-evolving model of care of older hospitalized patients who had already developed delirium.