Advance Care Planning: Communicating With Outpatients for Vital Informed Decision

Covid19 Clinical Trial

— ACP-COVID  

Official title:

Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660422
• Other study ID #: 20-600
• Secondary ID: UH3AG060626-03S1
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42019
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Directives
• Advanced Care Planning
• Communication Skills
• COVID-19
• Covid19
• Natural Language Processing
• Shared Decision Making
• Video Decision Aids

Intervention

Other:
• VitalTalk communication skills training
Clinicians will receive VitalTalk intensive communication skills training via highly structured Zoom conference. They will learn skills relevant to discussions about ACP and COVID-19 including delivering serious news, eliciting goals of care, and managing difficult conversations via telehealth platforms.
• ACP Decisions Video Program
All clinicians will also be trained remotely on the ACP Decisions Video Program using the ACP app. Training will instruct clinicians on how to: 1. Introduce the COVID-19 videos to patients and caregivers; 2. Select the appropriate video(s) from the entire suite according to patients' needs; and, 3. Prescribe videos for patients and caregivers using the electronic platform. The suite of ACP videos is designed to address common ACP decisions confronting patients at risk or with COVID-19 and the caregivers.
• Intervention training:
Training will instruct the clinicians on how to: i. more effectively communicate with patients regarding COVID- 19, ii. have ACP conversations with patients, iii. introduce the videos to patients and families, iv. use the videos as an adjunct to ACP counseling by clinicians, v. select the appropriate video(s) from the entire suite as according to patients' needs, and, vi. use the app or electronic platform for prescribing videos to be seen at home (telehealth visits), or to be viewed in clinic with an iPad.
• Medical Record Review
13,000 (total) patients aged 65 or older for our primary (completed advance care plans) outcome. ACP can include designating a health care proxy, discussion of advance directives, goals-of-care discussions, CPR discussions, palliative care discussions and referrals, as well as hospice. Each of these ACP outcomes will also be compared in secondary analyses using NLP. These data will be obtained from the EHR. All patient participants will only be included for medical record review.

Locations

Country	Name	City	State
United States	Northwell Health	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate for Advanced Care Planning (ACP) documentation	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.	2 Years
Secondary	Rate of orders for resuscitation preferences	Same methodology as Primary Outcome	2 years
Secondary	Rate of palliative care consultation	Same methodology as Primary Outcome	2 years
Secondary	Rate of referral to hospice	Same methodology as Primary Outcome	2 years
Secondary	Advanced Care Planning (ACP) documentation rates among under-represented minority groups.	The analysis will use a difference in differences approach comparing the changes from the control period to the intervention period between White and non-White racial minority and between non-Medicaid and Medicaid patients.	2 Years