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