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Aspiring to Awesome- Patient Preference Privacy Selections in EMR

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862133
First Posted: May 24, 2013
Last Update Posted: April 30, 2015
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.
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Indiana University
Results First Submitted: March 12, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Sexually Transmitted Diseases
Intervention: Other: Patient preferences

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study

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.

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.

  • 11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study
  • 2 physicians were excluded because their patients were mainly Spanish speaking
  • 1 physician verbally agreed to be in the study but never signed the informed consent statement
  • 8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study

Participant Flow:   Overall Study
    Patient Preferences   Primary Care Providers
STARTED   105   31 
Returned During 6 mo Study   92   31 
COMPLETED   105 [1]   31 
NOT COMPLETED   0   0 
[1] All 105 patients recorded preferences; 92 (88%) returned to the study clinic during the 6 mo. study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data collected from enrolled patients was limited to gender, race/ethnicity, age, and whether they had highly sensitive information (as defined in Methods) in their electronic health records. This information was obtained from patients' electronic medical records only.

Reporting Groups
  Description
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.

Baseline Measures
   Patient Preferences 
Overall Participants Analyzed 
[Units: Participants]
 105 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (13) 
Gender 
[Units: Participants]
 
Female   73 
Male   32 
Region of Enrollment 
[Units: Participants]
 
United States   105 


  Outcome Measures

1.  Primary:   Number of Patients Recording Preferences to Restrict Provider Access to Some or All EHR Data   [ Time Frame: 6 month study ]

2.  Primary:   Providers' Opinion of Patients' Controlling EHR Access   [ Time Frame: 6 month study ]
Results not yet reported.   Anticipated Reporting Date:   03/2015  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William M. Tierney, MD
Organization: Regenstrief Institute
phone: (317) 274-9094
e-mail: wtierney@regenstrief.org


Publications of Results:
Other Publications:

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01862133     History of Changes
Other Study ID Numbers: CFDA# 93.719
First Submitted: May 15, 2013
First Posted: May 24, 2013
Results First Submitted: March 12, 2015
Results First Posted: March 23, 2015
Last Update Posted: April 30, 2015