Transitioning Young Patients' Health Care Trajectories

February 20, 2024 updated by: Haukeland University Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway, 5021
        • Haukeland universitet sykehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Control group is recieving treatment as ususal
New intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child
Experimental: Intervention group
The intervention group getting the new assessment by a complementary professional team
New intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years
Contentment with the intervention - Parents
Time Frame: Baseline
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
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.
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years
Mental health status
Time Frame: Baseline
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
Mental health status
Time Frame: 1 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.
1 year after the intervention
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.
2 year after the intervention
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.

Baseline
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.

1 year after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contact with specialist healthcare
Time Frame: 1 year after the intervention after the intervention
Post evaluation of use of health services - numbers of new referrals
1 year after the intervention after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Hans Olav Instefjord, Master, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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