Increasing Notifications of Tuberculosis From Private Practitioners

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study statistician will not be aware of intervention assignment

Study Groups

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Intervention

The intervention arm will comprise study participants who receive intervention package (i.e. private practitioners in the selected areas who agree to participate).

Group Type EXPERIMENTAL

INSTEP2 intervention package

Intervention Type OTHER

The Intervention will comprise: An electronic notification system, a standardized education about the signs and symptoms of TB and TB management and an individualised plan for each PP with respect to their approach to the diagnosis and management of TB suspects.

The electronic system is a refinement of the electronic referral and report-back system using a mobile phone 'app'. The system will enable essential data to be uploaded, consistent with National TB Control Programme forms.

The education package will be focused on TB suspect identification, provisional diagnosis and referral, including how to use the mobile phone 'app'. We will also develop a simple individualised approach for the management of TB suspects, which takes into account the context around each PP's practice, identifying the most efficient and feasible approach to obtaining a diagnosis and notifying TB patients.

Control

Private practitioners in the control areas will receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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INSTEP2 intervention package

The Intervention will comprise: An electronic notification system, a standardized education about the signs and symptoms of TB and TB management and an individualised plan for each PP with respect to their approach to the diagnosis and management of TB suspects.

The electronic system is a refinement of the electronic referral and report-back system using a mobile phone 'app'. The system will enable essential data to be uploaded, consistent with National TB Control Programme forms.

The education package will be focused on TB suspect identification, provisional diagnosis and referral, including how to use the mobile phone 'app'. We will also develop a simple individualised approach for the management of TB suspects, which takes into account the context around each PP's practice, identifying the most efficient and feasible approach to obtaining a diagnosis and notifying TB patients.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No