NCT04239209

Brief Summary

This study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. Participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an ICU patient to die.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

Study Start

First participant enrolled

September 27, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

20 days

First QC Date

January 15, 2020

Last Update Submit

January 23, 2020

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Participant perception of the intensivist's prognostic estimate.

    Participant response to the question "If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?" answered on a 0-100% percentage scale. 0% signifies no chance of survival and 100% signifies definitely will survive.

    approximately 5 minutes

Secondary Outcomes (2)

  • Participant prognostic estimate.

    approximately 5 minutes

  • Participant difference in belief about prognosis.

    approximately 5 minutes

Other Outcomes (2)

  • Participant confidence that they understood the intensivist's belief about prognosis.

    approximately 5 minutes

  • Participant confidence in their own prognostic estimate.

    approximately 5 minutes

Study Arms (4)

Direct Communication (control)

PLACEBO COMPARATOR

A direct response where the intensivist acknowledges that he is not certain but believes the patient will not survive hospitalization.

Behavioral: Direct communication

Indirect - other patients

ACTIVE COMPARATOR

An indirect response describing the prognosis of other people similar to the patient in question.

Behavioral: Indirect - other patients

Indirect - physiology

ACTIVE COMPARATOR

An indirect response describing the severe physiologic abnormalities present in the patient and potential future problems.

Behavioral: Indirect - physiology

Redirection

ACTIVE COMPARATOR

Redirection to a conversation about the values of the patient and possible future decisions.

Behavioral: Redirection

Interventions

Indirect - other patientsBEHAVIORAL

Video depicting an indirect response focusing on a comparison to other patients.

Indirect - other patients
Indirect - physiologyBEHAVIORAL

Video of an indirect response focusing on the physiology of the patient.

Indirect - physiology
RedirectionBEHAVIORAL

Video of a redirection towards discussing the patient's values and possible future decisions.

Redirection
Direct communicationBEHAVIORAL

Video of a direct response.

Direct Communication (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spouse/partner, sibling, or adult child of a patient with Chronic Obstructive Pulmonary Disease (COPD) on home oxygen
  • over age 18

You may not qualify if:

  • ever working in healthcare as a nurse, advanced practice provider, or physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (32)

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    PMID: 20837950BACKGROUND

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    PMID: 25271745BACKGROUND

  • Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.

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  • Turnbull AE, Hartog CS. Goal-concordant care in the ICU: a conceptual framework for future research. Intensive Care Med. 2017 Dec;43(12):1847-1849. doi: 10.1007/s00134-017-4873-2. Epub 2017 Jun 27. No abstract available.

    PMID: 28656453BACKGROUND

  • Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); 2015 Mar 19. Available from http://www.ncbi.nlm.nih.gov/books/NBK285681/

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  • Lee Char SJ, Evans LR, Malvar GL, White DB. A randomized trial of two methods to disclose prognosis to surrogate decision makers in intensive care units. Am J Respir Crit Care Med. 2010 Oct 1;182(7):905-9. doi: 10.1164/rccm.201002-0262OC. Epub 2010 Jun 10.

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    PMID: 27187301BACKGROUND

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    PMID: 14511159BACKGROUND

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    PMID: 25687030BACKGROUND

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    PMID: 20228686BACKGROUND

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    PMID: 24898893BACKGROUND

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    PMID: 30057337BACKGROUND

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    PMID: 11588447BACKGROUND

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    PMID: 15665319BACKGROUND

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  • Turnbull AE, Krall JR, Ruhl AP, Curtis JR, Halpern SD, Lau BM, Needham DM. A scenario-based, randomized trial of patient values and functional prognosis on intensivist intent to discuss withdrawing life support. Crit Care Med. 2014 Jun;42(6):1455-62. doi: 10.1097/CCM.0000000000000227.

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  • 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.

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  • Oppenheim IM, Lee EM, Vasher ST, Zaeh SE, Hart JL, Turnbull AE. Effect of Intensivist Communication in a Simulated Setting on Interpretation of Prognosis Among Family Members of Patients at High Risk of Intensive Care Unit Admission: A Randomized Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201945. doi: 10.1001/jamanetworkopen.2020.1945.

    PMID: 32236533DERIVED

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alison E Turnbull, DVM MPH PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are randomized in a 1:1:1:1 ratio to view a video depicting one of four different ways intensivists answered a patient surrogate's prognostic question "What do you think is most likely to happen?" during a simulated ICU family meeting.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 27, 2020

Study Start

September 27, 2019

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Plan would be to share aggregate, de-identified with other researchers if requested.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Would become available within 6 months of study publication and available indefinitely.
Access Criteria
Access requests from other researchers will be evaluated by the study PI.

Locations

US(1)