- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856060
Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits: A Randomized Controlled Trial (EHR Study #2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To compare patients' perception of physicians' compassion after they watch the first scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
SECONDARY OBJECTIVES:
I. To compare patients' perception of physicians' compassion after they watch the second scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
II. To compare patients' perception of physicians' communication skills after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
III. To compare patients' perception of physicians' professionalism after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
IV. To compare patients' perception of physicians' compassion, communication skills and professionalism after they watch two scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
V. To compare patients' preference after they watch two scripted-video vignettes of physicians sequentially: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
VI. To examine patients' perception of EHR in healthcare delivery. VII. To establish demographic and clinical factors of patients preference for the physician.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete questionnaires and watch a video portraying a physician using a standard electronic health record (EHR) and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.
GROUP II: Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a diagnosis of cancer either early disease or advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow-ups) seen in the Supportive Care Clinic.
- English speaking.
- Patients with normal cognitive status (Memorial Delirium Assessment Scale [MDAS] =< 6/30) who can understand the nature and purpose of the study and have the ability to complete the consent process.
Exclusion Criteria:
- Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be measured by the Edmonton Symptom Assessment Scale (ESAS) and Memorial Delirium Assessment Scale (MDAS), and will be determined by the principal 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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (questionnaires, videos)
Patients complete questionnaires and watch a video portraying a physician using a standard EHR and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.
|
Complete questionnaires
Watch videos of doctor and patient interaction in different settings
|
Experimental: Group II (video, questionnaire)
Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.
|
Complete questionnaires
Watch videos of doctor and patient interaction in different settings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' perception of physicians' compassion after they watch the first video
Time Frame: 1 year" or "up to 24 weeks", "through study completion
|
Quantified by the total score of ratings from a comprehensive 5-item tool which assesses dimensions such as warm/cold, pleasant/unpleasant, compassionate/distant, sensitive/insensitive, and caring/uncaring (ranging from 0 to 10 for each item, and from 0 to 50 for the total score).
Physicians' compassion, communication skills and professionalism will be compared between standard electronic health record (EHR) and integrated EHR groups at the end of each video using a two-sample t-test or Wilcoxon rank-sum test when appropriate.
The mixed model will be applied to further explore the patterns of physicians' compassion, communication skills and professionalism from both videos.
Patients' preference of physician and perception of EHR will be compared between standard EHR and integrated EHR groups using Chi-squared test or Fisher's exact test when appropriate.
Logistic regression model will also be employed.
|
1 year" or "up to 24 weeks", "through study completion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ali Haider, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1016 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-00508 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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.
Clinical Trials on Malignant Neoplasm
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Puerto Rico
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingLi-Fraumeni SyndromeUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Caregiver | Advanced Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
Istituto Auxologico ItalianoCompletedObesity | Eating DisordersItaly
-
Vanderbilt-Ingram Cancer CenterTerminatedMalignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Federico II UniversityUnknownSleep Disorder | Renal Transplant | Hypertension; NephropathyItaly