Patient Doctor TrustNCT02179632
Disclosure of Industry Payments to Physicians and the Patient-Doctor Relationship
A study testing Exposure to disclosure website in people with Patient Doctor Trust, run by Harvard Medical School (HMS and HSDM).
Trial summary
Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and the companies often pay large sums for consulting and advising services. Recipients of these payments and companies have stated that these financial relationships contribute to innovation in health care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Doctor Trust
- What is being tested?
- Exposure to disclosure website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2014
- 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
- Participants must be over 18 years of age, English-speaking, reside in Massachusetts, and have had an appointment with a physician within the last calendar year. These criteria will demonstrate a baseline level of interaction with the health care system. Our project uses data from health care professionals in Massachusetts, so we only wish to include people who live in Massachusetts.
Who cannot join
- Individuals under 18 years of age, non-English-speaking, who do not live in Massachusetts, and who have not had at least 1 appointment with a physician in the last calendar year.
About this study
Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and the companies often pay large sums for consulting and advising services. Recipients of these payments and companies have stated that these financial relationships contribute to innovation in health care. However, multiple studies have also found that such payments have the potential to bias prescribing and treatment behaviors, and thus may lead to increases in health care costs.
One way to address potential conflicts of interest in medicine is public disclosure. As part of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a national disclosure website that posts all payments from pharmaceutical, medical device, and biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10 must be reported, and they will be listed by category, such as speaking engagements, meals, travel, and consulting services.
The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final Regulations for the PPSA that the disclosure website "will permit patients to make better informed decisions when choosing health care professionals and making treatment decisions," but the ways in which patients will evaluate and interpret disclosure remain unclear. One prominent topic in the discussion of disclosure is patient trust in health care providers and how transparency will affect the patient-doctor relationship-and, consequently, how the new law may affect physicians and hospitals.
Read the detailed description
Patient trust is associated with improved self-care among patients with conditions from diabetes mellitus to HIV, and patient trust has also been found to correlate with medication adherence and continuity with physician. Therefore, an exploration of how large-scale public disclosure of payments will affect patient trust in doctors and the medical profession can help predict the effect of the policy on patient care.
Past studies of patient responses to disclosure present contradictory findings: some patients may refuse to see doctors who accept payments, while others may see the potential for conflicts of interest as only a small factor in the choice of physician. In one literature review, both patients and participants believed that disclosure would lead to increased confidence in their providers' decisions. Yet another study found that while disclosure does not have much impact on a person's willingness to participate in research, 59% of participants said that disclosure did not change their trust in the researcher or institution and 36% of participants indicated that their trust decreased. Moreover, in a role-playing experiment, patients who heard a disclosure statement said they would feel uncomfortable turning down a doctor's recommendations for fear of suggesting that the doctor was corrupt. However, none of these studies explicitly measured trust in a clinical relationship in the context of large-scale disclosure, which will be the setting for the PPSA website.
Defining Trust Both in the medical context and beyond, many definitions of trust have been proposed, and multiple measurement tools have been developed. Trust is generally thought of as "the willingness of a party to be vulnerable to the actions of another party based on the expectation that the other will perform a particular action important to the trustor, irrespective of the ability to monitor or control that other party." One of the most comprehensive conceptual models for trust in physicians and medical institutions is based on 5 dimensions: 1) fidelity, pursuing a patient's best interests; 2) competence, avoiding mistakes and producing the best results; 3) honesty, or telling the truth, 4) confidentiality, protection of private information, and 5) global trust, a holistic aspect.
There are multiple predictions for how disclosure will influence patient-provider relations when considering these dimensions. For example, the increased transparency about ties to industry could increase patient perceptions of honesty. Physicians who receive payments for consulting may be viewed as experts in their fields, and therefore may be seen as more competent. Alternatively, patients may question the fidelity of a doctor who receives payments, wondering if she has the patient's best interests as her priority. Thus, the implications for a national disclosure website on patient trust in physicians and the institution of medicine are unclear, despite CMS' claims that the PPSA will aid consumer decision-making. This project sets out to explore the effects of disclosure on patient trust in doctors and the medical profession.
- Conditions
- Patient Doctor Trust
- Being tested
- Exposure to disclosure website
- Keywords
- disclosure, conflicts of interest, trust, patient doctor relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to disclosure websiteBehavioural
Participants are exposed to a physician payment disclosure website.
