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Trial Title:
Remote Education Strategies Training Oncology Residents for End-of-Life Discussions
NCT ID:
NCT05810987
Condition:
Oncology
Conditions: Official terms:
Neoplasms
Death
Conditions: Keywords:
Communication, Serious Illness, Education, Palliative Care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
RESTORE
Description:
Virtual educational curriculum organized into the following modules:
Module Specific Communication Strategies
1. Introduction
2. Preparing for and introducing a conversation [Consider personal bias /Building
rapport /Ask permission]
3. Assessing understanding [Avoid correcting /Open ended questions]
4. Giving information [Give a warning shot /Using silence /Wish/worry/wonder]
5. Explore goals [Reflective listening /Naming, validating emotion
6. Summarizing and recommending a plan [Values-based recommendation /Aligning with
goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)]
Arm group label:
ELMs alone
Arm group label:
ELMs and virtual SP encounters
Intervention type:
Behavioral
Intervention name:
Medical Interaction and Coaching
Description:
Skills sessions with standardized patients (SPs) along with coaching feedback.
Arm group label:
ELMs and virtual SP encounters
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Medical and radiation oncology residents and fellows at McMaster University, and
medical oncology residents at the Universities of Ottawa and Toronto.
- Enrollment in a participating training program, ability to participate in
study-related activities in English, access to internet and a video-enabled computer
(either personal or institutional) to support study-related activities
Exclusion Criteria:
- Not enrolled in a participating training program
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Juravinski Cancer Centre - Hamilton Health Sciences
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Start date:
January 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
McMaster University
Agency class:
Other
Source:
McMaster University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05810987