Clinical trial NCT05810987: Remote Education Strategies Training Oncology Residents for End-of-Life Discussions
Official title: Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (The RESTORED Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Keywords: Communication, Serious Illness, Education, Palliative Care
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: COM-ON (Communication in Oncology) Checklist
timeFrame: 3 months
measure: QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)
timeFrame: 3 months
measure: Assessment rubric for 'entrustable professional activities' (EPAs)
timeFrame: 3 months
measure: Global rating scale
timeFrame: 3 months
Secondary outcomes:
measure: End-of-Life Professional Caregiver Survey (EPCS)
timeFrame: 3 months
measure: RESTORED Questionnaire
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre - Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Oren Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: