Promoting Medication Reimbursement Policy (PAPMed)

Chronic Illness Clinical Trial

— PAPMed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731194
• Other study ID #: 2020DUKE0002
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: July 2021
• Source: Duke Kunshan University
• Contact: Lijing Yan
• Phone: (+86) 512 3665 7057
• Email: lijing.yan[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

To be eligible to register in the medication reimbursement policy, patients need to be:

1. Living in the service areas of the village clinics

2. Officially diagnosed with hypertension and/or diabetes in a township level hospital or above

3. Registered as a hypertensive and/or diabetic patient in the public health service system Exclusion criteria: Not part of the New Cooperative Medical Scheme (NCMS) for rural residents

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

Intervention

Behavioral:
• Performance-based financial incentive program
Enhance policy awareness through verbal communication with patients, distributing picture-rich fliers to patients, and putting up large posters in public places of the villages. Support patients' registration in the reimbursement system Follow-up patients after the first, third, and sixth months after the start of the study, measuring blood pressure and blood glucose level. Encourage patients to purchase medications from public institutions and to take their medications on time. Receive financial incentives based on performance in the amount of 3 RMB per patient enrolled (first month) and 5 RMB per patient (at third and sixth month) buying medications with reimbursement from the policy.

Locations

Country	Name	City	State
China	Nantong University	Nantong	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Duke Kunshan University	Duke University, Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration Rate	The percentage of patients registered to the policy in the health insurance system	6 months
Secondary	Registration number	The number of all registered patients in the village served by the village clinic	6 months
Secondary	Medical costs saved	The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses	6 months
Secondary	Doctor visiting frequency	Rate and visiting frequency of registered patients seeing doctors in designated hospitals	6 months
Secondary	Medication compliance rate	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	6 months
Secondary	Blood pressure	Average systolic and diastolic blood pressure level among all rural hypertensive patients	6 months
Secondary	Blood glucose	Average blood glucose level among rural diabetic patients	6 months
Secondary	Blood lipids	Average blood lipids level among rural hypertensive and diabetic patients	6 months