Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial

Claudia Bausewein, Caroline Jolley, Charles Reilly, Paula Lobo, Jane Kelly, Helene Bellas, Preety Madan, Caty Panell, Elmien Brink, Chiara De Biase, Wei Gao, Caroline Murphy, Paul McCrone, John Moxham, Irene J Higginson, Claudia Bausewein, Caroline Jolley, Charles Reilly, Paula Lobo, Jane Kelly, Helene Bellas, Preety Madan, Caty Panell, Elmien Brink, Chiara De Biase, Wei Gao, Caroline Murphy, Paul McCrone, John Moxham, Irene J Higginson

Abstract

Background: Breathlessness is a common and distressing symptom affecting many patients with advanced disease both from malignant and non-malignant origin. A combination of pharmacological and non-pharmacological measures is necessary to treat this symptom successfully. Breathlessness services in various compositions aim to provide comprehensive care for patients and their carers by a multiprofessional team but their effectiveness and cost-effectiveness have not yet been proven. The Breathlessness Support Service (BSS) is a newly created multiprofessional and interdisciplinary outpatient service at a large university hospital in South East London. The aim of this study is to develop and evaluate the effectiveness and cost effectiveness of this multidisciplinary out-patient BSS for the palliation of breathlessness, in advanced malignant and non-malignant disease.

Methods: The BSS was modelled based on the results of qualitative and quantitative studies, and systematic literature reviews. A randomised controlled fast track trial (RCT) comprising two groups: 1) intervention (immediate access to BSS in addition to standard care); 2) control group (standard best practice and access to BSS after a waiting time of six weeks). Patients are included if suffering from breathlessness on exertion or at rest due to advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), interstitial lung disease (ILD) or motor neurone disease (MND) that is refractory to maximal optimised medical management. Both quantitative and qualitative outcomes are assessed in face to-face interviews at baseline, after 6 and 12 weeks. The primary outcome is patients' improvement of mastery of breathlessness after six weeks assessed on the Chronic Respiratory Disease Questionnaire (CRQ). Secondary outcomes for patients include breathlessness severity, symptom burden, palliative care needs, service use, and respiratory measures (spirometry). For analyses, the primary outcome, mastery of breathlessness after six weeks, will be analysed using ANCOVA. Selection of covariates will depend on baseline differences between the groups. Analyses of secondary outcomes will include patients' symptom burden other than breathlessness, physiological measures (lung function, six minute walk distance), and caregiver burden.

Discussion: Breathlessness services aim to meet the needs of patients suffering from this complex and burdensome symptom and their carers. The newly created BSS is different to other current services as it is run in close collaboration of palliative medicine and respiratory medicine to optimise medical care of patients. It also involves professionals from various medical, nursing, physiotherapy, occupational therapy and social work background.

Trial registration: ClinicalTrials.gov (NCT01165034).

Figures

Figure 1
Figure 1
Flow diagram of patients through the study.

