Guiding intensive care physicians' communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL)

Nancy Kentish-Barnes, Sylvie Chevret, Elie Azoulay, Nancy Kentish-Barnes, Sylvie Chevret, Elie Azoulay

Abstract

Background: Providing appropriate support and care for end-of-life patients and their relatives is a major concern and a daily responsibility for intensivists. Bereaved relatives of non-surviving patients in intensive care units (ICUs) often suffer from prolonged grief, posttraumatic stress disorder, anxiety, and depression. A physician-driven intervention, consisting of three meetings with the family, might reduce the post-ICU burden of bereaved family members 6 month after death. The patient's nurse is actively involved at each step. We hypothesize that this strategy will improve communication in the end-of-life setting and thus, should reduce the post-ICU burden for family members, specifically the development of prolonged grief 6 months after the death.

Methods/design: The COSMIC-EOL trial is a prospective, multicenter, cluster randomized controlled trial in which centers are allocated to two parallel arms: (1) intervention centers where relatives benefit from three-step physician-driven support during the dying and death process and (2) control centers where, during the dying and death process, relatives receive the standard of care practice. Each of the 36 participating centers will include 25 relatives of patients with a length of stay ≥2 days. Participating relatives will be followed up by phone at 1, 3, and 6 months after the patient's death to complete questionnaires permitting evaluation of their post-ICU burden. The main outcome is prolonged grief measured 6 months after the death using the PG-13. Other outcomes include evaluation of quality of dying, quality of communication, anxiety, depression, and post-traumatic stress. The estimated duration of the study is 36 months.

Discussion: The results of the trial will provide information about the effectiveness of physician-driven support for relatives of patients dying in an ICU. The study is expected to demonstrate a decrease in the ICU burden for bereaved relatives who benefitted from this intervention.

Trial registration: ClinicalTrials.gov, NCT02955992 . Registered on November 3rd 2016.

Keywords: Communication; End-of-life; Intensive care; Palliative care.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by our local institutional review board (Comité de protection des personnes, Ile de France IV, Saint Louis; number 2016/13), Commission Nationale de l’Informatique et des Libertés (which is responsible for ensuring that data privacy law is applied to the collection, storage, and use of personal data; number MMS/ABD/AR1611499), and Comité Consultatif sur les Traitements de l’Information en matière de Recherche dans le domaine de la Santé (number 16–315). All participating relatives signed an informed consent form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT figure. HADS Hospital Anxiety and Depression Scale, ICU intensive care unit, IES-R Impact of Event Scale, Revised, MISS-21 Medical Interview Satisfaction Scale, PG-13 Prolonged Grief 13-item questionnaire, QODD-1 Quality of Dying and Death 1-item questionnaire
Fig. 2
Fig. 2
Study design

