Clinical trial NCT02721810: Patient Engagement Initiative
Official title: Engaging Surrogates and Physicians to Ensure Concordant Critical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
First posted: 2016-03-29
Enrollment: 116
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A no-cost intervention may improve adherence with a recommendation for higher-quality, lower-cost care for patients with critical illness endorsed by a collaborative of critical care societies. The investigators propose prompting consideration of functional outcomes. This trial will help establish the impact of the intervention on practice patterns including proxy engagement and elements of shared decision-making.


Eligibility criteria: Inclusion Criteria:

* Licensed physicians
* At least 4 weeks of clinical work in an I.C.U. in the U.S.A. during the past 12 months

Exclusion Criteria:

* \<25 years old
* Non-English speaking
* Primarily practicing medicine outside the U.S.A.

Primary outcomes:
measure: Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.
timeFrame: 0 to 5 minutes after prompting an intervention
Secondary outcomes:
measure: Level of conflict with proxy with a previously validated single question
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Level of shared decision-making measured using CollaboRATE scale
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Medical interactions assessed using the Roter Interaction Analysis System (RIAS)
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Prevalence of the discussed option of stopping life support as assessed by blinded assessors
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Prevalence of conveying prognosis as assessed by blinded assessors
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors
timeFrame: 0 to 5 minutes after prompting an intervention
measure: The Observer OPTIONS5 measure completed by blinded assessors
timeFrame: 0 to 5 minutes after prompting an intervention
measure: Consulting services requested by study participants
timeFrame: 0 to 5 minutes after prompting an intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alison E Turnbull
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abshire MA, Li X, Basyal PS, Teply ML, Singh AL, Hayes MM, Turnbull AE. Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation. PLoS One. 2020 May 29;15(5):e0233538. doi: 10.1371/journal.pone.0233538. eCollection 2020.
citation: Turnbull AE, Hayes MM, Brower RG, Colantuoni E, Basyal PS, White DB, Curtis JR, Needham DM. Effect of Documenting Prognosis on the Information Provided to ICU Proxies: A Randomized Trial. Crit Care Med. 2019 Jun;47(6):757-764. doi: 10.1097/CCM.0000000000003731.