PROLONG: a cluster controlled trial to examine identification of patients with COPD with poor prognosis and implementation of proactive palliative care

BMC Pulmonary Medicine

Yvonne Engels²  Kris CP Vissers²  Richard PNR Dekhuijzen¹  Stans C Verhagen²  Yvonne Heijdra¹  Ria G Duenk² 

[1] Department of Lung Diseases, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen 6500 HB, the Netherlands;Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen 6500 HB, the Netherlands

关键词: Quality of life;    Proactive palliative care;    Prognosis;    Indicators;    Exacerbation;    COPD;   

Others  :  863137
DOI  :  10.1186/1471-2466-14-54

 received in 2014-03-13, accepted in 2014-03-20,  发布年份 2014

【 摘 要 】

Background

Proactive palliative care is not yet common practice for patients with COPD. Important barriers are the identification of patients with a poor prognosis and the organization of proactive palliative care dedicated to the COPD patient. Recently a set of indicators has been developed to identify those patients with COPD hospitalized for an acute exacerbation who are at risk for post-discharge mortality. Only after identification of these patients with poor prognosis a multi disciplinary approach to proactive palliative care with support of a specialized palliative care team can be initiated.

Methods/Design

The PROLONG study is a prospective cluster controlled trial in which 6 hospitals will participate. Three hospitals are selected for the intervention condition based on the presence of a specialized palliative care team. The study population consists of patients with COPD and their main informal caregivers. Patients will be included during hospitalization for an acute exacerbation. All patients in the study receive standard care (usual care). Besides, patients in the intervention condition who meet two or more criteria of the set of indicators for proactive palliative care will have additionally regular consultations with a specialized palliative care team. The objectives of the PROLONG study are: 1) to assess the discriminating power of the proposed set of indicators (indicator study) and 2) to assess the effects of proactive palliative care for qualifying patients with COPD on the wellbeing of these patients and their informal caregivers (intervention study). The primary outcome measure of the indicator study is time to death for any cause. The primary outcome measure of the intervention study is the change in quality of life measured by the St George Respiratory Questionnaire (SGRQ) three months after inclusion.

Discussion

The PROLONG study may lead to better understanding of the conditions to start and the effectiveness of proactive palliative care for patients with COPD. Innovative aspects of the PROLONG study are the use of a set of indicators for proactive palliative care, the active involvement of a specialized palliative care team and the use of a patient-tailored proactive palliative care plan.

