Study of Provider Computer Alerts Designed to Improve Delivery of HIV Care

Study Overview
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Brief Summary
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The purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts.

Detailed Description
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This study will compare the effectiveness of standard and enhanced care alerts in HIV infected participants at Massachusetts General Hospital in Boston, Massachusetts. Participants will be a part of this study for 4 years or until they are no longer followed at Massachusetts General Hospital. Participants will be assigned randomly to one of two arms. Participants assigned to Arm 1 will receive standard care, involving standard provider alerts which will be posted on the participant's health record. Participants assigned to Arm 2 will receive enhanced care, involving improved functionality. Experimental informatics-based provider alerts and support systems will be used to develop a pilot system designed to optimize delivery of HIV clinical care. All participants will be monitored for new laboratory toxicities, suboptimal follow up, and virologic failure at their normally scheduled appointments.

Official Title
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Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Standard (static) Computer Alerts
* Other: Enhanced Computer Alerts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected Followed in the Massachusetts General Hospital HIV clinic. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard (static) Computer Alerts<br>Participants in this arm will be assigned to standard care. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Provider computer alerts will be posted on the participant's electronic health record summary page. | Other: Standard (static) Computer Alerts<br>* Static Computer Alerts on Patient's EMR webpage.<br>|
| Experimental: Enhanced Computer Alerts<br>Participants in this arm will be assigned to the enhanced alert arm. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Providers will receive population and asynchronous computer alerts with improved functionality. | Other: Enhanced Computer Alerts<br>* Population level and asynchronous alerts with enhanced functionality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 count |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to repeat laboratory testing |  | Throughout study | 
| Time to follow up appointment |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informatics, Alerts, Toxicity, Virologic failure, Suboptimal follow up