References

    1. Kentish-Barnes N, Chaize M, Seegers V, et al. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015;45(5):1341–1352. doi: 10.1183/09031936.00160014.
    1. Aslakson RA, Curtis JR, Nelson JE. The changing role of palliative care in the ICU. Crit Care Med. 2014;42(11):2418–2428. doi: 10.1097/CCM.0000000000000573.
    1. Pochard F, Darmon M, Fassier T, et al. Symptoms of anxiety and depression in family members of intensive care unit patients before discharge or death. A prospective multicenter study. J Crit Care. 2005;20(1):90–96. doi: 10.1016/j.jcrc.2004.11.004.
    1. Azoulay E, Pochard F, Kentish-Barnes N, et al. Risk of Post-traumatic Stress Symptoms in Family Members of Intensive Care Unit Patients. Am J Respir Crit Care Med. 2005;171:987–994. doi: 10.1164/rccm.200409-1295OC.
    1. Prigerson HG, Maciejewski PK, Peynolds CF, et al. Inventory of complicated grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995;59:65–79. doi: 10.1016/0165-1781(95)02757-2.
    1. Kersting A, Brähler E, Glaesmer H, Wagner B. Prevalence of complicated grief in a representative population-based sample. J Affect Disord. 2011;131(1–3):339–343. doi: 10.1016/j.jad.2010.11.032.
    1. Nelson JE, Mulkerin CM, Adams LL, et al. Improving comfort and communication in the ICU: a practical new tool for palliative care performance measurement and feedback. Qual Saf Health Care. 2006;15:264–271. doi: 10.1136/qshc.2005.017707.
    1. Nelson JE, Puntillo KA, Pronovost PJ, Walker AS, McAdam JL, Ilaoa D, Penrod J. In their own words: patients and families define high-quality palliative care in the intensive care unit. Crit Care Med. 2010;38(3):808–818. doi: 10.1097/CCM.0b013e3181c5887c.
    1. Long AC, Curtis JR. Quality of dying in the ICU: understanding ways to make it better. Intensive Care Med. 2014;40(11):1793. doi: 10.1007/s00134-014-3512-4.
    1. Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: post intensive care syndrome-family. Crit Care Med. 2012;40(2):618–624. doi: 10.1097/CCM.0b013e318236ebf9.
    1. Gries CJ, Engelberg R, et al. Predictors of symptoms of post traumatic stress and depression in family members after patient death in the ICU. Chest. 2010;137(2):280–287. doi: 10.1378/chest.09-1291.
    1. Siegel MD, Hayes E, Vanderwerker LC, et al. Psychiatric illness in the next of kin of patients who die in the intensive care unit. Crit Care Med. 2008;36(6):1722–1728. doi: 10.1097/CCM.0b013e318174da72.
    1. Curtis JR, Engelberg RA, Wenrich MD, et al. Missed opportunities during family conferences about end-of-life care in the intensive care unit. Am J Respir Crit Care Med. 2005;171:844–849. doi: 10.1164/rccm.200409-1267OC.
    1. Selph RB, Shiang J, Engelberg R, et al. Empathy and life support decisions in intensive care units. J Gen Intern Med. 2008;23(9):1311–1317. doi: 10.1007/s11606-008-0643-8.
    1. Nelson JE, Azoulay E, Curtis JR, Mosenthal AC, Mulkerin CM, Puntillo K, Siegel MD. Palliative care in the ICU. J Palliat Med. 2012;15(2):168–174. doi: 10.1089/jpm.2011.9599.
    1. Mularski RA, Osborne ML. Palliative care and intensive care unit care: daily intensive care unit care plan checklist #123. J Palliat Med. 2006;9(5):1205–1206. doi: 10.1089/jpm.2006.9.1205.
    1. Teno JM, Byock I, Field MJ. Research agenda for developing measures to examine quality of care and quality of life of patients diagnosed with life-limiting illness. J Pain Symptom Manag. 1999;17(2):75–82. doi: 10.1016/S0885-3924(98)00134-1.
    1. Davidson JE. Family-Centered Care: Meeting the Needs of Patients’ Families and Helping Families Adapt to Critical Illness. Crit Care Nurse. 2009;29(3):28–34. doi: 10.4037/ccn2009611.
    1. Kirchhoff KT, Walker L, Hutton A, et al. The Vortex: Families’ Experiences With Death in the Intensive Care Unit. Am J Crit Care. 2002;11:200–209.
    1. Gauntlett R, Laws D. Communication skills in critical care. Continuing Education in Anaesthesia. Crit Care Pain J. 2008;8(4):121–124.
    1. Lautrette A, Darmon M, Megarbane B, et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007;356:469–478. doi: 10.1056/NEJMoa063446.
    1. Curtis JR, White DB. Practical Guidance for Evidence-Based ICU Family Conferences. Chest. 2008;134(4):835–843. doi: 10.1378/chest.08-0235.
