‘Moral distress in end-of-life care in the intensive care unit’Ethical Considerations in studies

Una St LedgerR&D Research Fellow,

Queen’s University, Belfast

Study funded by Research & Development Office, Public Health Agency

Adopted & supported by NICRN & TRG Critical Care Registered with INVOLVE

Trinity Annual Multi-disciplinary Conference, Doctoral Colloquium06.11.2012

Presentation overview

• Ethical considerations in research• Study – background, rationale, methods

• Key ethical issues relating to this study• References• Acknowledgements

Ethical Considerations in Research• Aristotle • 2nd world war Nuremberg Code • Declaration of Helsinki (WMA, 1964; 2008)• HSC Research Governance Framework (DoH, 2005)• Protect and safeguard: dignity, rights, safety and

well-being

Principles

• Respect for Autonomy – self determination (veracity, informed consent, refuse, retract participation)

• Non-maleficence – ‘do no harm’ (assess and manage risks)• Beneficence – ‘do good’ (benefits, risks, burdens)• Justice – fair distribution (benefits, risks, costs)• Right to Privacy, Confidentiality , Anonymity• Fidelity – conflicts of interest (Holloway & Wheeler, 2008)

Study Aim

• Aim – ‘Explore experiences of moral distress in healthcare professionals and relatives in end-of-life decisions in ICU’

Background

• What is Moral distress?

‘A state of anguish that individuals experience when they know what the morally right thing to do is but they are prevented from doing it due to internal or external constraints’

(McCarthy and Deady, 2008)

Rationale

• 19% patients die in ICU • Decisions to withdraw or withhold treatment

(Sprung et al, 2003; ICNARC, 2009)• Potential for Moral Distress• End-of-Life Care Strategy (DoH, 2008) • Neglected feature in palliative care and ICU

education programmes• Studies mainly North American- major nursing focus• Impact on patient’s families unknown

Methods• Design - Narrative Inquiry Case Study Design• Cases - (1) Withdrawal (2) Non-escalation (3) Brain

Stem Death• Purposive Sample – 1 nurse, 1 doctor, and 2

relatives per case• Data Collection – in-depth narrative interviews• Narrative Analysis – thematic, content• Dissemination – relatives interviews video/audio

recorded and copyrighted to ‘healthtalkonline’ website

Research Ethics Approval

• Office for Research Ethics Committee Northern Ireland (ORECNI)

• Challenged to think about ethics of design:Rationale Methodology Processes – who, how, where, whenKnowledge, skills, & training requiredParticipant and research team welfare

Specific issues

• Recruitment - who - how

- when• Informed consent• Narrative research • Confidentiality & anonymity• Narrative interviewing• Participant welfare

Who - is it right to study the recently bereaved?

• Marginalised from research (Seymour, 2005; Addington-Hall & McPherson, 2001)

• Our discomfort or on basis of well-founded evidence? • Risk of distress no greater than that currently experienced

(Morse & Corbin, 2004)• Talking about experiences - helpful, therapeutic ? (Grinyer,

2004; Hynson et al. 2006; Reid, 2009; Koffman et al. 2012)• Altruistic (Scott et al. 2002; Hynson et al. 2006; Koffman et al.

2012)• Improve systems and practice• Social justice – voices of bereaved empowered and heard

The how & when of recruitment

• Potential for Coercion Identification of and approach to participants

• Causing or adding to Emotional DistressTiming of approach to participantsSensitivity of approachVolume of study informationTiming of follow-up phone call to relativesTiming of data collection

Consent: an on-going process • Study information - clearly communicated, comprehensive,

understandable language• Participants need to know:

purpose what is expected benefits and burdens how findings used Who will have access Confidentiality, anonymity, data management arrangements Issues of malpractice and patient safety Background and contact details of researcher team how to make a compliant

• ‘Cool off period’• Right to decline, withdraw at any time• Written consent

Informed consent: relatives• Training - consenting and recording • Informed consent 2 stage process (before and after interview)• Demonstration of www.healthtalkonline.org• Inform - potential loss of anonymity

- avoid names of others/places• Consent form• Option - use own name/alias

- interview video/audio recorded - HTO clips video/audio/or fully anonymised written only

• Copy of transcript to review and edit• Copyright Form• Process consent - may withdraw consent at any time - even after website

gone live. Interview removed, recordings and transcripts destroyed• Raises issues of Internet Ethics

Narrative Research & Ethics

• Narrative research - interactive and relational (Holloway and Freshwater, 2007)• Specific ethical issues (Elliott, 2005)

Researcher/participant relationship Impact of research on all involved Personal narrative - meaning of life experiences and self identity Identity and coherence – threatened by deconstruction and

interpretation of narrative Risks to confidentiality and anonymity Analysis and interpretation of stories presented using participants

voices.

Anonymity and Confidentiality

• Pseudo names - transcripts and quotes• Restricted data access -research team• Avoid using names (people, places, hospitals) • Transcripts and recordings – names edited out• HTO - Participants can be identified by own or

pseudo name (family names not used)

Data Storage• Data password protected • University computers, secure server• Desktop security – usernames,

updated passwords, back-up procedures

• Personal info stored separate from transcripts, recordings

• Recordings and transcripts - anonymised PIN

• Locked cabinet, locked office• Restricted access • Study info archived – university

requirements

Narrative interview

• Safe environment – describe experience to interested, empathetic person

• In-depth qualitative interview – participant determines pace and direction of interview and discusses what they feel is important

