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«Citation: Dalkin, Sonia (2014) The Realist Evaluation of a Palliative Integrated Care Pathway in Primary Care: What Works, For Whom and in What ...»

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Will taking part in the project be private and confidential?

Yes. We will follow ethical and legal practice and all information the practice provides will be handled in confidence. This research is also for an educational project, as the chief investigator (Sonia Dalkin) is doing a PhD. All information the practice provides will be completely confidential in regards to this educational project and any future publications. Anything that you provide will not be able to be traced back to the practice in published reports. The researchers will not be able to access any information about the patients as the data will be anonymised before the researchers are given access. All information will be stored on a secure, password protected computer within Northumbria University. It will only be able to be accessed by Sonia Dalkin, (the chief investigator), Dr. Anna Jones (academic supervisor), Dr. Monique Lhussier (academic supervisor) and Dr. Bill Cunningham (academic supervisor and GP). Any written and recorded information will be destroyed six years after the study ends. Practices will be provided with feedback from the analysis that is completed in order to help them improve their current performance.

What will happen if the practice does not want to carry on with the research?

The practice can withdraw from the research at any time they can and they do not need to provide a reason. There will be no detrimental effects on the practice and your patients will still have access to services on the palliative are pathway.

Who has reviewed the study?

All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by Newcastle and North Tyneside 1 Research Ethics Committee.

What if there is a problem?

If you have any query, please feel free to contact the researcher (contact details provided below). We hope this is not the case, but would you wish to complain formally about the study, you can do this through the NHS complaints procedure or by contacting the Principal Supervisor, Dr. Anna Jones at Northumbria University. Both

of their contact details are below:

Dr. Anna Jones [contact information] NHS North of Tyne PCT complaints [contact information] Contact details Please feel free to contact the chief investigator if you have any further questions.

Sonia Dalkin (Chief Investigator) [contact details] What happens now?

Many thanks for taking time to read about this study. If you would like to take part please reply to this email within 2 weeks of receiving it. Consent should be given by the practice manager on behalf of the practice. You will then receive a confirmation email.

Many Thanks, Dr. Bill Cunningham [contact details] Appendix 5 Consent form for Practices to agree to the use of MIQUEST and death audit data Version 1 – 7.10.11

–  –  –

2. I understand that the participation is voluntary and that the practice is free to withdraw at any time without giving any reason, without legal rights being affected.

–  –  –

Name of Participant _________________________

Date _____________________________________

Signature _________________________________

Name of Researcher ________________________

Date _____________________________________

Signature _________________________________

If you would like more details about the project, please do not hesitate to contact the

researcher, Sonia Dalkin, by email: sonia.dalkin@northumbria.ac.uk or by telephone:

07792768226.

Appendix 6 Invitation letter for bereaved relatives for Quality of Death and Dying Measure Version 2

–  –  –

Dear Sir/Madam, Firstly may we say that we are extremely sorry for the recent loss of your loved one.

We are contacting you as we are doing research into the new Palliative Care Integrated Care Pathway in [the locality] that your loved one had experience of. It is a study funded by NHS North of Tyne Primary Care Trust and Northumbria University and we think you could help contribute to the research.

What will this study do?

This study is part of Sonia Dalkin’s PhD at Northumbria University which investigates the new palliative care system in [the locality]. It hopes to find out new and interesting things about the system, including how it works, and who it works for (for example, patients, family, carers, GPs, nurses). It will also help the system improve itself, therefore improving palliative care as the study is taking place. This research is important as its overall aim is to inform and improve palliative care practice on both a local and national level so that individuals have open and easy access to the supportive care they need, which will ultimately lead to a peaceful death.

How could you take part?

If you are interested in taking part, we will ask you to fill in a short questionnaire which will ask questions about your relative’s death. This is so that we can find out how well the system is working and if it is helping individuals die peacefully.

What to do if you are interested in taking part and want more information?

If you would like to find out more information about the study, please take the time to read the Information Sheet included with this letter. This will give you more information about the study and what you would do if you participated. We would like you to share the information sheet with your friends and family if you wish to, as they could possibly be involved also. You may also contact the researcher if you would like to find out more information or ask questions. The contact details of Sonia Dalkin are at the end of this letter and in the information sheet.





If you have decided you do not want to take part in the study, you do not need to do anything.

Thank you for taking the time to read this letter.

Contact Details Sonia Dalkin, Principal Researcher.

Room H007 Coach Lane Campus East Northumbria University Newcastle upon Tyne NE7 7XA sonia.dalkin@northumbria.ac.uk Appendix 7 Information Sheet for bereaved relatives approached to complete the Quality of Death and Dying Measure Version 2 Understanding integrated care pathways in palliative care – context, approaches, outcomes.

[A Research Study] Information Sheet Part 1 We would like to invite you to take part in this research project. Before you make a decision about taking part we want to make sure you understand why the research is being done and what it would involve for you. Please take the time to read the following information carefully and talk to others about the study if you wish. Part 1 will provide a brief summary of the research and part 2 will give more detailed information about the study.

