Physician-Patient Communication Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Derjung Tarn, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01530867
First received: January 2, 2012
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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
Dietary Supplements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physician-Patient Communication Project

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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


Enrollment: 456
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • English or Spanish-speaking
  • Aged 18 and older

Exclusion Criteria:

  • Does not speak English or Spanish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530867

Locations
United States, California
Center for East-West Medicine
Los Angeles, California, United States, 90404
LA Net Practice Based Research Network
Los Angeles, California, United States, 90808
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
Community-based provider offices
Los Angeles, California, United States
University of California, Los Angeles
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Derjung M Tarn, MD, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Derjung Tarn, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01530867     History of Changes
Other Study ID Numbers: R01 AT005883-02, R01AT005883-02
Study First Received: January 2, 2012
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Los Angeles:
Dietary Supplements
Physician-patient communication
Qualitative study
Audio recorded office visits

ClinicalTrials.gov processed this record on September 18, 2014