Sexually Transmitted DiseasesNCT01862133
Aspiring to Awesome- Patient Preference Privacy Selections in EMR
An observational study of Sexually Transmitted Diseases, run by Indiana University at 1 site in United States.
Trial summary
Health information technology, including health information exchange, offers the potential to improve care by providing an integrated view of relevant, integrated patient information from multiple health care providers practicing in multiple sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Patient preferences
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Primary Care Clinic
Who may be able to join
- For Patients:
- all adults 18 years or older who were fluent in English and had visited the study primary care clinic at least twice in the previous year
- For Providers:
- all personnel of all types practicing in General Medicine Clinic, both Firms A and B, on the 4th floor of Wishard's Primary Care Center. For those physicians who agree to participate, attempted to recruit 10 patients who had visited their primary care physician at least twice in the previous 1 year.
Who cannot join
- will be lack of English fluency and inability to communicate due to physiologic or cognitive difficulties.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard Health Services, Primary Care Center
Indianapolis, Indiana, 46202
About this study
Health information technology, including health information exchange, offers the potential to improve care by providing an integrated view of relevant, integrated patient information from multiple health care providers practicing in multiple sites. However, realizing that potential can be difficult, particularly with respect sensitive information. Increasingly, patients, patient advocate groups, and even the National Coordinator for Health Information Technology are pushing for patients to have more granular control over specifically who can see what personal health information in their electronic health records.
This will be a demonstration project aimed at showing the initial feasibility a system allowing patient controls on their electronic health records. Because of the exploratory nature of the research, the investigators do not have specific hypotheses. The investigators hope that this demonstration and feasibility project will lead to more extensive prospective evaluations of patient control of access to their health records and other tools for enhancing patient control over access to their health records.
Read the detailed description
In 2010, ONC launched a Challenge Grant program that called for proposals for "enabling enhanced query for patient care." Under this program, the Regenstrief Institute and Indiana University developed a Web-based program for patients' to express their preferences for who can access data in their electronic health records (EHR). It then applied these preferences by modifying an existing EHR viewer called Careweb® that is used by the Indiana Network for Patient Care and Eskenazi Health, an urban public health system in Indianapolis.
This study:
- Produced a bioethical report on "points to consider" to inform electronic health record designers concerning giving patients granular control over access to their health data.
- Interviewed patients to assess their desires for granular level of control over which personal health information should be shared, with whom, and for what purpose, and whether those preferences vary depending on the sensitivity of patients' health information.
- Developed a Web-based patient-centered user interface that allows them to choose whether to provide or restrict access to their health information, focusing on who (health care providers and non-providers), what information (all, none, sensitive information only), and when (periods of time in their lives during which they desire restricting access to their health information) .
- Reprogrammed the user interface of Careweb®, a data viewing system used by clinicians in Eskenazi Health, the third largest safety net health system in the U.S., and the Indiana Network for Patient Care, the oldest, largest, and most comprehensive health information exchange in the country. The reprogrammed viewer interface allows patients' preferences to control who sees what information in a patient's electronic health record.
- Performed a demonstration study among 32 health care providers (9 physicians and 23 clinical staff) and 105 patients in an inner city primary care practice where patients recorded their preferences concerning who could access what information in their electronic health records, and then implemented those preferences during a 6-month real-world study in Eskenazi Health.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Patient preferences
- Keywords
- Electronic Health Record, Health Information Technology, Patient Privacy, Personal Health Information
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient preferencesOther
Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.
| Study group | Role | What they receive |
|---|---|---|
| Patient Preferences | Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays. | |
| Primary Care Providers | All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data. Receives: Other: Patient preferences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data
Patients had to restrict access to either all data or one of five categories of "sensitive" data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers.
Measured: 6 month study
Providers' Opinion of Patients' Controlling EHR Access
Percent of providers answering "Strongly Agree" or "Agree" to the following question on the post-study survey: "I think it is OK for patients to have control over who sees what information in their electronic health records."
Measured: 6 month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Regenstrief Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- William Tierney, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862133
- Sponsor's protocol ID
- CFDA# 93.719
- Status last verified
- Dec 2017
- First submitted
- 15 May 2013
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Caine K, Tierney WM. Point and counterpoint: patient control of access to data in their electronic health records. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S38-41. doi: 10.1007/s11606-014-3061-0.
PubMed 25480723Meslin EM, Schwartz PH. How bioethics principles can aid design of electronic health records to accommodate patient granular control. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S3-6. doi: 10.1007/s11606-014-3062-z.
PubMed 25480724Leventhal JC, Cummins JA, Schwartz PH, Martin DK, Tierney WM. Designing a system for patients controlling providers' access to their electronic health records: organizational and technical challenges. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s11606-014-3055-y.
PubMed 25480722Schwartz PH, Caine K, Alpert SA, Meslin EM, Carroll AE, Tierney WM. Patient preferences in controlling access to their electronic health records: a prospective cohort study in primary care. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S25-30. doi: 10.1007/s11606-014-3054-z.
PubMed 25480721Tierney WM, Alpert SA, Byrket A, Caine K, Leventhal JC, Meslin EM, Schwartz PH. Provider responses to patients controlling access to their electronic health records: a prospective cohort study in primary care. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S31-7. doi: 10.1007/s11606-014-3053-0.
PubMed 25480720Caine K, Kohn S, Lawrence C, Hanania R, Meslin EM, Tierney WM. Designing a patient-centered user interface for access decisions about EHR data: implications from patient interviews. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S7-16. doi: 10.1007/s11606-014-3049-9.