References

    1. National Institute for Clinical Excellence (NICE) Lung cancer. The diagnosis and treatment of lung cancer. National Collaborating Centre for Acute Care. 2005. .
    1. Katsura H, Kanemaru A, Yamada K, Motegi T, Wakabayashi R, Kida K. Long-term effectiveness of an inpatient pulmonary rehabilitation program for elderly COPD patients: Comparison between young-elderly and old-elderly groups. Respirology. 2004;9:230–236. doi: 10.1111/j.1440-1843.2004.00561.x.
    1. Rennard S, Decramer M, Calverley PM, Pride NB, Soriano JB, Vermeire PA, Vestbo J. Impact of COPD in North America and Europe in 2000: subjects' perspective of Confronting COPD International Survey. Eur Respir J. 2002;20(4):799–805. doi: 10.1183/09031936.02.03242002.
    1. Lynn J, Ely EW, Zhong Z, McNiff KL, Dawson NV, Connors A, Desbiens NA, Claessens M, McCarthy EP. Living and dying with chronic obstructive pulmonary disease. J Am Geriatr Soc. 2000;48(5 Suppl):S91–100.
    1. Edmonds P, Karlsen S, Khan S, Addington-Hall J. A comparison of the palliative care needs of patients dying from chronic respiratory diseases and lung cancer. Palliat Med. 2001;15(4):287–295. doi: 10.1191/026921601678320278.
    1. Austin J, Williams R, Ross L, Moseley L, Hutchison S. Randomised controlled trial of cardiac rehabilitation in elderly patients with heart failure. Eur J Heart Fail. 2005;7(3):411–417. doi: 10.1016/j.ejheart.2004.10.004.
    1. Seow H, Barbera L, Sutradhar R, Howell D, Dudgeon D, Atzema C, Liu Y, Husain A, Sussman J, Earle C. Trajectory of performance status and symptom scores for patients with cancer during the last six months of life. J Clin Oncol. 2011;29(9):1151–1158. doi: 10.1200/JCO.2010.30.7173.
    1. Reuben DB, Mor V. Dyspnea in terminally ill cancer patients. Chest. 1986;89(2):234–236. doi: 10.1378/chest.89.2.234.
    1. Escalante CP, Martin CG, Elting LS, Cantor SB, Harle TS, Price KJ, Kish SK, Manzullo EF, Rubenstein EB. Dyspnea in cancer patients: Etiology, resource utilization, and survival-Implications in a managed care world. Cancer. 1996;78(6):1314–1319. doi: 10.1002/(SICI)1097-0142(19960915)78:6<1314::AID-CNCR21>;2-2.
    1. Higginson IJ. Refractory breathlessness: oxygen or room air? Lancet. 2010;376(9743):746–748. doi: 10.1016/S0140-6736(10)61346-3.
    1. D-C Man W, Polkey MI, Donaldson N, Gray BJ, Moxham J. Community pulmonary rehabilitation after hospitalisation for acute exacerbations of chronic obstructive pulmonary disease: randomised controlled study. BMJ. 2004;329(7476):1209. doi: 10.1136/bmj.38258.662720.3A.
    1. Coats AJS, Adamopoulos S, Meyer TE, Conway J, Sleight P. Effects of physical training in chronic heart failure. Lancet. 1990;335(8681):63–66. doi: 10.1016/0140-6736(90)90536-E.
    1. Bausewein C, Booth S, Gysels M, Higginson Irene J. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database of Systematic Reviews. 2008;2:CD005623.
    1. Bredin M. Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer. BMJ. 1999;318:901–904. doi: 10.1136/bmj.318.7188.901.
    1. Corner J, Plant H, A'Hern R, Bailey C. Non-pharmacological intervention for breathlessness in lung cancer. Pall Med. 1996;10(4):299–305. doi: 10.1177/026921639601000405.
    1. Booth S. The impact of a breathlessness intervention service (BIS) on the lives of patients with intractable dyspnoea: a qualitative phase 1 study. Palliat Support Care. 2006;4:287–293.
    1. Farquhar M, Higginson I, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliative Care. 2009;8(1):9. doi: 10.1186/1472-684X-8-9.
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–696. doi: 10.1136/bmj.321.7262.694.
    1. Medical Research Council. MRC framework for development and evaluation of RCTs for complex interventions to improve health. London; 2000. (Medical Research Council).
    1. Higginson I, Vivat B, Silber E, Saleem T, Burman R, Hart S, Edmonds P. Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service. BMC Palliat Care. 2006;5(1):7. doi: 10.1186/1472-684X-5-7.
    1. Moore S, Corner J, Haviland J, Wells M, Salmon E, Normand C, Brada M, Smith I. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ. 2002;325(7373):1145. doi: 10.1136/bmj.325.7373.1145.
    1. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The Comprehensive Care Team: A Controlled Trial of Outpatient Palliative Medicine Consultation. Arch Intern Med. 2004;164(1):83–91. doi: 10.1001/archinte.164.1.83.
    1. Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003;327(7414):523–528. doi: 10.1136/bmj.327.7414.523.
    1. Jennings Anne L, Davies Andrew N, Higgins Julian PT, Anzures-Cabrera J, Broadley Karen E. Opioids for the palliation of breathlessness in advanced disease and terminal illness. Cochrane Database of Systematic Reviews. 2001;4:CD002066.
