Application of RCS in Pulmonary Rehabilitation

NCT05747885 | Completed

• 1 other identifier: ICS Maugeri CE 2713
• Study Type: observational
• Target: 547
• Locations: 1 country
• Sites: 16

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.

Conditions

Respiratory Disease

Keywords

Appropriateness; motor pulmonary rehabilitation; Rehabilitation Complexity Scale

Outcome Measures

Primary Outcomes (7)

• 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.

  At the date of admission in rehabilitation

• 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)

  At the date of admission in rehabilitation

• 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)

  At the date of admission in rehabilitation

• 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)

  At the date of admission in rehabilitation

• 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)

  At the date of admission in rehabilitation

• 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)

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

• 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.

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

Secondary Outcomes (1)

• Comparison of RCS-E among groups

  At the date of admission in rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (16)

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Telese

Telese Terme, Benevento, 82037, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

Location

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

Rovato, Brescia, 25038, Italy

Location

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

Rivolta d'Adda, Cremona, 26027, Italy

Location

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

Casatenovo, Lecco, 23880, Italy

Location

Ospedale di Codogno- Centro di riabilitazione cardio-respiratorio

Codogno, Lodi, 26845, Italy

Location

Presidio Ospedaliero di Sant'Angelo Lodigiano, Respiratory rehabilitation

Sant'Angelo Lodigiano, Lodi, 26866, Italy

Location

Ospedale Villa Pineta, Respiratory rehabilitation

Pavullo nel Frignano, Modena, 41026, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno

Veruno, Novara, 28010, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano

Montescano, Pavia, 27040, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

Tradate, Varese, 21049, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari

Bari, 70100, Italy

Location

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

Florence, 50143, Italy

Location

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

Milan, 20148, Italy

Location

Ospedale Monaldi, Aziende Ospedaliera Specialistica dei Colli, Respiratory rehabilitation

Napoli, 80131, Italy

Location

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia

Pavia, 27100, Italy

Location

Related Publications (15)

• 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.

  PMID: 18193708 BACKGROUND

• 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.

  PMID: 19587391 BACKGROUND

• 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.

  PMID: 22115200 BACKGROUND

• 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.

  PMID: 27384499 BACKGROUND

• 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.

  PMID: 22070989 BACKGROUND

• 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.

  PMID: 24068767 BACKGROUND

• 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.

  PMID: 24621987 BACKGROUND

• 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.

  PMID: 25875050 BACKGROUND

• 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.

  PMID: 29045409 BACKGROUND

• 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.

  PMID: 25541570 BACKGROUND

• 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.

  PMID: 14976324 BACKGROUND

• 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.

  PMID: 26484508 BACKGROUND

• 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.

  PMID: 24127811 BACKGROUND

• 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.

  PMID: 28099192 BACKGROUND

• 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.

  PMID: 33929307 BACKGROUND

Related Links

• King's College London - RCS-E - Rehabilitation Complexity Scale Extended
• Report of Global Initiative for Lung Disease (GOLD) criteria for COPD

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Michele Vitacca, MD

  ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane

  STUDY DIRECTOR

• Paolo Banfi, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 28, 2023
• Study Start: January 30, 2023
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IT (16)