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Clinical Trials/NCT04778761
NCT04778761
Recruiting
Not Applicable

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

Massachusetts General Hospital1 site in 1 country500 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Care Utilization
Sponsor
Massachusetts General Hospital
Enrollment
500
Locations
1
Primary Endpoint
Hospice utilization
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 1, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

El-Jawahri, Areej,M.D.

Assistant Professor Of Medicine

Massachusetts General Hospital

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.

Outcomes

Primary Outcomes

Hospice utilization

Time Frame: up to one year follow-up or death

Compare the use of hospice (yes vs. no) between the study groups

Secondary Outcomes

  • Rates of documented resuscitation preferences in the Electronic Health Record(up to one year follow-up or death)
  • Patient reported satisfaction with clinician communication(up to two days following the intervention visit)
  • Patient knowledge about Advance Care Planning(Up to two days following the intervention visit)
  • Patient reported confidence in care(up to two days following the intervention visit)
  • Patient reported decisional certainty(up to two days following the intervention visit)
  • Hospice length of stay(up to one year follow-up or death)
  • Rates of Advance Care Planning documentation in the Electronic Health Record(up to one year follow-up or death)
  • Patient reported decisional satisfaction(up to two days following the intervention visit)

Study Sites (1)

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