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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Harvard University

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00678600

First received: May 13, 2008

Last updated: NA

Last verified: May 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 13, 2008

Last Updated Date

May 13, 2008

Start Date ^ICMJE

Not Provided

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 management than current methods.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Other: Provider Computer Alerts
Standard provider computer alerts
Other: Enhanced Provider Computer Alerts
Population level and asynchronous alerts with enhanced functionality

Study Arm (s)

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.

Intervention: Other: 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.

Intervention: Other: Enhanced Provider Computer Alerts

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV infected
Followed in the Massachusetts General Hospital HIV clinic.

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00678600

Other Study ID Numbers ^ICMJE

1K01AI062435, 5K01AI062435-04

Has Data Monitoring Committee

Responsible Party

Rona Siskind, DAIDS

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Harvard University

Investigators ^ICMJE

Principal Investigator:

Gregory K Robbins, MD MPH

Massachusetts General Hospital

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top