Clinical trial NCT03323502: Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Hebrew SeniorLife
name: Regenstrief Institute, Inc.
First posted: 2017-10-27
Enrollment: 22650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: ACP Specialist Program
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Hospital Transfers
timeFrame: 12 months
Secondary outcomes:
measure: ACP preferences documentation
timeFrame: 12 months
measure: hospice enrollment
timeFrame: 12 months
measure: death in hospital
timeFrame: 12 months
measure: family satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Miller's Merry Manor
state: Indiana
city: Louisville
country: United States
facility: Signature HealthCARE LLC
state: Kentucky
Study officials:
affiliation: Indiana University
name: Susan Hickman, PhD
role: PRINCIPAL_INVESTIGATOR
References: