Patient Engagement Initiative

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Behavioral: Consideration of 3-month functional prognosis

• Registration Number: NCT02721810
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-29
• Study Start: 2016-10
• Primary Completion: 2018-02
• Study Completion: 2019-03-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prompting Intervention	Consideration of 3-month functional prognosis	Prompting consideration of 3-month functional outcome.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States