Effect of Intensivist Communication on Surrogate Prognosis Interpretation

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT04239209

Collaborator

Gordon and Betty Moore Foundation (Other)

302

Enrollment

Location

Arms

Actual Duration (Days)

459.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Behavioral: Indirect - other patients Behavioral: Indirect - physiology Behavioral: Redirection Behavioral: Direct communication	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

302 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 27, 2019

Actual Primary Completion Date :

Oct 17, 2019

Actual Study Completion Date :

Oct 17, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Participant perception of the intensivist's prognostic estimate. [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.

Secondary Outcome Measures

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

Other Outcome Measures

Participant confidence that they understood the intensivist's belief about prognosis. [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).
Participant confidence in their own prognostic estimate. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Johns Hopkins University
Gordon and Betty Moore Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04239209

Other Study ID Numbers:

IRB00204036

First Posted:

Jan 27, 2020

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Jan 27, 2020