Health Care UtilizationNCT05117333
Reminders, Cost Sharing, and Healthcare Use
A study testing Reminder (information letter) in people with Health Care Utilization and Health Care Seeking Behavior, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Health Care Seeking Behavior, Health Behavior
- What is being tested?
- Reminder (information letter)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,398 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2021to 1 Apr 2022
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals living in households (postal address) with more than three individuals aged 55 and above.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Reminder (information letter)
- Keywords
- Cost-sharing, primary care, health care utilization
- Medical subject headings
- Patient Acceptance of Health Care, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder (information letter)Other
Reminders
| Study group | Role | What they receive |
|---|---|---|
| Basic letter | Active comparator | This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed. Receives: Other: Reminder (information letter) |
| Co-pay | Active comparator | 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. Receives: Other: Reminder (information letter) |
| GP-Co-pay | Active comparator | 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. Receives: Other: Reminder (information letter) |
| Control treatment | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of nurse visits (as recorded in the Finnish National Register of Primary Health Care Visits)
Measured: 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)
Measured: Six months starting from the date the letters are sent
Secondary outcomes (2)
Number of referrals to specialized care (as recorded in the Finnish National Register of Primary Health Care Visits)
Measured: 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)
Measured: Six months starting from the date the letters are sent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies 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
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lauri Sääksvuori, Finnish Institute for Health and Welfare
- Investigators
- Lauri Sääksvuori, PhD, Principal investigator, Finnish Institute for Health and Welfare and University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117333
- Sponsor's protocol ID
- THL/3181/6.02.01/2021
- Status last verified
- Aug 2022
- First submitted
- 5 Oct 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminders, Cost Sharing, and Healthcare Use
- ClinicalTrials.gov ID
- NCT05117333
- Acronym / sponsor ID
- THL/3181/6.02.01/2021
- Keywords
- Cost-sharing, primary care, health care utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,398 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Nov 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Basic letter | Active comparator | Other: Reminder (information letter)This reminder states that if healthcare is not consumed at the right time, health may deteriorate and diagnoses and treatment may be delayed. |
| Co-pay | Active comparator | Other: Reminder (information letter)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. |
| GP-Co-pay | Active comparator | Other: Reminder (information letter)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. |
| Control treatment | No intervention | –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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals living in households (postal address) with more than three individuals aged 55 and above.
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 |
|---|---|---|
| Reminder (information letter)Reminders | Other | Basic letter, Co-pay, GP-Co-pay |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No. 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.
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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.
Lauri Sääksvuori, PhD principal investigator
Finnish Institute for Health and Welfare and University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder (information letter) in people with Health Care Utilization and Health Care Seeking Behavior, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 3 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: finished, as of the sponsor's last update on 26 Aug 2022. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2022.