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

This study has been completed.
Sponsor:
Collaborators:
MIT William Asbjornsen Albert Memorial Fellowship
Bill and Melinda Gates Foundation
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01201941
First received: September 9, 2010
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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.

Condition Intervention
Tuberculosis, Multidrug-Resistant
Other: e-Chasqui

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Median "Laboratory turn-around-time" (TAT) [ Time Frame: Days from the date a culture or drug susceptibility test (DST) result is obtained to the date when the result is obtained at health center ] [ Designated as safety issue: No ]
  • Percent laboratory errors, by type of error for health establishments in the intervention versus the control group. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DST lab Turn Around Time greater than 60 days [ Time Frame: 60 days after multi-drug resistant tuberculosis drug susceptibility result ] [ Designated as safety issue: No ]
    The proportion of DST results with a laboratory TAT greater than or equal to 60 days

  • Culture conversion Turn Around Time [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Number of days between the result date of the first DST resistant to INH, RIF, or both and the sample date of the first of two negative consecutive cultures taken at least 30 days apart

  • Approximate cost of the intervention as a whole and per patient [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Qualitative assessment of the acceptability and usability of e-Chasqui among users in health establishments with access with to the system. [ Time Frame: at end of study, 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 1849
Study Start Date: November 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
Other Name: e-Chasqui
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.


Detailed Description:

Delays in starting patients with multi-drug resistant tuberculosis (MDR-TB) on appropriate medication treatment lead to worsened patient outcomes and increased risk of transmission. In Peru, the National Tuberculosis Program (NTP) has provided treatment for patients with MDR-TB since 1996, with cure rates ranging from 48% to 83%. Nonetheless, significant delays exist in the diagnosis of MDR cases and timely treatment initiation, in particular since MDR-TB treatment has been scaled to a national level. Our preliminary work has found that the average turn-around-time (TAT) from the request of a DST to the prescription of appropriate treatment was 148 days (4.9 months).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes those individuals with pulmonary TB who have a risk factor for MDR-TB in the region of Lima Ciudad.

Risk factors:

  • Confirmed mdr-tb by previous dst
  • Failure, default or relapse from a treatment containing 2nd line drugs
  • Patient who will initiate treatment with 2nd line drugs
  • Patient who has received at least 30 days of any second-line drug
  • Contact with confirmed mdr-tb, contact in treatment for mdr-tb, or contact who has previously been treated with 2nd line drugs
Criteria

Inclusion Criteria:

  • Individuals with pulmonary TB who have a risk factor for MDR-TB and live within a zone that has implemented the intervention of the overarching study (i.e. within the catchment area of an intermediate laboratory which has implemented DST as per NTP protocol).

Exclusion Criteria:

  • Non Spanish speakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201941

Locations
Peru
Socios En Salud
Lima, Peru
Sponsors and Collaborators
Brigham and Women's Hospital
MIT William Asbjornsen Albert Memorial Fellowship
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Sonya S Shin, MD Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonya Shin, Partners Healthcare
ClinicalTrials.gov Identifier: NCT01201941     History of Changes
Other Study ID Numbers: 2005-P-002606/2, 1F31AI075897-01A1
Study First Received: September 9, 2010
Last Updated: September 14, 2010
Health Authority: United States: Institutional Review Board
Peru: Ethics Committee

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014