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Effect of Intensivist Communication on Surrogate Prognosis Interpretation

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indirect - other patients
Indirect - physiology
Redirection
Direct communication
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Direct Communication (control)

Indirect - other patients

Indirect - physiology

Redirection

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Participant prognostic estimate.
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.
Participant difference in belief about prognosis.
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%.

Full Information

First Posted
January 15, 2020
Last Updated
January 23, 2020
Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04239209
Brief Title
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
Official Title
The Effect of Intensivist Communication on Prognosis Interpretation by Family Members of Patients at High Risk for Intensive Care Unit Admission: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Gordon and Betty Moore Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Communication (control)
Arm Type
Placebo Comparator
Arm Description
A direct response where the intensivist acknowledges that he is not certain but believes the patient will not survive hospitalization.
Arm Title
Indirect - other patients
Arm Type
Active Comparator
Arm Description
An indirect response describing the prognosis of other people similar to the patient in question.
Arm Title
Indirect - physiology
Arm Type
Active Comparator
Arm Description
An indirect response describing the severe physiologic abnormalities present in the patient and potential future problems.
Arm Title
Redirection
Arm Type
Active Comparator
Arm Description
Redirection to a conversation about the values of the patient and possible future decisions.
Intervention Type
Behavioral
Intervention Name(s)
Indirect - other patients
Intervention Description
Video depicting an indirect response focusing on a comparison to other patients.
Intervention Type
Behavioral
Intervention Name(s)
Indirect - physiology
Intervention Description
Video of an indirect response focusing on the physiology of the patient.
Intervention Type
Behavioral
Intervention Name(s)
Redirection
Intervention Description
Video of a redirection towards discussing the patient's values and possible future decisions.
Intervention Type
Behavioral
Intervention Name(s)
Direct communication
Intervention Description
Video of a direct response.
Primary Outcome Measure Information:
Title
Participant perception of the intensivist's prognostic estimate.
Description
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.
Time Frame
approximately 5 minutes
Secondary Outcome Measure Information:
Title
Participant prognostic estimate.
Description
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.
Time Frame
approximately 5 minutes
Title
Participant difference in belief about prognosis.
Description
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%.
Time Frame
approximately 5 minutes
Other Pre-specified Outcome Measures:
Title
Participant confidence that they understood the intensivist's belief about prognosis.
Description
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).
Time Frame
approximately 5 minutes
Title
Participant confidence in their own prognostic estimate.
Description
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).
Time Frame
approximately 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison E Turnbull, DVM MPH PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Effect of Intensivist Communication on Surrogate Prognosis Interpretation

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