Physician-Patient Communication Project

Dietary Supplements Clinical Trial

Official title:

Physician-Patient Communication Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530867
• Other study ID #: R01AT005883-02
• Secondary ID: R01AT005883-02
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: June 5, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

Sixty one 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English or Spanish-speaking

• Aged 18 and older

Exclusion Criteria:

• Does not speak English or Spanish

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dietary Supplements

Locations

Country	Name	City	State
United States	Center for East-West Medicine	Los Angeles	California
United States	Community-based provider offices	Los Angeles	California
United States	Kaiser Permanente LAMC	Los Angeles	California
United States	LA Net Practice Based Research Network	Los Angeles	California
United States	University of California, Los Angeles	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients disclosing dietary supplement use	Number of patients who disclosed dietary supplement use during audio recorded office visit	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.	No