Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3U54AG063546-02S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Care Planning Video | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Advance Care Planning Billing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vincent Mor, PhD | Brown University, School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bluestone Physician Services | Stillwater | Minnesota | 55082-6788 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 4 months |
|
Adverse event data was collected during the four months followup period for each resident
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Director | Brown University | (401) 863-7345 | ellen_mccreedy@brown.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2021 | May 25, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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. | 4 months |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| 35 |
| 1,166 |
| 0 |
| 1,166 |
| 0 |
| 1,166 |
| EG001 | 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. | 39 | 1,198 | 0 | 1,198 | 0 | 1,198 |
Not provided
Not provided
| D001523 | Mental Disorders |