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Patient Engagement Initiative (PEI)

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ClinicalTrials.gov Identifier: NCT02721810
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Gordon and Betty Moore Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Critical Illness Behavioral: Consideration of 3-month functional prognosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Engaging Surrogates and Physicians to Ensure Concordant Critical Care
Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Level of conflict with proxy with a previously validated single question [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  2. Level of shared decision-making measured using CollaboRATE scale [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  3. 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 ]
  4. Medical interactions assessed using the Roter Interaction Analysis System (RIAS) [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  5. Prevalence of the discussed option of stopping life support as assessed by blinded assessors [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  6. Prevalence of conveying prognosis as assessed by blinded assessors [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  7. Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  8. The Observer OPTIONS5 measure completed by blinded assessors [ Time Frame: 0 to 5 minutes after prompting an intervention ]
  9. Consulting services requested by study participants [ Time Frame: 0 to 5 minutes after prompting an intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721810


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Gordon and Betty Moore Foundation
Investigators
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Principal Investigator: Alison E Turnbull Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02721810    
Other Study ID Numbers: IRB00082272
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes