- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778761
ACP Video Intervention for Patients With Life-Limiting Illness
Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ACP is a process that allows patients to communicate their wishes and preferences or medical care, when they are seriously ill, to their medical providers. The study investigators would like to assess whether a home-ACP video can improve patient-clinician communication about patients wishes for their medical care and lead to more patient-centered care.
This study is a randomized clinical trial of a Home-ACP intervention among 500 adult patients with serious illness receiving medical care at home with the Clover Health House Calls Program. Study participants will be assigned to one of two groups. In one group, participants will continue to receive usual care with their home-based care team. In the second group, participants will continue to receive their usual care with their home-based care team and also view an ACP video that helps them understand ACP and provides education about ACP and hospice care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Areej El-Jawahri, MD
- Phone Number: 617-724-4000
- Email: ael-jawahri@partners.org
Study Locations
-
-
New Jersey
-
Jersey City, New Jersey, United States, 07302
- Recruiting
- Clover Health
-
Contact:
- Kumar Dharmarajian, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 21 or over
- Have a one-year prognosis or less as determined by Clover Health's validated algorithm
- Speak either English or one of the other 25 languages in which the video intervention is available
Exclusion Criteria:
- Visually impaired beyond 20/200 corrected
- Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
Usual care entails receiving usual medical care by the home-based care team.
|
|
|
Experimental: Video intervention
In addition to usual care, the intervention will entail having a visit by a trained study clinician to provide access to the ACP video.
The study clinician will discuss the content of the video and answer any questions.
|
A video focused on Advance Care Planning and Hospice for patients with serious illness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospice utilization
Time Frame: up to one year follow-up or death
|
Compare the use of hospice (yes vs. no) between the study groups
|
up to one year follow-up or death
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospice length of stay
Time Frame: up to one year follow-up or death
|
Compare hospice length-of-stay between the study groups
|
up to one year follow-up or death
|
|
Rates of documented resuscitation preferences in the Electronic Health Record
Time Frame: up to one year follow-up or death
|
Compare documented resuscitation preferences in the Electronic Health Record between the two groups
|
up to one year follow-up or death
|
|
Rates of Advance Care Planning documentation in the Electronic Health Record
Time Frame: up to one year follow-up or death
|
Compare advance care planning documentation in the Electronic Health Record between the two groups
|
up to one year follow-up or death
|
|
Patient knowledge about Advance Care Planning
Time Frame: Up to two days following the intervention visit
|
Compare patient's knowledge about advance care planning using a 5-item knowledge questionnaire (range 0-5), higher score indicate more knowledge
|
Up to two days following the intervention visit
|
|
Patient reported confidence in care
Time Frame: up to two days following the intervention visit
|
Compare patient's reported confidence in their medical care using a single Likert response question between the two study groups.
Score range from 0-4.
Higher scores indicate higher confidence in care
|
up to two days following the intervention visit
|
|
Patient reported satisfaction with clinician communication
Time Frame: up to two days following the intervention visit
|
Compare patient satisfaction with their communication with their clinician using the CAHPS subscale.
Score range 0-20.
Higher score indicate better satisfaction with communication
|
up to two days following the intervention visit
|
|
Patient reported decisional satisfaction
Time Frame: up to two days following the intervention visit
|
Compare patient reported decisional satisfaction between the study groups using the Satisfaction with Decision Scale.
Scale range from 6-30.
Higher scores indicate higher satisfaction with decision
|
up to two days following the intervention visit
|
|
Patient reported decisional certainty
Time Frame: up to two days following the intervention visit
|
Compare patient reported decisional certainty between the two groups using the Decision Conflict Scale.
Score ranges from 0 to 100.
Higher scores indicate higher decisional conflict
|
up to two days following the intervention visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of care in the last year of life
Time Frame: 1 year
|
Compare cost of care in the last year of life between the study groups
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P001277
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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