Physician-Patient Communication Project

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01530867
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 456
• Locations: 5
• Duration (Months): 18
• Patients Per Site: 91.2
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplements

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 456 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Physician-Patient Communication Project
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Outcome Measures

Primary Outcome Measures

1. patients disclosing dietary supplement use [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.]

   Number of patients who disclosed dietary supplement use during audio recorded office visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• English or Spanish-speaking

• Aged 18 and older

Exclusion Criteria:

• Does not speak English or Spanish

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente LAMC	Los Angeles	California	United States	90027
2	Center for East-West Medicine	Los Angeles	California	United States	90404
3	LA Net Practice Based Research Network	Los Angeles	California	United States	90808
4	Community-based provider offices	Los Angeles	California	United States
5	University of California, Los Angeles	Santa Monica	California	United States	90404

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Derjung M Tarn, MD, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Derjung Tarn, Assistant Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01530867
• Other Study ID Numbers: R01AT005883-02; R01AT005883-02
• First Posted: Feb 10, 2012
• Last Update Posted: Jun 6, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Derjung Tarn, Assistant Professor, University of California, Los Angeles: Dietary Supplements; Physician-patient communication; Qualitative study; Audio recorded office visits

Study Results

No Results Posted as of Jun 6, 2013