Advance Care Planning: Communicating With Outpatients for Vital Informed Decision

NCT ID: NCT04660422

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

42019 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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,

Medical Record Review

Intervention Type OTHER

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

Medical Record Review

Intervention Type OTHER

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

VitalTalk communication skills training

Intervention Type OTHER

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

Intervention Type OTHER

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:

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James A. Tulsky

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James A. Tulsky, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwell Health

New Hyde Park, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Murray GF, Lakin JR, Paasche-Orlow MK, Tulsky JA, Volandes A, Davis AD, Zupanc SN, Carney MT, Burns E, Martins-Welch D, LaVine N, Itty JE, Fix GM. Structural Barriers to Well-grounded Advance Care Planning for the Seriously Ill: a Qualitative Study of Clinicians' and Administrators' Experiences During a Pragmatic Trial. J Gen Intern Med. 2023 Dec;38(16):3558-3565. doi: 10.1007/s11606-023-08320-2. Epub 2023 Jul 24.

Reference Type DERIVED
PMID: 37488368 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35201306 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UH3AG060626-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-600

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Palliative Care Educator
NCT04857060 COMPLETED NA