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

NCT ID: NCT00678600

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1011 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Informatics Alerts Toxicity Virologic failure Suboptimal follow up

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Standard (static) Computer Alerts

Intervention Type OTHER

Static Computer Alerts on Patient's EMR webpage.

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.

Group Type EXPERIMENTAL

Enhanced Computer Alerts

Intervention Type OTHER

Population level and asynchronous alerts with enhanced functionality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard (static) Computer Alerts

Static Computer Alerts on Patient's EMR webpage.

Intervention Type OTHER

Enhanced Computer Alerts

Population level and asynchronous alerts with enhanced functionality

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV infected
* Followed in the Massachusetts General Hospital HIV clinic.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory K Robbins, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23208165 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K01AI062435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K01AI062435

Identifier Type: NIH

Identifier Source: org_study_id

View Link