Promoting Medication Reimbursement Policy (PAPMed) (PAPMed)

July 17, 2021 updated by: Duke Kunshan University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226019
        • Recruiting
        • Nantong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Registration Rate
Time Frame: 6 months
The percentage of patients registered to the policy in the health insurance system
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Registration number
Time Frame: 6 months
The number of all registered patients in the village served by the village clinic
6 months
Medical costs saved
Time Frame: 6 months
The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses
6 months
Doctor visiting frequency
Time Frame: 6 months
Rate and visiting frequency of registered patients seeing doctors in designated hospitals
6 months
Medication compliance rate
Time Frame: 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
6 months
Blood pressure
Time Frame: 6 months
Average systolic and diastolic blood pressure level among all rural hypertensive patients
6 months
Blood glucose
Time Frame: 6 months
Average blood glucose level among rural diabetic patients
6 months
Blood lipids
Time Frame: 6 months
Average blood lipids level among rural hypertensive and diabetic patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke Kunshan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Nantong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020DUKE0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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