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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02969031
Other study ID # 16-099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2017
Est. completion date August 31, 2018

Study information

Verified date December 2019
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced SCOPE training
Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
Standard Communication training
Standard Communication training

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute American Board of Internal Medicine, Duke University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Provider to Patient Communication Score 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 Empathic Response to Patient Expressions of Negative Emotions 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
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