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OpenTrials
Completed

NCT Number: NCT02721810

Patient Engagement Initiative

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Consideration of 3-month functional prognosis

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Gordon and Betty Moore Foundation

Registry information

Official study title

Engaging Surrogates and Physicians to Ensure Concordant Critical Care

Acronym: PEI

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2016
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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