Testing an individualised digital decision assist system for the diagnosis and management of mental and behavior disorders in children and adolescents
| ISRCTN | ISRCTN12094788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12094788 |
| Secondary identifying numbers | 269117 |
- Submission date
- 01/04/2020
- Registration date
- 08/04/2020
- Last edited
- 16/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
In Norway, 10-20% of the child and adolescent population have impairing mental health disorders. While many of these illnesses are single episodes that resolve, they can become chronic, or even lifelong conditions. Early evaluations, diagnosis, and treatment are critical to shortening single episodes of care, reducing possible comorbidity and long-term disability. Approximately 29% of child and adolescent mental diagnoses in Norway are Attention Deficit Hyperactivity Disorder (ADHD). It is a common disorder with high levels of comorbidity and nearly 2/3 of affected individuals have symptoms that persist into adulthood.
The Individualized Digital Decision Assist System (IDDEAS) is a new clinical decision support system (CDSS) for child and adolescent mental health services in Norway. CDSSs are technological advances that are designed to enhance clinical care –including evaluation, diagnosis, and treatment– by providing clinicians with step-by-step guidance, through a user-interface on their computer. The support provided by the system is based on standardized guidelines, big-data sets, and data from patient electronic health records. The IDDEAS system focuses on preventive care, early diagnostics and early intervention, as well as treatment and case management for ADHD in children and adolescents to start with. Later it will be expanded to other mental disorders. The system uses the latest clinical guidelines and Norwegian health datasets, along with data from the individual patient electronic health record, to present the clinician with evidence-based guidance in real-time. The project is developed from a service-user perspective to help develop a potential model for other future CDSS implementation and will serve as an important learning opportunity for the field and the healthcare system.
The study aims to improve the quality, competency and efficiency of child and adolescent mental health services by supporting diagnosis and treatment planning decision making with use of the IDDEAS clinical decision support system, during clinical care in real-time.
Who can participate?
Child and adolescent psychologists and psychiatrists working in CAMHS in 6 randomly selected child and adolescent mental health clinics located around Norway.
What does the study involve?
The study involves the design, modelling, development and mixed-method evaluation of IDDEAS. The participants will evaluate the system’s usability, acceptability, validity and utility in a non-live and a live setting.
What are the possible benefits and risks of participating?
The main possible benefit of the study is the provision of decision support for clinicians in real-time during clinical sessions and improvement of clinical care. There are no major risks for clinicians taking part in the study. The main possible risk is the protection of data used in the system, which will be accounted for by following formal data protection procedures, including completion of a data privacy impact assessment (DPIA) to minimize these risks.
Where is the study run from?
NTNU - Regionalt kunnskapssenter for barn og unge - psykisk helse og barnevern (RKBU Midt-Norge) (Norway)
When is the study starting and how long is it expected to run for?
August 2020 to December 2023
Who is funding the study?
The Research Council of Norway (Norges forskningsråd)
Who is the main contact?
Prof. Norbert Skokauskas, norbert.skokauskas@ntnu.no
Contact information
Scientific
RKBU Midt-Norge
NTNU
Klostergata 46
Trondheim
7030
Norway
| Phone | +47 73558973 |
|---|---|
| norbert.skokauskas@ntnu.no |
Study information
| Study design | Mixed-methods study |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Individualised Digital DEcision Assist System (IDDEAS) for the diagnosis and management of mental and behavior disorders in children and adolescents |
| Study acronym | IDDEAS |
| Study hypothesis | Providing clinicians with access to a real-time clinical decision support system will improve their clinical practices, including adherence to care guidelines, with respect to diagnosis and treatment of child and adolescent mental health disorders. |
| Ethics approval(s) | The Regional Committees for Medical and Health Research Ethics, South East (REK, Sør-Øst) has assessed the IDDEAS application on the 9th of October 2019, concluding that “the project falls outside the scope of the Health Research Act, cf. section 2, and can therefore be implemented without approval of REK.” (+ 47 22 84 55 02; post@helseforskning.etikkom.no), ref: 2018/2186 |
| Condition | Child and adolescent mental health health disorders |