PubMed 25480719
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiring to Awesome- Patient Preference Privacy Selections in EMR
- ClinicalTrials.gov ID
- NCT01862133
- Acronym / sponsor ID
- CFDA# 93.719
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Electronic Health Record, Health Information Technology, Patient Privacy, Personal Health Information
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Regenstrief Institute, Inc.
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health information technology, including health information exchange, offers the potential to improve care by providing an integrated view of relevant, integrated patient information from multiple health care providers practicing in multiple sites. However, realizing that potential can be difficult, particularly with respect sensitive information. Increasingly, patients, patient advocate groups, and even the National Coordinator for Health Information Technology are pushing for patients to have more granular control over specifically who can see what personal health information in their electronic health records.
This will be a demonstration project aimed at showing the initial feasibility a system allowing patient controls on their electronic health records. Because of the exploratory nature of the research, the investigators do not have specific hypotheses. The investigators hope that this demonstration and feasibility project will lead to more extensive prospective evaluations of patient control of access to their health records and other tools for enhancing patient control over access to their health records.
Detailed description
In 2010, ONC launched a Challenge Grant program that called for proposals for "enabling enhanced query for patient care." Under this program, the Regenstrief Institute and Indiana University developed a Web-based program for patients' to express their preferences for who can access data in their electronic health records (EHR). It then applied these preferences by modifying an existing EHR viewer called Careweb® that is used by the Indiana Network for Patient Care and Eskenazi Health, an urban public health system in Indianapolis.
This study:
- Produced a bioethical report on "points to consider" to inform electronic health record designers concerning giving patients granular control over access to their health data.
- Interviewed patients to assess their desires for granular level of control over which personal health information should be shared, with whom, and for what purpose, and whether those preferences vary depending on the sensitivity of patients' health information.
- Developed a Web-based patient-centered user interface that allows them to choose whether to provide or restrict access to their health information, focusing on who (health care providers and non-providers), what information (all, none, sensitive information only), and when (periods of time in their lives during which they desire restricting access to their health information) .
- Reprogrammed the user interface of Careweb®, a data viewing system used by clinicians in Eskenazi Health, the third largest safety net health system in the U.S., and the Indiana Network for Patient Care, the oldest, largest, and most comprehensive health information exchange in the country. The reprogrammed viewer interface allows patients' preferences to control who sees what information in a patient's electronic health record.
- Performed a demonstration study among 32 health care providers (9 physicians and 23 clinical staff) and 105 patients in an inner city primary care practice where patients recorded their preferences concerning who could access what information in their electronic health records, and then implemented those preferences during a 6-month real-world study in Eskenazi Health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Preferences | – | –Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays. |
| Primary Care Providers | – | Other: Patient preferencesAll healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (4 listed)
- all adults 18 years or older who were fluent in English and had visited the study primary care clinic at least twice in the previous year
- all personnel of all types practicing in General Medicine Clinic, both Firms A and B, on the 4th floor of Wishard's Primary Care Center. For those physicians who agree to participate, attempted to recruit 10 patients who had visited their primary care physician at least twice in the previous 1 year.
Key exclusion criteria (1 listed)
- will be lack of English fluency and inability to communicate due to physiologic or cognitive difficulties.
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 |
|---|---|---|
| Patient preferencesSoftware for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences. | Other | Primary Care Providers |
Primary outcome
Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data
Time frame: 6 month study
Patients had to restrict access to either all data or one of five categories of "sensitive" data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers.
Providers' Opinion of Patients' Controlling EHR Access
Time frame: 6 month study
Percent of providers answering "Strongly Agree" or "Agree" to the following question on the post-study survey: "I think it is OK for patients to have control over who sees what information in their electronic health records."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25480723Caine K, Tierney WM. Point and counterpoint: patient control of access to data in their electronic health records. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S38-41. doi: 10.1007/s11606-014-3061-0.
- Background: PubMed 25480724Meslin EM, Schwartz PH. How bioethics principles can aid design of electronic health records to accommodate patient granular control. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S3-6. doi: 10.1007/s11606-014-3062-z.
- Results publication: PubMed 25480722Leventhal JC, Cummins JA, Schwartz PH, Martin DK, Tierney WM. Designing a system for patients controlling providers' access to their electronic health records: organizational and technical challenges. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s11606-014-3055-y.
- Results publication: PubMed 25480721Schwartz PH, Caine K, Alpert SA, Meslin EM, Carroll AE, Tierney WM. Patient preferences in controlling access to their electronic health records: a prospective cohort study in primary care. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S25-30. doi: 10.1007/s11606-014-3054-z.
- Results publication: PubMed 25480720Tierney WM, Alpert SA, Byrket A, Caine K, Leventhal JC, Meslin EM, Schwartz PH. Provider responses to patients controlling access to their electronic health records: a prospective cohort study in primary care. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S31-7. doi: 10.1007/s11606-014-3053-0.
- Results publication: PubMed 25480719Caine K, Kohn S, Lawrence C, Hanania R, Meslin EM, Tierney WM. Designing a patient-centered user interface for access decisions about EHR data: implications from patient interviews. J Gen Intern Med. 2015 Jan;30 Suppl 1(Suppl 1):S7-16. doi: 10.1007/s11606-014-3049-9.
Related trials for Sexually Transmitted Diseases
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
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.
William Tierney, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, run by Indiana University at 1 site in United States.
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 4 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data (time frame: 6 month study). The study lists 2 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 NCT01862133, which also lists 6 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 19 Jan 2018.