Aspiring to Awesome- Patient Preference Privacy Selections in EMR

NCT01862133 | Completed Results

• 1 other identifier: CFDA# 93.719
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Diseases

Keywords

Electronic Health Record; Health Information Technology; Patient Privacy; Personal Health Information

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Interventions

Patient preferences OTHER

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 Care Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Department of Health and Human Services: collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Wishard Health Services, Primary Care Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

• 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.

  PMID: 25480723 BACKGROUND

• 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(Suppl 1):S3-6. doi: 10.1007/s11606-014-3062-z.

  PMID: 25480724 BACKGROUND

• 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(Suppl 1):S17-24. doi: 10.1007/s11606-014-3055-y.

  PMID: 25480722 RESULT

• 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(Suppl 1):S25-30. doi: 10.1007/s11606-014-3054-z.

  PMID: 25480721 RESULT

• 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(Suppl 1):S31-7. doi: 10.1007/s11606-014-3053-0.

  PMID: 25480720 RESULT

• 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(Suppl 1):S7-16. doi: 10.1007/s11606-014-3049-9.

  PMID: 25480719 RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We could not separate the anonymous post-study provider survey results and comments by provider type because the numbers within the physicians and nurses were sufficiently small that anonymity could have been lost.

Results Point of Contact

• Title: William M. Tierney, MD
• Organization: Regenstrief Institute

wtierney@regenstrief.org

(317) 274-9094

Study Officials

• William Tierney, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 24, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: January 19, 2018
• Results First Posted: March 23, 2015

Record last verified: 2017-12

Locations

US (1)