Aspiring to Awesome- Patient Preference Privacy Selections in EMR

Sexually Transmitted Diseases Clinical Trial

Official title:

Aspiring to Awesome- Patient Preference Privacy Selections in EMR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862133
• Other study ID #: CFDA# 93.719
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: December 20, 2017
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. 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.

2. 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.

3. 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) .

4. 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.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• will be lack of English fluency and inability to communicate due to physiologic or cognitive difficulties.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

Other:
• Patient preferences
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.

Locations

Country	Name	City	State
United States	Wishard Health Services, Primary Care Center	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Department of Health and Human Services, Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

Caine 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:S7-16. doi: 10.1007/s11606-014-3049 — View Citation

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:S38-41. doi: 10.1007/s11606-014-3061-0. — View Citation

Leventhal 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:S17-24. doi: 10. — View Citation

Meslin 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:S3-6. doi: 10.1007/s11606-014-3062-z. — View Citation

Schwartz 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:S25-30. doi: 10.1007/s11606 — View Citation

Tierney 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:S31-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month study
Primary	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."	6 month study