Outpatient palliative care referral system (PCRS) for patients with advanced cancer: an impact evaluation protocol

Cinzia Brunelli, Ernesto Zecca, Alessandra Pigni, Paola Bracchi, Mariangela Caputo, Silvia Lo Dico, Viviana Fusetti, Antonino Tallarita, Cristiana Bergamini, Marta Brambilla, Alessandra Raimondi, Monica Niger, Salvatore Provenzano, Pierangela Sepe, Sara Alfieri, Gabriele Tinè, Filippo De Braud, Augusto Tommaso Caraceni, Cinzia Brunelli, Ernesto Zecca, Alessandra Pigni, Paola Bracchi, Mariangela Caputo, Silvia Lo Dico, Viviana Fusetti, Antonino Tallarita, Cristiana Bergamini, Marta Brambilla, Alessandra Raimondi, Monica Niger, Salvatore Provenzano, Pierangela Sepe, Sara Alfieri, Gabriele Tinè, Filippo De Braud, Augusto Tommaso Caraceni

Abstract

Introduction: Early palliative care (PC) in the clinical pathway of advanced cancer patients improves symptom control, quality of life and has a positive impact on overall quality of care. At present, standardised criteria for appropriate referral for early PC in oncology care are lacking. The aim of this project is to develop a set of standardised referral criteria and procedures to implement appropriate early PC for advanced cancer patients (the palliative care referral system, PCRS) and test its impact on user perception of quality of care received, on patient quality of life and on the use of healthcare resources.

Setting: Selected oncology clinics and PC outpatient clinic.

Methods and analysis: A scoping literature review and an expert consultation through a nominal group technique will be used to revise existing referral tools and to develop a new one, the PCRS. 25 patients will be enrolled in a pilot study to assess feasibility of the implementation of PCRS; 10 interviews with patients and healthcare professionals will be carried out to evaluate applicability.A pretest-post-test quasiexperimental study involving 150 patients before implementation of the PCRS and 150 patients after implementation will be carried out.Patient satisfaction with care received, quality of life and use of resources, and caregiver satisfaction with care will also be assessed to explore the impact of the intervention.

Ethics and dissemination: Ethical approval for the study has been granted by the Institutional Review board of the Fondazione IRCCS Istituto Nazionale Tumori; approval reference INT201/19.Results will be disseminated through open access publications and through scientific communication presented at national and international conferences.

Trial registration number: NCT04936568.

Keywords: Adult oncology; Adult palliative care; QUALITATIVE RESEARCH.

Conflict of interest statement

Competing interests: AC has received consultant honoraria from Mundipharma, Pfizer/Eli Lilly Italia Spa, Angelini, Shionogi, Molteni and Kyowa Kirin. He has also received research grants from Molteni & C Soc Esercizio Spa and Ipsen. EZ has received consultant honoraria from Amgen. MN has received travel expenses from Celgene, speaker honorarium from Accademia della Medicina and consultant honoraria from EMD Serono, Basilea Pharmaceutica, Incyte and MSD Italia. FDB has received consultant honoraria from Roche, EMD Serono, NMS Nerviano Medical Science, Sanofi, MSD, Novartis and Incyte. He has received speaker honoraria from BMS, Healthcare Research & Pharmacoepidemiology, Merck Group, ACCMED, Nadirex, MSD, Pfizer, Servier, Sanofi, Roche and AMGEN. He has also received research grants from Novartis, Roche, BMS, Celgene, Incyte, NMS, Merck KGAA, Kymab, Pfizer, Tesaro and MSD. AP, PB, MC, SLD, VF, CBe, MB, PS, SP, SA, AR, GT and CBr declare no conflicts of interest.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Project scheme. NGT, nominal group technique; PCRS, palliative care referral system.

