Trial Outcomes & Findings for Effect of an Advance Care Planning Intervention (NCT NCT04852055)
NCT ID: NCT04852055
Last Updated: 2025-11-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2364 participants
Primary outcome timeframe
4 months
Results posted on
2025-11-04
Participant Flow
Unit of analysis: Assisted Living Centers
Participant milestones
| Measure |
Usual Care
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
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.
Advance Care Planning Video: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
1166 80
|
1198 80
|
|
Overall Study
COMPLETED
|
997 79
|
1011 80
|
|
Overall Study
NOT COMPLETED
|
169 1
|
187 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of an Advance Care Planning Intervention
Baseline characteristics by cohort
| Measure |
Usual Care
n=997 Participants
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
n=1011 Participants
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.
Advance Care Planning Video: 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.
|
Total
n=2008 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.0 years
STANDARD_DEVIATION 7.5 • n=15 Participants
|
83.1 years
STANDARD_DEVIATION 7.6 • n=161 Participants
|
83.1 years
STANDARD_DEVIATION 7.5 • n=100 Participants
|
|
Sex: Female, Male
Female
|
695 Participants
n=15 Participants
|
707 Participants
n=161 Participants
|
1402 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
302 Participants
n=15 Participants
|
304 Participants
n=161 Participants
|
606 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
817 Participants
n=15 Participants
|
795 Participants
n=161 Participants
|
1612 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
40 Participants
n=15 Participants
|
30 Participants
n=161 Participants
|
70 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
23 Participants
n=15 Participants
|
17 Participants
n=161 Participants
|
40 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
117 Participants
n=15 Participants
|
169 Participants
n=161 Participants
|
286 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
997 participants
n=15 Participants
|
1011 participants
n=161 Participants
|
2008 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercentage 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
Outcome measures
| Measure |
Usual Care
n=997 Participants
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
n=1011 Participants
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.
Advance Care Planning Video: 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.
|
|---|---|---|
|
Do-Not-Resuscitate
|
144 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPercentage 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
Outcome measures
| Measure |
Usual Care
n=997 Participants
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
n=1011 Participants
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.
Advance Care Planning Video: 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.
|
|---|---|---|
|
Do-Not-Hospitalize
|
35 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only Medicare fee-for-service patients with linked claims data and complete Medicare coverage information were included in this analysis. Medicare Advantage patients were excluded from this analysis.
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.
Outcome measures
| Measure |
Usual Care
n=743 Participants
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
n=770 Participants
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.
Advance Care Planning Video: 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.
|
|---|---|---|
|
Advance Care Planning Billing
|
11 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only Medicare fee-for-service patients with linked claims data and complete Medicare coverage information were included in this analysis. Medicare Advantage patients were excluded from this analysis.
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.
Outcome measures
| Measure |
Usual Care
n=743 Participants
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
n=770 Participants
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.
Advance Care Planning Video: 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.
|
|---|---|---|
|
Hospitalization
|
110 Participants
|
113 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 35 deaths
Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 39 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place