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临床试验/NCT04652154
NCT04652154Unknown不适用

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

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Contentment with the intervention - Parents

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Not within age range
  • Less than 3 referrals

研究组 & 干预措施

Control

Other

Control group is recieving treatment as ususal

干预措施: Transitioning young patients' health care trajectories (Other)

Intervention group

Experimental

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

干预措施: Transitioning young patients' health care trajectories (Other)

结局指标

主要结局

Contentment with the intervention - Parents

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

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

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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