References

    1. Haun MW, Estel S, Rücker G, et al. . Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev 2017;6:CD011129. 10.1002/14651858.CD011129.pub2
    1. Ferrell BR, Temel JS, Temin S, et al. . Integration of palliative care into standard oncology care: ASCO clinical practice guideline update summary. J Oncol Pract 2017;13:119–21. 10.1200/JOP.2016.017897
    1. Earle CC, Landrum MB, Souza JM, et al. . Aggressiveness of cancer care near the end of life: is it a quality-of-care issue? J Clin Oncol 2008;26:3860–6. 10.1200/JCO.2007.15.8253
    1. Hui D, Meng Y-C, Bruera S, et al. . Referral criteria for outpatient palliative cancer care: a systematic review. Oncologist 2016;21:895–901. 10.1634/theoncologist.2016-0006
    1. US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health . Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79. 10.1186/1477-7525-4-79
    1. Van de Ven AH, Delbecq AL. The nominal group as a research instrument for exploratory health studies. Am J Public Health 1972;62:337–42. 10.2105/ajph.62.3.337
    1. Cantrill JA, Sibbald B, Buetow S. The Delphi and nominal group techniques in health services research. Int J Pharm Pract 2011;4:67–74. 10.1111/j.2042-7174.1996.tb00844.x
    1. Lo C, Burman D, Hales S, et al. . The FAMCARE-patient scale: measuring satisfaction with care of outpatients with advanced cancer. Eur J Cancer 2009;45:3182–8. 10.1016/j.ejca.2009.09.003
    1. Groenvold M, Petersen MA, Aaronson NK, et al. . The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer 2006;42:55–64. 10.1016/j.ejca.2005.06.022
    1. Kristjanson LJ. Validity and reliability testing of the FAMCARE scale: measuring family satisfaction with advanced cancer care. Soc Sci Med 1993;36:693–701. 10.1016/0277-9536(93)90066-d
    1. Chattat R, Ottoboni G, Zeneli A, et al. . The Italian version of the FAMCARE scale: a validation study. Support Care Cancer 2016;24:3821–30. 10.1007/s00520-016-3187-1
    1. Koller M, Aaronson NK, Blazeby J, et al. . Translation procedures for standardised quality of life questionnaires: the European organisation for research and treatment of cancer (EORTC) approach. Eur J Cancer 2007;43:1810–20. 10.1016/j.ejca.2007.05.029
    1. Brunelli C, Borreani C, Caraceni A, et al. . Patient voices, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study. Health Qual Life Outcomes 2020;18:252. 10.1186/s12955-020-01501-1
    1. Machin D, Campbell M, Fayers P. Sample size tables for clinical studies. 2nd еd, 1997.
    1. Groenvold M, Petersen MA, Damkier A, et al. . Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: the Danish palliative care trial. Palliat Med 2017;31:814–24. 10.1177/0269216317705100
    1. Temel JS, Greer JA, Muzikansky A, et al. . Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010;363:733–42. 10.1056/NEJMoa1000678
    1. Zimmermann C, Swami N, Krzyzanowska M, et al. . Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet 2014;383:1721–30. 10.1016/S0140-6736(13)62416-2
    1. Maltoni M, Scarpi E, Dall'Agata M, et al. . Systematic versus on-demand early palliative care: a randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life. Eur J Cancer 2016;69:110–8. 10.1016/j.ejca.2016.10.004
    1. Temel JS, Greer JA, El-Jawahri A, et al. . Effects of early integrated palliative care in patients with lung and GI cancer: a randomized clinical trial. J Clin Oncol 2017;35:834–41. 10.1200/JCO.2016.70.5046
    1. Vanbutsele G, Pardon K, Van Belle S, et al. . Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol 2018;19:394–404. 10.1016/S1470-2045(18)30060-3
    1. Brims F, Gunatilake S, Lawrie I, et al. . Early specialist palliative care on quality of life for malignant pleural mesothelioma: a randomised controlled trial. Thorax 2019;74:354–61. 10.1136/thoraxjnl-2018-212380
    1. Scarpi E, Dall'Agata M, Zagonel V, et al. . Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. Support Care Cancer 2019;27:2425–34. 10.1007/s00520-018-4517-2
