Physician Disclosures in the Real World of Conflicting Interests
- Conditions
- Conflicts of Interest
- Interventions
- Behavioral: Disclosure Letter-BENEFITSBehavioral: Letter-APPOINTMENT REMINDERBehavioral: Disclosure Letter-RISKSBehavioral: Disclosure Letter-NO RISKS OR BENEFITSBehavioral: Disclosure Letter-RISKS AND BENEFITS
- Registration Number
- NCT02793115
- Lead Sponsor
- The Cleveland Clinic
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 895
- 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.
- Patients under 18 years of age.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 2 Disclosure Letter-BENEFITS Disclosure Letter-BENEFITS Arm 5 Letter-APPOINTMENT REMINDER Letter-APPOINTMENT REMINDER Arm 1 Disclosure Letter-RISKS Disclosure Letter-RISKS Arm 4 Disclosure Letter-NO RISKS OR BENEFITS Disclosure Letter-NO RISKS OR BENEFITS Arm 3 Disclosure Letter-RISKS AND BENEFITS Disclosure Letter-RISKS AND BENEFITS
- Primary Outcome Measures
Name Time Method Patient Trust in Hospital Within approximately 1 month of intervention Self-reported trust in hospital, as assessed by standardized survey
Accuracy of Patient Knowledge of their Physicians' Industry Relationships Within approximately 1 month of intervention Self-reported, assessed by survey questions.
Patient Trust in Physician Within approximately 1 month of intervention Self-reported trust in physicians, as assessed by standardized survey instrument.
- Secondary Outcome Measures
Name Time Method