Promoting Medication Reimbursement Policy (PAPMed) (PAPMed)
Primary Purpose
Chronic Illness
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Performance-based financial incentive program
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Illness
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
Not part of the New Cooperative Medical Scheme (NCMS) for rural residents
Sites / Locations
- Nantong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
performance-based financial incentive program
current situation
Arm Description
Village doctors in villages of the intervention group will promote policy awareness, support registration, follow-up patients, and receive financial incentives based on their performance.
Village doctors in villages of the control group will not be contacted. The control group would serve as a natural baseline and do not receive any intervention.
Outcomes
Primary Outcome Measures
Registration Rate
The percentage of patients registered to the policy in the health insurance system
Secondary Outcome Measures
Registration number
The number of all registered patients in the village served by the village clinic
Medical costs saved
The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses
Doctor visiting frequency
Rate and visiting frequency of registered patients seeing doctors in designated hospitals
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
Blood pressure
Average systolic and diastolic blood pressure level among all rural hypertensive patients
Blood glucose
Average blood glucose level among rural diabetic patients
Blood lipids
Average blood lipids level among rural hypertensive and diabetic patients
Full Information
NCT ID
NCT04731194
First Posted
January 14, 2021
Last Updated
July 17, 2021
Sponsor
Duke Kunshan University
Collaborators
Duke University, Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT04731194
Brief Title
Promoting Medication Reimbursement Policy (PAPMed)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke Kunshan University
Collaborators
Duke University, Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
performance-based financial incentive program
Arm Type
Experimental
Arm Description
Village doctors in villages of the intervention group will promote policy awareness, support registration, follow-up patients, and receive financial incentives based on their performance.
Arm Title
current situation
Arm Type
No Intervention
Arm Description
Village doctors in villages of the control group will not be contacted. The control group would serve as a natural baseline and do not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Performance-based financial incentive program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Registration Rate
Description
The percentage of patients registered to the policy in the health insurance system
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Registration number
Description
The number of all registered patients in the village served by the village clinic
Time Frame
6 months
Title
Medical costs saved
Description
The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses
Time Frame
6 months
Title
Doctor visiting frequency
Description
Rate and visiting frequency of registered patients seeing doctors in designated hospitals
Time Frame
6 months
Title
Medication compliance rate
Description
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
Time Frame
6 months
Title
Blood pressure
Description
Average systolic and diastolic blood pressure level among all rural hypertensive patients
Time Frame
6 months
Title
Blood glucose
Description
Average blood glucose level among rural diabetic patients
Time Frame
6 months
Title
Blood lipids
Description
Average blood lipids level among rural hypertensive and diabetic patients
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
Not part of the New Cooperative Medical Scheme (NCMS) for rural residents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijing Yan
Phone
(+86) 512 3665 7057
Email
lijing.yan@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yuexia Gao
Phone
13962968819
Email
386912453@qq.com
Facility Information:
Facility Name
Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226019
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuexia Gao
Phone
13962968819
Email
386912453@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36109757
Citation
He Z, Cao X, Zhao D, Tang Z, Zhao J, Beasley M, Renne A, Liu L, Zhu S, Gao Y, Yan LL. Promoting the adoption of local governmental policy on the reimbursement of chronic disease medicines (PAPMed): study protocol of a field-based cluster randomized trial in rural Nantong, China. Trials. 2022 Sep 15;23(1):785. doi: 10.1186/s13063-022-06710-1.
Results Reference
derived
Learn more about this trial
Promoting Medication Reimbursement Policy (PAPMed)
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