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

Primary Purpose

Oncology

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
RESTORE
Medical Interaction and Coaching
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncology focused on measuring Communication, Serious Illness, Education, Palliative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Juravinski Cancer Centre - Hamilton Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ELMs and virtual SP encounters

ELMs alone

Arm Description

A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback.

A virtual communication curriculum featuring electronic learning modules (ELMs) only.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 28, 2023
Last Updated
April 12, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05810987
Brief Title
Remote Education Strategies Training Oncology Residents for End-of-Life Discussions
Acronym
RESTORED
Official Title
Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (The RESTORED Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology
Keywords
Communication, Serious Illness, Education, Palliative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ELMs and virtual SP encounters
Arm Type
Experimental
Arm Description
A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback.
Arm Title
ELMs alone
Arm Type
Active Comparator
Arm Description
A virtual communication curriculum featuring electronic learning modules (ELMs) only.
Intervention Type
Other
Intervention Name(s)
RESTORE
Intervention Description
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)]
Intervention Type
Behavioral
Intervention Name(s)
Medical Interaction and Coaching
Intervention Description
Skills sessions with standardized patients (SPs) along with coaching feedback.
Primary Outcome Measure Information:
Title
COM-ON (Communication in Oncology) Checklist
Description
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.
Time Frame
3 months
Title
QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)
Description
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.
Time Frame
3 months
Title
Assessment rubric for 'entrustable professional activities' (EPAs)
Description
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.
Time Frame
3 months
Title
Global rating scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
End-of-Life Professional Caregiver Survey (EPCS)
Description
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.
Time Frame
3 months
Title
RESTORED Questionnaire
Description
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.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Levine, MD
Phone
9053879711
Email
levineo@HHSC.CA
First Name & Middle Initial & Last Name or Official Title & Degree
Daryl Bainbridge, PhD
Phone
12895250708
Email
bainbridgd@hhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren Levine, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre - Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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