Below is a list of terms used in this document that you may not be familiar with:

 Service user: This is any person who comes into contact with the National Health Service (NHS). This includes patients, carers, family members and advocates.

 Integrated Care Pathway (ICP): An integrated care pathway involves many teams working together, for example the GP surgery, the community nurses, the North east ambulance service and Tynedale hospice at home all working together to provide the best possible care for patients.

If you have any difficulties, or need help to understand the information please contact us and we will be happy to help. By taking part, you will be contributing to a local study that aims to make a real difference to life limiting illness and palliative care.

This will be done through identification of pathway mechanisms that contribute to a successful outcome in an ICP. This could then improve the quality of palliative care delivered in [the locality], and the rest of the county. Please take time to decide whether you would like to take part.

What is the purpose of the study?

[The locality] has created a new ICP which provides individuals who have life limiting illness with access to supportive palliative care including the best symptom control, shared decision making about treatment and generally increased choice about care, leading to a peaceful death with an individual’s needs fully met. The ICP is now in place and you will have experienced it in some way or form in your late loved ones care. This research wants to find out how the ICP works, for example, does it enable better communication between patients and GPs, or better planning and co-ordination?

We also want to look at who the ICP is benefitting, does it benefit palliative care patients? Are families happy with it? Are health professionals happy with it? So, we would like to hear from patients, family members, carers and health professionals, in a variety of ways, about their experience of the ICP.

Why have I been invited to take part in the study?

You have been invited to take part as you have recently been bereaved and it is our understanding your loved one was a palliative care patient. We are very interested in hearing about your experience and how you found the ICP. We may also ask how you think your loved one felt about the care they received. Your loved one’s GP will fill in the same questionnaire as you so we can get an idea of how everybody felt the experience was. The GP will not see your answers to the questionnaire and you will not see their answers. Your loved one’s GP practice will have no access to the data you provide in this study.

Do I have to take part?

No, taking part in this study is voluntary and you do not have to take part. We will explain the study to you in this Information Sheet and if you have any questions or you are unsure whether you understand everything please feel free to contact us (our contact details are on the bottom of this information sheet). If you decide you would like to take part, we will ask you to sign the reply slip at the end of this Information Sheet to show you have agreed for a member of the research team to contact you to arrange the questionnaire to be posted to you.

If you take part and decide that you have changed your mind and no longer wish to be involved you can stop taking part and withdraw at any time. You do not need to provide a reason. There will be no detrimental effects on you or your care form the NHS. You and your family will still have access to services on the palliative care pathway.

What will happen to me if I take part?

If you decide you would like to take part in this research, we would like you to fill in the reply slip at the end of this Information Sheet. The researcher (Sonia Dalkin) will then send you a questionnaire that you will fill in and send back. We will provide you with a stamped and addressed envelope. You will also receive a consent form which will just make sure that you understand what we are doing with the information you give us.

You will not be contacted again once you have returned the questionnaire and consent form in the stamped and addressed envelope provided.

What will be the cost of taking part?

There will be no financial cost to taking part. We will however ask for 30 minutes (maximum) of your time.

How might taking part affect me?

This study will not involve any physical risks, but answering questions about your experiences might be emotional or tiring. We cannot promise the study will help you but the information we get from this study will help improve the treatment of palliative care patients. If you do feel distressed or upset by the questionnaire you can contact Dr. Bill Cunningham who will be happy to talk to you about the study and provide support.

This completes Part 1. If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decision.

Part 2 Will taking part in the project be private and confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. This research is also for an educational project, as the chief investigator (Sonia Dalkin) is doing a PhD. All information you provide will be completely confidential. Anything that you provide will not be able to be traced back to you as you will be given a number instead of using your name. Additionally, your loved one’s GP practice will not have access to any of the recorded data from this study.

All information will be stored on a secure, password protected computer within Northumbria University. It will only be able to be accessed by Sonia Dalkin, (the chief investigator), Dr. Anna Jones (academic supervisor), Dr. Monique Lhussier (academic supervisor) and Dr. Bill Cunningham (academic supervisor and GP). All personal information will be destroyed when the study ends (names will already have been replaced with a number and addresses will be destroyed) and any written and recorded information will be destroyed six years after the study ends.

Breaking confidentiality If you tell us something during the study that suggests you or someone else is at serious risk of harm we would then have to breach confidentiality. This means that we would report the issue to someone who could help. We will however inform you that we are going to do this, and it will not affect the standard of care that you receive.

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

If you wish to withdraw from the research at any time you can and you do not need to provide a reason. Please remember there will be no detrimental effects on you or your care from the NHS. You and your family will still have access to services on the palliative care pathway.

Who has reviewed the study?

All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by Newcastle and North Tyneside 1 Research Ethics Committee.

What if there is a problem?

If there is a problem or you are not happy with the study please contact one of the researchers (contact details provided below) and we will do our best to answer any questions or queries you may have. We hope this is not the case, but if you are still unhappy and wish to complain formally, you can do this through the NHS complaints procedure or by contacting the Principal Supervisor, Dr. Anna Jones at Northumbria

University. Both of their contact details are below:



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