- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957565
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Study Groups:
After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups.
Each group will watch 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and will discuss the same content, but setting of each video will be different.
After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete.
After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires.
Length of Study:
It should take about 38 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.
Other Information:
You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions.
This is an investigational study.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow ups) seen in the Supportive Care Clinic.
- Age >/= 18 years old
- English speaking
- Patients with normal cognitive status (Memorial Delirium Assessment Scale (MDAS) </=6/30) who are able to understand the nature and purpose of the study and have the ability to complete the consent process.
Exclusion Criteria:
1) Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video 1: No EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Other Names:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Other Names:
|
Experimental: Video 1: No EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Other Names:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Other Names:
|
Experimental: Video 2: With EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Other Names:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Other Names:
|
Experimental: Video 2: With EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Other Names:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant's Rating of Physician's Compassion
Time Frame: 1 day
|
Participant's rating of physician's compassion assessed by using a 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate distant, sensitive insensitive, caring-uncaring.
The sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant's Rating of Physician Communication Skills
Time Frame: 1 day
|
Participant's rating of physician communication skills assessed by using a 14-item tool consisting of 1 to 4 numerical rating scales assessing communication skills.
The sum of these 14 scales gives a final score representing physician's communication skills with a 14 to 70 scale.
|
1 day
|
Participant's Rating of Physician's Professionalism
Time Frame: 1 day
|
Participant's rating of physician's professionalism assessed by using a 4-item tool assessing politeness, listening, explaining the condition and treatment to the participant and participant's involvement in treatment decisions.
Participant rates from poor to very good.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Haider, MBBS, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0494
- NCI-2017-00621 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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