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临床试验/NCT04175366
NCT04175366Unknown不适用

Shared Decision Making in Psychiatric Inpatient Care to Enhance Patient Participation

Umeå University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Level of patient perceived participation

研究概览

简要总结

Introduction

National guidelines and The Patient Act from 2014 call for an active role for the patient in the decision making process. The role of the doctor is not only to give advice and to prescribe treatments, but also to present different alternatives with pros and cons. The method of Shared Decision Making (SDM) is meant to improve patient participation in line with ethical guidelines and legal demands. In summary, SDM consists of three steps:

  1. To introduce a choice.
  2. To discuss the options.
  3. To make a shared decision. Systematic studies on SDM show patients becoming better informed and less uncertain regarding decisions made, and decisions closer to clinical guidelines compared to treatment as usual (TAU). It is still unresolved if SDM leads to improved clinical outcomes.

Aim

The aim of the study is to investigate outcomes of SDM carried out in psychiatric inpatient care: the patients' perceived participation (primary outcome) and health related outcomes (secondary).

Method

The decision situation in focus for this project is the planning of hospital discharge and future outpatient care. The participants are randomized to either SDM or TAU. Patient participation will be measured by questionnaires, interviews with patients and recorded decision talks. Clinical outcomes will be measured 12 months after discharge.

Preliminary results

A pilot study conducted in 2017-2018 clarified the feasibility of instruments and the intervention, and gave data for power estimation.

详细描述

TITLE

DEAL Shared Decision Making in psychiatric inpatient care to enhance participation and autonomy.

PURPOSE AND AIMS

The purpose is to investigate patients' participation and autonomy in psychiatric inpatient care and the potential of Shared Decision Making (SDM) to strengthen patients' participation in clinical decision making.

PRIMARY OUTCOME:

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to psychiatric inpatient care.
  • Informed consent to study participation.

排除标准

  • Lack of basic language skills in Swedish.
  • Earlier enrollment in the study.

结局指标

主要结局

Level of patient perceived participation

时间窗: Measurement 6 weeks after inclusion or at discharge if earlier.

Measurement with the questionnaire Dyadic OPTION, with a sum score of 1-44 where 44 is the highest perceived participation.

次要结局

  • Percentage of carried out planned outpatient visits(1 year)
  • Number of rehospitalisations(1 year)
  • Days of compulsory care(1 year)
  • Number of episodes of compulsory care(1 year)
  • Number of inpatient days(1 year)
  • Number of emergency visits(1 year)
  • Days until rehospitalisation(1 year)
  • Percentage of decisions on social support carried out(1 year)
  • Level of quality of Life: EuroQol EQ-5D(Measurement 6 weeks after inclusion or at discharge if earlier.)
  • Level of quality of Life: EuroQol EQ-VAS(Measurement 6 weeks after inclusion or at discharge if earlier.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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