Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
NCT ID: NCT01201941
Last Updated: 2017-10-25
Study Results
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.
COMPLETED
1849 participants
OBSERVATIONAL
2004-11-30
2009-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
An information system could be used to virtually eliminate part of this delay: the time to communicate results between the different institutions. In 2001 we developed and deployed a web based medical record system, the PIH-EMR, to assist in the clinical management of these MDR-TB patients. This system includes a substantial set of data entry and analysis tools for laboratory results including sputum smears, cultures and DSTs. Over the last six months the PIH-EMR has been modified to support the decentralization of DSTs in the regional laboratories. This 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.
The NTP and the National Reference Laboratory (NRL) have agreed to integrate e-Chasqui into the current management of patients at risk of MDR-TB in two regions, and if effective, to provide a national network of all laboratories performing DST. Because of the intensive initial demands on resources and training, the implementation of the information system will occur in stages (parts A and B of this study).
Broadly put, this study will provide data on whether the use of information systems can be shown to improve quality of patient care. More specifically, it will assess the impact of e-Chasqui on reducing reporting delays and laboratory data errors, and improving patient outcomes.
This is a prospective observational controlled study to compare the effects of a web-based laboratory information system (e-Chasqui) between a network of health establishments with e-Chasqui access (intervention group) compared with a network of health establishments without e-Chasqui access (control group). The data is being collected by the overarching study "Operational Assessment of Diagnostic Methods for MDR-TB in Lima, Peru."
The study is planned in two parts: Part A will be a simultaneous control study occurring in the "transition" period comparing endpoints in those health establishments with e-Chasqui access to those in matched health establishments without e-Chasqui access. Part B will be an historical control study comparing endpoints in the establishments which gain initial e-Chasqui access, before (historical control) and after (intervention) the implementation. Data sources include: patient charts, interview with health providers to confirm or clarify accuracy of data in patient charts, microbiology registries at local, regional and national laboratories, and the information system database. The total number of subjects to be enrolled study-wide is 1849.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
During the first part of the study, the intervention group will not have access to the e-Chasqui system.
During the second part of the study, the intervention group will have access to the e-Chasqui system.
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.
Simultaneous/historical control group
During the first part of the study, the intervention group will not have access to the e-Chasqui system.
During the second part of the study, the intervention group will not have access to the e-Chasqui system.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MIT William Asbjornsen Albert Memorial Fellowship
UNKNOWN
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Bill and Melinda Gates Foundation
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sonya Sunhi Shin
Associate Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sonya S Shin, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Socios En Salud
Lima, , Peru
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Blaya JA, Shin SS, Yagui M, Contreras C, Cegielski P, Yale G, Suarez C, Asencios L, Bayona J, Kim J, Fraser HS. Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial. PLoS One. 2014 Apr 10;9(4):e90110. doi: 10.1371/journal.pone.0090110. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-P-002606/2
Identifier Type: -
Identifier Source: org_study_id