Who Benefit From School Doctors' Health Checks?

Sponsor
University of Helsinki (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03178331
Collaborator
Päivikki and Sakari Sohlberg Foundation, Finland (Other), City of Helsinki (Other), Finnish Foundation for General Practice (Other), General Practitioners in Finland (Other), Network of Academic Health Centres, Finland (Other), Foundation for Paediatric Research, Finland (Other), Pediatric Research Center, University of Helsinki (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Study questionnaires

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1013 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
Actual Study Start Date :
Aug 22, 2017
Actual Primary Completion Date :
Aug 31, 2018
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Grade 1 children

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

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

Grade 5 children

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

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

Outcome Measures

Primary Outcome Measures

  1. The need for a school doctor's health check [Baseline]

    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".

  2. The benefit/harm of school doctors' routine health checks [Baseline]

    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

Secondary Outcome Measures

  1. Interventions and plans arising from school doctors' routine health checks [Baseline]

    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

  2. The implementations of the school doctors' follow-up plans [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Grade 1 and grade 5 children

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School and Student Health Services Helsinki Finland
2 School and Student Health Services Kerava Finland
3 School and Student Health Services Kirkkonummi Finland
4 School and Student Health Services Tampere Finland

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Kirsi M Nikander, MD, Doctoral School in Health Sciences, University of Helsinki, Finland
  • Study Director: Elina Hermanson, MD, PhD, Pikkujätti Medical Centre for Children and Youth, Finland
  • Study Director: Silja Kosola, MD, PhD, Helsinki University Hospital and University of Helsinki, Finland
  • Study Chair: Minna Kaila, Professor, Faculty of Medicine, University of Helsinki, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirsi Nikander, Principal Investigator, University of Helsinki
ClinicalTrials.gov Identifier:
NCT03178331
Other Study ID Numbers:
  • HUS/2174/2017
First Posted:
Jun 6, 2017
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kirsi Nikander, Principal Investigator, University of Helsinki

Study Results

No Results Posted as of Mar 29, 2022