    1. Abernethy AP, McDonald CF, Frith PA, Clark K, Herndon JE, Marcello J, Young IH, Bull J, Wilcock A, Booth S. et al.Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial. Lancet. 2010;376(9743):784–793. doi: 10.1016/S0140-6736(10)61115-4.
    1. Gysels MH, Higginson IJ. Caring for a person in advanced illness and suffering from breathlessness at home: Threats and resources. Palliat Support Care. 2009;7(02):153–162. doi: 10.1017/S1478951509000200.
    1. Gysels M, Higginson I. Self-management for breathlessness in COPD: the role of pulmonary rehabilitation. J Chronic Dis. 2009;6(3):133–140. doi: 10.1177/1479972309102810.
    1. Gysels M, Higginson IJ. Access to Services for Patients with Chronic Obstructive Pulmonary Disease: The Invisibility of Breathlessness. J Pain Symptom Manage. 2008;36(5):451–460. doi: 10.1016/j.jpainsymman.2007.11.008.
    1. Gysels MH, Higginson IJ. The lived experience of breathlessness and its implications for care: a qualitative comparison in cancer, COPD, heart failure and MND. BMC Palliat Care. 2011;10:15. doi: 10.1186/1472-684X-10-15.
    1. Altman DG. Practical Statistics for Medical Research, First Edition edn. London: Chapman & Hall; 1991.
    1. Sewell L, Singh SJ, Williams JEA, Collier R, Morgan MDL. How long should outpatient pulmonary rehabilitation be? A randomised controlled trial of 4 weeks versus 7 weeks. Thorax. 2006;61(9):767–771. doi: 10.1136/thx.2005.048173.
    1. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987;42(10):773–778. doi: 10.1136/thx.42.10.773.
    1. Schunemann HJ, Goldstein R, Mador MJ, McKim D, Stahl E, Puhan M, Griffith LE, Grant B, Austin P, Collins R. et al.A randomised trial to evaluate the self-administered standardised chronic respiratory questionnaire. Eur Respir J. 2005;25(1):31–40. doi: 10.1183/09031936.04.00029704.
    1. Gift A, Narsavage G. Validity of the numeric rating scale as a measure of dyspnea. Am J Respir Crit Care Med. 1998;7(3):200–204.
    1. Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010;65(1):21–26. doi: 10.1136/thx.2009.118521.
    1. Hearn J, Higginson IJ. Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative Care Core Audit Project Advisory Group. Qual Health Care. 1999;8(4):219–227. doi: 10.1136/qshc.8.4.219.
    1. Garrod R, Paul EA, Wedzicha JA. An evaluation of the reliability and sensitivity of the London Chest Activity of Daily Living Scale (LCADL) Resp Med. 2002;96(9):725–730. doi: 10.1053/rmed.2002.1338.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Williams A. The Role of the EUROQOL Instrument in QALY Calculations Centre for Health Economics. University of York. 1995. .
    1. Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview. Gerontologist. 2001;41(5):652–657. doi: 10.1093/geront/41.5.652.
    1. American Thoracic Society. Standardization of Spirometry, 1994 Update. ATS. Am J Respir Crit Care Med. 1995;3:1107–1136.
    1. American Thoracic Society. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111–117.
    1. Hill K, Jenkins SC, Cecins N, Philippe DL, Hillman DR, Eastwood PR. Estimating Maximum Work Rate During Incremental Cycle Ergometry Testing From Six-Minute Walk Distance in Patients With Chronic Obstructive Pulmonary Disease. Arch Phys Med Rehabil. 2008;89(9):1782–1787. doi: 10.1016/j.apmr.2008.01.020.
    1. Kasymjanova G, Correa JA, Kreisman H, Dajczman E, Pepe C, Dobson S, Lajeunesse L, Sharma R, Small D. Prognostic Value of the Six-Minute Walk in Advanced Non-small Cell Lung Cancer. J Thorac Oncol. 2009;4(5):602–607. doi: 10.1097/JTO.0b013e31819e77e8. 610.1097/JTO.1090b1013e31819e31877e31818.
    1. Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity Index in Chronic Obstructive Pulmonary Disease. N Eng J Med. 2004;350(10):1005–1012. doi: 10.1056/NEJMoa021322.
    1. Puhan MA, Guyatt GH, Goldstein R, Mador J, McKim D, Stahl E, Griffith L, Schünemann HJ. Relative responsiveness of the Chronic Respiratory Questionnaire. St. Georges Respiratory Questionnaire and four other health-related quality of life instruments for patients with chronic lung disease. Resp Med. 2007;101(2):308–316. doi: 10.1016/j.rmed.2006.04.023.
    1. Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010;13(9):1109–1118. doi: 10.1089/jpm.2010.0068.
    1. Farquhar M, Higginson IJ, Fagan P, Booth S. Results of a pilot investigation into a complex intervention for breathlessness in advanced chronic obstructive pulmonary disease (COPD): Brief report. Palliat Support Care. 2010;2:143–149. Epub 2010 Mar 23.
    1. Booth S, Moffat C, Farquhar M, Higginson IJ, Burkin J. Developing a breathlessness intervention service for patients with palliative and supportive care needs, irrespective of diagnosis. J Palliat Care. 2011;27(1):28–36.

Source: PubMed

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