Patient Engagement Initiative

Critical Illness Clinical Trial

— PEI  

Official title:

Engaging Surrogates and Physicians to Ensure Concordant Critical Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721810
• Other study ID #: IRB00082272
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 19, 2019

Study information

• Verified date: May 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 19, 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Behavioral:
• Consideration of 3-month functional prognosis

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Gordon and Betty Moore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.		0 to 5 minutes after prompting an intervention
Secondary	Level of conflict with proxy with a previously validated single question		0 to 5 minutes after prompting an intervention
Secondary	Level of shared decision-making measured using CollaboRATE scale		0 to 5 minutes after prompting an intervention
Secondary	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
Secondary	Medical interactions assessed using the Roter Interaction Analysis System (RIAS)		0 to 5 minutes after prompting an intervention
Secondary	Prevalence of the discussed option of stopping life support as assessed by blinded assessors		0 to 5 minutes after prompting an intervention
Secondary	Prevalence of conveying prognosis as assessed by blinded assessors		0 to 5 minutes after prompting an intervention
Secondary	Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors		0 to 5 minutes after prompting an intervention
Secondary	The Observer OPTIONS5 measure completed by blinded assessors		0 to 5 minutes after prompting an intervention
Secondary	Consulting services requested by study participants		0 to 5 minutes after prompting an intervention