Conflicts of InterestNCT02793115
Physician Disclosures in the Real World of Conflicting Interests
A study testing Disclosure Letter-RISKS, Disclosure Letter-BENEFITS and Disclosure Letter-RISKS AND BENEFITS in people with Conflicts of Interest, run by The Cleveland Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conflicts of Interest
- What is being tested?
- Disclosure Letter-RISKS, Disclosure Letter-BENEFITS and Disclosure Letter-RISKS AND BENEFITS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 895 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age.
About this study
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.
Read the 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
- Being tested
- Disclosure Letter-RISKS, Disclosure Letter-BENEFITS, Disclosure Letter-RISKS AND BENEFITS, Disclosure Letter-NO RISKS OR BENEFITS, Letter-APPOINTMENT REMINDER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure Letter-RISKSBehavioural
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.
Disclosure Letter-BENEFITSBehavioural
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.
Disclosure Letter-RISKS AND BENEFITSBehavioural
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.
Disclosure Letter-NO RISKS OR BENEFITSBehavioural
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.
Letter-APPOINTMENT REMINDERBehavioural
This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Disclosure Letter-RISKS Receives: Behavioral: Disclosure Letter-RISKS |
| Arm 2 | Experimental | Disclosure Letter-BENEFITS Receives: Behavioral: Disclosure Letter-BENEFITS |
| Arm 3 | Experimental | Disclosure Letter-RISKS AND BENEFITS Receives: Behavioral: Disclosure Letter-RISKS AND BENEFITS |
| Arm 4 | Experimental | Disclosure Letter-NO RISKS OR BENEFITS Receives: Behavioral: Disclosure Letter-NO RISKS OR BENEFITS |
| Arm 5 | Placebo comparator | Letter-APPOINTMENT REMINDER Receives: Behavioral: Letter-APPOINTMENT REMINDER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Trust in Physician
Self-reported trust in physicians, as assessed by standardized survey instrument.
Measured: Within approximately 1 month of intervention
Patient Trust in Hospital
Self-reported trust in hospital, as assessed by standardized survey
Measured: Within approximately 1 month of intervention
Accuracy of Patient Knowledge of their Physicians' Industry Relationships
Self-reported, assessed by survey questions.
Measured: Within approximately 1 month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conflicts of InterestStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 895 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susannah Rose, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793115
- Sponsor's protocol ID
- 14-1438
- Status last verified
- Jul 2016
- First submitted
- 3 Jun 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16484700Mayer RC, Davis JH, Schoorman FD. An integrative model of organizational trust. The Academy of Management Review 20(3): 709-734, 1995.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Disclosures in the Real World of Conflicting Interests
- ClinicalTrials.gov ID
- NCT02793115
- Acronym / sponsor ID
- 14-1438
- Conditions
- Conflicts of Interest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 895 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Disclosure Letter-RISKSDisclosure Letter-RISKS |
| Arm 2 | Experimental | Behavioral: Disclosure Letter-BENEFITSDisclosure Letter-BENEFITS |
| Arm 3 | Experimental | Behavioral: Disclosure Letter-RISKS AND BENEFITSDisclosure Letter-RISKS AND BENEFITS |
| Arm 4 | Experimental | Behavioral: Disclosure Letter-NO RISKS OR BENEFITSDisclosure Letter-NO RISKS OR BENEFITS |
| Arm 5 | Placebo comparator | Behavioral: Letter-APPOINTMENT REMINDERLetter-APPOINTMENT REMINDER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosure Letter-RISKSThis 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. | Behavioural | Arm 1 |
| Disclosure Letter-BENEFITSThis 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. | Behavioural | Arm 2 |
| Disclosure Letter-RISKS AND BENEFITSThis 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. | Behavioural | Arm 3 |
| Disclosure Letter-NO RISKS OR BENEFITSThis 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. | Behavioural | Arm 4 |
| Letter-APPOINTMENT REMINDERThis letter only includes a standard statement reminding the patient about the appointment and the location of the appointment. | Behavioural | Arm 5 |
Primary outcome
Patient Trust in Physician
Time frame: Within approximately 1 month of intervention
Self-reported trust in physicians, as assessed by standardized survey instrument.
Patient Trust in Hospital
Time frame: 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
Time frame: Within approximately 1 month of intervention
Self-reported, assessed by survey questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Background: PubMed 16484700Gordon 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.
- BackgroundMayer RC, Davis JH, Schoorman FD. An integrative model of organizational trust. The Academy of Management Review 20(3): 709-734, 1995.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure Letter-RISKS, Disclosure Letter-BENEFITS and Disclosure Letter-RISKS AND BENEFITS in people with Conflicts of Interest, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Trust in Physician (time frame: Within approximately 1 month of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.