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

• ClinicalTrials.gov Identifier: NCT03323502
• Recruitment Status: Completed
• First Posted: October 27, 2017
• Last Update Posted: January 6, 2023
• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA); Hebrew SeniorLife; Regenstrief Institute, Inc.
• Information provided by (Responsible Party): Susan Elizabeth Hickman, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia	Behavioral: ACP Specialist Program	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Behavioral: ACP Specialist Program
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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)
• Actual Study Start Date: February 1, 2020
• Actual Primary Completion Date: August 31, 2022
• Actual Study Completion Date: August 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACP Specialist Program; The ACP Specialist will work with nursing home leaders to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP with patients who have Alzheimer's Disease/related dementias and their family caregivers.	Behavioral: ACP Specialist Program; New structured role with responsibility for ACP
No Intervention: Control; There is no study interaction with control facilities. Facility will follow usual ACP procedures.

Outcome Measures

Primary Outcome Measures :

1. Hospital Transfers [ Time Frame: 12 months ]
   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

Secondary Outcome Measures :

1. ACP preferences documentation [ Time Frame: 12 months ]
   % 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
2. hospice enrollment [ Time Frame: 12 months ]
   % ADRD patients who use hospice
3. death in hospital [ Time Frame: 12 months ]
   % ADRD patients who die in the hospital
4. family satisfaction [ Time Frame: 12 months ]
   family satisfaction with care

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Miller's Merry Manor

Warsaw, Indiana, United States, 46580

United States, Kentucky

Signature HealthCARE LLC

Louisville, Kentucky, United States, 40299

Sponsors and Collaborators

Indiana University

National Institute on Aging (NIA)

Hebrew SeniorLife

Regenstrief Institute, Inc.

Investigators

• Principal Investigator: Susan Hickman, PhD; Indiana University

More Information

• Responsible Party: Susan Elizabeth Hickman, Professor, Community Health Systems, Indiana University
• ClinicalTrials.gov Identifier: NCT03323502
• Other Study ID Numbers: 00481769; R21AG057463-01 ( U.S. NIH Grant/Contract )
• First Posted: October 27, 2017
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Elizabeth Hickman, Indiana University:

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

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders