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Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru

NCT01201941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1849

Last updated 2017-10-25

No results posted yet for this study

Summary

The objective of this study is to compare the effects of a web-based laboratory information system (e-Chasqui) between a network of health establishments with access to e-Chasqui (intervention group) and a network of health establishments without access to e-Chasqui (control group).

The specific aims are:

1. To compare the "laboratory turn-around-time" (from the date a culture or drug susceptibility test (DST) result is obtained to the date the result is obtained at the health center) of samples pertaining to health establishments in the intervention versus the control group.
2. To compare the "clinical turn-around-time" (from the date the DST result is obtained to the date the patient is evaluated by a physician in possession of that result) among multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments in the intervention versus control group.
3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST results) between health establishments in the intervention versus control group.
4. To qualitatively assess the acceptability and usability of e-Chasqui among users in health establishments with access to the system.

The investigators aim to test the following hypotheses:

1. The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access.
2. The clinical turn-around-time for patients pertaining to health establishments with e-Chasqui access will be smaller than that for patients in establishments without e-Chasqui access.
3. Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access.
4. Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.

Conditions

  • Tuberculosis, Multidrug-Resistant

Interventions

OTHER

e-Chasqui

The laboratory component of the PIH-EMR, termed "e-Chasqui," permits web-based entry of culture and DST results at all regional and central laboratories performing these tests. In addition, the system includes applications to assess quality control, generate aggregate reports, notify health centers of new results or contaminated samples, and track enrolled patients and the status of pending laboratory tests.

Sponsors & Collaborators

  • MIT William Asbjornsen Albert Memorial Fellowship

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Sonya S Shin, MD · Brigham and Women's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201941 on ClinicalTrials.gov