NCT02793115

Physician Disclosures in the Real World of Conflicting Interests

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 895 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Conflicts of Interest

Interventions

Type	Name	Description
BEHAVIORAL	Disclosure Letter-RISKS	This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential RISKS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
BEHAVIORAL	Disclosure Letter-BENEFITS	This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential BENEFITS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
BEHAVIORAL	Disclosure Letter-RISKS AND BENEFITS	This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential RISKS AND BENEFITS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
BEHAVIORAL	Disclosure Letter-NO RISKS OR BENEFITS	This letter includes a standard statement reminding the patient about the appointment and the location of the appointment.and DOES NOT provide any information on the physicians' financial relationships with industry nor information regarding the potential risks and benefits of physicians' conflicts of interest with for-profit industry.
BEHAVIORAL	Letter-APPOINTMENT REMINDER	This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-06-08
• Last updated: 2016-07-28