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Aspiring to Awesome- Patient Preference Privacy Selections in EMR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01862133
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : March 23, 2015
Last Update Posted : January 19, 2018
Department of Health and Human Services
Regenstrief Institute, Inc.
Information provided by (Responsible Party):
Indiana University

Brief 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.

Condition or disease Intervention/treatment
Sexually Transmitted Diseases Other: Patient preferences

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:

  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.

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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspiring to Awesome- Patient Preference Privacy Selections in EMR
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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.

  2. 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."

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01862133

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United States, Indiana
Wishard Health Services, Primary Care Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Department of Health and Human Services
Regenstrief Institute, Inc.
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Principal Investigator: William Tierney, MD Indiana University
Publications of Results:
Other Publications:
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Responsible Party: Indiana University Identifier: NCT01862133    
Other Study ID Numbers: CFDA# 93.719
First Posted: May 24, 2013    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: January 19, 2018
Last Verified: December 2017
Keywords provided by Indiana University:
Electronic Health Record
Health Information Technology
Patient Privacy
Personal Health Information
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases