Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Access to treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.
研究组 & 干预措施
Health care under the strategic purchase-Clinical pathway
Health care under the strategic purchase and the Clinical pathway for the treatment of chronic Hepatitis C
干预措施: Health care under the strategic purchase-Clinical pathway (Other)
Usual care process prior strategic purchase-clinical pathway
Usual care process prior to the establishment of the strategic purchase and the Clinical Pathway
干预措施: Usual care process prior strategic purchase-clinical pathway (Other)
结局指标
主要结局
Access to treatment
时间窗: 2 months
Proportion of patients who initiates treatment, in comparison with the total number of patients with indication of treatment (confirmed diagnosis and prescription of treatment).
次要结局
- Opportunity at the start of treatment(2 months)
- Effectiveness(6 months)
- Drug-related problem(6 months)