Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia (HEPCSTRATEGY)

Universidad de Antioquia

Status: Unknown

Conditions: Hepatitis C

Treatments: Other: Usual care process prior strategic purchase-clinical pathway; Other: Health care under the strategic purchase-Clinical pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03895294

Universidad de Antioquia

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with Chronic Hepatitis C confirmed by quantitative HCV RNA test
• Patient affiliated to the contributory system of one Health Promoting Enterprise from Colombia.
• Patients with prescription of pharmacological treatment for Hepatitis C.

Exclusion criteria

• Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Health care under the strategic purchase-Clinical pathway

Experimental group

Description:

Health care under the strategic purchase and the Clinical pathway for the treatment of chronic Hepatitis C

Treatment:

Other: Health care under the strategic purchase-Clinical pathway

Usual care process prior strategic purchase-clinical pathway

Active Comparator group

Description:

Usual care process prior to the establishment of the strategic purchase and the Clinical Pathway

Treatment:

Other: Usual care process prior strategic purchase-clinical pathway