Increasing Notifications of Tuberculosis From Private Practitioners

NCT04187313 | Completed

• 1 other identifier: TB-201911.02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Public-Private Sector Partnership; Mobile Applications

Outcome Measures

Primary Outcomes (1)

• Increased notification of tuberculosis (TB) by study participants

  Increased notifications of TB by private practitioners in Bandung, Indonesia

  12 months before to the 12 months after the intervention

Secondary Outcomes (2)

• Proportion of referred patients in the intervention and control arms that are actually diagnosed with TB

  12 months before to the 12 months after the intervention

• Restricted analysis of primary outcome

  12 months before to the 12 months after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: INSTEP2 intervention package

Control

NO INTERVENTION

Private practitioners in the control areas will receive no intervention.

Interventions

INSTEP2 intervention package 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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• University of Otago: collaborator
• Harvard University: collaborator

Study Sites (1)

Universitas Padjadjaran Teaching Hospital

Bandung, West Java, 40161, Indonesia

Location

Related Publications (8)

• Mahendradhata Y, Lestari T, Probandari A, Indriarini LE, Burhan E, Mustikawati D, Utarini A. How do private general practitioners manage tuberculosis cases? A survey in eight cities in Indonesia. BMC Res Notes. 2015 Oct 14;8:564. doi: 10.1186/s13104-015-1560-7.

  PMID: 26468010 BACKGROUND

• Irawati SR, Basri C, Arias MS, Prihatini S, Rintiswati N, Voskens J, Kimerling ME. Hospital DOTS linkage in Indonesia: a model for DOTS expansion into government and private hospitals. Int J Tuberc Lung Dis. 2007 Jan;11(1):33-9.

  PMID: 17217127 BACKGROUND

• Surya A, Setyaningsih B, Suryani Nasution H, Gita Parwati C, Yuzwar YE, Osberg M, Hanson CL, Hymoff A, Mingkwan P, Makayova J, Gebhard A, Waworuntu W. Quality Tuberculosis Care in Indonesia: Using Patient Pathway Analysis to Optimize Public-Private Collaboration. J Infect Dis. 2017 Nov 6;216(suppl_7):S724-S732. doi: 10.1093/infdis/jix379.

  PMID: 29117347 BACKGROUND

• Probandari A, Utarini A, Hurtig AK. Achieving quality in the Directly Observed Treatment Short-course (DOTS) strategy implementation process: a challenge for hospital Public-Private Mix in Indonesia. Glob Health Action. 2008 Dec 17;1. doi: 10.3402/gha.v1i0.1831.

  PMID: 20027243 BACKGROUND

• Reviono R, Setianingsih W, Damayanti KE, Ekasari R. The dynamic of tuberculosis case finding in the era of the public-private mix strategy for tuberculosis control in Central Java, Indonesia. Glob Health Action. 2017;10(1):1353777. doi: 10.1080/16549716.2017.1353777.

  PMID: 28766465 BACKGROUND

• 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.

  PMID: 28807020 BACKGROUND

• Lei X, Liu Q, Escobar E, Philogene J, Zhu H, Wang Y, Tang S. Public-private mix for tuberculosis care and control: a systematic review. Int J Infect Dis. 2015 May;34:20-32. doi: 10.1016/j.ijid.2015.02.015. Epub 2015 Feb 23.

  PMID: 25722284 BACKGROUND

• Artawan Eka Putra IW, Utami NW, Suarjana IK, Duana IM, Astiti CI, Putra IW, Probandari A, Tiemersma EW, Wahyuni CU. Factors associated to referral of tuberculosis suspects by private practitioners to community health centres in Bali Province, Indonesia. BMC Health Serv Res. 2013 Oct 28;13:445. doi: 10.1186/1472-6963-13-445.

  PMID: 24165352 BACKGROUND

Related Links

• World Health Organisation. PPM DOTS in Indonesia: a strategy for action

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip Hill, Professor

  University of Otago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study statistician will not be aware of intervention assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: July 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)