Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05810987 |
| Other study ID # |
14948 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
March 1, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
McMaster University |
| Contact |
Oren Levine, MD |
| Phone |
9053879711 |
| Email |
levineo[@]HHSC.CA |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Difficult conversations are common in oncology practice and patient-centered communication is
essential to care for individuals with cancer. Within oncology training programs,
communication training is mostly unstructured observation and feedback in the clinic and many
learners receive inadequate training. Currently, educational resources are limited, and
residents have indicated a desire for more education on end-of-life communication skills. A
formal communication curriculum could fill a gap and help to standardize teaching and
evaluation.
The overall goal of this study is to establish an effective communication skills curriculum
for oncology residents that can be delivered remotely and that addresses difficult
conversations with cancer patients. Through this preliminary study, we will explore the
feasibility of a randomized controlled trial comparing different training experiences to
understand how best to help oncology residents develop strong end-of-life communication
skills.
Description:
Background:
Patient-centered communication is essential to care for individuals with cancer. High quality
communication benefits patients, families, and clinicians. Proficiency in a variety of
communication tasks is now a requirement within competency-based medical education (CBME) in
Canada. Within oncology training programs, communication training is mostly unstructured
observation and feedback in the clinic and many learners receive inadequate training. A
formal communication curriculum could fill a gap and help to standardize teaching and
evaluation, but current resources are limited.
Virtual care has been quickly adopted within oncology practice in the context of the COVID19
pandemic. This limits opportunities for direct observation of learners making assessment of
communication skills more difficult. How best to teach communication skills in the context of
virtual care is unclear. To mitigate current challenges, we will adapt two recognized
educational tools, electronic learning modules (ELMs) and standardized patients (SPs), to
create a novel virtual training strategy. Typically, SP skills sessions occur in person and
effectiveness of SP encounters in a virtual care context has not been evaluated. Moreover, it
is uncertain whether SPs are necessary for creation of psychological fidelity or improvement
of transfer of communication skills. Thus, we aim to explore the relative impact of each
component of a virtual communication curriculum. In this study, we will explore the
feasibility of a randomized controlled trial comparing different training experiences.
Methods:
ELMs will be developed to teach communication skills for difficult conversations in oncology
care. A framework for patient-centered communication and specific communication strategies
will be introduced. Scenarios will be developed for virtual SP encounters related to each
ELM. Virtual SP encounters will occur through the Zoom platform and include feedback from a
remote faculty observer.
A randomized feasibility trial will be conducted. Consenting medical and radiation oncology
residents in participating training programs (McMaster, University of Ottawa, University of
Toronto) will be randomly assigned to complete the ELMs and virtual SP encounters
(experimental arm) vs the ELMs alone (control arm). Video recorded simulated patient
encounters will be conducted before and after the curricular activities. Recordings will be
scored by trained assessors with multiple rating scales to evaluate communication skills of
the learner. Standardized patients will also rate quality of physician communication with a
patient-directed rating scale. This design will allow testing of our innovative educational
interventions and exploration of the likelihood of success of a future RCT which will
evaluate the impact of different training experiences. Outcome measures will include
feasibility metrics such as recruitment, randomization, representativeness, adherence to
intervention, and completeness of data collection. We will determine variance in scores on
multiple rating scales within this study population to inform sample size of a future RCT. In
addition, surveys completed pre- and post-intervention will assess change in self-efficacy
rating and satisfaction with the learning experience.
Analysis:
The proposed sample size is 40 (20 per arm). This is based on achieving a 95% confidence
interval (CI) of 60 to 85% around an estimated recruitment proportion of 75%. The primary
outcome will be whether feasibility metrics meet criteria for success. Descriptive statistics
with corresponding 95% CIs will summarize recruitment, adherence to study procedures,
satisfaction and self-efficacy rating. For assessment of video recorded virtual simulated
patient encounters, correlations between scores from different rating scales will be
performed using Pearson's coefficient. Inter-rater reliability for rating scales will be done
using Cohen's Kappa.
Conclusions:
If criteria for success are met among feasibility outcomes, a national RCT will follow to
evaluate impact of virtual SPs added to the ELM curriculum. These novel educational resources
simulate virtual care, a new paradigm that will likely persist beyond the pandemic. This is a
scalable intervention which may standardize and strengthen communication training among
oncology residency programs across Canada.
