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

NCT03323502 | Completed Results DMC

• 2 other identifiers: 00481769R21AG057463-01
• Study Type: interventional
• Target: 47,396
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alzheimer Disease; Dementia

Keywords

Nursing Homes; Skilled Nursing Facilities; Advance Care Planning; Advance Directives; Alzheimer Disease; Dementia; Do Not Resuscitate Orders; Physician Orders for Life-Sustaining Treatment; Artificial Nutrition; Hospitalization; Intubation; Pragmatic Clinical Trials; Randomized Controlled Trials; Patient Preferences; Resuscitation Orders

Outcome Measures

Primary Outcomes (1)

• Hospital Transfers

  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 Outcomes (2)

• Hospice Enrollment

  12 months

• Death in Hospital

  12 months

Study Arms (2)

APPROACHES ACP Specialist Program

EXPERIMENTAL

Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.

Behavioral: APPROACHES ACP Specialist Program

Control

ACTIVE COMPARATOR

Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.

Other: Standard of care

Interventions

Standard of care OTHER

Standard of care Advance Care Planning (ACP) procedures

Control

APPROACHES ACP Specialist Program BEHAVIORAL

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.

APPROACHES ACP Specialist Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator
• Hebrew SeniorLife: collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (2)

Miller's Merry Manor

Warsaw, Indiana, 46580, United States

Location

Signature HealthCARE LLC

Louisville, Kentucky, 40299, United States

Location

Related Publications (1)

• Hickman SE, Mitchell SL, Hanson LC, Tu W, Stump TE, Unroe KT. The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia. Clin Trials. 2022 Dec;19(6):623-635. doi: 10.1177/17407745221108992. Epub 2022 Jul 10.

  PMID: 35815777 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Patient Preference

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Susan Hickman
• Organization: Indiana University School of Nursing

hickman@iu.edu

317-274-0032

Study Officials

• Susan Hickman, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Cluster Randomized Pragmatic Trial: Randomization will occur at the facility level. In order to implement the intervention in the treatment arms facilities, study staff will be required to know the identity of participating facilities. Since this trial involves training staff at intervention facilities, the masking will be 'open label'.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Community Health Systems

Model Details: Behavioral: ACP Specialist Program

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: February 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 11, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-11

Locations

US (2)