Clinical trial NCT04778761: ACP Video Intervention for Patients With Life-Limiting Illness
Official title: Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Utilization
End Stage Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospice utilization
timeFrame: up to one year follow-up or death
Secondary outcomes:
measure: Hospice length of stay
timeFrame: up to one year follow-up or death
measure: Rates of documented resuscitation preferences in the Electronic Health Record
timeFrame: up to one year follow-up or death
measure: Rates of Advance Care Planning documentation in the Electronic Health Record
timeFrame: up to one year follow-up or death
measure: Patient knowledge about Advance Care Planning
timeFrame: Up to two days following the intervention visit
measure: Patient reported confidence in care
timeFrame: up to two days following the intervention visit
measure: Patient reported satisfaction with clinician communication
timeFrame: up to two days following the intervention visit
measure: Patient reported decisional satisfaction
timeFrame: up to two days following the intervention visit
measure: Patient reported decisional certainty
timeFrame: up to two days following the intervention visit
Other outcomes:
measure: Cost of care in the last year of life
timeFrame: 1 year
Locations:
city: Jersey City
country: United States
facility: Clover Health
state: New Jersey
Study officials:
References: