Physician Disclosures in the Real World of Conflicting Interests

NCT ID: NCT02793115

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 895 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Conflicts of Interest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1

Disclosure Letter-RISKS

Group Type: EXPERIMENTAL

Disclosure Letter-RISKS

Intervention Type: BEHAVIORAL

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.

Arm 2

Disclosure Letter-BENEFITS

Group Type: EXPERIMENTAL

Disclosure Letter-BENEFITS

Intervention Type: BEHAVIORAL

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.

Arm 3

Disclosure Letter-RISKS AND BENEFITS

Group Type: EXPERIMENTAL

Disclosure Letter-RISKS AND BENEFITS

Intervention Type: BEHAVIORAL

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.

Arm 4

Disclosure Letter-NO RISKS OR BENEFITS

Group Type: EXPERIMENTAL

Disclosure Letter-NO RISKS OR BENEFITS

Intervention Type: BEHAVIORAL

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.

Arm 5

Letter-APPOINTMENT REMINDER

Group Type: PLACEBO_COMPARATOR

Letter-APPOINTMENT REMINDER

Intervention Type: BEHAVIORAL

This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Letter-APPOINTMENT REMINDER

This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Susannah Rose

Associate Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Gordon HS, Street RL Jr, Sharf BF, Kelly PA, Souchek J. Racial differences in trust and lung cancer patients' perceptions of physician communication. J Clin Oncol. 2006 Feb 20;24(6):904-9. doi: 10.1200/JCO.2005.03.1955.

Reference Type: BACKGROUND

PMID: 16484700 (View on PubMed)

Mayer RC, Davis JH, Schoorman FD. An integrative model of organizational trust. The Academy of Management Review 20(3): 709-734, 1995.

Reference Type: BACKGROUND

Other Identifiers

14-1438

Identifier Type: -

Identifier Source: org_study_id