Alzheimer DiseaseAPPROACHESNCT03323502
Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support
A study testing APPROACHES ACP Specialist Program in people with Alzheimer Disease and Dementia, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- APPROACHES ACP Specialist Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,396 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Problematic or unstable facilities will be removed in consultation with NH corporate leaders prior to randomization
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Signature HealthCARE LLC
Louisville, Kentucky, 40299
Miller's Merry Manor
Warsaw, Indiana, 46580
About this study
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)
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- APPROACHES ACP Specialist Program, Standard of care
- 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
- Medical subject headings
- Alzheimer Disease, Dementia, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPROACHES ACP Specialist ProgramBehavioural
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.
Standard of careOther
Standard of care Advance Care Planning (ACP) procedures
| Study group | Role | What they receive |
|---|---|---|
| APPROACHES ACP Specialist Program | Experimental | Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program. Receives: Behavioral: APPROACHES ACP Specialist Program |
| Control | Active comparator | Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Hospice Enrollment
% ADRD patients who use hospice
Measured: 12 months
Death in Hospital
% ADRD decedents who died in the hospital
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Feb 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: ACP Specialist Program
- Masking
- None (open label)
- Enrolment
- 47,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife, Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Susan Elizabeth Hickman, Indiana University
- Investigators
- Susan Hickman, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323502
- Sponsor's protocol ID
- 00481769
- Other IDs
- R21AG057463-01
- Acronym
- APPROACHES
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2017
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35815777
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03323502
- Acronym / sponsor ID
- APPROACHES / 00481769
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,396 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife, Regenstrief Institute, Inc.
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral: ACP Specialist Program
| Arm | Type | Receives |
|---|---|---|
| APPROACHES ACP Specialist Program | Experimental | Behavioral: APPROACHES ACP Specialist ProgramEnrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program. |
| Control | Active comparator | Other: Standard of careEnrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Problematic or unstable facilities will be removed in consultation with NH corporate leaders prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPROACHES ACP Specialist ProgramThe 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. | Behavioural | APPROACHES ACP Specialist Program |
| Standard of careStandard of care Advance Care Planning (ACP) procedures | Other | Control |
Primary outcome
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
2 secondary outcomes
Hospice Enrollment
Time frame: 12 months
Death in Hospital
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35815777Hickman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hickman, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APPROACHES ACP Specialist Program in people with Alzheimer Disease and Dementia, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Transfers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.