Transitioning Young Patients' Health Care Trajectories

NCT04652154 | Unknown

• 1 other identifier: 2018/344
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Utilization; Mental Health Impairment; Child, Only; Multi-morbidity

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Contact with specialist healthcare

  1 year after the intervention after the intervention

Study Arms (2)

Control

OTHER

Control group is recieving treatment as ususal

Other: Transitioning young patients' health care trajectories

Intervention group

EXPERIMENTAL

The intervention group getting the new assessment by a complementary professional team

Other: Transitioning young patients' health care trajectories

Interventions

Transitioning young patients' health care trajectories OTHER

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

Control; Intervention group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-16 years,
• Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.

You may not qualify if:

• Not within age range
• Less than 3 referrals

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland universitet sykehus

Bergen, 5021, Norway

Location

Related Publications (6)

• 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.

  PMID: 37780046 RESULT

• 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.

  PMID: 35004532 RESULT

• 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.

  PMID: 32159873 RESULT

• 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. eCollection 2021.

  PMID: 33898364 RESULT

• 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/s12913-023-10250-y.

  PMID: 37951903 RESULT

• 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/s12913-020-05666-9.

  PMID: 32831078 RESULT

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hans Olav Instefjord, Master

  Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are invited to either intervention or treatment as usual

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: December 3, 2020
• Study Start: February 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)