Hepatitis C Clinical Trial
Official title:
Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
Hepatitis C is a public health problem and the high cost of the Direct-Acting Antivirals
(DAA) is one of the main limitations for treatment worldwide.
In Colombia, the Ministry of Health and Social Protection (MoHSP) has made progress in
addressing Hepatitis C problem in order to control the infection and resolve barriers to
access to medicines. One of the strategies implemented was the purchase of DAA, in
association with the PAHO, and the instauration of the Clinical Pathway for the treatment of
chronic hepatitis C.
The implementation of the Clinical Pathway has required the integration of health care
processes and the respective report in the health information systems, allowing a high level
of control in the monitoring of the Hepatitis C and the subsequent generation of indicators.
However, there is limited information on the effects of the strategic purchase and the
instauration of the Clinical Pathway on the costs of care, clinical outcomes and the quality
of health care for patients with Hepatitis C in Colombia.
The aim of this study is to establish the effect of strategic purchasing and the Clinical
Pathway for the treatment of chronic Hepatitis C, in the clinical results, in the general
costs and quality of health care of Hepatitis C patients in Colombia.
A quasi-experimental design with a non-equivalent control group will be performed, where
there will be an intervention group and a control group formed naturally before the
investigation. In order to reduce the possible selection bias due to the lack of
randomization, the propensity score method will be used. 62 patients will be included in each
arm.
An estimation and comparison of the direct costs of the care of patients with Hepatitis C,
before and after the implementation of the strategic purchase and the Clinical Pathway will
be made, using a "top to bottom" method.
A questionnaire will be applied to the patients of the intervention group in order to
identify barriers and facilitators to Hepatitis C health care and patient satisfaction with
health care process under the Clinical Pathway.
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