| Intervention | The Individualized Digital Decision Assist System (IDDEAS) is a new clinical decision support system (CDSS) for child and adolescent mental health services in Norway. CDSSs are technological advances that are designed to enhance clinical care –including evaluation, diagnosis, and treatment– by providing clinicians with step-by-step guidance, through a user-interface on their computer. The support provided by the system is based on standardized guidelines, big-data sets, and data from patient electronic health records. The IDDEAS system focuses on preventive care, early diagnostics and early intervention, as well as treatment and case management for ADHD in children and adolescents to start with. Later it will be expanded to other mental disorders. The system uses the latest clinical guidelines and Norwegian health datasets, along with data from the individual patient electronic health record, to present the clinician with evidence-based guidance in real-time. The project is developed from a service-user perspective to help develop a potential model for other future CDSS implementation and will serve as an important learning opportunity for the field and the healthcare system. Child and adolescent psychologists and psychiatrists representing four randomly selected child and adolescent mental health clinics around Norway will participate. The participants will evaluate the system’s usability, acceptability, validity and utility in a non-live and a live setting; in the non-live evaluation 10 fictional clinical case vignettes will be appraised and in the live evaluation 7 standard patient-encounter videos will be assessed with and without the use of the IDDEAS system. |
| Intervention type | Other |
| Primary outcome measure | Clinical Utility of the IDDEAS CDSS for diagnosis and treatment of child is measured by reviewing the participant’s clinical diagnosis and treatment plan responses as a measure of sensitivity and specificity with the use of the CDSS compared to without the CDSS upon completion of the non-live evaluation and the live evaluation |
| Secondary outcome measures | 1. Perceived clinical usability of the CDSS is measured using the system usability scale (SUS) directly following the evaluation (within 24 hours) 2. Perceived clinical relevance and validity of the system’s user-interface content is measured using the content validity index (CVI) directly following the evaluation (within 24 hours) 3. Perceived appropriateness of the CDSS is measured using the User-Engagement Scale (UES) directly following the evaluation (within 24 hours) |
| Overall study start date | 01/01/2018 |
| Overall study end date | 30/12/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | Child and adolescent psychologists and psychiatrists working in CAMHS |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/08/2020 |
| Recruitment end date | 01/08/2023 |
Locations
Countries of recruitment
- Norway
Study participating centre
Trondheim
7030
Norway
Sponsor information
University/education
1327 Lysaker
Oslo
564
Norway
| Phone | +47 22037000 |
|---|---|
| post@forskningsradet.no | |
| Website | https://www.forskningsradet.no |
"ROR" |
https://ror.org/00epmv149 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | 01/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Papers will be submitted for publication in line with the progression of the study and information will be disseminated to the academic community, healthcare professionals, and the general public. IDDEAS recognises the value of both the Golden Road and Green Road for publication and dissemination. The IDDEAS will use both routes for sharing information about the development and implementation of CHASE. CHASE will target peer-reviewed publications in major international journals: European Journal of Child and Adolescent Psychiatry, Lancet Psychiatry, Journal of the American Academy of Child & Adolescent Psychiatry. The dissemination plan also includes the following presentations at conferences, congresses, workshops, and other events, including: World Psychiatry Congresses, European World Psychiatry Congress, European ADHD meetings, Medical Informatics Europe Conference, MEDINFO: World conference on medical informatics. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/09/2020 | 21/09/2020 | Yes | No |
| Other publications | Article | 15/12/2020 | 16/02/2022 | Yes | No |
| Other publications | Editorial | 01/05/2021 | 16/02/2022 | Yes | No |
| Other publications | Review article | 10/04/2017 | 16/02/2022 | Yes | No |
| Other publications | Systematic review | 01/11/2017 | 16/02/2022 | Yes | No |
| Abstract results | 01/10/2021 | 21/02/2022 | No | No | |
| Other publications | article in Dagens medisin | 05/05/2021 | 21/02/2022 | Yes | No |
| Other publications | patient awareness, attitudes, and opinions about EHR data storage and sharing | 16/03/2022 | 16/03/2022 | Yes | No |
Editorial Notes
16/03/2022: Publication reference added.
21/02/2022: Publication references added.
16/02/2022: Publication references added.
21/09/2020: Publication reference added.
07/04/2020: Trial’s existence confirmed by Regional Committees for Medical and Health Research Ethics, South East (REK, Sør-Øst).
