Promoting Medication Reimbursement Policy (PAPMed)

Not Applicable

• Conditions: Chronic Illness

• Registration Number: NCT04731194
• Lead Sponsor: Duke Kunshan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-01-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-17
• Last Update Posted: 2021-07-20
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Registration Rate	6 months	The percentage of patients registered to the policy in the health insurance system

Secondary Outcome Measures

Name	Time	Method
Medical costs saved	6 months	The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses
Blood lipids	6 months	Average blood lipids level among rural hypertensive and diabetic patients
Medication compliance rate	6 months	Prescription frequency and doses, medication purchasing rate among registered patients, times of reimbursement during intervention and follow-up period among registered patients, insulin usage rate among registered diabetic patients
Doctor visiting frequency	6 months	Rate and visiting frequency of registered patients seeing doctors in designated hospitals
Registration number	6 months	The number of all registered patients in the village served by the village clinic
Blood pressure	6 months	Average systolic and diastolic blood pressure level among all rural hypertensive patients
Blood glucose	6 months	Average blood glucose level among rural diabetic patients

Trial Locations

Locations (1)

Nantong University; 🇨🇳 Nantong, Jiangsu, China