Impact of the 'Reserved Therapeutic Space' Nursing Intervention on Patient Health Outcomes: an Intervention Study in Acute Mental Health Units in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version
研究概览
简要总结
Aims:
To evaluate the effectiveness of the "Reserved Therapeutic Space" intervention for improving the nurse-patient therapeutic relationship in acute mental health units in Spain, as well as its impact in terms of quality of care and patients' perceptions of coercion.
Design:
Multicenter intervention study with control group.
Methods:
The study will be carried out in 12 mental health units in Spain. Given the conditions of evaluation in real clinical practice, paired randomization will be performed to assign centers to intervention and control groups. The "Reserved Therapeutic Space" intervention to be tested has been co-designed and validated by both nurses and patients. The quality of the therapeutic relationship, the care received, and perceived coercion among patients will be assessed at baseline and at discharge using instruments validated in our context. An estimated 131 patients per group are expected to participate. Funding was granted in July 2021 by the Institute of Health Carlos III (PI21/00605, Ministry of Science and Innovation) and in October 2021 by the College of Nurses of Barcelona (PR-487/2021). The proposal was approved by all the Research Ethics Committees of participating centers.
Discussion:
This study is expected to demonstrate the effectiveness of a specific nursing intervention on patient health outcomes including the level of the therapeutic relationship, the quality of care, the level of coercion and other specific indicators for acute mental health units.
Impact:
This project will lead to changes in clinical practice, transforming the current models of organization and care management in mental health hospitalization units, promoting the quality of the therapeutic relationship and, ultimately, the quality of person-centered care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults hospitalized in mental health inpatient units who voluntarily consent to participate in the study
排除标准
- •Adults hospitalized in mental health inpatient units who present a language barrier, mechanical restraint, contraindication by the clinical referent, cognitive impairment, or intellectual disability at the time of recruitment.
结局指标
主要结局
Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version
时间窗: At baseline and at discharge from the inpatient unit (an average of 16 days)
The Working Alliance Inventory Short Questionnaire (WAI-S), patient version. This is an instrument for measuring the working alliance, and therefore, the therapeutic relationship between professional and patient (Horvath \& Greenberg, 1989). Scores range from 12-84 with higher scores indicating greater levels of therapeutic alliance.
次要结局
- Change from baseline Quality in Psychiatric Care at discharge assessed by QPC(At baseline and at discharge from the inpatient unit (an average of 16 days))
- Experience of coercion assessed by CES-18(At discharge from the inpatient unit (an average of 16 days))
研究者
Antonio R. Moreno Poyato
PhD, Professor
University of Barcelona