Promoting Medication Reimbursement Policy (PAPMed)

NCT ID: NCT04731194

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-30

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Chronic Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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performance-based financial incentive program

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.

Group Type EXPERIMENTAL

Performance-based financial incentive program

Intervention Type BEHAVIORAL

1. 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.
2. Support patients' registration in the reimbursement system
3. 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.
4. 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.

current situation

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Performance-based financial incentive program

1. 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.
2. Support patients' registration in the reimbursement system
3. 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.
4. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Nantong University

OTHER

Sponsor Role collaborator

Duke Kunshan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lijing Yan

Role: CONTACT

(+86) 512 3665 7057

Yuexia Gao

Role: CONTACT

13962968819

Facility Contacts

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Yuexia Gao

Role: primary

13962968819

References

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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.

Reference Type DERIVED
PMID: 36109757 (View on PubMed)

Other Identifiers

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2020DUKE0002

Identifier Type: -

Identifier Source: org_study_id

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