Advance Care Planning: Communicating With Outpatients for Vital Informed Decision (ACP-COVID)

Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions

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

Study Overview

• Status: Completed
• Conditions: Covid19; Advanced Care Planning; Shared Decision Making; Advance Directives; Communication Skills; Video Decision Aids; Natural Language Processing
• Intervention / Treatment: Other: Medical Record Review; Other: VitalTalk communication skills training; Other: ACP Decisions Video Program; Other: Intervention training:

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.

• Study Type: Observational
• Enrollment (Actual): 42019

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-COVID-19 ACP baseline; Two six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate. September 15, 2019 - March 14, 2020,	Other: 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.
COVID-19 rate; Two six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate. March 15, 2020 - September 14, 2020	Other: 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.
ACP rate; ACP rate during the implementation period, which begins December 15, 2020 and continues for six months, to the rates in the previous two control periods December 15, 2020-June 15, 2021	Other: 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.; 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of orders for resuscitation preferences	Same methodology as Primary Outcome	2 years
Rate of palliative care consultation	Same methodology as Primary Outcome	2 years
Rate of referral to hospice	Same methodology as Primary Outcome	2 years
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Institute on Aging (NIA)

Publications and helpful links

General Publications

• Volandes AE, Zupanc SN, Paasche-Orlow MK, Lakin JR, Chang Y, Burns EA, LaVine NA, Carney MT, Martins-Welch D, Emmert K, Itty JE, Moseley ET, Davis AD, El-Jawahri A, Gundersen DA, Fix GM, Yacoub AM, Schwartz P, Gabry-Kalikow S, Garde C, Fischer J, Henault L, Burgess L, Goldman J, Kwok A, Singh N, Alvarez Suarez AL, Gromova V, Jacome S, Tulsky JA, Lindvall C. Association of an Advance Care Planning Video and Communication Intervention With Documentation of Advance Care Planning Among Older Adults: A Nonrandomized Controlled Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220354. doi: 10.1001/jamanetworkopen.2022.0354.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Shared decision making; Covid 19; Advance directives; Natural language processing; Communication skills; Advanced Care Planning; Video decision aids; Serious illness decision making; Health care proxy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-600; UH3AG060626-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No