Effect of Intensivist Communication on Surrogate Prognosis Interpretation

January 23, 2020 updated by: Johns Hopkins University

The Effect of Intensivist Communication on Prognosis Interpretation by Family Members of Patients at High Risk for Intensive Care Unit Admission: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intensivist-surrogate discordance about prognosis is common in the intensive care unit. Minimizing discordance and empowering families to make informed decisions about participants' loved one's care is important, but it is unclear how best to communicate prognostic information to vulnerable surrogates when a patient is expected to die. Participants are randomized to view one of 4 intensivist communication styles in response to the question "What do you think is most likely to happen?": 1) a direct response (control), 2) an indirect response comparing the patient's condition to other patients, 3) an indirect response describing physiology, or 4) redirection to a discussion of patient values and goals.

The participant will then be asked a series of questions to measure participants' interpretation of what the intensivist says.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Direct Communication (control)
A direct response where the intensivist acknowledges that he is not certain but believes the patient will not survive hospitalization.
Behavioral: Direct communication
Video of a direct response.
Active Comparator: Indirect - other patients
An indirect response describing the prognosis of other people similar to the patient in question.
Behavioral: Indirect - other patients
Video depicting an indirect response focusing on a comparison to other patients.
Active Comparator: Indirect - physiology
An indirect response describing the severe physiologic abnormalities present in the patient and potential future problems.
Behavioral: Indirect - physiology
Video of an indirect response focusing on the physiology of the patient.
Active Comparator: Redirection
Redirection to a conversation about the values of the patient and possible future decisions.
Behavioral: Redirection
Video of a redirection towards discussing the patient's values and possible future decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant perception of the intensivist's prognostic estimate.
Time Frame: approximately 5 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant prognostic estimate.
Time Frame: approximately 5 minutes
Participant response to the question "What do you think are the chances 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
Participant difference in belief about prognosis.
Time Frame: approximately 5 minutes
This is the difference between outcome #2 (participant prognostic estimate) and outcome #1 (participant perception of the intensivist's prognostic estimate), expressed as a difference in percentage. In other words, if for a given participant outcome #2 was a 50% chance of survival and outcome #1 was a 30% chance of survival then outcome #3 (participant difference in belief about prognosis) would be 50% - 30% = 20%.
approximately 5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant confidence that they understood the intensivist's belief about prognosis.
Time Frame: approximately 5 minutes
Participant confidence in their ability to interpret the doctor's prognostic estimate of survival (primary outcome) using a 5-item Likert scale, measuring from not confident at all (1) to very confident (5).
approximately 5 minutes
Participant confidence in their own prognostic estimate.
Time Frame: approximately 5 minutes
Participant confidence in their own estimate of their loved one's chances of survival to discharge using a 5-item Likert scale, measuring from not confident at all (1) to very confident (5).
approximately 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Gordon and Betty Moore Foundation

Investigators

  • Principal Investigator: Alison E Turnbull, DVM MPH PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

October 17, 2019

Study Completion (Actual)

October 17, 2019

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00204036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

Would become available within 6 months of study publication and available indefinitely.

IPD Sharing Access Criteria

Access requests from other researchers will be evaluated by the study PI.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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