Transitioning Young Patients' Health Care Trajectories

Sponsor
Haukeland University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04652154
Collaborator
University of Bergen (Other)
50
1
2
62.9
0.8

Study Details

Study Description

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 6-12 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 two years follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.

Condition or Disease Intervention/Treatment Phase
  • Other: Transitioning young patients' health care trajectories
N/A

Detailed Description

200 children with multi-referrals will be invited and randomised 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 and 24 mth.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomised to either intervention or treatment as usualParticipants are randomised to either intervention or treatment as usual
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Contentment with the intervention - Patient [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.

  2. Contentment with the intervention - Parents [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.

  3. Contentment with the intervention - Parents [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.

  4. Contentment with the intervention - Professionals [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.

  5. Mental health status [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.

  6. Mental health status [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.

  7. Mental health status [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.

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

  9. Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år [1year after the intervention]

    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.

  10. Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år [2 years after the intervention]

    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 Outcome Measures

  1. Contact with specialist healthcare [1 year after the intervention and 2 year after the intervention]

    Post evaluation of use of health services - numbers of new referrals

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haukeland universitet sykehus Bergen Norway 5021

Sponsors and Collaborators

  • Haukeland University Hospital
  • University of Bergen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT04652154
Other Study ID Numbers:
  • 2018/344
First Posted:
Dec 3, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 8, 2021