• Informal, intimate and conversational manner• May disclose confidential and intimate information• Talking about painful or unresolved event – raw

emotions may surface

Welfare of participants

• key ethical consideration• Pre, during, and after interview• Sensitivity and timing of approach• Consenting• Interview potentially emotionally charged experience• Potential to re-traumatise participants • Talking about experiences maybe helpful and

therapeutic

Support Strategy: minimise harm• Researcher – experienced ICU nurse and facilitator• Interviewing vulnerable populations and managing challenging interviews

training• PIS – alert to accessing painful emotions, feelings of loss and grief• Process consent• Participant distress strategy - interview on hold, terminate, reschedule• Information pack – support services• Post-interview debrief - normalise• CRUSE Bereavement Care counselling services (relatives)• Inform family doctor• 2 weeks post interview - follow-up phone call - thank relatives and

ascertain emotional well-being• Staff Care and Here for U initiatives (HCPs)

Research Team Safety/SupportDickson-Swift et al (2007)

Researcher•Safety/Support Protocol•Training•Lone worker protocol•Debrief & counselling

• (1) supervisors • (2) university student counselling

•Support networks•Spacing /scheduled breaks

Supervisors•Safety/Support Protocol•Supervisors - access to Occupational Health Services

Transcriber•Regular contact •Support of researcher•Space recordings•Counselling

To conclude

• Position of trust and privilege• Responsibility• Sensitivity, empathy and compassion• Minimise harm• Maximise benefits

‘At the heart of all robust and ethical research is respect for individuals and

protection of those who may be vulnerable’.

(RCN, 2009 p.11)

References• Addington-Hall, J., McPherson, C. (2001) After-Death Interviews with Surrogates/Bereaved Family Members: Some issues of validity.

Journal of Pain and Symptom Management, 22(3), 784-790.• Corbin J. & Morse J. (2003) The Unstructured Interactive Interview: Issues of Reciprocity and Risks when Dealing with Sensitive Topics.

Qualitative Inquiry 9(3), 335-354.• Department of Health (2005) Research Governance Framework for Health & Social Care. 2nd Edition. Department of Health, London.• Department of Health (2008) End of Life Care Strategy: Promoting high quality care for all adults at the end of life. Department of

Health, London.• Dickson-Swift, V., James, EL., Kippen, s. et al (2007) Doing sensitive research: what challenges do qualitative interviewers face?

Qualitative Research, 7(3), 327-353.• Elliott, J. (2005) Using Narrative in Social Research: Qualitative and Quantitative Approaches. London: Sage.• Holloway, I., Freshwater, D. (2007) Narrative Research in Nursing. Oxford: Blackwell Publishing Ltd. • Hynson, JL., Aroni, R., Bauld, C., Sawyer, SM. (2006) Research with bereaved parents: a question of how not why. Palliative Medicine,

20(8), 805-11.• Intensive Care National Audit and Research Centre (ICNARC). Case Mix Programme Summary Statistics. www.icnarc.org. Accessed on

08/06/09.• Koffman, J., Higginson, IJ., Hall, S., Riley, J et al (2012) Bereaved relatives’ views about participating in cancer research. Palliative

Medicine, 26(4), 379-83.• McCarthy, J., Deady, T. (2008) Moral distress reconsidered. Nursing Ethics, 15(2), 254-262.• Reid, J. ((2009) Conducting qualitative research with palliative cancer patients and their families: Ethical considerations. International

Journal of Palliative Nursing, 15(1): 30-3.• Royal College of Nursing (2009) Research Ethics: RCN guidance for nurses. RCN, London. • Scott, DA., Valery, PC., Boyle, FM., Bain, CJ. (2002) Does research into sensitive areas do harm? Experiences of research participation

after a child’s diagnosis with Ewing’s sarcoma. Medical Journal of Australia, 177(9), 507-10.• Seymour, J., Rietjens, J., Brown, J., van der Heide, A. et al (2011) The perspectives of clinical staff and bereaved informal care-givers on

the use of continuous sedation until death for cancer patient. BMC Palliative Care, 10:5 http://www.biomedcentral.com/1472-684x/10/5 [accessed 20.10.12]

• Sprung, C.L., Cohen, S.L., Sjokvist, P., Baras, M., Bulow, H.H., Hovilehto, S., Ledoux, D., Lippert, A., Maia, P., Phelan, D., Schobersberger, W., Wennberg, E., Woodcock, T. Ethicus Study Group. (2003) End-of-life practices in European intensive care units: the Ethicus study. Journal of the American Medical Association 290, 790-797.

• Webster, C.G., Baylis, F. (2000) Moral residue. In: Rubin, SB, & Zoloth, L. (Eds). Margin of error. The ethics of mistakes in the practice of medicine. University Publishing Group, Hagerstown, MD.

Acknowledgements

Research Team

•Dr Bronagh Blackwood (CI) – Senior Lecturer, School of Medicine, Dentistry & Biological Sciences, QUB •Dr Ann Begley – Lecturer in Ethics, Virtual University of Uganda

•Prof Lindsay Prior – Professor of Sociology, School of Sociology, Social Policy & Social Work, QUB

•Dr Joanne Reid - Lecturer, School of Nursing, QUB

•Prof Danny McAuley (PI) - Consultant & Professor Intensive Care Medicine, RICU, BHSCT, & School of Medicine, Dentistry & Biological Sciences, QUB

Advisory Group

•Barry Williams – Patient & Relatives Committee Chair (Intensive Care Society)

•Stephen Carter – Independent Patient and Family Representative, Organ Donation

•Monica Hackett - Team Manager, Organ Donation Services Team (NHS BT)

•Heather Russell – Bereavement Co-ordinator (BHSCT)

•Lesley Rutherford – Nurse Consultant in Palliative Care (Marie Curie, BHSCT, QUB)