Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT04731194
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Medication Reimbursement Policy (PAPMed)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-17', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registration Rate', 'timeFrame': '6 months', 'description': 'The percentage of patients registered to the policy in the health insurance system'}], 'secondaryOutcomes': [{'measure': 'Registration number', 'timeFrame': '6 months', 'description': 'The number of all registered patients in the village served by the village clinic'}, {'measure': 'Medical costs saved', 'timeFrame': '6 months', 'description': 'The amount of money saved on outpatient expenses, hospital expenses, personal out-of-pocket expenses, and medical insurance reimbursement expenses'}, {'measure': 'Doctor visiting frequency', 'timeFrame': '6 months', 'description': 'Rate and visiting frequency of registered patients seeing doctors in designated hospitals'}, {'measure': 'Medication compliance rate', 'timeFrame': '6 months', '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'}, {'measure': 'Blood pressure', 'timeFrame': '6 months', 'description': 'Average systolic and diastolic blood pressure level among all rural hypertensive patients'}, {'measure': 'Blood glucose', 'timeFrame': '6 months', 'description': 'Average blood glucose level among rural diabetic patients'}, {'measure': 'Blood lipids', 'timeFrame': '6 months', 'description': 'Average blood lipids level among rural hypertensive and diabetic patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Illness']}, 'referencesModule': {'references': [{'pmid': '36109757', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nTo be eligible to register in the medication reimbursement policy, patients need to be:\n\n1. Living in the service areas of the village clinics\n2. Officially diagnosed with hypertension and/or diabetes in a township level hospital or above\n3. Registered as a hypertensive and/or diabetic patient in the public health service system\n\nExclusion criteria:\n\nNot part of the New Cooperative Medical Scheme (NCMS) for rural residents'}, 'identificationModule': {'nctId': 'NCT04731194', 'acronym': 'PAPMed', 'briefTitle': 'Promoting Medication Reimbursement Policy (PAPMed)', 'organization': {'class': 'OTHER', 'fullName': 'Duke Kunshan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2020DUKE0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'performance-based financial incentive program', '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.', 'interventionNames': ['Behavioral: Performance-based financial incentive program']}, {'type': 'NO_INTERVENTION', 'label': 'current situation', '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.'}], 'interventions': [{'name': 'Performance-based financial incentive program', 'type': 'BEHAVIORAL', 'description': "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.\n2. Support patients' registration in the reimbursement system\n3. 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.\n4. 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.", 'armGroupLabels': ['performance-based financial incentive program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '226019', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuexia Gao', 'role': 'CONTACT', 'email': '386912453@qq.com', 'phone': '13962968819'}], 'facility': 'Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}], 'centralContacts': [{'name': 'Lijing Yan', 'role': 'CONTACT', 'email': 'lijing.yan@duke.edu', 'phone': '(+86) 512 3665 7057'}, {'name': 'Yuexia Gao', 'role': 'CONTACT', 'email': '386912453@qq.com', 'phone': '13962968819'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke Kunshan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Nantong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}