Application of RCS in Pulmonary Rehabilitation

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747885
• Other study ID #: ICS Maugeri CE 2713
• Status: Completed
• Start date: January 30, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari	Bari
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	Fondazione Don Carlo Gnocchi ONLUS, IRCCS "Don Carlo Gnocchi", Respiratory rehabilitation	Firenze
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane	Lumezzane	Brescia
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	Ospedale Monaldi, Aziende Ospedaliera Specialistica dei Colli, Respiratory rehabilitation	Napoli
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia	Pavia
Italy	Ospedale Villa Pineta, Respiratory rehabilitation	Pavullo Nel Frignano	Modena
Italy	Ospedale "Santa Marta" di Rivolta d'Adda, Respiratory rehabilitation	Rivolta d'Adda	Cremona
Italy	Fondazione Don Carlo Gnocchi ONLUS, Centro "Spalenza", Respiratory rehabilitation	Rovato	Brescia
Italy	Presidio Ospedaliero di Sant'Angelo Lodigiano, Respiratory rehabilitation	Sant'Angelo Lodigiano	Lodi
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Telese	Telese Terme	Benevento
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate	Tradate	Varese
Italy	ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno	Veruno	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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)	At the date of admission in rehabilitation

External Links

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