Trial registration

Netherlands Trial Register (NTR): NTR4037

【 授权许可】

   
2014 Duenk et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]WHO Definition of Palliative Care [http://www.who.int/cancer/palliative/definition/en/ webcite]
• [2]Gore JM, Brophy CJ, Greenstone MA: How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax 2000, 55:1000-1006.
• [3]Solano JP, Gomes B, Higginson IJ: A comparison of symptom prevalence in far advanced cancer, AIDS, heart disease, chronic obstructive pulmonary disease and renal disease. J Pain Symptom Manage 2006, 31:58-69.
• [4]Claessens MT, Lynn J, Zhong Z, Desbiens NA, Phillips RS, Wu AW, Harrell FE Jr, Connors AF Jr: Dying with lung cancer or chronic obstructive pulmonary disease: insights from SUPPORT. Study to understand prognoses and preferences for outcomes and risks of treatments. J Am Geriatr Soc 2000, 48:S146-S153.
• [5]Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR: Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med 2006, 166:326-331.
• [6]Rocker GM, Dodek PM, Heyland DK, Canadian Researchers at the End of Life N: Toward optimal end-of-life care for patients with advanced chronic obstructive pulmonary disease: insights from a multicentre study. Can Respir J 2008, 15:249-254.
• [7]Yohannes AM: Palliative care provision for patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes 2007, 5:17. BioMed Central Full Text
• [8]Fox E, Landrum-McNiff K, Zhong Z, Dawson NV, Wu AW, Lynn J: Evaluation of prognostic criteria for determining hospice eligibility in patients with advanced lung, heart, or liver disease. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. JAMA 1999, 282:1638-1645.
• [9]Partridge MR, Khatri A, Sutton L, Welham S, Ahmedzai SH: Palliative care services for those with chronic lung disease. Chron Respir Dis 2009, 6:13-17.
• [10]Hardin KA, Meyers F, Louie S: Integrating palliative care in severe chronic obstructive lung disease. COPD 2008, 5:207-220.
• [11]Carlucci A, Guerrieri A, Nava S: Palliative care in COPD patients: is it only an end-of-life issue? Eur Respir Rev 2012, 21:347-354.
• [12]Pinnock H, Kendall M, Murray SA, Worth A, Levack P, Porter M, MacNee W, Sheikh A: Living and dying with severe chronic obstructive pulmonary disease: multi-perspective longitudinal qualitative study. BMJ 2011, 342:d142.
• [13]Morstad Boldt A, Yusuf F, Himelstein BP: Perceptions of the term palliative care. J Palliat Med 2006, 9:1128-1136.
• [14]Fadul N, Elsayem A, Palmer JL, Del Fabbro E, Swint K, Li Z, Poulter V, Bruera E: Supportive versus palliative care: what’s in a name?: a survey of medical oncologists and midlevel providers at a comprehensive cancer center. Cancer 2009, 115:2013-2021.
• [15]Dalal S, Palla S, Hui D, Nguyen L, Chacko R, Li Z, Fadul N, Scott C, Thornton V, Coldman B, Amin Y, Bruera E: Association between a name change from palliative to supportive care and the timing of patient referrals at a comprehensive cancer center. Oncologist 2011, 16:105-111.
• [16]Murray SA, Pinnock H, Sheikh A: Palliative care for people with COPD: we need to meet the challenge. Prim Care Respir J 2006, 15:362-364.
• [17]Lunney JR, Lynn J, Foley DJ, Lipson S, Guralnik JM: Patterns of functional decline at the end of life. JAMA 2003, 289:2387-2392.
• [18]Giacomini M, DeJean D, Simeonov D, Smith A: Experiences of living and dying with COPD: a systematic review and synthesis of the qualitative empirical literature. Ont Health Technol Assess Ser 2012, 12:1-47.
• [19]Curtis JR: Palliative and end-of-life care for patients with severe COPD. Eur Respir J 2008, 32:796-803.
• [20]Patel K, Janssen DJ, Curtis JR: Advance care planning in COPD. Respirology 2012, 17:72-78.
• [21]Coventry PA, Grande GE, Richards DA, Todd CJ: Prediction of appropriate timing of palliative care for older adults with non-malignant life-threatening disease: a systematic review. Age Ageing 2005, 34:218-227.
• [22]Reinke LF, Engelberg RA, Shannon SE, Wenrich MD, Vig EK, Back AL, Curtis JR: Transitions regarding palliative and end-of-life care in severe chronic obstructive pulmonary disease or advanced cancer: themes identified by patients, families, and clinicians. J Palliat Med 2008, 11:601-609.
• [23]Burge S, Wedzicha JA: COPD exacerbations: definitions and classifications. Eur Respir J Suppl 2003, 41:46s-53s.
• [24]Hurst JR, Donaldson GC, Quint JK, Goldring JJ, Baghai-Ravary R, Wedzicha JA: Temporal clustering of exacerbations in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009, 179:369-374.
• [25]Dewan NA, Rafique S, Kanwar B, Satpathy H, Ryschon K, Tillotson GS, Niederman MS: Acute exacerbation of COPD: factors associated with poor treatment outcome. Chest 2000, 117:662-671.
• [26]Steer J, Gibson GJ, Bourke SC: Predicting outcomes following hospitalization for acute exacerbations of COPD. QJM 2010, 103:817-829.
• [27]Murray S, Boyd K: Using the ‘surprise question’ can identify people with advanced heart failure and COPD who would benefit from a palliative care approach. Palliat Med 2011, 25:382.
• [28]Divo M, Cote C, de Torres JP, Casanova C, Marin JM, Pinto-Plata V, Zulueta J, Cabrera C, Zagaceta J, Hunninghake G, Celli B, BODE Collaborative Group: Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012, 186:155-161.
