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

Key Points Question Do intensivist communication patterns affect the way family members understand their loved one’s prognosis in the intensive care unit? Findings In this randomized trial of 302 family members of people with chronic obstructive pulmonary disease receiving long-term oxygen therapy, participants were asked to imagine their family member was in the intensive care unit, and the participants were presented video vignettes of an intensivist who expected a patient to die answering the prognostic question “What do you think is most likely to happen?” Participants who viewed videos of the intensivist using indirect or redirection language perceived the intensivist to be more optimistic than participants who viewed a video of the intensivist answering the question directly. Meaning These findings suggest that family members interpret physicians’ indirect responses to questions about prognosis as more optimistic than direct responses.


111
The protocol, informed consent form(s), and all participant materials will be submitted to the IRB for review and 112 approval. Approval of both the protocol and the consent form(s) must be obtained before any participant is 113 consented. Any amendment to the protocol will require review and approval by the IRB before the changes are 114 implemented to the study. All changes to the consent form(s) will be IRB approved. 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 they expect an ICU patient to die.
2) Quantify participant differences in belief about prognosis.
3) Describe participant confidence that they understood the intensivist's belief about prognosis. 4) Describe participant confidence in their own prognostic estimate.

Endpoints*:
Primary Endpoint: 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% probability scale.
Secondary Endpoints: 1) 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% probability scale.
2) The difference between the participant's prognostic estimate and the participant's perception of the intensivist's prognostic estimate.
3) Participant confidence in their ability to interpret the doctor's prognostic estimate of survival (primary outcome) using a 5-item Likert scale. 4) Participant confidence in their own estimate of their loved one's chances of survival to discharge using a 5-item Likert scale.

Study Population:
People age ≥18 years who are a spouse/partner, sibling, or adult child of a patient with Chronic Obstructive Pulmonary Disease (COPD) on home oxygen. Phase* or Stage: n/a Description of Sites/Facilities Enrolling Participants: Web-based trial.

157
When the option of speaking directly to the patient is absent, such as in the ICU, this recommendation also applies to 158 patient surrogates. Previous trials have examined different methods for communicating prognosis to ICU surrogates, 15 16 159 but substantial intensivist-surrogate discordance about prognosis remains 15 17 18 even when surrogates rate the quality 160 of physician communication highly. 19 Recent research suggests intensivist-surrogate discordance about prognosis is a 161 result of both surrogate misunderstanding and differences between physician and surrogate belief systems. 17  167 common in this population, 21 22 23 24 and may affect decision making. 21 22 25 Surveys aimed at surrogates of current ICU 168 patients may be biased towards respondents who are white, 26 visit the hospital more frequently, 27 and are of a higher 169 socioeconomic status. 26 28 To address these problems, we will study close family members (spouses, siblings, and adult 170 children) of outpatients who are ill enough that ICU admission in the near future is likely, thus examining a population of 171 potential surrogates who are not acutely stressed about a loved one's day-to-day survival in the ICU. Specifically, we will 172 study family members of adults with Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen, as these 173 family members are likely to become patient surrogates in the near future. 29 30 174

183
Hopkins Hospital Simulation Center where they reviewed paper-based medical records of a hypothetical patient 184 scenario, developed so that in-hospital death was highly probable but not certain. Physicians in both the control and 185 intervention groups were then asked a series of questions about their management plan; intensivists randomized to the 186 intervention group also answered 3 additional questions about the hypothetical patient's prognosis. One question, 187 which we will use the responses to in our study, was "Do you expect this patient to survive to hospital discharge?" 15 17 All

207
The risks involved with this study are minimal and benefits to ICU care in general could be large.

398
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:

399
 UPs that are serious adverse events (SAEs) will be reported to the IRB within 7 business days of the investigator becoming

415
We hypothesize that participants will perceive intensivists to be less optimistic when randomized to view a direct 416 answer to their question about prognosis.

418
We hypothesize that participants will be less optimistic when they are randomized to view a direct answer to their 419 question about prognosis.

421
We hypothesize that differences in belief about prognosis (defined as the difference between the proxy's prognostic 422 estimate and the intensivist's perceived estimate) will be unaffected by intensivist communication style.

433
The per-protocol population will be analyzed. Participants who did not complete the trial will not be analyzed.

438
Descriptive statistics and data visualizations will be used to summarize primary and secondary endpoints, baseline 439 descriptive statistics, and exploratory analyses as described below. Generalized linear regression will be used to 440 estimate the effect of intensivist communication style on primary and secondary outcomes. All analyses will assume a 2-441 sided alpha of 0.05.

442
The Effect of Intensivist

443
Multivariable linear regression will be used to estimate the effect of communication pattern (i.e. which video the 444 participant is randomized to view) on perception of the intensivist's prognostic estimate. The direct communication 445 pattern will be treated as the comparator (control group) in all models. All models will be adjusted for the following 446 variables which are hypothesized to confound the relationship between physician communication style and proxy 447 perception of the intensivist's prognostic estimate: 1) the relationship of the participant to their loved one, 2) whether 448 the participant's loved one has previously been mechanically ventilated, 3) education level, 4) numeracy score, 5) trust 449 in physicians score, and 6) health literacy score. Residual plots will be reviewed to evaluate model assumptions.

450
Unadjusted models will also be reported. 457 whether the participant's loved one has previously been mechanically ventilated, 3) education level, 4) numeracy score, 458 5) trust in physicians score, and 6) health literacy score. Residual plots will be reviewed to evaluate model assumptions.

459
Unadjusted models will also be reported.

503
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, the safety and 504 oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is extended to the data being collected 505 as part of this study. Data that could be used to identify a specific study participant will be held in strict confidence 506 within the research team. No personally-identifiable information from the study will be released to any unauthorized 507 third party without prior written approval of the sponsor/funding agency.

509
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional Review Board 510 (IRB), or regulatory agencies may inspect all documents and records required to be maintained by the investigator. The

511
clinical study site will permit access to such records. At the end of the study, all records will continue to be kept in a 512 secure location for as long a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted 515 to and stored at the Johns Hopkins University. This will not include the participant's contact or identifying information.

516
Rather, individual participants and their research data will be identified by a unique study identification number. The 517 study data entry and study management systems used by study site research staff will be secured and password 518 protected. At the end of the study, all study databases will be de-identified and archived at the Johns Hopkins University.

520
The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of 521 privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and 522 will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be 523 implemented, as appropriate.

544
Study documents will be retained for a minimum of 2 years after formal discontinuation of the study. It is the 545 responsibility of the investigator to determine when these documents no longer need to be retained.

547
The

564
The independence of this study from any actual or perceived influence, such as by the pharmaceutical industry, is 565 critical. Therefore any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, 566 or any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 567 will be required to have such conflicts managed in a way that is appropriate to their participation in the design and