Dietary SupplementsNCT01530867
Physician-Patient Communication Project
An observational study of Dietary Supplements, run by University of California, Los Angeles at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Supplements
- How many people
- 456 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care physicians Integrative medicine / complementary and alternative medicine physicians Patients aged 18 and older of physicians participating in the study
Who may be able to join
- English or Spanish-speaking
- Aged 18 and older
Who cannot join
- Does not speak English or Spanish
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kaiser Permanente LAMC
Los Angeles, California, 90027
Center for East-West Medicine
Los Angeles, California, 90404
LA Net Practice Based Research Network
Los Angeles, California, 90808
Community-based provider offices
Los Angeles, California
University of California, Los Angeles
Santa Monica, California, 90404
About this study
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.
Read the 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.
- Conditions
- Dietary Supplements
- Keywords
- Dietary Supplements, Physician-patient communication, Qualitative study, Audio recorded office visits
What is being measured
The primary outcome is the main question the study is designed to answer.
patients disclosing dietary supplement use
Number of patients who disclosed dietary supplement use during audio recorded office visit
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Derjung Tarn, University of California, Los Angeles
- Investigators
- Derjung M Tarn, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530867
- Sponsor's protocol ID
- R01AT005883-02
- Other IDs
- R01AT005883-02
- Status last verified
- Jun 2013
- First submitted
- 2 Jan 2012
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Patient Communication Project
- ClinicalTrials.gov ID
- NCT01530867
- Acronym / sponsor ID
- R01AT005883-02
- Conditions
- Dietary Supplements
- Keywords
- Dietary Supplements, Physician-patient communication, Qualitative study, Audio recorded office visits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care physicians Integrative medicine / complementary and alternative medicine physicians Patients aged 18 and older of physicians participating in the study
Key inclusion criteria (2 listed)
- English or Spanish-speaking
- Aged 18 and older
Key exclusion criteria (1 listed)
- Does not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Number of patients who disclosed dietary supplement use during audio recorded office visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derjung M Tarn, MD, PhD principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Supplements, run by University of California, Los Angeles at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013.