Tuberculosis, Multidrug-ResistantNCT01201941
Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
An observational study of Tuberculosis, Multidrug-Resistant, run by Brigham and Women's Hospital at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant
- What is being tested?
- e-Chasqui
- How many people
- 1,849 participants
- Where
- 1 sitePeru
- Study dates
- Nov 2004to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Non Spanish speakers
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- 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.
- To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST results) between health establishments in the intervention versus control group.
- 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:
- The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access.
- 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.
- Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access.
- Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.
Read the 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.
- Conditions
- Tuberculosis, Multidrug-Resistant
- Being tested
- e-Chasqui
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-ChasquiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median "Laboratory turn-around-time" (TAT)
Measured: 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.
Measured: 2.5 years
Secondary outcomes (4)
DST lab Turn Around Time greater than 60 days
The proportion of DST results with a laboratory TAT greater than or equal to 60 days
Measured: 60 days after multi-drug resistant tuberculosis drug susceptibility result
Culture conversion Turn Around Time
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
Measured: 2.5 years
Approximate cost of the intervention as a whole and per patient
Measured: 2 years
Qualitative assessment of the acceptability and usability of e-Chasqui among users in health establishments with access with to the system.
Measured: at end of study, 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startNov 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, Multidrug-ResistantStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MIT William Asbjornsen Albert Memorial Fellowship, National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Sonya Sunhi Shin, Brigham and Women's Hospital
- Investigators
- Sonya S Shin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201941
- Sponsor's protocol ID
- 2005-P-002606/2
- Other IDs
- 1F31AI075897-01A1
- Status last verified
- Oct 2017
- First submitted
- 9 Sep 2010
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24721980
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
- ClinicalTrials.gov ID
- NCT01201941
- Acronym / sponsor ID
- 2005-P-002606/2
- Conditions
- Tuberculosis, Multidrug-Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,849 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- MIT William Asbjornsen Albert Memorial Fellowship, National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Study start
- Nov 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST results) between health establishments in the intervention versus control group.
- 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:
- The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access.
- 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.
- Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access.
- Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: e-ChasquiDuring 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Non Spanish speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-ChasquiThe 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 | Intervention group |
Primary outcome
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
Percent laboratory errors, by type of error for health establishments in the intervention versus the control group.
Time frame: 2.5 years
4 secondary outcomes
DST lab Turn Around Time greater than 60 days
Time frame: 60 days after multi-drug resistant tuberculosis drug susceptibility result
Culture conversion Turn Around Time
Time frame: 2.5 years
Approximate cost of the intervention as a whole and per patient
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 24721980Blaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya S Shin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Multidrug-Resistant, run by Brigham and Women's Hospital at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.