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临床试验/NCT05747885
NCT05747885已完成不适用

The Rehabilitation Complexity Scale (RCS) in Pulmonary Rehabilitation: Utility and Limitations

Istituti Clinici Scientifici Maugeri SpA16 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
547
试验地点
16
主要终点
RCS-E correlation with clinical outcome (discharged home, transferred or dead)

研究概览

简要总结

In August 2021, the Italian Ministry of Health published the Ministerial Decree to define the "Criteria for the appropriateness concerning the access to hospital rehabilitation admission" (in neurological, respiratory, cardiological, and orthopedic Units), classifying patients by complexity, the severity of disability and the number of ICD-9 discharge codes. The Appropriateness Decree adopted some fundamental criteria used in the United Kingdom for over 10 years (2009) where the Ministry of Health defined 3 levels of specialized rehabilitation based on the different complexity of the patient's needs. Among the scales, the Rehabilitation Complexity Scale (RCS) has been proposed by the British Society of Rehabilitation Medicine (BSRM), clearly oriented to patients with motor disabilities (neurological and orthopedic), of which the RCS-E (i.e. Extended version) is the more up to date.

The Italian Ministry of Health has proposed the application of the RCS scale as a tool for measuring rehabilitation complexity based on the intensity and level of skills required in terms of nursing, medical and therapeutic care.

In this Clinical Study the Investigators intend to 1. test the application of the new RCS scale to rehabilitation admissions in 16 Italian Pulmonary Rehabilitation Units 2. correlate this scale to the most universally used clinical and functional measures evaluated in the respiratory field 3. investigate the responsiveness of the RCS scale at the end of rehabilitation 4. promote an audit to revise the clinical and rehabilitation conditions -described by items of the RCS-E- to get a specific RCS referable to respiratory patients with MDC4.

详细描述

Background In August 2021, the Italian Ministry of Health published the Ministerial Decree to define the "Criteria for the appropriateness concerning the access to hospital rehabilitation admission" (in neurological, respiratory, cardiologic, and orthopedic Units), classifying patients by complexity, the severity of disability and the number of ICD-9 discharge codes. The Appropriateness Decree adopts some fundamental criteria used in the United Kingdom for over 10 years (2009) where the Ministry of Health has defined 3 levels of specialized rehabilitation based on the different complexity of the patient's needs. Among the possible scales, the Rehabilitation Complexity Scale (RCS) has been proposed by the British Society of Rehabilitation Medicine (BSRM), clearly oriented to patients with motor disabilities (neurological and orthopedic), of which the RCS-E (i.e. Extended version) is the more up to date.

The Italian Ministry of Health has recently proposed the application of the RCS scale as a tool for measuring rehabilitation complexity based on the intensity and level of skills required in terms of nursing, medical and therapeutic care.

In this Clinical Study the Investigators intend to 1. test the application of the new RCS scale to rehabilitation admissions in 16 Italian Pulmonary Rehabilitation Units 2. correlate this scale to the most universally used clinical and functional measures evaluated in the respiratory field 3. investigate the responsiveness of the RCS scale at the end of rehabilitation 4. promote an audit to revise the clinical and rehabilitation conditions -described by items of the RCS-E- to obtain a specific RCS referable to respiratory patients with MDC4.

Methods This is a multicenter observational study. Patients hospitalized in 16 Pulmonary Rehabilitation Units for a period of respiratory rehabilitation, as defined by the latest guidelines of the American Thoracic Society / European Respiratory Society (ATS/ERS), will be considered. Clinical data [Diagnosis at admission, Demographic and anthropometric data, Provenience (home or hospital), Days of hospitalization in the rehabilitation unit], other than tests/evaluations/scales usually administered at the admission and discharge of the rehabilitation process will be collected.

All information will be used to fill in the RCS-E both at admission and discharge.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients hospitalized for Pulmonary Rehabilitation in two dedicated days (core drilling day 1 = 30 January 2023 and core drilling day 2 = 28 February 2023)

排除标准

  • 未提供

结局指标

主要结局

RCS-E correlation with clinical outcome (discharged home, transferred or dead)

时间窗: From the date of admission in rehabilitation to the date of discharge (up to three weeks)

To correlate RCS-E with one of the most universally used indicators in the respiratory field for clinical outcome (discharged home, transferred or dead)

Change in RCS-E

时间窗: From the date of admission in rehabilitation to the date of discharge (up to three weeks)

To evaluate the responsivity of RCS-E to Pulmonary rehabilitation in terms of the significative difference between baseline and end of program.The Rehabilitation Complexity Scale (RCS) describes the level of support the patient needs for either basic self-care or to maintain their safety. 0=best outcome; 22= worst outcome.

Rehabilitation Complexity Scale (RCS)-E description

时间窗: At the date of admission in rehabilitation

To evaluate the level of complexity and care needs with the RCS-E scale in patients hospitalized attending pulmonary rehabilitation centers. The Rehabilitation Complexity Scale (RCS) describes the level of support the patient needs for either basic self-care or to maintain their safety. 0=best outcome; 22= worst outcome.

RCS-E correlation with Baseline six minutes walking test (6MWT) distance

时间窗: At the date of admission in rehabilitation

To correlate RCS-E with one of the most universally used indicators at admission in the respiratory field for the effort tolerance (6MWT distance)

RCS-E correlation with Baseline Barthel Dyspnea Index

时间窗: At the date of admission in rehabilitation

To correlate RCS-E with one of the most universally used indicators at admission in the respiratory field for symptoms (Barthel Dyspnea Index)

RCS-E correlation with Baseline Medical Research Council (MRC)

时间窗: At the date of admission in rehabilitation

To correlate RCS-E with one of the most universally used indicators at admission in the respiratory field for symptoms (MRC)

RCS-E correlation with Baseline COPD Assessment Test (CAT)

时间窗: At the date of admission in rehabilitation

To correlate RCS-E with one of the most universally used indicators at admission in the respiratory field for the quality of life (CAT)

次要结局

  • Comparison of RCS-E among groups(At the date of admission in rehabilitation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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