| Study group | Role | What they receive |
|---|---|---|
| Disclosure intervention zero | Experimental | Treatment Group 1: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. A. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. A, according to manufacturer, in 2012. Dr. A will be a physician the researchers have chosen who does not appear on the website and therefore did not receive any payments in 2012. Participants should report $0/not listed as the response. Following this stage, participants will be told that Dr. A does not appear on the website and therefore did not receive any payments. Receives: Behavioral: Exposure to disclosure website |
| Disclosure intervention low | Experimental | Treatment Group 2: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. B. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. B, according to manufacturer, in 2012. Dr. B will be a physician the researchers have chosen who received an aggregate amount that is a "low payment" (below $100) in 2012. Participants should report the dollar amount listed as the response. Following this stage, participants will be told the exact dollar amount for payments received by Dr. B in 2012. Receives: Behavioral: Exposure to disclosure website |
| Disclosure intervention high | Experimental | Treatment Group 3: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. C. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. C, according to manufacturer, in 2012. Dr. C will be a physician the researchers have chosen who received an aggregate amount that is a "high payment" (above $250) in 2012. Participants should report the dollar amount listed as the response. Following this stage, participants will be told the exact dollar amount for payments received by Dr. C in 2012. Receives: Behavioral: Exposure to disclosure website |
| Control group | No intervention | Control Group: The control group will not be exposed to the disclosure website, but will participate in another online information-seeking task. These participants will visit the Farmer's Almanac website and be asked to search for temperature reports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trust-individual physician
This study will use the 10-item Wake Forest University Interpersonal Physician Trust Scale, rated on a 5-point Likert scale.
Measured: Immediately after tasks are completed, 1-hour total
Trust-medical profession
This study will use the 10-item Patient Trust in the Medical Profession Scale, rated on a 5-point Likert scale.
Measured: Immediately after tasks are completed, 1-hour total
Trust-industry
This study will an adapted 9-item Trust in Industry scale, rated on a 5-point Likert scale.
Measured: Immediately after tasks are completed, 1-hour total
Secondary outcomes (3)
Patient trust in own physician
Participants rate trust in own doctor on abbreviated 5-item interpersonal physician trust scale, rated on 5-point Likert scale.
Measured: Immediately after tasks are completed, 1-hour total
Willingness to see doctor for care
Participants rate willingness to see physician for care, given disclosed payments, on 5-point Likert scale.
Measured: Immediately after tasks are completed, 1-hour total
Change in trust score between rounds
Difference between trust scores for 1st doctor vs. second doctor.
Measured: Difference in scoring after 1st and 2nd round of tasks, 1 hour long total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Doctor TrustStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Hwong, Harvard Medical School (HMS and HSDM)
- Investigators
- Lisa S Lehmann, MD, PhD, Principal investigator, Harvard Medical School, Partners Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179632
- Sponsor's protocol ID
- IRB13-0727
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hwong AR, Sah S, Lehmann LS. The Effects of Public Disclosure of Industry Payments to Physicians on Patient Trust: A Randomized Experiment. J Gen Intern Med. 2017 Nov;32(11):1186-1192. doi: 10.1007/s11606-017-4122-y. Epub 2017 Jul 17.
PubMed 28717899
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosure of Industry Payments to Physicians and the Patient-Doctor Relationship
- ClinicalTrials.gov ID
- NCT02179632
- Acronym / sponsor ID
- IRB13-0727
- Conditions
- Patient Doctor Trust
- Keywords
- disclosure, conflicts of interest, trust, patient doctor relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Jul 2014 (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.
Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and the companies often pay large sums for consulting and advising services. Recipients of these payments and companies have stated that these financial relationships contribute to innovation in health care. However, multiple studies have also found that such payments have the potential to bias prescribing and treatment behaviors, and thus may lead to increases in health care costs.
One way to address potential conflicts of interest in medicine is public disclosure. As part of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a national disclosure website that posts all payments from pharmaceutical, medical device, and biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10 must be reported, and they will be listed by category, such as speaking engagements, meals, travel, and consulting services.
The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final Regulations for the PPSA that the disclosure website "will permit patients to make better informed decisions when choosing health care professionals and making treatment decisions," but the ways in which patients will evaluate and interpret disclosure remain unclear. One prominent topic in the discussion of disclosure is patient trust in health care providers and how transparency will affect the patient-doctor relationship-and, consequently, how the new law may affect physicians and hospitals.
Detailed description
Patient trust is associated with improved self-care among patients with conditions from diabetes mellitus to HIV, and patient trust has also been found to correlate with medication adherence and continuity with physician. Therefore, an exploration of how large-scale public disclosure of payments will affect patient trust in doctors and the medical profession can help predict the effect of the policy on patient care.
Past studies of patient responses to disclosure present contradictory findings: some patients may refuse to see doctors who accept payments, while others may see the potential for conflicts of interest as only a small factor in the choice of physician. In one literature review, both patients and participants believed that disclosure would lead to increased confidence in their providers' decisions. Yet another study found that while disclosure does not have much impact on a person's willingness to participate in research, 59% of participants said that disclosure did not change their trust in the researcher or institution and 36% of participants indicated that their trust decreased. Moreover, in a role-playing experiment, patients who heard a disclosure statement said they would feel uncomfortable turning down a doctor's recommendations for fear of suggesting that the doctor was corrupt. However, none of these studies explicitly measured trust in a clinical relationship in the context of large-scale disclosure, which will be the setting for the PPSA website.
