Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05365763 |
| Other study ID # |
STUDY02000696 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
Dartmouth-Hitchcock Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
