Participant Information for Friends and Family of Former ICU Patients

We would like to invite you to join our study and this page will help you decide whether or not to join our study. Before you decide whether to take part it is important that you understand why the research is being done and what it will involve. Please read this page carefully and discuss it with others if you wish.

Part 1 of this page tells you the purpose of the study and what will happen if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Next steps will direct you to the relevant contact forms.

Part 1: The Purpose of the Study and Taking Part

 

What is the CRITICAL study?

  • The full title of the study is ‘Conflict Resolution in the Intensive Care Unit for Incapacitated Adults (CRITICAL): Anticipating, Avoiding and Addressing Disagreements in “Best Interests” Decision-Making’

What is the study about?

  • Research shows that disagreements are unfortunately a common occurrence in the intensive care unit (ICU). This is partly due to the difficult and complex nature of decision-making. When an adult patient is unable to make decisions – due, for example, to the effects of critical illness – a decision must be made in their “best interests”.
  • In particular, disagreements may occur when a consensus cannot be reached (between the healthcare team and those close to the patient) on what is in the “best interests” of an adult patient, who is critically unwell and therefore unable to make decisions for his or herself.
  • Although there is some legal and professional guidance on how these disagreements should be resolved, little is known about how healthcare professionals, patients and patient representatives perceive this guidance. Even less is known about how these disagreements are anticipated, avoided and addressed in the real world.

What are the study aims?

  • The study aims to determine how and why disagreements occur between patient representatives and healthcare professionals over “best interests” decision-making in the adult ICU.
  • The study aims to explore former patients’, their representatives’ and healthcare professionals’ accounts of disagreements in best interests decision-making in the adult ICU.
  • Ultimately, the study aims to identify features of effective management of disagreements in the adult ICU, which may go onto inform professional guidance.

Who is organising this study?

  • The study is being run by Dr Harleen Kaur Johal, a junior doctor with interests in medical ethics and critical care. Harleen is conducting this research as part of her PhD studies at the University of Bristol. She has worked as an intensive care doctor through the COVID-19 pandemic. She will conduct all interviews.

Who is funding the study?

  • The study is being funded by the Wellcome Trust, a charity whose aims are to improve human wellbeing through advances in healthcare.

Who has been invited to take part?

  • All the types of people that may have been involved in the best interests decision-making process for adult patients in ICU, or people who are involved in processes through which disagreements might be resolved. These are broadly defined in two categories:
    • Professionals:
      • Adult intensive care doctors
      • Adult intensive care nurses
      • Adult intensive care allied healthcare professionals
      • Hospital lawyers
      • Mediators
      • Clinical ethics committee members
    • Patients and their Representatives:
      • Former ICU patients
      • Close relatives, friends and/or loved ones of former ICU patients (who were consulted as part of the best interests decision-making process)
      • Individuals who have previously acted as a legal representative of a former ICU patient (including those with Lasting Power of Attorney, Court-appointed Deputies, and Independent Mental Capacity Advocates)

Why have I been asked to take part?

  • As a close relative or friend of a former ICU patient, you are welcome to take part if they had an ICU admission of at least four days, and you were consulted in decisions being made in the best interests of that person.
  • As it takes time to start physically and psychologically recovering from an intensive care admission, you are invited to participate at least three months after your relative or friend was discharged from hospital.
  • If your relative or friend died in ICU, you are invited to participate from one year after their ICU admission. The bereavement journey is difficult, and this gives you time to begin reflecting on your experiences, before sharing them. If you want to wait longer before participating in the study, that is fine. You should not take part unless you are ready. Although discussing the details of the ICU admission may be difficult, you have been invited to participate as you have a unique perspective of being consulted as part of the best interests decision-making process.
  • Disagreements may or may not have arisen during the ICU admission, but we are interested in hearing about your personal experiences, and how you think disagreements were avoided and/or addressed. We are also interested in your views on how disagreements should be resolved if they arise.
  • If you are currently involved in active legal proceedings relating to the ICU admission, you will not be able to participate in the study. This is because discussing the case might place you “in contempt of court”, which is a serious legal offence.

How do I express my interest in participating?

  • In order to take part in the study you will need to complete this form. Alternatively, you can email or telephone the researcher directly.
  • The researcher will then contact you and answer any further questions you may have about the study, including addressing any concerns.
  • She will also ask if you would like to be interviewed individually or together, with your friend or relative.
  • If you are still interested in participating, the researcher will arrange a time to meet with you, in person or virtually. This can be at the hospital or at a place convenient for you. You will have further time to think about whether you want to take part or not.

What will taking part involve?

