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临床试验/NCT04731194
NCT04731194Unknown不适用

Promoting the Adoption of Local Government Policy on the Reimbursement of Chronic Disease Medicines (PAPMed): a Field-based Cluster-Randomized Controlled Trial in Rural Nantong, China

Duke Kunshan University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年1月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
1
主要终点
Registration Rate

研究概览

简要总结

Rationale: Chronic non-communicable diseases (NCDs) have become the leading cause of morbidity and mortality in China. Rural NCDs patients are more likely to suffer from poverty. Nantong city has established a reimbursement plan covering 50% of hypertension and diabetes medication costs, however, various barriers prevent patients from taking advantage of this policy. Objectives: To evaluate the effectiveness of the intervention on saving medical costs and promoting health in rural populations. Study design: a cluster-randomized controlled trial. Study population: village doctors and health insurance officials at township hospitals are implementors of the intervention. Patients in the basic public health service system are the target populations of the intervention. Randomization: 31 villages are included in the study. 1 village is randomly dropped, and the rest of the villages will be randomly assigned to the intervention and control group stratified by township with an allocation ratio of 1:1. Intervention and follow-up: village doctors will promote policy awareness and support patients registration. They will follow-up patients on the 1st, 3rd, and 6th month and receive financial incentives based on their performance of supporting patients registration and encouraging patients to buy medications in designated medical institutions to be reimbursed. Control: The control group would serve as a natural baseline and do not receive any intervention. Outcomes: Patients' registration rate, medical costs saved, medication compliance rate, and improvements on health indicators will be evaluated based on real-world medical examination, prescription, and insurance data. Sample size: an estimated sample of 5000 patients from 30 clusters will be registered in the policy.

详细描述

Rationale: Chronic non-communicable diseases (NCDs) have become the leading cause of morbidity and mortality in China. Rural NCDs patients are more likely to suffer from poverty. Nantong city has established a reimbursement plan covering 50% of hypertension and diabetes medication costs, however, various barriers prevent patients from taking advantage of this policy. Objectives: To evaluate the effectiveness of the intervention on saving medical costs and promoting health in rural populations. Study design: a cluster-randomized controlled trial. Study population: village doctors and health insurance officials at township hospitals are implementors of the intervention. Patients in the basic public health service system are the target populations of the intervention. Randomization: 31 villages are included in the study. 1 village is randomly dropped, and the rest of the villages will be randomly assigned to the intervention and control group stratified by township with an allocation ratio of 1:1. Intervention and follow-up: village doctors will promote policy awareness and support patients registration. They will follow-up patients on the 1st, 3rd, and 6th month and receive financial incentives based on their performance of supporting patients registration and encouraging patients to buy medications in designated medical institutions to be reimbursed. Control: The control group would serve as a natural baseline and do not receive any intervention. Outcomes: Patients' registration rate, medical costs saved, medication compliance rate, and improvements on health indicators will be evaluated based on real-world medical examination, prescription, and insurance data. Sample size: an estimated sample of 5000 patients from 30 clusters will be registered in the policy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • To be eligible to register in the medication reimbursement policy, patients need to be:
  • Living in the service areas of the village clinics
  • Officially diagnosed with hypertension and/or diabetes in a township level hospital or above
  • Registered as a hypertensive and/or diabetic patient in the public health service system

排除标准

  • Not part of the New Cooperative Medical Scheme (NCMS) for rural residents

结局指标

主要结局

Registration Rate

时间窗: 6 months

The percentage of patients registered to the policy in the health insurance system

次要结局

  • Medical costs saved(6 months)
  • Blood lipids(6 months)
  • Medication compliance rate(6 months)
  • Doctor visiting frequency(6 months)
  • Registration number(6 months)
  • Blood pressure(6 months)
  • Blood glucose(6 months)

研究者

发起方
Duke Kunshan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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