GuideMe - An evaluation project in school health services
| ISRCTN | ISRCTN24173836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24173836 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RCN Project Number: 320097 |
| Sponsor | The Research Council of Norway |
| Funders | Norges Forskningsråd, Regionsenter for barn og unges psykiek helse Øst og Sør, Norges Teknisk-Naturvitenskapelige Universitet(Norwegian University of Science and Technology), VID Specialized University |
- Submission date
- 09/07/2022
- Registration date
- 08/08/2022
- Last edited
- 07/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A national guideline with best practice recommendations for school health services in Norway was launched in 2017. To promote healthy life skills and identify students in need of follow-up, the guideline strongly recommends individual consultations with all 8th graders and increased cooperation with schools. Implementation of guidelines and practice change is a challenge in many sectors. Researchers have therefore co-created an implementation tool (SchoolHealth) together with practitioners, students, and other stakeholders consisting of three discrete implementation strategies:
1. Digital dialogue and administration tool
2. Dialogue support
3. School cooperation
The overall objectives of the current study are to help the service implement the guideline recommendations and reach its goals. The study expects to increase knowledge about effective implementation mechanisms and adolescent user pathways in health and welfare services.
The project will evaluate and optimize the SchoolHealth tool by studying the three strategies’ effectiveness on guideline fidelity and the extent to which fidelity helps reach guideline goals by using a hybrid evaluation design with a factorial experiment. We will also compare SchoolHealth with a similar Danish tool. In order to understand the importance of participation in the study over time, data received from pupils will be linked with data from national patient and population registers. Data collected will also be compared with existing population-based studies in Norway and Denmark.
Who can participate?
Students, school nurses and school personnel
What does the study involve?
The schools will be randomly selected to test different combinations of these three components. This means that a school gets none, one or more of the components. Regardless of the experimental group, participants will complete questionnaires at baseline, after the 8th-grade consultation, and 6 months post-consultation. Students, school nurses, and school personnel will be invited to individual and focus group interviews after consultations. By participating in the study, the informants will help with identifying successful strategies for implementing a guideline that can support adolescents in a life phase vital for future health and wellbeing. If successful, SchoolHealth will facilitate health promotion in schools, more effective youth services and systematic cooperation with schools The study will yield valuable knowledge about implementation strategies and service use, increase evidence-based practice, and promote cooperation between Nordic countries.
What are the possible benefits and risks of participating?
The risks of participating in the study are small because individual consultations with all 8th-grade students and cooperation with schools are part of the school nurse’s ordinary job. The aim of the study is to support this work. Thus, some school nurses may be more skilled and supported in implementing the 8th-grade health consultation and cooperate systematically with the school. Each participant will be asked to answer questions about implementation and user satisfaction. Students will also be asked about their mental health, quality of life and health behaviour, which may cause a degree of discomfort. However, all students will have an individual consultation with the school nurse. In addition, all students will be encouraged to contact the school nurse if they feel worried after answering the questions.
Where is the study run from?
The Regional Center for Child and Adolescent Mental Health, Eastern and Southern Norway (Regionsenter for barn og unges psykiek helse Øst og Sør; Norway)
When is the study starting and how long is it expected to run for?
June 2021 to May 2026
Who is funding the study?
The Research Council of Norway (Norges Forskningsråd; Norway)
Who is the main contact?
Dr Åse Sagatun National project manager (Norway)
aase.sagatun@r-bup.no
Contact information
Scientific
Regional Center for Child and Adolescent Mental Health
Eastern and Southern Norway
Askeladdveien 1
Oslo
NO-0852
Norway
| Phone | +47 91919946 |
|---|---|
| aase.sagatun@r-bup.no |
Scientific
Regional Center for Child and Adolescent Mental Health
Eastern and Southern Norway
Bekkestuveien 10
Bekkestua
NO-1357
Norway
| Phone | +47 9317779 |
|---|---|
| solveig.holen@r-bup.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter hybrid-design randomized factorial-experiment population-based study |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Guideline effectiveness and implementation mechanisms in school health services |
| Study acronym | GuideMe |
