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Clinical Trials/NCT04660422
NCT04660422
Completed
Not Applicable

Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions

Dana-Farber Cancer Institute1 site in 1 country42,019 target enrollmentDecember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Care Planning
Sponsor
Dana-Farber Cancer Institute
Enrollment
42019
Locations
1
Primary Endpoint
Rate for Advanced Care Planning (ACP) documentation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This Pre-Post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth Advanced Care Planning (ACP) Program by comparing ACP documentation among 13,000 patients over 65

Detailed Description

This study is investigating if the use of telehealth ACP Program will improve and sustain rates of ACP from the time that the intervention is implemented compared to two time periods prior to the intervention. The Comprehensive ACP Program combines two widely disseminated interventions to assess impact when used concurrently. * One is VitalTalk clinician communication skills training (www.vitaltalk.org) during which the primary care clinicians will practice ACP with simulated patient actors under the guidance of a trained VitalTalk facilitator. * The second is the ACP Decisions video decision aids (www.acpdecisions.org) which are directed to patients and provide education about ACP. This inclusive ACP approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to make decisions about COVID-19 medical care before the toughest choices arise. * The training is four cumulative hours, most of which is spent in communication skills work, and the remainder learning how to introduce the videos into one's practice. No patients participate in the training. The ambulatory practices included in this intervention gain access to the ACP Decisions videos, which can be introduced to patients. Videos may be seen in clinic or sent to patients' homes via an electronic or paper code. * We will recruit up to 30 clinicians from participating clinics who completed the intervention training and ask them to complete a qualitative interview to learn about their experience with the ACP intervention.

Registry
clinicaltrials.gov
Start Date
December 15, 2020
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James A. Tulsky

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Clinic Eligibility: Clinics affiliated with Northwell Health may be included in the study.
  • Clinician, Staff Eligibility: Any staff member identified by the site-PIs are affiliated with Northwell Health.
  • Patient Eligibility: To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period

Exclusion Criteria

  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Outcomes

Primary Outcomes

Rate for Advanced Care Planning (ACP) documentation

Time Frame: 2 Years

This study tests the effects of an ACP Program that trains clinicians and provides patients with a video decision aid on rates of ACP among 13,000 patients at risk, or with, COVID-19. All patients over 65 engaged with the enrolled clinics over the course of each time period in each of the three study periods will be included in the analysis. Rates of ACP are determined by natural language processing data extraction of electronic health records. Generalized linear mixed models will be used to compare outcomes between intervention and control periods.

Secondary Outcomes

  • Rate of orders for resuscitation preferences(2 years)
  • Rate of palliative care consultation(2 years)
  • Rate of referral to hospice(2 years)
  • Advanced Care Planning (ACP) documentation rates among under-represented minority groups.(2 Years)

Study Sites (1)

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