Clinical trial NCT04187313: Increasing Notifications of Tuberculosis From Private Practitioners
Official title: Increasing Notifications of Tuberculosis From Private Practitioners: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Public-Private Sector Partnership
Mobile Applications
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
Collaborators: name: University of Otago
name: Harvard University
First posted: 2019-12-05
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be administered to private practitioners in the selected areas (clusters), at their place of practice. Once the study participants have received the intervention, real-time monitoring of referral practice of patients for diagnosis and notification will be undertaken through the web-link to the app.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Tuberculosis (TB) is the third leading cause of death in Indonesia. Disturbingly, the prevalence survey showed that over half of TB cases in Indonesia are not notified. The huge private sector in Indonesia, comprising an estimated 70,000 practitioners, provides over 50% of health care but notifies less than 10% of all diagnosed TB cases.

INSTEP2 is a cluster randomised controlled intervention trial. The multi-component public health intervention will be administered to private practitioners (PP) in Community Health Centre (CHC) clusters. The change in the number of TB notifications over 12 months before, and 12 months after, the intervention will be compared between study arms. Hypothesis related to the Primary Efficacy Endpoint: A tailored intervention in PPs will increase TB notifications.

Detailed description: As part of advancing Public-Private Mix (PPM), the government made TB notification mandatory in 2016, but intervention is likely to be needed for notifications to increase substantially. Such intervention needs to be based on a sound understanding of contextual factors around PPs and how they relate to the public sector with respect to the diagnosis, treatment and reporting of TB cases.

This is a cluster randomised controlled trial of a multi-component public health intervention to increase notifications of TB from PPs in Bandung, Indonesia. Clusters are CHC areas and the intervention will be administered directly to PPs in sub-districts randomised to the intervention arm. The CHCs in both arms will be informed about the study and asked, through the National TB Control Programme, to make their notification data available and their willingness will be recorded. No intervention will be given to PPs in the control arm. Notifications will be obtained directly from routine records, with accompanying information gathered about the address of the patient and referring doctor. Notified TB cases are, by definition, TB cases who have been commenced on TB treatment, noting that some referred 'TB cases' will be diagnosed as not having TB by CHC staff.

The intervention will be administered to PPs in areas around 15 CHCs (clusters), at their place of practice. PPs in the control areas will receive no intervention. The intervention will comprise: (1) An electronic referral and notification system; (2) Education about signs and symptoms of TB and TB management; (3) An individualised practitioner plan for diagnostic and management pathways.

The primary endpoint is the change in the number of notifications of TB from the 12 months before to the 12 months after the intervention is fully implemented. This change in the number of notifications will be compared between intervention clusters and control clusters.

Safety oversight by a Data and Safety Monitoring Board (DSMB) will not be required for this public health intervention trial. However, an internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. A quality management plan will be developed to describe a site's quality management. Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be automatically generated on a weekly basis and any quality issues identified will be reviewed by the DMC and a plan put in place for resolution. Following written Standard Operating Procedures (SOPs), visiting investigators will verify that the trial is conducted and data are generated, documented (recorded), and reported in compliance with the protocol. The investigational site will provide direct access to all source data/documents, and reports for the purpose of the verification visits.

Eligibility criteria: Inclusion Criteria:

* All medically qualified private practitioners (PPs) in the intervention arm who reported having diagnosed at least one TB case in the past 3 months
* Intend to work in the current location for the duration of the study as their primary place of private practice

Exclusion Criteria:

* Unable to use an electronic device for referral/notification
* More than 3 months of non-practice during the study period is anticipated
* They are not a qualified medical practitioner, with the appropriate medical authority in Indonesia

Primary outcomes:
measure: Increased notification of tuberculosis (TB) by study participants
timeFrame: 12 months before to the 12 months after the intervention
Secondary outcomes:
measure: Proportion of referred patients in the intervention and control arms that are actually diagnosed with TB
timeFrame: 12 months before to the 12 months after the intervention
measure: Restricted analysis of primary outcome
timeFrame: 12 months before to the 12 months after the intervention
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Padjadjaran Teaching Hospital
state: Jawa Barat
Study officials:
affiliation: University of Otago
name: Philip Hill, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lestari BW, Arisanti N, Siregar AYM, Sihaloho ED, Budiman G, Hill PC, Alisjahbana B, McAllister S. Feasibility study of strengthening the public-private partnership for tuberculosis case detection in Bandung City, Indonesia. BMC Res Notes. 2017 Aug 14;10(1):404. doi: 10.1186/s13104-017-2701-y.
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