- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Study Overview
Detailed Description
Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.
Primary study question:
Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.
Secondary study questions:
- Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.
- There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients (>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).
- English fluency and literacy
- Able to provide informed consent
Exclusion Criteria:
- Pregnant Women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Visits are not videotaped
|
|
|
Experimental: Videoed Patients
Patients will have their visit videotaped.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Likert Scale for Satisfaction
Time Frame: At enrollment
|
At enrollment
|
|
Likert Scale for Satisfaction
Time Frame: 4-6 weeks
|
4-6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Time Frame: At enrollment
|
At enrollment
|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Time Frame: 4-6 weeks
|
4-6 weeks
|
|
Patient Health Questionnaire (PHQ-2)
Time Frame: at enrollment
|
at enrollment
|
|
Patient Health Questionnaire (PHQ-2)
Time Frame: 4-6 weeks
|
4-6 weeks
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Time Frame: At enrollment
|
At enrollment
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Time Frame: 4-6 weeks
|
4-6 weeks
|
|
Numerical Rating Scale for Pain
Time Frame: at enrollment
|
at enrollment
|
|
Numerical Rating Scale for Pain
Time Frame: 4-6 weeks
|
4-6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014P000132
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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