Defining Trust Both in the medical context and beyond, many definitions of trust have been proposed, and multiple measurement tools have been developed. Trust is generally thought of as "the willingness of a party to be vulnerable to the actions of another party based on the expectation that the other will perform a particular action important to the trustor, irrespective of the ability to monitor or control that other party." One of the most comprehensive conceptual models for trust in physicians and medical institutions is based on 5 dimensions: 1) fidelity, pursuing a patient's best interests; 2) competence, avoiding mistakes and producing the best results; 3) honesty, or telling the truth, 4) confidentiality, protection of private information, and 5) global trust, a holistic aspect.
There are multiple predictions for how disclosure will influence patient-provider relations when considering these dimensions. For example, the increased transparency about ties to industry could increase patient perceptions of honesty. Physicians who receive payments for consulting may be viewed as experts in their fields, and therefore may be seen as more competent. Alternatively, patients may question the fidelity of a doctor who receives payments, wondering if she has the patient's best interests as her priority. Thus, the implications for a national disclosure website on patient trust in physicians and the institution of medicine are unclear, despite CMS' claims that the PPSA will aid consumer decision-making. This project sets out to explore the effects of disclosure on patient trust in doctors and the medical profession.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disclosure intervention zero | Experimental | Behavioral: Exposure to disclosure websiteTreatment Group 1: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. A. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. A, according to manufacturer, in 2012. Dr. A will be a physician the researchers have chosen who does not appear on the website and therefore did not receive any payments in 2012. Participants should report $0/not listed as the response. Following this stage, participants will be told that Dr. A does not appear on the website and therefore did not receive any payments. |
| Disclosure intervention low | Experimental | Behavioral: Exposure to disclosure websiteTreatment Group 2: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. B. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. B, according to manufacturer, in 2012. Dr. B will be a physician the researchers have chosen who received an aggregate amount that is a "low payment" (below $100) in 2012. Participants should report the dollar amount listed as the response. Following this stage, participants will be told the exact dollar amount for payments received by Dr. B in 2012. |
| Disclosure intervention high | Experimental | Behavioral: Exposure to disclosure websiteTreatment Group 3: This group will be directed to ProPublica's Dollars For Docs physician payment disclosure registry for State of Massachusetts, and be asked to search for Dr. C. Participants will be asked to complete a worksheet reporting the total dollar amount listed for Dr. C, according to manufacturer, in 2012. Dr. C will be a physician the researchers have chosen who received an aggregate amount that is a "high payment" (above $250) in 2012. Participants should report the dollar amount listed as the response. Following this stage, participants will be told the exact dollar amount for payments received by Dr. C in 2012. |
| Control group | No intervention | –Control Group: The control group will not be exposed to the disclosure website, but will participate in another online information-seeking task. These participants will visit the Farmer's Almanac website and be asked to search for temperature reports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be over 18 years of age, English-speaking, reside in Massachusetts, and have had an appointment with a physician within the last calendar year. These criteria will demonstrate a baseline level of interaction with the health care system. Our project uses data from health care professionals in Massachusetts, so we only wish to include people who live in Massachusetts.
Key exclusion criteria (1 listed)
- Individuals under 18 years of age, non-English-speaking, who do not live in Massachusetts, and who have not had at least 1 appointment with a physician in the last calendar year.
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 |
|---|---|---|
| Exposure to disclosure websiteParticipants are exposed to a physician payment disclosure website. | Behavioural | Disclosure intervention high, Disclosure intervention low, Disclosure intervention zero |
Primary outcome
Trust-individual physician
Time frame: Immediately after tasks are completed, 1-hour total
This study will use the 10-item Wake Forest University Interpersonal Physician Trust Scale, rated on a 5-point Likert scale.
Trust-medical profession
Time frame: Immediately after tasks are completed, 1-hour total
This study will use the 10-item Patient Trust in the Medical Profession Scale, rated on a 5-point Likert scale.
Trust-industry
Time frame: Immediately after tasks are completed, 1-hour total
This study will an adapted 9-item Trust in Industry scale, rated on a 5-point Likert scale.
3 secondary outcomes
Patient trust in own physician
Time frame: Immediately after tasks are completed, 1-hour total
Willingness to see doctor for care
Time frame: Immediately after tasks are completed, 1-hour total
Change in trust score between rounds
Time frame: Difference in scoring after 1st and 2nd round of tasks, 1 hour long total
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 2 Jul 2014.
- Derived from this study: PubMed 28717899Hwong AR, Sah S, Lehmann LS. The Effects of Public Disclosure of Industry Payments to Physicians on Patient Trust: A Randomized Experiment. J Gen Intern Med. 2017 Nov;32(11):1186-1192. doi: 10.1007/s11606-017-4122-y. Epub 2017 Jul 17.
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.
Lisa S Lehmann, MD, PhD principal investigator
Harvard Medical School, Partners Healthcare
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to disclosure website in people with Patient Doctor Trust, run by Harvard Medical School (HMS and HSDM).
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 1 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 2 Jul 2014. 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. 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?
Trust-individual physician (time frame: Immediately after tasks are completed, 1-hour total). 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 NCT02179632, which also lists 1 linked publication.
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 2 Jul 2014.