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

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ClinicalTrials.gov Identifier: NCT00678600
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : November 20, 2013
Sponsor:
Collaborators:
Harvard Medical School
Massachusetts General Hospital
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Standard (static) Computer Alerts Other: Enhanced Computer Alerts Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1011 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : September 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard (static) Computer Alerts
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
Static Computer Alerts on Patient's EMR webpage.
Experimental: Enhanced Computer 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 Computer Alerts
Population level and asynchronous alerts with enhanced functionality



Primary Outcome Measures :
  1. Change in CD4 count [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Time to repeat laboratory testing [ Time Frame: Throughout study ]
  2. Time to follow up appointment [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • Followed in the Massachusetts General Hospital HIV clinic.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678600


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard Medical School
Massachusetts General Hospital
Investigators
Principal Investigator: Gregory K Robbins, MD MPH Massachusetts General Hospital

Publications of Results:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00678600     History of Changes
Other Study ID Numbers: 1K01AI062435 ( U.S. NIH Grant/Contract )
K01AI062435 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases