跳至主要内容
临床试验/NCT04314154
NCT04314154Unknown不适用

Using Clinical Process Indicators, Patient Reported Outcome Measures (PROMs), and Patient Reported Experience Measures (PREMs) to Improve the Quality and Continuity of Care for Psychiatric Patients

Shalvata Mental Health Center1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
125
试验地点
1
主要终点
GAF

研究概览

简要总结

The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.

详细描述

Background: Monitoring quality of care in the context of psychiatric hospitalization is crucial. The Israeli National quality, Service and Safety Administration project has signified a major step in this direction enhancing the measuring and monitoring the quality of care.

Purpose: The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.

Hypotheses: We hypothesize that 1) adherence to indicators will be associated with better PREMs, PROMs and clinician ratings 2) PROMs and clinician ratings will be positively related and 3) PREMs and PROMs will be positively related.

Method: 125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators ("between subject effect") and level of change in the PREMs, PROMs clinician along the research trajectory ("within subject effect").

Importance of the study: The mental health reform, implemented cross-nationally since 2015 emphasizes client centred and continuity of care and seeks to increase the quality, availability and accessibility of mental health services in Israel. Most of the discussion to date has been on the later issues of access and availability and much less on quality and continuity of care which requires standardized routine longitudinal assessment of process indicators and patients reported experience and outcome. The proposed study represents a pioneer effort to collect systematic data which can help evaluate the quality and impact of services over time. Findings can be useful to guide policy about the feasibility and impact of process indicators and their relation to PROMs and PREMs over time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to hospitalization in each of the participating departments
  • suffer from SMI (schizophrenia, bipolar disorder of any kind, major effective disorder, anxiety disorders in need of hospitalization, severe personality disorder required for hospitalization)
  • Speaking and reading and writing in fluent Hebrew
  • Sign a trial consent form

排除标准

  • unable to understand the content of the questionnaires, or their mental state does not allow them to answer the questionnaires as required

结局指标

主要结局

GAF

时间窗: 0,3, 6 and 9 months after enrollment

The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. An improvement will be regarded if the GAF will increase in 10% from start point (time=0 months) to end point (time=9 months). Assessments will be made also on 3 and 6 months in order to examine graduality in improvement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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