DementiaNCT04852055
Effect of an Advance Care Planning Intervention
A study testing Advance Care Planning Video in people with Dementia, run by Brown University at 1 site in United States.
Trial summary
The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Advance Care Planning Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,364 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 23 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients not on hospice
- Patients who do not have comfort care or do-not-hospitalize orders at baseline
Who cannot join
- Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients on hospice
- Patients with comfort care or do-not-hospitalize orders at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Bluestone Physician Services
Stillwater, Minnesota, 55082-6788
About this study
Official title: Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.
Read the detailed description
Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.
- Conditions
- Dementia
- Being tested
- Advance Care Planning Video
- Keywords
- assisted living facilities, dementia, advance care planning
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning VideoBehavioural
Clinical assistants determine who is the correct person to receive the informational materials. If the patient is the correct recipient, clinicians will send the informational materials to the patient at the assisted living center. If the proxy is the correct recipient, the clinical assistant will determine whether or not the proxy is using the existing online portal. If the proxy is using the portal, the informational materials will be sent electronically. If the proxy does not access the portal, the informational materials will be sent to their residences.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients and proxies in assisted living centers randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition. There is no standardized decision- or conversation-support tools used to have these discussions. |
| Information | Experimental | Patients and proxies in assisted living centers randomized to the information arm will receive a letter from their clinician with a link to an educational video describing the goals of care and how specific treatment decisions align with these goals. Patients and proxies will also continue to receive usual care advance care planning conversations. Receives: Behavioral: Advance Care Planning Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Do-Not-Resuscitate
Percentage of residents with do-not-resuscitate orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Measured: 4 months
Secondary outcomes (3)
Do-Not-Hospitalize
Percentage of residents in each arm with do-not-hospitalize or comfort care orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Measured: 4 months
Advance Care Planning Billing
Percentage of residents in each arm with current procedural terminology billing code for advance care planning during follow-up based on Medicare claims data, comparison between usual care and experimental arm.
Measured: 4 months
Hospitalization
Percentage of residents with any inpatient hospitalization during follow-up based on Medicare claims data (the MedPAR file), comparison between usual care and experimental arm.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start30 Mar 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 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.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Brown 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Vincent Mor, Brown University
- Investigators
- Vincent Mor, PhD, Principal investigator, Brown University, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852055
- Sponsor's protocol ID
- 2008002779
- Other IDs
- 3U54AG063546-02S1
- Status last verified
- Sep 2025
- First submitted
- 16 Apr 2021
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
- ClinicalTrials.gov ID
- NCT04852055
- Acronym / sponsor ID
- 2008002779
- Conditions
- Dementia
- Keywords
- assisted living facilities, dementia, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,364 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Posted 11 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.
Detailed description
Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients and proxies in assisted living centers randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition. There is no standardized decision- or conversation-support tools used to have these discussions. |
| Information | Experimental | Behavioral: Advance Care Planning VideoPatients and proxies in assisted living centers randomized to the information arm will receive a letter from their clinician with a link to an educational video describing the goals of care and how specific treatment decisions align with these goals. Patients and proxies will also continue to receive usual care advance care planning conversations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients not on hospice
- Patients who do not have comfort care or do-not-hospitalize orders at baseline
Key exclusion criteria (3 listed)
- Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
- Patients on hospice
- Patients with comfort care or do-not-hospitalize orders at baseline
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 |
|---|---|---|
| Advance Care Planning VideoClinical assistants determine who is the correct person to receive the informational materials. If the patient is the correct recipient, clinicians will send the informational materials to the patient at the assisted living center. If the proxy is the correct recipient, the clinical assistant will determine whether or not the proxy is using the existing online portal. If the proxy is using the portal, the informational materials will be sent electronically. If the proxy does not access the portal, the informational materials will be sent to their residences. | Behavioural | Information |
Primary outcome
Do-Not-Resuscitate
Time frame: 4 months
Percentage of residents with do-not-resuscitate orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
3 secondary outcomes
Do-Not-Hospitalize
Time frame: 4 months
Advance Care Planning Billing
Time frame: 4 months
Hospitalization
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vincent Mor, PhD principal investigator
Brown University, School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning Video in people with Dementia, run by Brown University at 1 site 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 3 inclusion and 3 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Sep 2023). 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?
Do-Not-Resuscitate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2025.