ACP Video Intervention for Patients With Life-Limiting Illness

Health Care Utilization Clinical Trial

Official title:

Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778761
• Other study ID #: 2020P001277
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-724-4000
• Email: ael-jawahri[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Disease
• Health Care Utilization

Intervention

Behavioral:
• Home ACP Video
A video focused on Advance Care Planning and Hospice for patients with serious illness

Locations

Country	Name	City	State
United States	Clover Health	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of care in the last year of life	Compare cost of care in the last year of life between the study groups	1 year
Primary	Hospice utilization	Compare the use of hospice (yes vs. no) between the study groups	up to one year follow-up or death
Secondary	Hospice length of stay	Compare hospice length-of-stay between the study groups	up to one year follow-up or death
Secondary	Rates of documented resuscitation preferences in the Electronic Health Record	Compare documented resuscitation preferences in the Electronic Health Record between the two groups	up to one year follow-up or death
Secondary	Rates of Advance Care Planning documentation in the Electronic Health Record	Compare advance care planning documentation in the Electronic Health Record between the two groups	up to one year follow-up or death
Secondary	Patient knowledge about Advance Care Planning	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
Secondary	Patient reported confidence in care	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
Secondary	Patient reported satisfaction with clinician communication	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
Secondary	Patient reported decisional satisfaction	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
Secondary	Patient reported decisional certainty	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