    1. Bakitas M, Lyons KD, Hegel MT, et al. . Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the project enable II randomized controlled trial. JAMA 2009;302:741–9. 10.1001/jama.2009.1198
    1. Bakitas MA, Tosteson TD, Li Z, et al. . Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the enable III randomized controlled trial. J Clin Oncol 2015;33:1438–45. 10.1200/JCO.2014.58.6362
    1. HN Tattersall M, Martin A, Devine R. Early contact with palliative care services: a randomized trial in patients with newly detected incurable metastatic cancer. J Palliat Care Med 2014;04. 10.4172/2165-7386.1000170
    1. McCorkle R, Jeon S, Ercolano E, et al. . An advanced practice nurse coordinated multidisciplinary intervention for patients with late-stage cancer: a cluster randomized trial. J Palliat Med 2015;18:962–9. 10.1089/jpm.2015.0113
    1. Hui D, Mori M, Watanabe SM, et al. . Referral criteria for outpatient specialty palliative cancer care: an international consensus. Lancet Oncol 2016;17:e552–9. 10.1016/S1470-2045(16)30577-0
    1. Kaasa S, Loge JH, Aapro M, et al. . Integration of oncology and palliative care: a Lancet oncology Commission. Lancet Oncol 2018;19:e588–653. 10.1016/S1470-2045(18)30415-7
    1. Hannon B, Swami N, Rodin G, et al. . Experiences of patients and caregivers with early palliative care: a qualitative study. Palliat Med 2017;31:72–81. 10.1177/0269216316649126
    1. Hoerger M, Greer JA, Jackson VA, et al. . Defining the elements of early palliative care that are associated with patient-reported outcomes and the delivery of end-of-life care. J Clin Oncol 2018;36:1096–102. 10.1200/JCO.2017.75.6676
    1. Costantini M, Apolone G, Tanzi S, et al. . Is early integration of palliative care feasible and acceptable for advanced respiratory and gastrointestinal cancer patients? A phase 2 mixed-methods study. Palliat Med 2018;32:46–58. 10.1177/0269216317731571
    1. Wentlandt K, Krzyzanowska MK, Swami N, et al. . Referral practices of oncologists to specialized palliative care. J Clin Oncol 2012;30:4380–6. 10.1200/JCO.2012.44.0248
    1. Ullgren H, Kirkpatrick L, Kilpeläinen S, et al. . Working in silos? - Head & Neck cancer patients during and after treatment with or without early palliative care referral. Eur J Oncol Nurs 2017;26:56–62. 10.1016/j.ejon.2016.12.003
    1. Lally K, Chua IS, Lin NU, et al. . Using quality improvement to increase access to palliative care. JCO Oncol Pract 2021;17:107–10. 10.1200/OP.20.00469
    1. Mayland CR, Ho QM, Doughty HC, et al. . The palliative care needs and experiences of people with advanced head and neck cancer: a scoping review. Palliat Med 2021;35:27–44. 10.1177/0269216320963892
    1. Salins N, Ghoshal A, Hughes S, et al. . How views of oncologists and haematologists impacts palliative care referral: a systematic review. BMC Palliat Care 2020;19:175-020-00671-5. 10.1186/s12904-020-00671-5
    1. Kayastha N, LeBlanc TW. When to integrate palliative care in the trajectory of cancer care. Curr Treat Options Oncol 2020;21:41-020-00743-x. 10.1007/s11864-020-00743-x
    1. Silva TH, Peres WAF, Rosa KSdaC, et al. . Advanced stage of disease and systemic inflammation as factors associated with referral of patients with colorectal cancer to a palliative care unit. Am J Hosp Palliat Care 2020;37:859–65. 10.1177/1049909120902789
    1. Ostgathe C, Wendt KN, Heckel M, et al. . Identifying the need for specialized palliative care in adult cancer patients - development and validation of a screening procedure based on proxy assessment by physicians and filter questions. BMC Cancer 2019;19:646-019-5809-8. 10.1186/s12885-019-5809-8
    1. Glare PA, Chow K. Validation of a simple screening tool for identifying unmet palliative care needs in patients with cancer. J Oncol Pract 2015;11:e81–6. 10.1200/JOP.2014.001487
    1. Zalenski R, Courage C, Edelen A, et al. . Evaluation of screening criteria for palliative care consultation in the MICU: a multihospital analysis. BMJ Support Palliat Care 2014;4:254–62. 10.1136/bmjspcare-2013-000570
