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Patient Engagement Initiative

Engaging Surrogates and Physicians to Ensure Concordant Critical Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02721810
Acronym
PEI
Enrollment
116
Registered
2016-03-29
Start date
2016-10-31
Completion date
2019-03-19
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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.

Interventions

BEHAVIORALConsideration of 3-month functional prognosis

Sponsors

Gordon and Betty Moore Foundation
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.0 to 5 minutes after prompting an intervention

Secondary

MeasureTime frame
Level of conflict with proxy with a previously validated single question0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale0 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 colleges0 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
Consulting services requested by study participants0 to 5 minutes after prompting an intervention
Prevalence of conveying prognosis as assessed by blinded assessors0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors0 to 5 minutes after prompting an intervention
The Observer OPTIONS5 measure completed by blinded assessors0 to 5 minutes after prompting an intervention
Prevalence of the discussed option of stopping life support as assessed by blinded assessors0 to 5 minutes after prompting an intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026