Advance Care Planning: Communicating With Outpatients for Vital Informed Decision
NCT ID: NCT04660422
Last Updated: 2022-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42019 participants
OBSERVATIONAL
2020-12-15
2021-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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COHORT
OTHER
Study Groups
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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
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Prisoners
65 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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James A. Tulsky
Principal Investigator
Principal Investigators
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James A. Tulsky, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Northwell Health
New Hyde Park, New York, United States
Countries
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References
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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.
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.
Other Identifiers
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20-600
Identifier Type: -
Identifier Source: org_study_id
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