Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT03895294
Status:
UNKNOWN
Last Update Posted:
2019-06-07
First Post:
2019-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia
Sponsor:
Universidad de Antioquia
Organization:
Study Overview
Official Title:
Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPCSTRATEGY
Brief Summary:
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: