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Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: Protocol for a cluster randomized controlled trial in Georgia
Chikovani, Ivdity Diaconu, Karin Sulaberidze, Lela Uchaneishvili, Maia Mohammed, Nuredin Zoidze, Akaki Witter, Sophie
Chikovani, Ivdity
Diaconu, Karin
Sulaberidze, Lela
Uchaneishvili, Maia
Mohammed, Nuredin
Zoidze, Akaki
Witter, Sophie
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Other contributors
Affiliation
Epub Date
Issue Date
2019-08-28
Submitted date
Alternative
Abstract
Background: Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management. Low remuneration for specialists, limited private-sector interest in provision of infectious disease care and incomplete integration in primary care are at the core of this problem. Methods: This protocol sets out the methods of a two-arm cluster randomized control trial which aims to generate evidence on the effectiveness of a performance-based financing and integrated care intervention on tuberculosis loss to follow-up and treatment adherence. The trial will be implemented in health facilities (clusters) under-performing in tuberculosis management. Eligible and consenting facilities will be randomly assigned to either intervention or control (standard care). Health providers within intervention sites will form a case management team and be trained in the delivery of integrated tuberculosis care; performance-related payments based on monthly records of patients adhering to treatment and quality of care assessments will be disbursed to health providers in these facilities. The primary outcomes include loss to follow-up among adult pulmonary drug-sensitive and drug-resistant tuberculosis patients. Secondary outcomes are adherence to treatment among drug-sensitive and drug-resistant tuberculosis patients and treatment success among drug-sensitive tuberculosis patients. Data on socio-demographic characteristics, tuberculosis diagnosis and treatment regimen will also be collected. The required sample size to detect a 6% reduction in loss to follow-up among drug-sensitive tuberculosis patients and a 20% reduction in loss to follow-up among drug-resistant tuberculosis patients is 948 and 136 patients, respectively. Discussion: The trial contributes to a limited body of rigorous evidence and literature on the effectiveness of supply-side performance-based financing interventions on tuberculosis patient outcomes. Realist and health economic evaluations will be conducted in parallel with the trial, and associated composite findings will serve as a resource for the Georgian and wider regional Ministries of Health in relation to future tuberculosis and wider health policies. The trial and complementing evaluations are part of Results4TB, a multidisciplinary collaboration engaging researchers and Georgian policy and practice stakeholders in the design and evaluation of a context-sensitive tuberculosis management intervention. Trial registration: ISRCTN, ISRCTN14667607. Registered on 14 January 2019.
Citation
Chikovani, I., Diaconu, K., Duric, P. et al. (2019) Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia. Trials 20, 536. https://doi.org/10.1186/s13063-019-3621-z
Publisher
Journal
Research Unit
PubMed ID
31462284 (pubmed)
PubMed Central ID
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Type
Journal article
Language
en
Description
© 2019 The Authors. Published by BMC. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1186/s13063-019-3621-z
Series/Report no.
ISSN
1745-6215
EISSN
1745-6215
ISBN
ISMN
Gov't Doc #
Sponsors
The research is funded through the Joint Health Systems Research Initiative of the Department of International Development, the Economic and Social Research Council, the Medical Research Council and the Wellcome Trust (March 2017–February 2021).
Rights
Licence for published version: Creative Commons Attribution 4.0 International