- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530867
Physician-Patient Communication Project
Over half of all Americans take dietary supplements (vitamins, minerals, herbal products) along with their prescription medications. With the economic downturn, dietary supplement sales have surged, perhaps as a result of people attempting to stave off or delay medical care. Supplements are generally thought to be harmless, but some can potentially interact with prescription medications, cause liver or kidney damage, and even adversely affect surgical outcomes. Those substituting dietary supplements for prescription medications also may suffer significant adverse consequences. The United States Food and Drug Administration and the Institute of Medicine recommend that patients considering dietary supplement use consult their providers. Unfortunately, patients fail to disclose dietary supplement use in up to two-thirds of outpatient office visits. To improve discussions, it is important to understand what prompts physicians and patients to communicate about dietary supplements.
The overall objectives of this application are to understand how, when and why physicians and patients communicate about dietary supplements, and to assess how patients respond to these discussions. An ethnically diverse group of patients and their physicians will be surveyed and their office visits will be audio recorded. Audio recordings of the visits will be used to assess the relationship of patient and physician attitudes and values, and the physician-patient relationship on dietary supplement discussions. A subset of these patients and physicians will be interviewed to explore how they made decisions to initiate or forgo discussions about supplements. They also will be asked questions concerning the necessity of and responsibility for initiating dietary supplement conversations. Patient responses and reactions to actual discussions also will be explored. Data from observed and reported interactions will be compared to provide a deeper understanding of factors related to disclosure. This project aims to provide a broad understanding of the content of physician-patient discussions about dietary supplements, and to describe how and why physician and patient attitudes and opinions affect these discussions. Identification of mutable factors can result in interventions to increase communication about dietary supplements, help maintain patient safety, and promote appropriate use of supplements concurrent with prescription medications.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente LAMC
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Los Angeles, California, United States, 90404
- Center for East-West Medicine
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Los Angeles, California, United States, 90808
- LA Net Practice Based Research Network
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Los Angeles, California, United States
- Community-based provider offices
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Santa Monica, California, United States, 90404
- University of California, Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- English or Spanish-speaking
- Aged 18 and older
Exclusion Criteria:
- Does not speak English or Spanish
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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patients disclosing dietary supplement use
Time Frame: Disclosure will be measured at a single time point - on the day the patient's office visit is audio recorded. A subset of patients will be selected for a semi-structured interview up to 1 week after the visit.
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Number of patients who disclosed dietary supplement use during audio recorded office visit
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Disclosure will be measured at a single time point - on the day the patient's office visit is audio recorded. A subset of patients will be selected for a semi-structured interview up to 1 week after the visit.
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Collaborators and Investigators
Investigators
- Principal Investigator: Derjung M Tarn, MD, PhD, University of California, Los Angeles
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
- R01AT005883-02 (U.S. NIH Grant/Contract)
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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