search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard (static) Computer Alerts
Enhanced Computer Alerts
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring Informatics, Alerts, Toxicity, Virologic failure, Suboptimal follow up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard (static) Computer Alerts

Enhanced Computer Alerts

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in CD4 count

Secondary Outcome Measures

Time to repeat laboratory testing
Time to follow up appointment

Full Information

First Posted
May 13, 2008
Last Updated
November 19, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Harvard Medical School (HMS and HSDM), Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00678600
Brief Title
Study of Provider Computer Alerts Designed to Improve Delivery of HIV 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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Harvard Medical School (HMS and HSDM), Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Informatics, Alerts, Toxicity, Virologic failure, Suboptimal follow up

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard (static) Computer Alerts
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced Computer Alerts
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Standard (static) Computer Alerts
Intervention Description
Static Computer Alerts on Patient's EMR webpage.
Intervention Type
Other
Intervention Name(s)
Enhanced Computer Alerts
Intervention Description
Population level and asynchronous alerts with enhanced functionality
Primary Outcome Measure Information:
Title
Change in CD4 count
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Time to repeat laboratory testing
Time Frame
Throughout study
Title
Time to follow up appointment
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infected Followed in the Massachusetts General Hospital HIV clinic. Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory K Robbins, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23208165
Citation
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: 10.7326/0003-4819-157-11-201212040-00003.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs