- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05117333
Reminders, Cost Sharing, and Healthcare Use
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.
This 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00271
- Finnish Institute for Health and Welfare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Residency in one of the 25 target municipalities as of September 15, 2021.
- Born in 1966 or earlier (aged 55 or more at the end of 2021).
- Living in a household with a maximum of three individuals aged 55 or above.
Exclusion Criteria:
- Individuals living in households (postal address) with more than three individuals aged 55 and above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Basic letter
This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed.
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Reminders
|
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Active Comparator: Co-pay
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.
|
Reminders
|
|
Active Comparator: GP-Co-pay
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.
|
Reminders
|
|
No Intervention: Control treatment
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of nurse visits (as recorded in the Finnish National Register of Primary Health Care Visits)
Time Frame: Six months starting from the date the letters are sent
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Six months starting from the date the letters are sent
|
|
Number of doctor visits (as recorded in the Finnish National Register of Primary Health Care Visits)
Time Frame: Six months starting from the date the letters are sent
|
Six months starting from the date the letters are sent
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of referrals to specialized care (as recorded in the Finnish National Register of Primary Health Care Visits)
Time Frame: Six months starting from the date the letters are sent
|
Six months starting from the date the letters are sent
|
|
Number of drug prescriptions for newly initiated therapies (as recorded in the Finnish national register for prescribed medicines)
Time Frame: Six months starting from the date the letters are sent
|
Six months starting from the date the letters are sent
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lauri Sääksvuori, PhD, Finnish Institute for Health and Welfare and University of Turku
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- THL/3181/6.02.01/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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