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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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Before the consultation, Sonia Dalkin will explain the study in person and answer any questions you may have. Your signed consent form will then be collected. Spare consent forms will also be available though we would prefer if you had ample time to read them before agreeing to participate. The consultation between you and your GP will be recorded using a digital voice recorder. The researcher (Sonia Dalkin) will not be sitting in on the consultation but will listen to the recording afterwards. Your GP may ask you to take part in more than one consultation recording. This consultation will be one of your regular consultations that you would normally have with your GP.

Your GP will ask for your consent to record the consultation a maximum of three times, and each time, they will check if you are still happy with that (meaning that a conversation will never be recorded without your prior agreement). Even if you agreed for one recording, just say if you would rather not have subsequent ones recorded. At the end of the study the GP will check that you are still happy with the recording being given to the researcher (Sonia Dalkin). Communication about palliative care has been reported as difficult by patients and GPs. So, we would like to see if this might be because professionals and patients might have a different approach to stressful situations. This questionnaire and audio recording of your consultation will help us discover this.

You will not be contacted again by the researcher once the consultation has taken place. However, you can contact the researcher to ask any question, add any comment to what you have already told them, and/or request a summary of what the research finds or a copy of the full report if you wish.

We would like to encourage you to bring along family, friends or carers to the consultation if you wish to do so. Please let the researcher know if this is the case so she can provide an information pack for them also.

What will be the cost of taking part?

There will be no financial cost to taking part. We will however ask for 1 hour (maximum) of your time.

How might taking part affect me?

You will not be at any physical risk in this study. The consultation between you and your GP will be a consultation that you would normally have any way so there should not be any questions that you will feel uncomfortable with. However, please remember you do not have to answer any questions you feel uncomfortable with. Also, please feel free to ask your GP questions, and use this consultation like any normal appointment you would usually have with your GP. 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 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 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.

Your GP will be told that you are taking part in the study, as they too will be invited to take part, as they will be recorded during your consultation also. They will not have access to your questionnaire answers though.

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 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.

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 questionnaire and consultation recording 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 send you the questionnaire and ask you to return it using the stamped and addressed envelope that we will provide. You will then meet with the researcher (Sonia Dalkin) before your consultation for her to explain the study in person, answer any questions you may have and collect your consent form.

 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. This will not affect my care from the NHS.

Name __________________________

Signature __________________________

Date __________________________

Home address to send questionnaire to:

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_________ Name of GP ___________________________________________________

Appendix 27 Consent forms for MBSS and consultation recording for palliative care patients Version 2

–  –  –

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 having my next consultation recorded by a digital voice recorder.

–  –  –

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 28 Invitation letter for MBSS and consultation recording for health care professional 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. A recording of a consultation with a palliative care patient (who has also filled in the questionnaire and given their consent to be recorded) will then be taken.

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. 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.

Sonia Dalkin, Principal Researcher [contact details] Appendix 29 Information sheet for MBSS and consultation recording for health professionals 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.

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 Integrated Care Pathway (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 health professional in [the locality] you have been selected as a potential participant due to your involvement with the ICP. 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 are identified as a health professional in [the locality] who has worked closely with a palliative care patient who has agreed to take part in this study also.

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.



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