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

November 24, 2025 updated by: Susan Elizabeth Hickman, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 APPROACHES 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 annual hospital transfers (admissions and emergency department visits). 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 2 nursing home corporations who operate a combined total of 142 diverse urban and rural facilities in 8 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 measures of quality of care at the end of life between the intervention versus control nursing homes. If successful, the APPROACHES 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 Centers for Medicare & Medicaid Services (CMS) claims and Minimum Data Set (MDS) data become available. Actual trial enrollment numbers will be updated at that time.

Study Type

Interventional

Enrollment (Actual)

47396

Phase

  • 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 Locations

  • United States
    • Indiana
      • Warsaw, Indiana, United States, 46580
        • Miller's Merry Manor
    • Kentucky
      • Louisville, Kentucky, United States, 40299
        • Signature HealthCARE LLC

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APPROACHES ACP Specialist Program
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
Behavioral: APPROACHES ACP Specialist Program
The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
Active Comparator: Control
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Other: Standard of care
Standard of care Advance Care Planning (ACP) procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Transfers
Time Frame: 12 months
Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospice Enrollment
Time Frame: 12 months
% ADRD patients who use hospice
12 months
Death in Hospital
Time Frame: 12 months
% ADRD decedents who died in the hospital
12 months

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

National Institute on Aging (NIA)
Regenstrief Institute, Inc.
Hebrew SeniorLife

Investigators

  • Principal Investigator: Susan Hickman, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Estimated)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00481769
  • R21AG057463-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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