Clinical trial NCT04652154: Transitioning Young Patients' Health Care Trajectories
Official title: Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Care Utilization
Mental Health Impairment
Child, Only
Multi-morbidity
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2020-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are invited to either intervention or treatment as usual
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services.

In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes:

* To implement the new team intervention in a clinical case-control study
* To scientifically evaluate the intervention
* To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.

Detailed description: 200 children with multi-referrals will be invited to either intervention or treatment as usual at their third or more referral to Haukeland university hospital.

In the intervention group the child and family will meet a complementary team of professionals for more than two hours aimimg to get a clarification of the patient's condition and giving coping strategies for their condition. Outcome defined as better mental health and quality of life as well as increased school attendence are some of the measures being collected. These outcomes will be compared to the control group after 12 mth.

Eligibility criteria: Inclusion Criteria:

* Age 6-16 years,
* Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.

Exclusion Criteria:

* Not within age range
* Less than 3 referrals

Primary outcomes:
measure: Contentment with the intervention - Patient
timeFrame: Through study completion, an average of 2 years
measure: Contentment with the intervention - Parents
timeFrame: Baseline
measure: Contentment with the intervention - Parents
timeFrame: Through study completion, an average of 2 years
measure: Contentment with the intervention - Professionals
timeFrame: Through study completion, an average of 2 years
measure: Mental health status
timeFrame: Baseline
measure: Mental health status
timeFrame: 1 year after the intervention
measure: Mental health status
timeFrame: 2 year after the intervention
measure: Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år
timeFrame: Baseline
measure: Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år
timeFrame: 1 year after the intervention
Secondary outcomes:
measure: Contact with specialist healthcare
timeFrame: 1 year after the intervention after the intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland universitet sykehus
Study officials:
affiliation: Haukeland University Hospital
name: Hans Olav Instefjord, Master
role: STUDY_CHAIR
References:
citation: Elgen I, Lygre RB, Arli A, Heggestad T. An interdisciplinary intervention for children with complex health complaints; a feasibility study of selection criteria. Front Pediatr. 2023 Sep 14;11:1167528. doi: 10.3389/fped.2023.1167528. eCollection 2023.
citation: Elgen I, Heggestad T, Tronstad R, Greve G. Bridging the Gap for Children With Compound Health Challenges: An Intervention Protocol. Front Pediatr. 2021 Dec 22;9:721926. doi: 10.3389/fped.2021.721926. eCollection 2021.
citation: Heggestad T, Greve G, Skilbrei B, Elgen I. Complex care pathways for children with multiple referrals demonstrated in a retrospective population-based study. Acta Paediatr. 2020 Dec;109(12):2641-2647. doi: 10.1111/apa.15250. Epub 2020 Apr 17.
citation: Elgen I, Lygre R, Greve G, Griffiths S, Heggestad T. Interdisciplinary Approaches Suggested for Children With Multiple Hospital Referrals Presenting With Non-specific Conditions. Front Pediatr. 2021 Apr 7;9:656939. doi: 10.3389/fped.2021.656939. eCollection 2021.
citation: Lygre RB, Gjestad R, Norekval TM, Mercer SW, Elgen IB. An interdisciplinary intervention for children and adolescents with multiple referrals and complex health complaints: a feasibility study. BMC Health Serv Res. 2023 Nov 11;23(1):1241. doi: 10.1186/s12913-023-10250-y.
citation: Lygre RB, Thuen VM, Gjestad R, Norekval TM, Greve G, Mildestvedt T, Elgen IB. How can we improve specialist health services for children with multi-referrals? Parent reported experience. BMC Health Serv Res. 2020 Aug 24;20(1):786. doi: 10.1186/s12913-020-05666-9.