Physician-Patient Communication Project
| Tracking Information | |||||
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| First Received Date ICMJE | January 2, 2012 | ||||
| Last Updated Date | October 3, 2012 | ||||
| Start Date ICMJE | November 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] Number of patients who disclosed dietary supplement use during audio recorded office visit |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01530867 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Physician-Patient Communication Project | ||||
| Official Title ICMJE | Physician-Patient Communication Project | ||||
| Brief Summary | 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. |
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| Detailed Description | Forty primary care and integrative or complementary and alternative medicine physicians will be recruited for the study. For each participating physician, ten patients will be recruited. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary care physicians Integrative medicine / complementary and alternative medicine physicians Patients aged 18 and older of physicians participating in the study |
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| Condition ICMJE | Dietary Supplements | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Enrollment ICMJE | 456 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01530867 | ||||
| Other Study ID Numbers ICMJE | R01 AT005883-02, R01AT005883-02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Derjung Tarn, University of California, Los Angeles | ||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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