Application of RCS in Pulmonary Rehabilitation

September 27, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

547

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70100
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
      • Firenze, Italy, 50143
        • Fondazione Don Carlo Gnocchi ONLUS, IRCCS "Don Carlo Gnocchi", Respiratory rehabilitation
      • Milano, Italy, 20148
        • Fondazione Don Carlo Gnocchi ONLUS, IRCCS Centro S. Maria Nascente, Respiratory rehabilitation
      • Napoli, Italy, 80131
        • Ospedale Monaldi, Aziende Ospedaliera Specialistica dei Colli, Respiratory rehabilitation
      • Pavia, Italy, 27100
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
    • Benevento
      • Telese Terme, Benevento, Italy, 82037
        • ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
      • Rovato, Brescia, Italy, 25038
        • Fondazione Don Carlo Gnocchi ONLUS, Centro "Spalenza", Respiratory rehabilitation
    • Cremona
      • Rivolta d'Adda, Cremona, Italy, 26027
        • Ospedale "Santa Marta" di Rivolta d'Adda, Respiratory rehabilitation
    • Lecco
      • Casatenovo, Lecco, Italy, 23880
        • Istituto nazionale Riposo e Cura per Anziani di Casatenovo, Respiratory rehabilitation
    • Lodi
      • Codogno, Lodi, Italy, 26845
        • Ospedale di Codogno- Centro di riabilitazione cardio-respiratorio
      • Sant'Angelo Lodigiano, Lodi, Italy, 26866
        • Presidio Ospedaliero di Sant'Angelo Lodigiano, Respiratory rehabilitation
    • Modena
      • Pavullo Nel Frignano, Modena, Italy, 41026
        • Ospedale Villa Pineta, Respiratory rehabilitation
    • Novara
      • Veruno, Novara, Italy, 28010
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
    • Pavia
      • Montescano, Pavia, Italy, 27040
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
    • Varese
      • Tradate, Varese, Italy, 21049
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in 16 Pulmonary Rehabilitation Units will be considered. These patients will participate in a pulmonary rehabilitation program, as defined by the latest guidelines of the American Thoracic Society / European Respiratory Society (ATS/ERS).

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehabilitation Complexity Scale (RCS)-E description
Time Frame: 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.
At the date of admission in rehabilitation
RCS-E correlation with Baseline Barthel Dyspnea Index
Time Frame: 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)
At the date of admission in rehabilitation
RCS-E correlation with Baseline Medical Research Council (MRC)
Time Frame: 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)
At the date of admission in rehabilitation
RCS-E correlation with Baseline COPD Assessment Test (CAT)
Time Frame: 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)
At the date of admission in rehabilitation
RCS-E correlation with Baseline six minutes walking test (6MWT) distance
Time Frame: 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)
At the date of admission in rehabilitation
RCS-E correlation with clinical outcome (discharged home, transferred or dead)
Time Frame: 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)
From the date of admission in rehabilitation to the date of discharge (up to three weeks)
Change in RCS-E
Time Frame: 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.
From the date of admission in rehabilitation to the date of discharge (up to three weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of RCS-E among groups
Time Frame: 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)
At the date of admission in rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Study Director: Paolo Banfi, MD, Fondazione Don Carlo Gnocchi ONLUS, IRCCS Centro S. Maria Nascente, Respiratory rehabilitation
  • Study Director: Michele Vitacca, MD, ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICS Maugeri CE 2713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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