• [29]Kocks JW, Asijee GM, Tsiligianni IG, Kerstjens HA, van der Molen T: Functional status measurement in COPD: a review of available methods and their feasibility in primary care. Prim Care Respir J 2011, 20:269-275.
• [30]Buxton KL, Stone RA, Buckingham RJ, Pursey NA, Roberts CM: Current and planned palliative care service provision for chronic obstructive pulmonary disease patients in 239 UK hospital units: comparison with the gold standards framework. Palliat Med 2010, 24:480-485.
• [31]Lanken PN, Terry PB, Delisser HM, Fahy BF, Hansen-Flaschen J, Heffner JE, Levy M, Mularski RA, Osborne ML, Prendergast TJ, Rocker G, Sibbald WJ, Wilfond B, Yankaskas JR, ATS End-of-Life Care Task Force: An official American Thoracic Society clinical policy statement: palliative care for patients with respiratory diseases and critical illnesses. Am J Respir Crit Care Med 2008, 177:912-927.
• [32]Knauft E, Nielsen EL, Engelberg RA, Patrick DL, Curtis JR: Barriers and facilitators to end-of-life care communication for patients with COPD. Chest 2005, 127:2188-2196.
• [33]Penrod JD, Deb P, Luhrs C, Dellenbaugh C, Zhu CW, Hochman T, Maciejewski ML, Granieri E, Morrison RS: Cost and utilization outcomes of patients receiving hospital-based palliative care consultation. J Palliat Med 2006, 9:855-860.
• [34]Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ: Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010, 363:733-742.
• [35]de Graeff HGM A, Krol RJA, Kuyper MB, Verhagen EH, Volaard EJ: Palliatieve zorg: Richtlijnen voor de praktijk. Utrecht: Vereniging van Integrale Kankercentra; 2006.
• [36]Jones PW, Quirk FH, Baveystock CM: The St George’s Respiratory Questionnaire. Respir Med 1991, 85(Suppl B):25-31. discussion 33–27
• [37]Cohen SR, Mount BM, Strobel MG, Bui F: The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med 1995, 9:207-219.
• [38]Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM: A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med 1997, 27:363-370.
• [39]Pot AM, van Dyck R, Deeg DJ: Perceived stress caused by informal caregiving. Construction of a scale. Tijdschr Gerontol Geriatr 1995, 26:214-219.
• [40]Osse BH, Vernooij-Dassen MJ, Schade E, Grol RP: A practical instrument to explore patients’ needs in palliative care: the Problems and Needs in Palliative Care questionnaire short version. Palliat Med 2007, 21:391-399.
• [41]Thoonsen B, Groot M, Engels Y, Prins J, Verhagen S, Galesloot C, van Weel C, Vissers K: Early identification of and proactive palliative care for patients in general practice, incentive and methods of a randomized controlled trial. BMC Fam Pract 2011, 12:123. BioMed Central Full Text
• [42]van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF: Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes 2003, 1:13. BioMed Central Full Text
• [43]Kocks JW, Kerstjens HA, Snijders SL, de Vos B, Biermann JJ, van Hengel P, Strijbos JH, Bosveld HE, van der Molen T: Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level. Health Qual Life Outcomes 2010, 8:135. BioMed Central Full Text
• [44]Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA: Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax 1999, 54:581-586.
• [45]Jones PW: Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002, 19:398-404.
• [46]Wilson CB, Jones PW, O’Leary CJ, Cole PJ, Wilson R: Validation of the St. George’s Respiratory Questionnaire in bronchiectasis. Am J Respir Crit Care Med 1997, 156:536-541.
• [47]Cohen SR, Mount BM, Bruera E, Provost M, Rowe J, Tong K: Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med 1997, 11:3-20.
• [48]Gardiner C, Gott M, Small N, Payne S, Seamark D, Barnes S, Halpin D, Ruse C: Living with advanced chronic obstructive pulmonary disease: patients concerns regarding death and dying. Palliat Med 2009, 23:691-697.
• [49]Habraken JM, ter Riet G, Gore JM, Greenstone MA, Weersink EJ, Bindels PJ, Willems DL: Health-related quality of life in end-stage COPD and lung cancer patients. J Pain Symptom Manage 2009, 37:973-981.
• [50]Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF: Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol 2011, 29:2319-2326.
• [51]Koff PB, Jones RH, Cashman JM, Voelkel NF, Vandivier RW: Proactive integrated care improves quality of life in patients with COPD. Eur Respir J 2009, 33:1031-1038.
• [52]Boland J, Martin J, Wells AU, Ross JR: Palliative care for people with non-malignant lung disease: summary of current evidence and future direction. Palliat Med 2013, 27:811-816.
• [53]Hoe vaak komt COPD voor en hoeveel mensen sterven eraan? [http://www.nationaalkompas.nl/gezondheid-en-ziekte/ziekten-en-aandoeningen/ademhalingswegen/copd/omvang/ webcite]
• [54]Smith TJ, Cassel JB: Cost and non-clinical outcomes of palliative care. J Pain Symptom Manage 2009, 38:32-44.
• [55]Gomez-Batiste X, Caja C, Espinosa J, Bullich I, Martinez-Munoz M, Porta-Sales J, Trelis J, Esperalba J, Stjernsward J: The Catalonia World Health Organization demonstration project for palliative care implementation: quantitative and qualitative results at 20 years. J Pain Symptom Manage 2012, 43:783-794.