Improving Communication Between Cancer Patients & Oncologists

December 16, 2019 updated by: James A. Tulsky, Dana-Farber Cancer Institute

Improving Communication Between Cancer Patients and Oncologists Using Patient Feedback on Actual Conversations and the ABIM Maintenance of Certification Program

The overarching goal of this project is to improve communication between oncologists and their patients by ensuring that the patient's voice is heard in the medical encounter. Thus, the hope is to improve the experience for patients living with cancer. The investigators seek to accomplish this goal by providing oncologists communication skills training that includes feedback on their own audio-recorded conversations. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters.

Study Overview

Detailed Description

The primary objective of the Enhanced SCOPE program is to teach oncologists to recognize the role of emotion in discussions with cancer patients, to increase their self-efficacy for addressing affective concerns, and to provide them with the skills for doing so. Oncologists are most likely to achieve competency in these areas when, in addition to didactic training, they can also observe their own conversation and receive feedback on their interactions. The Enhanced SCOPE program itself is an online web application that can be viewed from any computer with internet connectivity. The investigators will be conducting a randomized controlled trial to test the impact on patient satisfaction and medical visit quality of a communication skills teaching intervention for oncologists that is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process. Oncologists who choose to enroll in this pilot Practice Improvement Module (PIM) will complete a baseline questionnaire, send out satisfaction surveys to a sample of their patients, and then audio record (using a smartphone application) eight clinic visits with eight different patients. Oncologists who are assigned to the control arm will receive the results of the patient surveys and be asked to conduct a quality improvement activity that responds to the feedback (the current "standard" communication PIM). Oncologists assigned to the intervention arm will receive the survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web based interactive program. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria (e.g., empathic opportunities, use of open-ended questions) and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters. These patient reviewers will be drawn from our stakeholder partners and are active patient advocates. They will be treated as members of the research team, paid for the reviews, and are not patients of the study physicians. One month after reviewing their feedback, oncologists in both arms will audio record another eight encounters and send out satisfaction surveys to a new sample of patients.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All American Board of Internal Medicine (ABIM) Board certified oncologists practicing in the U. S. and enrolled in Maintenance of Certification.
  • Have a study-compatible smart phone.
  • Eligible patients will have metastatic cancer.
  • At least 18 years of age.
  • Speak and read English.
  • Receive oncology care from an enrolled oncologist.

Exclusion Criteria:

  • Dana Farber Cancer Institute oncologists and oncologists who do not speak English to their patients.
  • Patients who do not speak English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced SCOPE training
Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.
Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
Active Comparator: Standard Communication training
Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current "standard" communication PIM).
Standard Communication training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider to Patient Communication Score
Time Frame: 6 months
The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Empathic Response to Patient Expressions of Negative Emotions
Time Frame: 6 months

What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.

How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.

6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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