  • When you meet with the researcher, she will give you a further opportunity to ask questions about the study, and explore any concerns that you may have.
  • If you are happy to take part, she will ask for your written consent. A copy of the consent form will be given to you and the original paperwork will be kept by the researcher. With your agreement, the researcher will ask you about your experiences of best interests decision-making in intensive care, and will ask you if you thought any disagreements may have occurred.
  • She will then discuss different cases, and ask you about how you think these disagreements could be managed.
  • This discussion will take place individually or with your friend/relative – depending on your preferences and circumstances.
  • It is possible that the interview will uncover emotions or feelings you have not previously discussed, but you will have the opportunity to reflect on this after the interview, and you will also be given information about support for friends and family of former ICU patients
  • The interview is expected to take 60 – 90 minutes.
  • If you agree, the interview will be audio recorded for later analysis by the researcher.

What if I don’t want to take part?

  • If you would not like to participate, you can still be present for the duration of the interview to provide support, but you will be asked not to speak during the interview. If you do speak, anything you say will not be included in the study.
  • If you change your mind, and decide that would like to join the study after the interview has started, the interview will be paused. The researcher will address any questions you may have about the study, and ask for your written consent to participate in the study.

What are the disadvantages of taking part in the study?

  • You may find discussing the topic upsetting, and it may remind you of stressful or tragic episodes you have personally experienced. The cases discussed within the interview may also remind you of your own experiences and you may find discussing these difficult. Should you find the interview distressing, you will be able to stop it at any time, and the researcher will give you a chance to wind down and reflect on these emotions.
  • The time it takes to participate is also a disadvantage.

Are there any benefits to taking part?

  • There may be no direct benefits to taking part, although you may find talking about your experiences gives an outlet for your feelings.
  • The main benefit of the study will be to contribute to research that aims to improve the management of disagreements that arise in adult intensive care units.
  • We hope that having a better understanding of how and why disagreements occur, will enable us to improve the experiences of future patients, their representatives and staff.

Is the data from the study confidential?

  • Yes, the data from the study is confidential. All the information you give us will be anonymised and only used for research purposes. We may use transcription services to transcribe interviews, however these services will also be asked to sign a confidentiality agreement.
  • You will be asked to give consent to the University of Bristol to record and process the information you give for research purposes.
  • Neither your name nor personal details will be reported in any research papers or written reports. These may include some quotations from interviews. We will make sure no one can work out who you are from the reports we write.
  • An exception to this confidentiality would be a disclosure of serious criminal wrongdoing (for instance something that may have harmed or presently endanger a vulnerable person). Such a disclosure could not be kept in confidence and would need to be passed on to the appropriate authorities.

How will my data be stored?

  • The University of Bristol is the sponsor for this study based in the United Kingdom. We will be using information from you (and your medical records) in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly.
  • Anonymised electronic data will be stored on password protected computers for 20 years in accordance with the University of Bristol’s research governance policy.
  • We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. 

This completes Part 1 of the information. If the information in Part 1 has interested you and you think you may wish to participate, please continue to read the additional information in Part 2 before making a final decision.

Part 2: The Conduct of the Study

 

What will happen if I don’t want to carry on with the study?

  • Your participation is voluntary and if you decide to take part you will be free to withdraw at any time, without giving a reason.
  • However, if you decide to withdraw, we will retain use of the study data (i.e. the information you give us during your interview) that was collected prior to your withdrawal.
  • Withdrawing from the study or declining participation will have no repercussions upon your relationship with the hospital (including your current/future healthcare).

What will happen to the results of the study?

  • When the study has concluded, you will be provided with a report of the results if you wish.
  • The study results will also be published in a doctoral thesis being prepared by the researcher, as well as in medical and scientific journals.
  • The study results will also be presented at scientific conferences in order to circulate them as widely as possible.
  • There may also be an opportunity to attend public events, during which the findings of the study will be presented.

Is there anything else I should know about how my data will be used?

  • In this research study we will use information from you. We will only use information that we need for the research study.
  • We will let very few people know your name or contact details, and only if they really need it for this study.
  • When you agree to take part in a research study, the information you provide may be given to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
  • Everyone involved in this study, and future studies, will keep your data safe and secure. We will also follow all privacy rules. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
  • This information will be anonymised. It will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
  • Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
  • You can find out more about how we use your information on the Health Research Authority website or by contacting the research team.

What if something goes wrong?

  • If something has gone wrong or you wish to make a complaint, please contact the research team in the first instance here.

Who has reviewed this study?

  • This study has been given a favourable opinion for conduct in the NHS by the South Central (Oxford C) Research Ethics Committee (IRAS Project ID: 282331).

Thank you very much for taking the time to read this information.

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