Study of Provider Computer Alerts Designed to Improve Delivery of HIV Care - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Harvard University
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00678600

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

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Change in CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
Standard Care: Active Comparator 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
Enhanced Alerts: Experimental 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

Criteria

Inclusion Criteria:

HIV infected
Followed in the Massachusetts General Hospital HIV clinic.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 University

Investigators

Principal Investigator:

Gregory K Robbins, MD MPH

Massachusetts General Hospital, Harvard Medical School

More Information

Publications:

Safran C, Rind DM, Davis RB, Ives D, Sands DZ, Currier J, Slack WV, Makadon HJ, Cotton DJ. Guidelines for management of HIV infection with computer-based patient's record. Lancet. 1995 Aug 5;346(8971):341-6.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	1K01AI062435, 5K01AI062435-04
Study First Received:	May 13, 2008
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00678600
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009