NCT02721810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

March 23, 2016

Last Update Submit

May 16, 2019

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.

    0 to 5 minutes after prompting an intervention

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Prompts standard to rounds or electronic medical records.

Prompting Intervention

EXPERIMENTAL

Prompting consideration of 3-month functional outcome.

Behavioral: Consideration of 3-month functional prognosis

Interventions

Consideration of 3-month functional prognosisBEHAVIORAL
Prompting Intervention

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed physicians
  • At least 4 weeks of clinical work in an I.C.U. in the U.S.A. during the past 12 months

You may not qualify if:

  • \<25 years old
  • Non-English speaking
  • Primarily practicing medicine outside the U.S.A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • 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.

    PMID: 32469920DERIVED

  • 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.

    PMID: 30882479DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alison E Turnbull

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 19, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)