Clinical trial NCT03178331: Who Benefit From School Doctors' Health Checks?
Official title: Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: School Health Services
Keywords: Children
Student
Questionnaires
Screening
Health check
School health services
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Päivikki and Sakari Sohlberg Foundation, Finland
name: City of Helsinki
name: Finnish Foundation for General Practice
name: General Practitioners in Finland
name: Network of Academic Health Centres, Finland
name: Foundation for Paediatric Research, Finland
name: Pediatric Research Center, University of Helsinki
First posted: 2017-06-06
Enrollment: 1013
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Finnish public primary schools from four urban municipalities (Helsinki, Tampere, Kirkkonummi and Kerava) in Southern Finland

Brief summary: The aims of the study are 1) to evaluate the potential benefits or harm of school doctors' routine health checks and 2) to explore whether part of the school doctors' routine health checks can be omitted using study questionnaires which address the parents', school nurses' and teachers' concerns regarding each child.

Detailed description: The aim is to include 4 cities, 21 schools, 14 doctors and 1050 children from Southern Finland. From each doctor the aim is to get 25 children from both grades 1 and 5 (at ages 7 and 11) from 1-2 schools. Before the school doctor's check-up, the parents, nurses and teachers fill a questionnaire to identify any potential concerns about each child. The questions were partly chosen from the Strengths and Difficulties Questionnaire (SDQ). Additional questions concerning the child's growth, physical well-being, learning, school absenteeism and the well-being of the whole family are included. The doctor is blinded to the answers of the questionnaires. After the health check the doctors fill an electronic report including any instructions given, significant discussions and follow-up plans and their estimate of the potential benefit or harm of the medical appointment. The child and the parent fill patient-reported experience measure (PREM) forms where they evaluate the benefit or harm of the health check. The researchers compare the need for a doctor's appointment to the benefit gained. At one year after the check-up, the implementations of the follow-up plans are analyzed.

A data balance sheet has been prepared. The coordinating ethics committee of the Hospital District of Helsinki and Uusimaa (HUS) has approved the study protocol. Permissions for the study from the Department of Social Services and Healthcare and the Department of Education from all participating cities have been obtained. Informed consent will be obtained from all participating children, parents, doctors, nurses and teachers.

Eligibility criteria: Inclusion Criteria:

Grade 1 and grade 5 children

Exclusion Criteria:

Children studying mainly in special education groups or the need of an interpreter

Primary outcomes:
measure: The need for a school doctor's health check
timeFrame: Baseline
measure: The benefit/harm of school doctors' routine health checks
timeFrame: Baseline
Secondary outcomes:
measure: Interventions and plans arising from school doctors' routine health checks
timeFrame: Baseline
measure: The implementations of the school doctors' follow-up plans
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: School and Student Health Services
city: Kerava
country: Finland
facility: School and Student Health Services
city: Kirkkonummi
country: Finland
facility: School and Student Health Services
city: Tampere
country: Finland
facility: School and Student Health Services
Study officials:
affiliation: Doctoral School in Health Sciences, University of Helsinki, Finland
name: Kirsi M Nikander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pikkujätti Medical Centre for Children and Youth, Finland
name: Elina Hermanson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Hospital and University of Helsinki, Finland
name: Silja Kosola, MD, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Helsinki, Finland
name: Minna Kaila, Professor
role: STUDY_CHAIR
References:
citation: Nikander K, Hermanson E, Vahlberg T, Kaila M, Kosola S. Parent, teacher, and nurse concerns and school doctor actions: an observational study of general health checks. BMJ Open. 2022 Nov 15;12(11):e064699. doi: 10.1136/bmjopen-2022-064699.
citation: Nikander K, Kosola S, Vahlberg T, Kaila M, Hermanson E. Associating school doctor interventions with the benefit of the health check: an observational study. BMJ Paediatr Open. 2022 Feb;6(1):e001394. doi: 10.1136/bmjpo-2021-001394.
citation: Nikander K, Hermanson E, Vahlberg T, Kaila M, Sannisto T, Kosola S. Associations between study questionnaire-assessed need and school doctor-evaluated benefit of routine health checks: an observational study. BMC Pediatr. 2021 Aug 16;21(1):346. doi: 10.1186/s12887-021-02810-0.
citation: Nikander K, Kosola S, Kaila M, Hermanson E. Who benefit from school doctors' health checks: a prospective study of a screening method. BMC Health Serv Res. 2018 Jun 27;18(1):501. doi: 10.1186/s12913-018-3295-3.