Application of RCS in Pulmonary Rehabilitation
- Conditions
- Respiratory Disease
- Registration Number
- NCT05747885
- Lead Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Brief Summary
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.
- Detailed Description
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.
The Outcome measures are reported in the dedicated section.
The Sample size has been estimated at 400 patients (considering 25 patients with any DRG/center admitted on 2 specific days at each institute).
Summary statistics will be presented as a descriptive analysis of the mean and standard deviation or median and quartiles for continuous variables and as counts with percentages for categorical or dichotomous variables. Patients will be stratified according to the 3 main DRGs (invasive ventilation 566/565, 88 CRF, 87 COPD) and comparisons will be performed by ANOVA test for continuous variables and chi-square test for categorical or dichotomous variables.
Testing for significant differences in the distributions of discrete variables will be performed with the Chi-Square Test and the Student t-Test will be used for the comparison of pre to post-continuous variables (difference between Baseline and Post program).
Correlations between RCS-E and the standard respiratory/disability scales \[Barthel Dyspnea Index, Medical Resource Council (MRC), COPD Assessment Test (CAT), and meters covered in the 6 minutes\] will be performed by Spearman's test. An inadequate/adequate correlation with respect to the usual measurements will make it possible to define the "applicability/goodness"" of the scale proposed by the Ministry.
For all tests, a p-value \<.05 will be considered significant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 547
- 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)
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RCS-E correlation with clinical outcome (discharged home, transferred or dead) 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 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 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 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 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) 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) 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)
- Secondary Outcome Measures
Name Time Method Comparison of RCS-E among groups At the date of admission in rehabilitation To describe the distribution of RCS-E as a function of the 3 main DRGs (ventilated trachea 566/565, CRF, COPD)
Trial Locations
- Locations (16)
Presidio Ospedaliero di Sant'Angelo Lodigiano, Respiratory rehabilitation
🇮🇹Sant'Angelo Lodigiano, Lodi, Italy
Fondazione Don Carlo Gnocchi ONLUS, Centro "Spalenza", Respiratory rehabilitation
🇮🇹Rovato, Brescia, Italy
Ospedale "Santa Marta" di Rivolta d'Adda, Respiratory rehabilitation
🇮🇹Rivolta d'Adda, Cremona, Italy
Istituto nazionale Riposo e Cura per Anziani di Casatenovo, Respiratory rehabilitation
🇮🇹Casatenovo, Lecco, Italy
Ospedale di Codogno- Centro di riabilitazione cardio-respiratorio
🇮🇹Codogno, Lodi, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate
🇮🇹Tradate, Varese, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
🇮🇹Bari, Italy
Fondazione Don Carlo Gnocchi ONLUS, IRCCS Centro S. Maria Nascente, Respiratory rehabilitation
🇮🇹Milano, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
🇮🇹Montescano, Pavia, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Telese
🇮🇹Telese Terme, Benevento, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
🇮🇹Lumezzane, Brescia, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
🇮🇹Veruno, Novara, Italy
Ospedale Villa Pineta, Respiratory rehabilitation
🇮🇹Pavullo Nel Frignano, Modena, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
🇮🇹Pavia, Italy
Fondazione Don Carlo Gnocchi ONLUS, IRCCS "Don Carlo Gnocchi", Respiratory rehabilitation
🇮🇹Firenze, Italy
Ospedale Monaldi, Aziende Ospedaliera Specialistica dei Colli, Respiratory rehabilitation
🇮🇹Napoli, Italy