    1. Milnes S, Orford NR, Berkeley L, et al. . A prospective observational study of prevalence and outcomes of patients with gold standard framework criteria in a tertiary regional Australian hospital. BMJ Support Palliat Care 2019;9:92–9. 10.1136/bmjspcare-2015-000864
    1. Meffert C, Rücker G, Hatami I, et al. . Identification of hospital patients in need of palliative care--a predictive score. BMC Palliat Care 2016;15:21. 10.1186/s12904-016-0094-7
    1. Flaherty C, Fox K, McDonah D, et al. . Palliative care screening: appraisal of a tool to identify patients' symptom management and advance care planning needs. Clin J Oncol Nurs 2018;22:E92-E96. 10.1188/18.CJON.E92-E96
    1. Lambert S, Bellamy T, Girgis A. Routine assessment of unmet needs in individuals with advanced cancer and their caregivers: a qualitative study of the palliative care needs assessment tool (PC-NAT). J Psychosoc Oncol 2018;36:82–96. 10.1080/07347332.2017.1382645
    1. Molin Y, Gallay C, Gautier J, et al. . PALLIA-10, a screening tool to identify patients needing palliative care referral in comprehensive cancer centers: a prospective multicentric study (PREPA-10). Cancer Med 2019;8:2950–61. 10.1002/cam4.2118
    1. Marshall TF, Alfano CM, Sleight AG, et al. . Consensus-building efforts to identify best tools for screening and assessment for supportive services in oncology. Disabil Rehabil 2020;42:2178–85. 10.1080/09638288.2018.1555621
    1. Carrasco-Zafra MI, Gómez-García R, Ocaña-Riola R, et al. . Level of palliative care complexity in advanced cancer patients: a multinomial logistic analysis. J Clin Med 2020;9:1960. 10.3390/jcm9061960
    1. Le QV, Trinh HL, Mai KNT, et al. . Screening patients with cancer admitted to Hanoi medical university hospital for palliative care needs. JCO Glob Oncol 2020;6:1321–7. 10.1200/GO.20.00102
    1. Kwon JH, Baek SK, Kim DY, et al. . Pilot study for the psychometric validation of the Sheffield profile for assessment and referral to care (SPARC) in Korean cancer patients. Cancer Res Treat 2021;53:25–31. 10.4143/crt.2020.235
    1. Paiva CE, Paiva BSR, Menezes D, et al. . Development of a screening tool to improve the referral of patients with breast and gynecological cancer to outpatient palliative care. Gynecol Oncol 2020;158:153–7. 10.1016/j.ygyno.2020.04.701
    1. Dudgeon D. The impact of measuring patient-reported outcome measures on quality of and access to palliative care. J Palliat Med 2018;21:S-76–S-80. 10.1089/jpm.2017.0447
    1. Kamal AH, Bausewein C, Casarett DJ, et al. . Standards, guidelines, and quality measures for successful specialty palliative care integration into oncology: current approaches and future directions. J Clin Oncol 2020;38:987–94. 10.1200/JCO.18.02440
    1. Hui D, Anderson L, Tang M, et al. . Examination of referral criteria for outpatient palliative care among patients with advanced cancer. Support Care Cancer 2020;28:295–301. 10.1007/s00520-019-04811-3
    1. Singh S, Rodriguez A, Lee D, et al. . Usefulness of the surprise question on an inpatient oncology service. Am J Hosp Palliat Care 2018;35:1421–5. 10.1177/1049909118777990
    1. Rauenzahn SL, Schmidt S, Aduba IO, et al. . Integrating palliative care services in ambulatory oncology: an application of the Edmonton symptom assessment system. J Oncol Pract 2017;13:e401–7. 10.1200/JOP.2016.019372
    1. Beeler PE, Bates DW, Hug BL. Clinical decision support systems. Swiss Med Wkly 2014;144:w14073. 10.4414/smw.2014.14073
    1. De Conno F, Ripamonti C, Caraceni A, et al. . Palliative care at the National cancer Institute of Milan. Support Care Cancer 2001;9:141–7. 10.1007/s005200000219
    1. Caraceni A, Lo Dico S, Zecca E, et al. . Outpatient palliative care and thoracic medical oncology: referral criteria and clinical care pathways. Lung Cancer 2020;139:13–17. 10.1016/j.lungcan.2019.10.003

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren