Patient Engagement Initiative (PEI)

Engaging Surrogates and Physicians to Ensure Concordant Critical Care

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 Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: Consideration of 3-month functional prognosis

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Prompts standard to rounds or electronic medical records.
Experimental: Prompting Intervention; Prompting consideration of 3-month functional outcome.	Behavioral: Consideration of 3-month functional prognosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: Alison E Turnbull, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 19, 2019

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IRB00082272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO