Chronic IllnessPAPMedNCT04731194
Promoting Medication Reimbursement Policy (PAPMed)
A study testing Performance-based financial incentive program in people with Chronic Illness, run by Duke Kunshan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Illness
- What is being tested?
- Performance-based financial incentive program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not part of the New Cooperative Medical Scheme (NCMS) for rural residents
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nantong University
Nantong, Jiangsu, 226019
Yuexia Gao, 13962968819, 386912453@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Chronic Illness
- Being tested
- Performance-based financial incentive program
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance-based financial incentive programBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration Rate
The percentage of patients registered to the policy in the health insurance system
Measured: 6 months
Secondary outcomes (7)
Registration number
The number of all registered patients in the village served by the village clinic
Measured: 6 months
Medical costs saved
The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses
Measured: 6 months
Doctor visiting frequency
Rate and visiting frequency of registered patients seeing doctors in designated hospitals
Measured: 6 months
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
Measured: 6 months
Blood pressure
Average systolic and diastolic blood pressure level among all rural hypertensive patients
Measured: 6 months
Blood glucose
Average blood glucose level among rural diabetic patients
Measured: 6 months
Blood lipids
Average blood lipids level among rural hypertensive and diabetic patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start30 Jan 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke Kunshan University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Nantong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731194
- Sponsor's protocol ID
- 2020DUKE0002
- Acronym
- PAPMed
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36109757
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04731194
- Acronym / sponsor ID
- PAPMed / 2020DUKE0002
- Conditions
- Chronic Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Duke Kunshan UniversityUniversity, hospital or other
- Collaborators
- Duke University, Nantong University
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| performance-based financial incentive program | Experimental | Behavioral: Performance-based financial incentive programVillage doctors in villages of the intervention group will promote policy awareness, support registration, follow-up patients, and receive financial incentives based on their performance. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not part of the New Cooperative Medical Scheme (NCMS) for rural residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance-based financial incentive program1. 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. | Behavioural | performance-based financial incentive program |
Primary outcome
Registration Rate
Time frame: 6 months
The percentage of patients registered to the policy in the health insurance system
7 secondary outcomes
Registration number
Time frame: 6 months
Medical costs saved
Time frame: 6 months
Doctor visiting frequency
Time frame: 6 months
Medication compliance rate
Time frame: 6 months
Blood pressure
Time frame: 6 months
Blood glucose
Time frame: 6 months
Blood lipids
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 36109757He 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance-based financial incentive program in people with Chronic Illness, run by Duke Kunshan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijing Yan ((+86) 512 3665 7057, lijing.yan@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.