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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678600
• Other study ID #: 1K01AI062435
• Secondary ID: K01AI062435
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: November 19, 2013
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infected

• Followed in the Massachusetts General Hospital HIV clinic.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Standard (static) Computer Alerts
Static Computer Alerts on Patient's EMR webpage.
• Enhanced Computer Alerts
Population level and asynchronous alerts with enhanced functionality

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Harvard Medical School, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Robbins GK, Lester W, Johnson KL, Chang Y, Estey G, Surrao D, Zachary K, Lammert SM, Chueh HC, Meigs JB, Freedberg KA. Efficacy of a clinical decision-support system in an HIV practice: a randomized trial. Ann Intern Med. 2012 Dec 4;157(11):757-66. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4 count		Throughout study	No
Secondary	Time to repeat laboratory testing		Throughout study	No
Secondary	Time to follow up appointment		Throughout study	No