Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support

Alzheimer Disease Clinical Trial

— APPROACHES  

Official title:

A Nursing Home Pragmatic Trial of APPROACHES (Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Educ. and Support)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323502
• Other study ID #: 00481769
• Secondary ID: R21AG057463-01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nursing home (NH) patients with Alzheimer's disease and related dementias often receive unwanted, burdensome treatments such as hospitalization. Advance care planning (ACP) is a key strategy to support patients and family-caregivers in making informed decisions and ensuring treatment preferences are proactively known and honored. The ACP Specialist Program will improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by existing NH staff.

Description:

A significant number of patients with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Unfortunately, many of these patients experience unwanted and burdensome medical treatments, such as potentially avoidable hospitalizations, that negatively impact quality of life. Advance care planning (ACP) discussions with patients and family caregivers are important to explore goals in advance of a crisis and support informed, values-based decision-making. The ACP process helps ensure that preferences about treatments such as hospitalization are known, documented, and honored. Research indicates that ACP can reduce burdensome treatments and increase the likelihood that care will match documented preferences. Nursing homes are currently required by regulations to offer ACP to patients and families. However, there are no training requirements for nursing home staff and approaches to fulfilling this regulatory and ethical responsibility vary widely, resulting in inconsistent ACP. The "Aligning Patient Preferences - a Role Offering Alzheimer's patients, Caregivers, and Healthcare providers Education and Support (APPROACHES)" trial will test the ACP Specialist Program. Existing nursing home staff members will be trained to enhance care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation. The primary trial outcome is hospital transfers (admissions and emergency department visits) per 1000 person-days alive. Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical or billing purposes. In the 18 month R21 pilot phase, the aims are to: 1) Establish the trial's organizational structure and processes; and 2) Pilot test the intervention in 4 nursing homes. In the R33 phase, a pragmatic cluster randomized clinical trial will be conducted in partnership with 3 nursing home corporations who operate a combined total of 206 diverse urban and rural facilities in 14 states. The aims of the 42 month R33 phase are to: 3) Evaluate the primary outcome of hospital transfers over 12 months among patients with dementia in intervention versus control nursing homes; and 4) Compare ACP documentation, measures of quality of care at the end of life, and patient and family satisfaction between the intervention versus control nursing homes. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve quality of care for patients with dementia. Actual enrollment and outcomes will not be available until CMS claims and MDS data become available, approximately one year after the study completion date. Actual trial enrollment numbers will be updated at that time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22650
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Facilities are owned by NH corporate partners

• Facilities are Medicare/Medicaid-certified

• Facilities have an electronic medical records system

• Minimum bedsize of 50 or more;

• At least 50% long-stay as defined by a length of stay of 100 days or longer.

Exclusion Criteria:

• Problematic or unstable facilities will be removed in consultation with NH corporate leaders prior to randomization

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• ACP Specialist Program
New structured role with responsibility for ACP

Locations

Country	Name	City	State
United States	Signature HealthCARE LLC	Louisville	Kentucky
United States	Miller's Merry Manor	Warsaw	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Hebrew SeniorLife, National Institute on Aging (NIA), Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Transfers	Hospital transfers (admissions and emergency department visits)/1000 person-days alive between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs	12 months
Secondary	ACP preferences documentation	% ADRD patients with do not resuscitate, do not hospitalize, no tube-feeding, or do not intubate orders, and Physician Orders for Life-Sustaining Treatment forms	12 months
Secondary	hospice enrollment	% ADRD patients who use hospice	12 months
Secondary	death in hospital	% ADRD patients who die in the hospital	12 months
Secondary	family satisfaction	family satisfaction with care	12 months