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Clinical Trials/NCT02721810
NCT02721810CompletedNot Applicable

Engaging Surrogates and Physicians to Ensure Concordant Critical Care

Johns Hopkins University2 sites in 1 country116 target enrollmentStarted: October 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Locations
2
Primary Endpoint
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control

No Intervention

Prompts standard to rounds or electronic medical records.

Prompting Intervention

Experimental

Prompting consideration of 3-month functional outcome.

Intervention: Consideration of 3-month functional prognosis (Behavioral)

Outcomes

Primary Outcomes

Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.

Time Frame: 0 to 5 minutes after prompting an intervention

Secondary Outcomes

  • Level of conflict with proxy with a previously validated single question(0 to 5 minutes after prompting an intervention)
  • Level of shared decision-making measured using CollaboRATE scale(0 to 5 minutes after prompting an intervention)
  • Medical interactions assessed using the Roter Interaction Analysis System (RIAS)(0 to 5 minutes after prompting an intervention)
  • Prevalence of the discussed option of stopping life support as assessed by blinded assessors(0 to 5 minutes after prompting an intervention)
  • Prevalence of conveying prognosis as assessed by blinded assessors(0 to 5 minutes after prompting an intervention)
  • Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges(0 to 5 minutes after prompting an intervention)
  • Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors(0 to 5 minutes after prompting an intervention)
  • The Observer OPTIONS5 measure completed by blinded assessors(0 to 5 minutes after prompting an intervention)
  • Consulting services requested by study participants(0 to 5 minutes after prompting an intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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