Study of Provider Computer Alerts Designed to Improve Delivery of HIV Care
Recruitment status was Not yet recruiting
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Purpose
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 management than current methods.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Other: Provider Computer Alerts Other: Enhanced Provider Computer Alerts |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts |
- Change in CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Time to repeat laboratory testing [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Time to follow up appointment [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard Care
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 particpant's electronic health record summary page.
|
Other: Provider Computer Alerts
Standard provider computer alerts
|
|
Experimental: Enhanced Alerts
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 Provider Computer Alerts
Population level and asynchronous alerts with enhanced functionality
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected
- Followed in the Massachusetts General Hospital HIV clinic.
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Gregory K Robbins, MD MPH | Massachusetts General Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rona Siskind, DAIDS |
| ClinicalTrials.gov Identifier: | NCT00678600 History of Changes |
| Other Study ID Numbers: | 1K01AI062435, 5K01AI062435-04 |
| Study First Received: | May 13, 2008 |
| Last Updated: | May 13, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Informatics Alerts Toxicity Virologic failure Suboptimal follow up |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013