- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323502
Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES)
January 3, 2023 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 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 Type
Interventional
Enrollment (Actual)
22650
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
-
-
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
Genders Eligible for Study
All
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: Double
Arms and Interventions
Participant Group / 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.
|
New structured role with responsibility for ACP
|
No Intervention: Control
There is no study interaction with control facilities.
Facility will follow usual 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)/1000 person-days alive 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 |
---|---|---|
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
|
12 months
|
hospice enrollment
Time Frame: 12 months
|
% ADRD patients who use hospice
|
12 months
|
death in hospital
Time Frame: 12 months
|
% ADRD patients who die in the hospital
|
12 months
|
family satisfaction
Time Frame: 12 months
|
family satisfaction with care
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Hickman, PhD, Indiana University
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 (Estimate)
January 6, 2023
Last Update Submitted That Met QC Criteria
January 3, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
- Dementia
- Randomized Controlled Trials
- Alzheimer Disease
- Intubation
- Hospitalization
- Advance Care Planning
- Pragmatic Clinical Trials
- Nursing Homes
- Patient Preferences
- Advance Directives
- Skilled Nursing Facilities
- Do Not Resuscitate Orders
- Physician Orders for Life-Sustaining Treatment
- Artificial Nutrition
- Resuscitation Orders
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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