Physician Disclosures in the Real World of Conflicting Interests

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physician Disclosures in the Real World of Conflicting Interests

Conditions
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Conflicts of Interest

Intervention / Treatment
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* Behavioral: Disclosure Letter-RISKS
* Behavioral: Disclosure Letter-BENEFITS
* Behavioral: Disclosure Letter-RISKS AND BENEFITS
* Behavioral: Disclosure Letter-NO RISKS OR BENEFITS
* Behavioral: Letter-APPOINTMENT REMINDER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cleveland Clinic patients who have an appointment scheduled with a physician who receives at least $20,000 per year from a drug and device company. Patient's primary language is English. Exclusion Criteria: Patients under 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Disclosure Letter-RISKS | Behavioral: Disclosure Letter-RISKS<br>* 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.<br>|
| Experimental: Arm 2<br>Disclosure Letter-BENEFITS | Behavioral: Disclosure Letter-BENEFITS<br>* 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.<br>|
| Experimental: Arm 3<br>Disclosure Letter-RISKS AND BENEFITS | Behavioral: Disclosure Letter-RISKS AND BENEFITS<br>* 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.<br>|
| Experimental: Arm 4<br>Disclosure Letter-NO RISKS OR BENEFITS | Behavioral: Disclosure Letter-NO RISKS OR BENEFITS<br>* 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.<br>|
| Placebo Comparator: Arm 5<br>Letter-APPOINTMENT REMINDER | Behavioral: Letter-APPOINTMENT REMINDER<br>* This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Trust in Physician | Self-reported trust in physicians, as assessed by standardized survey instrument. | Within approximately 1 month of intervention | 
| Patient Trust in Hospital | Self-reported trust in hospital, as assessed by standardized survey | Within approximately 1 month of intervention | 
| Accuracy of Patient Knowledge of their Physicians' Industry Relationships | Self-reported, assessed by survey questions. | Within approximately 1 month of intervention |