| Study objectives | Primary research questions: 1. What is the effectiveness of elements in the SchoolHealth tool on fidelity to the recommendations for: 1.1. The individual 8th-grade consultations (consultations completed, recommended topics addressed, user involvement, quality, and adaptations)? 1.2. Cooperation with schools (e.g., systematic cooperation, nurses teaching in groups or classes, tailored group interventions in collaboration with schools)? 2. What is the effectiveness of elements in the SchoolHealth tool on: 2.1. The school nurses' work-related self-efficacy and relations with students? 2.2. Assisting school nurses in identifying vulnerable students? 2.3. Student's health literacy, general self-efficacy, health behavior and quality of life? 2.4. School climate and student's school attendance? 2.5. How are possible effects mediated by fidelity to the guideline? Secondary research questions: 3. What are the differences/similarities between the SchoolHealth tool and the equivalent Danish dialogue tool? 4. Regarding self-reported health status: 4.1. What are the associations between self-reported health status and user pathways in health- and welfare services in Norway (contacts with primary and secondary health care)? 4.2. How is self-reported health associated with use of the school health services in Norway and Denmark? 5. Regarding implementation elements: 5.1. How are implementation elements, implementation determinants, and guideline fidelity associated? 5.2. How are implementation elements, organizational- and implementation climate, perceptions about the guideline, and implementation leadership associated with guideline fidelity and effects? 6. Based on the results of the study; what are the cost-benefit of the optimized version of the SchoolHealth tool? We will also document and publish experiences with co-creating the SchoolHealth tool and designing the study, as well as use and user experiences with the SchoolHealth web dialogue |
| Ethics approval(s) | Approved 15/02/2022, Regional Committees for Medical and Health Research Ethics South (REK) and East C (Gullhaugveien 1-3, 0484 Oslo, Norway; +47 22 84 55 11; rek-sorost@medisin.uio.no), ref: 397998. The Regional Ethics Review Board concluded that the study does not require ethics approval as it falls outside the scope of the Health Research Act, cf. section 2, under Norway's law. |
| Health condition(s) or problem(s) studied | Promotion of the life skills, health and quality of life in 8th-grade students, and the identification of students in need of follow-up |
| Intervention | The ‘SchoolHealth’ tool consists of the following three components: 1. Web dialogue: A digital health information form that pupils complete before their health-promoting consultations. Pupils answer questions about their health and health habits, such as screen use and well-being at school, as well as questions about stressful life events. The school nurses can access the forms in connection with their day-to-day work. Summarised, anonymous reports are generated on areas that schools and the school health services can cooperate about, such as screen use, well-being at school, health and health habits. 2. Dialogue guide: A competence development package for school nurses, where the aim is to improve the quality of the health dialogue with 1st-year pupils in lower secondary school. 3. School cooperation: A competence development package for teachers, head teachers and school nurses, where the aim is to strengthen their cooperation. The schools will be randomly selected to test different combinations of these three components. This means that a school gets none, one or more of the components. The different combinations constitute eight different experimental groups. The randomisation process will be done in R statistical software. A school participates for one school year and 40 schools will be invited over a two-school year period. A total of about 2000 students, 70 nurses and 60 school personnel will be invited. Data collection in schools will start in autumn 2022 and end in spring 2024. Students, school nurses, and school personnel will complete questionnaires at baseline, after the 8th-grade consultation, and 6 months post-consultation. Students, school nurses, and school personnel will be invited to individual and focus group interviews after consultations. In Denmark, we will conduct focus group interviews with school nurses, school personnel, and teams implementing BørnUngeLiv.dk. We will also conduct individual interviews with school nurses and school personnel. Linking of data with the national register will be done before December 2032. Then all personally identifiable information will be deleted. Associations between self-reported health status, intervention group and user pathways in health- and welfare services will be investigated by linking student questionnaires in the current study with national register data follow-up (e.g., follow-up by the school health services, the general practitioner and referrals to outpatient clinics). To compare self-reported health and use of the school health service, data from the current study will be compared with existing population studies in Norway (UngHUNT) and Denmark (BørnUngeLiv.dk). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Fidelity to recommendations in the guideline will be indexed by three constructs: Adherence to guidelines, adaptations to guidelines, and quality in using guidelines. Questions are tailored according to the National guideline for school health services |
| Key secondary outcome measure(s) |
1. Differences/similarities between SchoolHealth and the equivalent Danish dialog tool (BørnUngeLiv.dk) measured using qualitative semi-structured focus group interviews with school nurses and personnel implementing BørnUngeLiv.dk, and individual interviews with school nurses and school personnel in Denmark and Norway between timepoint T2 and T3 |
| Completion date | 31/05/2026 |
Eligibility
| Participant type(s) | Health professional, Learner/student, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 1725 |
| Key inclusion criteria | 1. Normal population of 8th-grade students (aged 13 to 14 years old) 2. Public health nurses in the School health service (aged 23 to 70 years old) 3. Upper secondary school personnel/teachers (aged 23 to 70 years old) |
| Key exclusion criteria | Students who for any reason are not able to answer the questions in the web-based health information form |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Norway
Study participating centres
Nydalen
Oslo
NO- 0405
Norway
Trondheim
NO-7491
Norway
Oslo
NO-0319
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 15/11/2023 | 16/11/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/06/2024: The overall study end date was changed from 31/05/2025 to 31/05/2026.
16/11/2023: Publication reference added.
02/09/2022: Internal review.
26/07/2022: Trial's existence confirmed by the Research Council of Norway.