Dementia
Conditions
Keywords
assisted living facilities, dementia, advance care planning
Brief summary
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.
Interventions
BEHAVIORALAdvance 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.
Sponsors
National Institute on Aging (NIA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Do-Not-Resuscitate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Do-Not-Hospitalize | 4 months | 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 |
| Advance Care Planning Billing | 4 months | 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. |
| Hospitalization | 4 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 997 |
| 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. | 1,011 |
| Total | 2,008 |
Baseline characteristics
| Characteristic | Usual Care | Information | Total |
|---|---|---|---|
| Age, Continuous | 83.0 years STANDARD_DEVIATION 7.5 | 83.1 years STANDARD_DEVIATION 7.6 | 83.1 years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized Race African American | 40 Participants | 30 Participants | 70 Participants |
| Race/Ethnicity, Customized Race Caucasian | 817 Participants | 795 Participants | 1612 Participants |
| Race/Ethnicity, Customized Race Missing | 117 Participants | 169 Participants | 286 Participants |
| Race/Ethnicity, Customized Race Other | 23 Participants | 17 Participants | 40 Participants |
| Region of Enrollment United States | 997 participants | 1011 participants | 2008 participants |
| Sex: Female, Male Female | 695 Participants | 707 Participants | 1402 Participants |
| Sex: Female, Male Male | 302 Participants | 304 Participants | 606 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 35 / 1,166 | 39 / 1,198 |
| other Total, other adverse events | 0 / 1,166 | 0 / 1,198 |
| serious Total, serious adverse events | 0 / 1,166 | 0 / 1,198 |
Outcome results
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
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Do-Not-Resuscitate | 144 Participants |
| Information | Do-Not-Resuscitate | 136 Participants |
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Advance Care Planning Billing | 11 Participants |
| Information | Advance Care Planning Billing | 23 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
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Do-Not-Hospitalize | 35 Participants |
| Information | Do-Not-Hospitalize | 31 Participants |
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Hospitalization | 110 Participants |
| Information | Hospitalization | 113 Participants |