Trial Outcomes & Findings for Aspiring to Awesome- Patient Preference Privacy Selections in EMR (NCT NCT01862133)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

136 participants

Primary outcome timeframe

6 month study

Results posted on

2018-01-19

Participant Flow

107 primary care clinic patients were enrolled and signed informed consent statements. 2 failed to complete the patient preference dialog and study questionnaire.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	105	31
Overall Study Returned During 6 mo Study	92	31
Overall Study COMPLETED	105	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspiring to Awesome- Patient Preference Privacy Selections in EMR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Preferences n=105 Participants 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.
Age, Continuous	55 years STANDARD_DEVIATION 13 • n=93 Participants
Sex: Female, Male Female	73 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Region of Enrollment United States	105 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 month study

Population: All patients recorded their preferences and completed the questionnaire. 24 (77%) of the 31 providers completed the anonymous post-study questionnaire.

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.

Outcome measures

Outcome measures
Measure	Patient Preferences n=105 Participants 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 n=24 Participants 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 * 24
Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data	45 participants	13 participants

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome data not reported

Adverse Events

Patient Preferences

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Primary Care Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William M. Tierney, MD

Regenstrief Institute

Phone: (317) 274-9094

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place