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

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
Control group is recieving treatment as ususal
Other: Transitioning young patients' health care trajectories
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
Other: Transitioning young patients' health care trajectories
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haukeland University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bergen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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