Effect of an Advance Care Planning Intervention

Dementia Clinical Trial

Official title:

Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852055
• Other study ID #: 2008002779
• Secondary ID: 3U54AG063546-02S
• Status: Completed
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: March 23, 2022

Study information

• Verified date: September 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2611
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Bluestone Physician Services	Stillwater	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	4 months
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	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. Requires access to claims data which delays reporting	4 months
Secondary	Hospitalization	Percentage of residents with any inpatient hospitalization during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting	4 months