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Respiratory DiseaseNCT05747885

Application of RCS in Pulmonary Rehabilitation

An observational study of Respiratory Disease, run by Istituti Clinici Scientifici Maugeri SpA at 16 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Respiratory Disease
How many people
547 participants
Where
16 sitesItaly
Study dates
30 Jan 2023to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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)

Who cannot join

  • none

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari

    Bari, 70100

  • Istituto nazionale Riposo e Cura per Anziani di Casatenovo, Respiratory rehabilitation

    Casatenovo, Lecco, 23880

  • Ospedale di Codogno- Centro di riabilitazione cardio-respiratorio

    Codogno, Lodi, 26845

  • Fondazione Don Carlo Gnocchi ONLUS, IRCCS "Don Carlo Gnocchi", Respiratory rehabilitation

    Florence, 50143

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

    Lumezzane, Brescia, 25065

  • Fondazione Don Carlo Gnocchi ONLUS, IRCCS Centro S. Maria Nascente, Respiratory rehabilitation

    Milan, 20148

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano

    Montescano, Pavia, 27040

  • Ospedale Monaldi, Aziende Ospedaliera Specialistica dei Colli, Respiratory rehabilitation

    Naples, 80131

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia

    Pavia, 27100

  • Ospedale Villa Pineta, Respiratory rehabilitation

    Pavullo nel Frignano, Modena, 41026

  • Ospedale "Santa Marta" di Rivolta d'Adda, Respiratory rehabilitation

    Rivolta d'Adda, Cremona, 26027

  • Fondazione Don Carlo Gnocchi ONLUS, Centro "Spalenza", Respiratory rehabilitation

    Rovato, Brescia, 25038

  • Presidio Ospedaliero di Sant'Angelo Lodigiano, Respiratory rehabilitation

    Sant'Angelo Lodigiano, Lodi, 26866

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Telese

    Telese Terme, Benevento, 82037

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

    Tradate, Varese, 21049

  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno

    Veruno, Novara, 28010

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Keywords
Appropriateness, motor pulmonary rehabilitation, Rehabilitation Complexity Scale
Medical subject headings
Respiration Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rehabilitation Complexity Scale (RCS)-E description

    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.

    Measured: At the date of admission in rehabilitation

  2. RCS-E correlation with Baseline Barthel Dyspnea Index

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

    Measured: At the date of admission in rehabilitation

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

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

    Measured: At the date of admission in rehabilitation

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

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

    Measured: At the date of admission in rehabilitation

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

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

    Measured: At the date of admission in rehabilitation

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

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

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

  7. Change in RCS-E

    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.

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

Secondary outcomes (1)

  1. Comparison of RCS-E among groups

    To describe the distribution of RCS-E as a function of the 3 main DRGs (ventilated trachea 566/565, CRF, COPD)

    Measured: At the date of admission in rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start30 Jan 2023
  3. Primary completion31 Mar 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05747885
Sponsor's protocol ID
ICS Maugeri CE 2713
Status last verified
Sep 2023
First submitted
31 Jan 2023
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Turner-Stokes L, Disler R, Williams H. The Rehabilitation Complexity Scale: a simple, practical tool to identify 'complex specialised' services in neurological rehabilitation. Clin Med (Lond). 2007 Dec;7(6):593-9. doi: 10.7861/clinmedicine.7-6-593.

    PubMed 18193708

  • Turner-Stokes L, Williams H, Siegert RJ. The Rehabilitation Complexity Scale version 2: a clinimetric evaluation in patients with severe complex neurodisability. J Neurol Neurosurg Psychiatry. 2010 Feb;81(2):146-53. doi: 10.1136/jnnp.2009.173716. Epub 2009 Jul 8.

    PubMed 19587391

  • Turner-Stokes L, Scott H, Williams H, Siegert R. The Rehabilitation Complexity Scale--extended version: detection of patients with highly complex needs. Disabil Rehabil. 2012;34(9):715-20. doi: 10.3109/09638288.2011.615880. Epub 2011 Nov 24.

    PubMed 22115200

  • Pedersen AR, Nielsen JF, Jensen J, Maribo T. Referral decision support in patients with subacute brain injury: evaluation of the Rehabilitation Complexity Scale - Extended. Disabil Rehabil. 2017 Jun;39(12):1221-1227. doi: 10.1080/09638288.2016.1189610. Epub 2016 Jul 6.

    PubMed 27384499

  • Turner-Stokes L, Sutch S, Dredge R, Eagar K. International casemix and funding models: lessons for rehabilitation. Clin Rehabil. 2012 Mar;26(3):195-208. doi: 10.1177/0269215511417468. Epub 2011 Nov 9.

    PubMed 22070989

  • Koh GC, Chen CH, Petrella R, Thind A. Rehabilitation impact indices and their independent predictors: a systematic review. BMJ Open. 2013 Sep 24;3(9):e003483. doi: 10.1136/bmjopen-2013-003483.

    PubMed 24068767

  • Roda F, Agosti M, Corradini E, Lombardi F, Maini M, Brianti R. Cross-cultural adaptation and preliminary test-retest reliability of the Italian version of the Complexity Rehabilitation Scale-Extended (13th version). Eur J Phys Rehabil Med. 2015 Aug;51(4):439-46. Epub 2014 Mar 4.

    PubMed 24621987

  • Galletti L, Benedetti MG, Maselli S, Zanoli G, Pignotti E, Iovine R. Rehabilitation Complexity Scale: Italian translation and transcultural validation. Disabil Rehabil. 2016;38(1):87-96. doi: 10.3109/09638288.2015.1024340. Epub 2015 Apr 15.

    PubMed 25875050

  • Roda F, Agosti M, Merlo A, Maini M, Lombardi F, Tedeschi C, Benedetti MG, Basaglia N, Contini M, Nicolotti D, Brianti R; GRECo. Psychometric validation of the Italian Rehabilitation Complexity Scale-Extended version 13. PLoS One. 2017 Oct 18;12(10):e0178453. doi: 10.1371/journal.pone.0178453. eCollection 2017.

    PubMed 29045409

  • Chang EY, Chang EH, Cragg S, Cramer SC. Predictors of Gains During Inpatient Rehabilitation in Patients with Stroke- A Review. Crit Rev Phys Rehabil Med. 2013;25(3-4):203-221. doi: 10.1615/CritRevPhysRehabilMed.2013008120.

    PubMed 25541570

  • Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability measures in stroke: relationship among the Barthel Index, the Functional Independence Measure, and the Modified Rankin Scale. Stroke. 2004 Apr;35(4):918-23. doi: 10.1161/01.STR.0000119385.56094.32. Epub 2004 Feb 19.

    PubMed 14976324

  • Balasch i Bernat M, Balasch i Parisi S, Sebastian EN, Moscardo LD, Ferri Campos J, Lopez Bueno L. Determining cut-off points in functional assessment scales in stroke. NeuroRehabilitation. 2015;37(2):165-72. doi: 10.3233/NRE-151249.

    PubMed 26484508

  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PubMed 24127811

  • Paneroni M, Simonelli C, Vitacca M, Ambrosino N. Aerobic Exercise Training in Very Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2017 Aug;96(8):541-548. doi: 10.1097/PHM.0000000000000667.

    PubMed 28099192

  • Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST.

    PubMed 33929307

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Disease, run by Istituti Clinici Scientifici Maugeri SpA at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rehabilitation Complexity Scale (RCS)-E description (time frame: At the date of admission in rehabilitation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05747885, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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