Child, Only Clinical Trial
Official title:
Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"
Verified date | February 2023 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland universitet sykehus | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
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. — View 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. eCollecti — View 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. — View 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. — View 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/s12 — View 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- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Contentment with the intervention - Patient | Patient evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Patient)" with two items and for each item has a score 1-4 and 4 is most positive. | Through study completion, an average of 2 years | |
Primary | Contentment with the intervention - Parents | Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive. | Baseline | |
Primary | Contentment with the intervention - Parents | Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive. | Through study completion, an average of 2 years | |
Primary | Contentment with the intervention - Professionals | Professionals evaluate the intervention - A questionnaire for the study has been developed Usefulness of the TpT intervention with two items and score for each item has 1-4 and 4 is most positive. | Through study completion, an average of 2 years | |
Primary | Mental health status | Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems. | Baseline | |
Primary | Mental health status | Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems. | 1 year after the intervention | |
Primary | Mental health status | Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems. | 2 year after the intervention | |
Primary | Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år | Using KIDSCREEN-27 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items).
Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome. |
Baseline | |
Primary | Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år | Using KIDSCREEN-10 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items).
Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome. |
1 year after the intervention | |
Secondary | Contact with specialist healthcare | Post evaluation of use of health services - numbers of new referrals | 1 year after the intervention after the intervention |
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