Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (RESTORED)

Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (The RESTORED Study)

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.

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Other: RESTORE; Behavioral: Medical Interaction and Coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre - Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELMs and virtual SP encounters; A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback.	Other: RESTORE; Virtual educational curriculum organized into the following modules: Module Specific Communication Strategies; Introduction; Preparing for and introducing a conversation [Consider personal bias /Building rapport /Ask permission]; Assessing understanding [Avoid correcting /Open ended questions]; Giving information [Give a warning shot /Using silence /Wish/worry/wonder]; Explore goals [Reflective listening /Naming, validating emotion; Summarizing and recommending a plan [Values-based recommendation /Aligning with goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)]; Behavioral: Medical Interaction and Coaching; Skills sessions with standardized patients (SPs) along with coaching feedback.
Active Comparator: ELMs alone; A virtual communication curriculum featuring electronic learning modules (ELMs) only.	Other: RESTORE; Virtual educational curriculum organized into the following modules: Module Specific Communication Strategies; Introduction; Preparing for and introducing a conversation [Consider personal bias /Building rapport /Ask permission]; Assessing understanding [Avoid correcting /Open ended questions]; Giving information [Give a warning shot /Using silence /Wish/worry/wonder]; Explore goals [Reflective listening /Naming, validating emotion; Summarizing and recommending a plan [Values-based recommendation /Aligning with goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COM-ON (Communication in Oncology) Checklist	Validated rating scale assessing general and specific communication skills in oncology. Items are rated on a five-point Likert scale ranging from 0 = ''Skill not demonstrated at all'' to 5 = ''Skill fully demonstrated'', with higher scores denoting higher quality communication.	3 months
QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)	Validated patient-facing rating scale of for quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.	3 months
Assessment rubric for 'entrustable professional activities' (EPAs)	Medical interaction analysis rating scale as defined by the Royal College of Physicians and Surgeons of Canada. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.	3 months
Global rating scale	Overall rating scale of quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-of-Life Professional Caregiver Survey (EPCS)	Validated instrument assessing educational needs relating to palliative care for interprofessional members of the healthcare team. Items are rated on a five-point Likert scale ranging from 1 (lowest level of skill) to 5 (greatest level of skill), with higher scores denoting a higher level of skill.	3 months
RESTORED Questionnaire	Participant satisfaction with training intervention. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher satisfaction.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Oren Levine, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Communication, Serious Illness, Education, Palliative Care
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Death
• Other Study ID Numbers: 14948

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No