Who Benefit From School Doctors' Health Checks?

School Health Services Clinical Trial

Official title:

Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178331
• Other study ID #: HUS/2174/2017
• Status: Completed
• Start date: August 22, 2017
• Est. completion date: June 26, 2023

Study information

• Verified date: May 2024
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: June 26, 2023
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

Grade 1 and grade 5 children

Exclusion Criteria:

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

Related Conditions & MeSH terms

• School Health Services

Intervention

Other:
• Study questionnaires
filled by parents, school nurse and teacher

Locations

Country	Name	City	State
Finland	School and Student Health Services	Helsinki
Finland	School and Student Health Services	Kerava
Finland	School and Student Health Services	Kirkkonummi
Finland	School and Student Health Services	Tampere

Sponsors (8)

Lead Sponsor	Collaborator
University of Helsinki	City of Helsinki, Finnish Foundation for General Practice, Foundation for Paediatric Research, Finland, General Practitioners in Finland, Network of Academic Health Centres, Finland, Päivikki and Sakari Sohlberg Foundation, Finland, Pediatric Research Center, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for a school doctor's health check	The need for a school doctor's health check according to the study questionnaires filled by parents, nurse and teacher.; Areas of concern in study questionnaires: growth, physical symptom, hearing, school absenteeism, learning, concentration, behavior, emotions, getting on with others, eating, sleeping, wellbeing of family, free description of concern, wish to talk about concerns with the school doctor; The responses will be categorized into three groups: 1) "Needs doctor's health check" 2) "No need for doctor's health check and 3) "Consultation of the nurse or doctor may be sufficient".	Baseline
Primary	The benefit/harm of school doctors' routine health checks	A seven point likert scale that is based on: Measures from the doctor's electronic report: instruction, other significant discussion, referral to laboratory test/physiotherapist/speech therapist/nutritionist/secondary care, guidance to or contact of a specialised worker or other unit: teacher/special education teacher/school psychologist/school social worker/health center/family guidance center/home service/child welfare, prescription, medical imaging, individual follow-up plan; School doctor's evaluation of benefit/harm; Patient reported experience measures (PREM) of benefit/harm by child and parent	Baseline
Secondary	Interventions and plans arising from school doctors' routine health checks	Measures from the doctor's electronic report: instruction, other significant discussion, referral to laboratory test/physiotherapist/speech therapist/nutritionist/secondary care, guidance to or contact of a specialised worker or other unit: teacher/special education teacher/school psychologist/school social worker/health center/family guidance center/home service/child welfare, prescription, medical imaging, individual follow-up plan	Baseline
Secondary	The implementations of the school doctors' follow-up plans	The implementations of measures from the doctor's electronic report (yes, no, information not accessible): instruction, referral to laboratory test/physiotherapist/speech therapist/nutritionist/secondary care, guidance to or contact of a specialised worker or other unit: teacher/special education teacher/school psychologist/school social worker/health center/family guidance center/home service/child welfare, prescription, medical imaging, individual follow-up plan	12 months