Track topics on Twitter Track topics that are important to you
This study seeks to ascertain the best way to inform patients about their physicians' conflicts of interest (COI) with industry. Currently, there is no institutional or national standard for such physician-to-patient disclosures. The primary aim of this study is to test different written disclosures and assess their impact on patients' knowledge of their physicians' COIs and on patients' trust in their physician and their healthcare institution. The secondary aim is to investigate whether physician disclosures of significant financial industry relationships are desired by patients and whether disclosures impact patients' knowledge, perceptions, and behaviors. The tertiary aim is to investigate physicians' current practices of disclosure and perceptions about the risks, benefits, and feasibility of using patient disclosures to manage financial relationships, and to determine whether any physician fears are borne out in practice once disclosures are implemented.
This study uses a mixed-methods design. A randomized intervention (RCT) will be a mailed letter sent to approximately 1310 patients, disclosing their physicians' financial relationships with industry before patients meet with their physicians. There are 4 experimental conditions, systematically varying the wording of the COI disclosures, and one control condition. These patients will be briefly surveyed after they see their physicians, using standardized measures of trust and other questions. The goal is to achieve a 65% response rate (final n=850).
The sample size was determined based on a 0.3 unit change in Mayer Trust Scale adapted to refer to "physician" rather than "management" between the subgroups using the POWER procedure in SAS software version 9.3. In its original presentation, the Mayer Trust Scale lists a standard deviation for the 4-item trust score as 0.66 - 0.68. A sample size of 850 patients (170 in each of the 5 groups) would provide 82% power to detect a 0.3 unit difference in Mayer Trust Scale after Bonferroni correction for the 10 possible comparisons, assuming a standard deviation of 0.7 and that the significance level of 0.005 (0.05 / 10 comparisons) would be used in these analyses. In addition, this sample size would allow for multivariable regression models sufficient parameters to be fit following the suggested ratio of 10 patients for each predictor in the model.
Additionally, to supplement patient-derived RCT survey results, approximately 25 Cleveland Clinic physicians with industry relationships over $20,000 will be interviewed to gather their perspectives on COI disclosure. These interviews will occur before and after the RCT, and will collect qualitative and quantitative data. Qualitative data will be analyzed using content analysis, an iterative process of data immersion and data coding, whereby narrative data is categorized into discrete codes based on thematic content and then used to compute descriptive statistics.
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Disclosure of Physicians' Relationships With Drug and Device Companies
Disclosure of Physicians' Financial Industry Relationships
Active, not recruiting
The Cleveland Clinic
Published on BioPortfolio: 2016-06-08T16:23:22-0400
The goal of this research is to evaluate the relative advantage of remote counseling over usual care in community health practices without access to genetic services. We will evaluate abil...
The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipo...
A technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclos...
The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease. The study is desig...
This is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly impro...
Our objective was to determine specialist physicians' attitudes and practices regarding disclosure of pre-referral errors.
It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became app...
Insights into disclosure by PLWHA can inform strategies for treatment and support, yet Vietnamese women's self-disclosure patterns are poorly understood. We conducted interviews with 12 HIV-positive w...
In the USA and most European countries, cancer diagnoses are disclosed to patients. In China, however, the trend towards full disclosure has progressed slowly. The present study aimed to explore attit...
Although error disclosure is critical in promoting safety and patient-centered care, physicians are inconsistently trained in its practice, and few objective methods to assess competence exist. We use...
Includes relationships between hospitals, their governing boards, and administrators in regard to physicians, whether or not the physicians are members of the medical staff or have medical staff privileges.
Physicians employed in a company or corporate setting that is generally not in the health care industry.
Those physicians who have completed the education requirements specified by the American Academy of Family Physicians.
A willingness to reveal information about oneself to others.
The privacy of information and its protection against unauthorized disclosure.
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...