Promoting Medication Reimbursement Policy (PAPMed)

NCT04731194 | Unknown

• 1 other identifier: 2020DUKE0002
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illness

Outcome Measures

Primary Outcomes (1)

• Registration Rate

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

  6 months

Secondary Outcomes (7)

• Registration number

  6 months

• Medical costs saved

  6 months

• Doctor visiting frequency

  6 months

• Medication compliance rate

  6 months

• Blood pressure

  6 months

Study Arms (2)

performance-based financial incentive program

EXPERIMENTAL

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.

Behavioral: Performance-based financial incentive program

current situation

NO INTERVENTION

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.

Interventions

Performance-based financial incentive program 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.

performance-based financial incentive program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke Kunshan University: lead
• Duke University: collaborator
• Nantong University: collaborator

Study Sites (1)

Nantong University

Nantong, Jiangsu, 226019, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36109757 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lijing Yan

CONTACT

(+86) 512 3665 7057; lijing.yan@duke.edu

Yuexia Gao

CONTACT

13962968819; 386912453@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 29, 2021
• Study Start: January 30, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 30, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)