    1. Hudson PL, Aranda S, Kristjanson LJ. Meeting the supportive needs of family caregivers in palliative care: challenges for health professionals. J Palliat Med. 2004;7(1):19–25. doi: 10.1089/109662104322737214.
    1. Hudson P, Quinn K, OHanlon B, Aranda S. Family meetings in palliative care: Multidisciplinary clinical practice guidelines. BMC Palliat Care. 2008;19:7–12.
    1. Hudson P, Thomas T, Quinn K, Aranda S. Family meetings in palliative care: are they effective? Palliat Med. 2009;23(2):150–157. doi: 10.1177/0269216308099960.
    1. Curtis JR, Patrick DL, Shannon SE, et al. The family conference as a focus to improve communication about end-of-life care in the intensive care unit: opportunities for improvement. Crit Care Med. 2001;29(Suppl 2):N26–N33. doi: 10.1097/00003246-200102001-00006.
    1. Kentish-Barnes N, McAdam JL, Kouki S, et al. Research Participation for Bereaved Family Members: Experience and Insights From a Qualitative Study. Crit Care Med. 2015;43(9):1839–1845. doi: 10.1097/CCM.0000000000001092.
    1. Puntillo K, Nelson JE, Weissman D, et al. Palliative care in the ICU: relief of pain, dyspnea, and thirst--a report from the IPAL-ICU Advisory Board. Intensive Care Med. 2014;40(2):235–248. doi: 10.1007/s00134-013-3153-z.
    1. Steinhauser KE, Voils CI, Bosworth H, Tulsky JA. What constitutes quality of family experience at the end of life? Perspectives from family members of patients who died in the hospital. Palliat Support Care. 2014;8:1–8. doi: 10.1097/SPC.0000000000000035.
    1. Kentish-Barnes N, Prigerson HG. Is this bereaved relative at risk of prolonged grief? Intensive Care Med. 2016;42(8):1279–81.
    1. Andershed B. Relatives in end-of-life care--part 1: a systematic review of the literature the five last years, January 1999-February 2004. J Clin Nurs. 2006;15(9):1158–1169. doi: 10.1111/j.1365-2702.2006.01473.x.
    1. Curtis JR, Nielsen EL, Treece PD, et al. Effect of a quality-improvement intervention on end-of-life care in the intensive care unit: a randomized trial. Am J Respir Crit Care Med. 2011;183(3):348–355. doi: 10.1164/rccm.201006-1004OC.
    1. Carson SS, Cox CE, Wallenstein S, et al. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016;316(1):51–62. doi: 10.1001/jama.2016.8474.
    1. Borbas C, Morris N, McLaughlin B, et al. The role of clinical opinion leaders in guideline implementation and quality improvement. Chest. 2000;118(2 Supplement):24S–32S. doi: 10.1378/chest.118.2_suppl.24S.
    1. Bero LA, Grilli R, Grimshaw JM, et al. Closing the gap between research and practice : overview of systematic reviews of interventions to promote the implementation of research findings. BMJ. 1998;317:465–468. doi: 10.1136/bmj.317.7156.465.
    1. Davis DA, Taylor-Vaisey A. Translating guidelines into practice. Can Med Assoc. 1997;157(4):408–416.
    1. Prigerson HG, Horowitz MJ, Jacobs SC, et al. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009;6(8):e1000121. doi: 10.1371/journal.pmed.1000121.
    1. Kentish-Barnes N, Seegers V, Legriel S, et al. CAESAR: a new tool to assess relatives' experience of dying and death in the ICU. Intensive Care Med. 2016;42(6):995–1002. doi: 10.1007/s00134-016-4260-4.
    1. Curtis JR, Patrick DL, Engelberg RA, et al. A measure of the quality of dying and death. Initial validation using after-death interviews with family members. J Pain Symptom Manag. 2002;24(1):17–31. doi: 10.1016/S0885-3924(02)00419-0.
    1. Meakin R, Weinman J. The 'Medical Interview Satisfaction Scale' (MISS-21) adapted for British general practice. Fam Pract. 2002;19(3):257–263. doi: 10.1093/fampra/19.3.257.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Weiss DS, Marmar CR. The impact of event scale – revised. In: Wilson JP, Keane TM, editors. Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. pp. 399–411.
    1. Campbell MK. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328(7441):702–708. doi: 10.1136/bmj.328.7441.702.
    1. Donner A, Klar N. Pitfalls of and Controversies in Cluster Randomization Trials. Am J Public Health. 2004;94(3):416–422. doi: 10.2105/AJPH.94.3.416.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj