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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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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 in regards to this educational project. 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.

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.

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 that whether you decide to take part, not take part or take part then withdraw, the standard of care you and our family receive from the NHS will not be affected.

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 by contacting NHS North of Tyne Primary Care Trust or by contacting the Principal Supervisor, Dr. Anna Jones at

Northumbria University. Both of their details are below:

Dr. Anna Jones [contact details] NHS North of Tyne complaints procedure [contact details]

Additional Information

This study aims to identify how palliative care can be improved and provide best support to people with life limiting illnesses. If, for any reason, you are no longer able to provide us with any feedback once your interview is completed, we would still really value being able to use the interview data. This is so that your experiences may help improve palliative care for other people. By agreeing to take part in the study, you are also giving consent for us to use your interview data at any point in the future, in relation to studying palliative care.

Contact details If you have any concerns or would like further information about the study, please feel free to contact us.

Sonia Dalkin (Chief Investigator), [contact details] Dr. Bill Cunningham, GP and Chair of the Palliative Care Partnership [contact details] What happens now?

Many thanks for taking time to read about this study. If you would like to take part please fill in the reply slip below and return it using the stamped and addressed envelope enclosed within 2 weeks. Sonia Dalkin (chief investigator) will then contact you to arrange a convenient time and place for the interview.

 I would be interested in taking part in the study, and hereby give permission to be contacted by a member of the research team. I understand that before taking part, I will need to fill in a consent form and that if I want I can withdraw from the study at any time and this will not affect the care my family or I receive.

Name __________________________

Signature __________________________

Date __________________________

Telephone number for researcher to contact you on (to arrange an interview):

_____________________________

Appendix 22 Consent form for interviews with Palliative care patients Version 1

–  –  –

2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected.

3. I agree to being recorded by a digital voice recorder YesNo 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 23 Consent forms for interviews with bereaved relatives and carers of palliative patients.





Version 1

–  –  –

2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or 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 24 Consent form for interviews with palliative care patients’ relatives Version 1

–  –  –

2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or 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 25 Invitation letter for coping style questionnaire and consultation recording for palliative care patients Version 2

–  –  –

You are invited to take part in this research study.

We are doing research into the new Palliative Care Integrated Care Pathway in [the locality]. It is a study funded by NHS North of Tyne Primary Care Trust and Northumbria University.

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 questionnaire about how you cope with stressful health information. Your consultation with your GP will then be recorded.

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, family are carers 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 [contact details] Appendix 26 Information sheet for MBSS questionnaire and consultation recording for palliative care patients Version 3 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 other 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 as a palliative care patient in [the locality] you have been selected as a potential participant. This research wants to find out how the ICP works, for example, does it allow for 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 are on the palliative care register at your GP surgery.

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 fill in the reply slip at the bottom of this information sheet and return it to the chief investigator (Sonia Dalkin) with the stamped and addressed envelope provided.

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 from 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 complete and return the reply slip at the bottom of this information sheet, using the stamped and addressed envelope provided. The chief investigator (Sonia Dalkin) will then send you a questionnaire that asks questions about how you cope in various situations. It is well known that we are all different, and that different people cope in different ways. We are trying to find out if the way that people cope (for example, wanting to ask lots of questions or not wanting to know everything at once) affects how well a consultation goes between a GP and a patient.

We will also ask you to tell us when our next consultation with your GP is as we will wish to audio record it. We would ask that you bring the consent form provided in this pack with you to the consultation. This consent form will ensure sure that you understand what we are doing with the information you provide us with in the study.



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