Back to resultsPatient Engagement Initiative (PEI)
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consideration of 3-month functional prognosis
Sponsored by
About this trial
This is an interventional health services research trial for Critical Illness
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Prompting Intervention
Arm Description
Prompts standard to rounds or electronic medical records.
Prompting consideration of 3-month functional outcome.
Outcomes
Primary Outcome Measures
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.
Secondary Outcome Measures
Level of conflict with proxy with a previously validated single question
Level of shared decision-making measured using CollaboRATE scale
Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges
Medical interactions assessed using the Roter Interaction Analysis System (RIAS)
Prevalence of the discussed option of stopping life support as assessed by blinded assessors
Prevalence of conveying prognosis as assessed by blinded assessors
Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors
The Observer OPTIONS5 measure completed by blinded assessors
Consulting services requested by study participants
Full Information
NCT ID
NCT02721810
First Posted
March 23, 2016
Last Updated
May 16, 2019
Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02721810
Brief Title
Patient Engagement Initiative
Acronym
PEI
Official Title
Engaging Surrogates and Physicians to Ensure Concordant Critical Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Prompts standard to rounds or electronic medical records.
Arm Title
Prompting Intervention
Arm Type
Experimental
Arm Description
Prompting consideration of 3-month functional outcome.
Intervention Type
Behavioral
Intervention Name(s)
Consideration of 3-month functional prognosis
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Level of conflict with proxy with a previously validated single question
Time Frame
0 to 5 minutes after prompting an intervention
Title
Level of shared decision-making measured using CollaboRATE scale
Time Frame
0 to 5 minutes after prompting an intervention
Title
Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges
Time Frame
0 to 5 minutes after prompting an intervention
Title
Medical interactions assessed using the Roter Interaction Analysis System (RIAS)
Time Frame
0 to 5 minutes after prompting an intervention
Title
Prevalence of the discussed option of stopping life support as assessed by blinded assessors
Time Frame
0 to 5 minutes after prompting an intervention
Title
Prevalence of conveying prognosis as assessed by blinded assessors
Time Frame
0 to 5 minutes after prompting an intervention
Title
Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors
Time Frame
0 to 5 minutes after prompting an intervention
Title
The Observer OPTIONS5 measure completed by blinded assessors
Time Frame
0 to 5 minutes after prompting an intervention
Title
Consulting services requested by study participants
Time Frame
0 to 5 minutes after prompting an intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison E Turnbull
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32469920
Citation
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.
Results Reference
derived
PubMed Identifier
30882479
Citation
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.
Results Reference
derived
Learn more about this trial
Patient Engagement Initiative
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