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Clinical Trials/NCT04652154
NCT04652154
Enrolling by Invitation
N/A

Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"

Haukeland University Hospital1 site in 1 country100 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Care Utilization
Sponsor
Haukeland University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Contentment with the intervention - Parents
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Contentment with the intervention - Parents

Time Frame: Through study completion, an average of 2 years

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.

Contentment with the intervention - Patient

Time Frame: Through study completion, an average of 2 years

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.

Contentment with the intervention - Professionals

Time Frame: Through study completion, an average of 2 years

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.

Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år

Time Frame: 1 year after the intervention

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.

Mental health status

Time Frame: 2 year after the intervention

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.

Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år

Time Frame: Baseline

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.

Secondary Outcomes

  • Contact with specialist healthcare(1 year after the intervention after the intervention)

Study Sites (1)

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