Clinical trial NCT04660422: Advance Care Planning: Communicating With Outpatients for Vital Informed Decision
Official title: Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Care Planning
Shared Decision Making
Video Decision Aids
Communication Skills
Advance Directives
Natural Language Processing
Covid19
Keywords: Covid 19
Advanced Care Planning
Shared decision making
Video decision aids
Communication skills
Serious illness decision making
Health care proxy
Advance directives
Natural language processing
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-09
Enrollment: 42019
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Rate for Advanced Care Planning (ACP) documentation
timeFrame: 2 Years
Secondary outcomes:
measure: Rate of orders for resuscitation preferences
timeFrame: 2 years
measure: Rate of palliative care consultation
timeFrame: 2 years
measure: Rate of referral to hospice
timeFrame: 2 years
measure: Advanced Care Planning (ACP) documentation rates among under-represented minority groups.
timeFrame: 2 Years
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Dana-Farber Cancer Institute
name: James A. Tulsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.