Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-08 @ 1:58 AM
Study NCT ID:
NCT05117333
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reminders, Cost Sharing, and Healthcare Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This is a randomized experiment in which individuals receive different types of reminders. All outcome variables are based on administrative (secondary) data. Individuals receiving letters and care providers are not aware of the experiment. Investigators will not have any contact with the participants.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial with three active treatment arms and a control group (not assigned to any treatment, information and services as usual).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of nurse visits (as recorded in the Finnish National Register of Primary Health Care Visits)', 'timeFrame': 'Six months starting from the date the letters are sent'}, {'measure': 'Number of doctor visits (as recorded in the Finnish National Register of Primary Health Care Visits)', 'timeFrame': 'Six months starting from the date the letters are sent'}], 'secondaryOutcomes': [{'measure': 'Number of referrals to specialized care (as recorded in the Finnish National Register of Primary Health Care Visits)', 'timeFrame': 'Six months starting from the date the letters are sent'}, {'measure': 'Number of drug prescriptions for newly initiated therapies (as recorded in the Finnish national register for prescribed medicines)', 'timeFrame': 'Six months starting from the date the letters are sent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cost-sharing, primary care, health care utilization'], 'conditions': ['Health Care Utilization', 'Health Care Seeking Behavior', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'The investigators conduct a large-scale randomized controlled trial in Finland by sending three types of information letters to households to examine whether the reminder letters affect healthcare use. All letters remind of the importance of seeking care to treat potential health problems.\n\nThis study has two primary objectives are: to evaluate the effects of an information nudge reminding on the importance of diagnosing and treating health problems and to evaluate the effects of additionally providing information on the fact that primary care nurse visits have become exempt from copayments. Main outcomes include the number of primary care nurse visits and general practitioner (GP) visits in a six-month follow-up.', 'detailedDescription': 'This study has two main objectives: (i) to evaluate the effect of an information nudge reminding on the importance of diagnosing and treating health problems and (ii) to evaluate the effect of providing information on the fact that primary care nurse visits have become exempt from co-payments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residency in one of the 25 target municipalities as of September 15, 2021.\n* Born in 1966 or earlier (aged 55 or more at the end of 2021).\n* Living in a household with a maximum of three individuals aged 55 or above.\n\nExclusion Criteria:\n\n* Individuals living in households (postal address) with more than three individuals aged 55 and above.'}, 'identificationModule': {'nctId': 'NCT05117333', 'briefTitle': 'Reminders, Cost Sharing, and Healthcare Use', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'Reminders, Cost Sharing, and Healthcare Use', 'orgStudyIdInfo': {'id': 'THL/3181/6.02.01/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Basic letter', 'description': 'This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed.', 'interventionNames': ['Other: Reminder (information letter)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Co-pay', 'description': 'This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed AND informs recipients about a new law that abolished all co-payments for all primary care nurse visits in Finland.', 'interventionNames': ['Other: Reminder (information letter)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GP-Co-pay', 'description': 'This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed AND informs recipients about a new law that abolished all co-payments for all primary care nurse visits in Finland, AND informs recipients that the new law did not abolish co-payments related to general practitioner visits.', 'interventionNames': ['Other: Reminder (information letter)']}, {'type': 'NO_INTERVENTION', 'label': 'Control treatment', 'description': 'There is no intervention in the control treatment. The entire population aged 55 and above in the treatment regions will serve as a control group.'}], 'interventions': [{'name': 'Reminder (information letter)', 'type': 'OTHER', 'description': 'Reminders', 'armGroupLabels': ['Basic letter', 'Co-pay', 'GP-Co-pay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00271', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Finnish Institute for Health and Welfare', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Lauri Sääksvuori, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare and University of Turku'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This paper uses administrative health records maintained by the Finnish Institute for Health and Welfare. Access to health records is regulated in Finland under the Act on the Secondary Use of Health and Social Data (552/2019). De-identified individual participant data will be shared subject to approval by the competent data protection authority. All statistical code used to organize and analyze the data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Lauri Sääksvuori', 'investigatorAffiliation': 'Finnish Institute for Health and Welfare'}}}}