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

NCT01201941 | Completed

• 2 other identifiers: 2005-P-002606/21F31AI075897-01A1
• Study Type: observational
• Target: 1,849
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 4.To qualitatively assess the acceptability and usability of e-Chasqui among users in health establishments with access to the system.
5. 5.The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access.
6. 6.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.
7. 7.Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access.
8. 8.Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.

Conditions

Tuberculosis, Multidrug-Resistant

Outcome Measures

Primary Outcomes (2)

• Median "Laboratory turn-around-time" (TAT)

  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

• Percent laboratory errors, by type of error for health establishments in the intervention versus the control group.

  2.5 years

Secondary Outcomes (4)

• DST lab Turn Around Time greater than 60 days

  60 days after multi-drug resistant tuberculosis drug susceptibility result

• Culture conversion Turn Around Time

  2.5 years

• Approximate cost of the intervention as a whole and per patient

  2 years

• Qualitative assessment of the acceptability and usability of e-Chasqui among users in health establishments with access with to the system.

  at end of study, 2.5 years

Study Arms (2)

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

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.

Interventions

e-Chasqui OTHER

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• Non Spanish speakers

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• MIT William Asbjornsen Albert Memorial Fellowship: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Socios En Salud

Lima, Peru

Location

Related Publications (1)

• 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.

  PMID: 24721980 DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sonya S Shin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 15, 2010
• Study Start: November 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

PE (1)