Clinical trial NCT05365763: Developing an Experimental Framework to Evaluate Oncologist Emotion Regulation
Official title: Developing an Experimental Framework to Evaluate Oncologist Emotion Regulation and Its Effect on Prognostic Disclosure During Telehealth Encounters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication
Keywords: serious illness conversation
serious illness communication
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-05-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attending physicians in medical oncology or palliative care

Brief summary: The research team recruited physicians (medical oncologists and specialty palliative care providers) trained in a communication tool called the serious illness conversation guide. Physicians conducted a simulated, telehealth serious illness conversation with an actor playing the role of a patient with advanced cancer. Physicians completed psychologic inventories before and after the encounter, documented the encounter using a template in the electronic medical record, and then participated in a structured interview afterwards discussing what they were feeling during the encounter and how it impacted the encounter. Physicians also wore three heart rate variability sensors during the simulated encounter.

Detailed description: Aim 1: Assess the feasibility and acceptability of measuring physician emotion regulation (ER) abilities and strategies when disclosing prognosis in a simulated, outpatient telehealth encounter with a patient with advanced cancer.

This works seeks to address a technical gap in measurement relevant to the field of serious illness communication by assessing the feasibility and acceptability of collecting psychologic inventories and physiologic data in clinicians during a simulated patient encounter. The research team will purposely recruit physician of varied communication skill, assess communication behavior and triangulate different measures of emotion and ER (e.g. self-report, observation and biometric data sources). This exploratory aim will provide information regarding the feasibility of collecting data from physicians, variability in predictor (ER abilities) and outcome (prognostic disclosure and responding to patient emotion) measures, and preliminarily assess the construct validity of novel measures of physician ER. The research team plan to use an iterative approach (aka adaptive design); results and analysis from the first participants will be used to influence data collection moving forward for future participants (e.g. interview questions asked, timing and duration of biometric sensors being worn, etc.). See Section 4.0 for the definition of feasibility.

Note: The rationale for using telehealth is for human subjects' protections in the context of COVID-19 era infection control practices. Specifically, subject health care providers and study actors cannot currently meet inside in person without wearing masks. Masks will adversely affect the study of communication and emotion. Given that serious illness conversations are increasingly occurring by telehealth in the COVID-19 era, this scientific change could be considered a strength as the research team seeks to learn more about the exchangeability of telehealth for in-person clinical services.

Aim 2: Compare and test two wearable biometric sensors against wearable ECG chest band (gold standard) to evaluate reliability, accuracy, and ease of use from participant and investigator perspectives. The study purpose is to critically appraise the less expensive sensor versus the more expensive research model in different tasks (resting vs patient encounter vs interview) and over different domains (reliability, accuracy, ease of use). To compare the sensors, each participant will wear all three: (one on each arm and the chest band) during the encounter. The research team will define the benchmark for reliability as heart rate variability available ≥90% of the task against the gold standard (e.g. ECG chest band). The research team will use feedback from investigators and participants to grade ease of use. Accuracy will be measured in terms of the time-weighted absolute difference in resting heart rate variability between the consumer and the gold standard sensor.

Aim 3: Assess the correlation between study clinicians' documentation of serious illness conversations using an electronic template against independent expert review and documentation of the video-recorded and transcribed conversation.

Documenting serious illness conversations is an important way to record and share the patient's preferences, goals of care, and illness understanding with other clinicians. Embedded documentation tools, like a template, are common strategies to promote this documentation by reducing the labor to generate the documentation and encourages a uniform structure. Yet little is known about this process of translation - from what the patient says to what the clinician documents - specific to serious illness communication. By using a mixed-methods comparison of clinician-generated serious illness documentation to the transcribed conversations, the research team can perform an exploratory analysis of individual clinician and clinician specialty (e.g. palliative care, oncology) differences in the translation of the serious illness conversation into a documented note. Examples of correlation metrics that the research team may use include agreement and/or inter-rater reliability for closed-ended template items and narrative length and qualitative content analysis for open-ended template items between the study clinician and expert reviewer.

Eligibility criteria: Inclusion Criteria:

Clinicians who have been previously trained in the serious illness conversation guide. Two groups of participants will be recruited.

* hematology/oncology faculty
* specialty-trained palliative care clinicians

Exclusion Criteria:

* individuals who have a diagnosis of cardiovascular dysfunction

Primary outcomes:
measure: Investigator Assessed Feasibility of collecting clinician derived data on emotion regulation
timeFrame: Day 1
Secondary outcomes:
measure: The number of participants with heart rate variability data collected for more than 90% of the conversation task
timeFrame: Day 1
measure: Completeness of Documentation
timeFrame: Day 1
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth Cancer Center
name: Garrett T Wasp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: