跳至主要内容
临床试验/NCT04862897
NCT04862897招募中不适用

Patient-controlled Admissions to Inpatient Care for Patients With Severe Psychiatric Conditions in Region Stockholm

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 564 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
564
试验地点
1
主要终点
Days in involuntary care

研究概览

简要总结

Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having the healthcare providers make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels, and increase quality of life and autonomy for the patient. The current research project aims to evaluate the implementation of patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care).

详细描述

Patients with severe psychiatric conditions represent a group who have extensive care needs and for whom few effective interventions exist. Diagnoses such as schizophrenia and borderline personality disorder usually have a poor prognostic outlook in terms of recovery, and patients often suffer from life-long disabilities. Meanwhile, their healthcare expenditures are typically high. In case of increased symptoms and novel sickness spells, healthcare providers make an assessment if admission to inpatient care is needed. This gatekeeper-model is typical of most western countries and infers that the decision to be admitted is always made by a third party. Since about a decade, attempts at transferring the responsibility of admissions to patients themselves is being implemented and tested in several countries and contexts, referred to as patient-controlled admissions. The idea is to increase patient involvement, enhance self-determination, and improve their ability to manage signs of illness. Patient-controlled admissions involve signing an agreement between inpatient care, outpatient care, and those patients that are deemed to have the highest care needs, whereby the patients can contact an inpatient ward and be admitted when required. Previous research has revealed that patient-controlled admissions decrease involuntary admissions and that both healthcare providers and patients are positive towards its use. These studies have however been small and used limited outcome measures. The current research project aims to study the results of implementing patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care). Apart from determining the possible impact on both number of admissions and days in admission (voluntary and involuntary), other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions, self-report measures will be used to assess the effects on symptom levels, quality of life, and autonomy. A matched control group (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions) will also be utilised to determine the effects of patient-controlled admissions on all primary outcomes measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have an on-going contact with outpatient care.
  • Have an individual care plan and crisis plan.
  • Have had at least one inpatient care period the previous year.
  • Are expected to have the greatest need of inpatient care.
  • Are interested in, and understand the concept of, patient-controlled admissions.

排除标准

  • No informed consent to participate in the research project (concerns only self-reported outcomes).
  • Matched control group:
  • - A matched control group consisting of seven times the number of of patients receiving patient-control admissions will be utilised for all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed prescriptions (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions)

结局指标

主要结局

Days in involuntary care

时间窗: Change in number of days in involuntary care between baseline and at 36 months

Number of days in involuntary care

Admissions to inpatient care

时间窗: Change in number of admissions to inpatient care between baseline and at 36 months

Number of admissions to inpatient care

Days in inpatient care

时间窗: Change in number of days in inpatient care between baseline and 36 months

Number of days in inpatient care

Admissions to involuntary care

时间窗: Change in number of admissions to involuntary care between baseline and at 36 months

Number of admissions to involuntary care

Coercive measures

时间窗: Change in number of coercive measures between baseline and at 36 months

Number of coercive measures (forced medication, seclusion, and restraint)

次要结局

  • EQ5D-5L(Change in self-rated quality of life (somatic) between baseline and at 12 months)
  • World Health Organization Disability Assessment Schedule(Change in self-rated quality of life (somatic) between baseline and at 12 months)
  • Clinical Global Impression(Change in clinician-rated functional level between baseline and at 12 months)
  • Brunnsviken Brief Quality of life scale(Change in self-rated quality of life (psychological) between baseline and at 12 months)
  • General Self-Efficacy scale(Change in self-rated self-efficacy between baseline and at 12 months)
  • Generalized Anxiety Disorder - 7 items(Change in self-rated anxiety between baseline and at 12 months)
  • The Patient Health Questionnaire - 9 items(Change in self-rated depression between baseline and at 12 months)
  • Visual Analogue Scales(Change in self-rated care needs and current health status between baseline and at 12 months)
  • Other psychiatric or somatic healthcare consumption(Change in number of other psychiatric or somatic healthcare consumption between baseline and 12 months)
  • Sick-leave(Change in number of days in sick-leave between baseline and 12 months)
  • Redeemed medical prescriptions(Change in number of redeemed medical prescriptions between baseline and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Rozental

Principal investigator

Karolinska Institutet

研究点 (1)

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