NCT05117333

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47,398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

October 5, 2021

Last Update Submit

August 23, 2022

Conditions

Keywords

Cost-sharing, primary care, health care utilization

Outcome Measures

Primary Outcomes (2)

  • Number of nurse visits (as recorded in the Finnish National Register of Primary Health Care Visits)

    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)

    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)

    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)

    Six months starting from the date the letters are sent

Study Arms (4)

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.

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.

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.

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.

Interventions

Reminders

Basic letterCo-payGP-Co-pay

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals living in households (postal address) with more than three individuals aged 55 and above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute for Health and Welfare

Helsinki, 00271, Finland

Location

MeSH Terms

Conditions

Patient Acceptance of Health CareHealth Behavior

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceBehavior

Study Officials

  • Lauri Sääksvuori, PhD

    Finnish Institute for Health and Welfare and University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 5, 2021

First Posted

November 11, 2021

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

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.

Locations