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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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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, your patients, or your employment. Your pati9ents will still have access to the services on the palliative care pathway.

What will happen to me if I take part?

If you decide that 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. 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 successful a consultation is between a GP and a patient.

We will also ask you to confirm with us when your next consultation with your palliative care patient is (we will inform you which patient has agreed to take part in this study, and they will have already told us when their appointment with you is). We wish to know when this appointment is as we would like to digitally voice 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.

Before the consultation, Sonia Dalkin will explain the study in person and answer any questions you or the patient 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 interview will be recorded using a digital voice recorder. The consultation between you and your palliative care patient 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. We understand that conversations about palliative care and death do not occur in one consultation, therefore you may ask to record up to 3 consultations (maximum) with one patient. The patient will give written consent at the beginning to the chief investigator (Sonia Dalkin) and there after you will confirm with the patient, whilst the audio recorder is taping, that they are still happy to be recorded and participate in the research. Additionally, at the end of the last recording you will have to confirm that they are still happy to participate and that it is ok to pass on the recording to the research team. 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.

What will be the cost of taking part?

There will be no financial cost to taking part in this study. 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 palliative care patient will be a consultation that you would normally have any way. We would like you to please use this consultation like any normal appointment you would usually have with your palliative care patient. We cannot promise the study will help you personally 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 of the information sheet. 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 allocated a number instead of using your name in the study write up.

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 palliative care patient will be told that you are taking part in the study, as they will be recorded during your consultation also.

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. There will be no detrimental effects on you, your patients or your employment. Your patients 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:

Dr. Anna Jones [contact details] NHS North of Tyne PCT compaints 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 you will return it using the stamped and addressed envelope we will provide. You will then meet with the researcher 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. If I withdraw this will have no effect on my employment or my patient’s access to palliative care pathway services.

Name __________________________

Signature __________________________

Date __________________________

Address to send questionnaire to:

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________

Date of next consultation with GP __________________________________

Appendix 30 Consent form for MBSS and consultation recording for health professional.

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 31- Miller Behavioural Style Scale Miller Behavioural Style Scale (MBSS) Version 1 Monitor/Blunter Style Scale

1. Vividly imagine that you are afraid of the dentist and have to get some dental work done. Which of the following would you do? Check all of the statements that might apply to you.

I would ask the dentist exactly what work was going to be done.

I would take a tranquilizer or have a drink before going.

I would try to think about pleasant memories.

I would want the dentist to tell me when I would feel pain.

I would try to sleep.

I would watch all the dentist's movements and listen for the sound of the drill.

I would watch the flow of water from my mouth to see if it contained blood.

I would do mental puzzles in my mind.

2. Vividly imagine that you are being held hostage by a group of armed terrorists in a public building. Which of the following would you do? Check all of the statements that might apply to you.

I would sit by myself and have as many daydreams and fantasies as I could.

I would stay alert and try to keep myself from falling asleep.

I would exchange life stories with the other hostages.

If there was a radio present, I would stay near it and listen to the bulletins about what the police were doing.

I would watch every movement of my captors and keep an eye on their weapons.

I would try to sleep as much as possible.

I would think about how nice it's going to be when I get home.

I would make sure I knew where every possible exit was.

3. Vividly imagine that, due to a large drop in sales, it is rumored that several people in your department at work will be laid off. Your supervisor has turned in an evaluation of your work for the past year. The decision about lay-offs has been made and will be announced in several days. Check all of the statements that might apply to you.

I would talk to my fellow workers to see if they knew anything about what the supervisor evaluation of me said.

I would review the list of duties for my present job and try to figure out if I had fulfilled them all.

I would go to the movies to take my mind off things.

I would try to remember any arguments or disagreements I might have had that would have resulted in the supervisor having a lower opinion of me.

I would push all thoughts of being laid off out of my mind.

I would tell my spouse that I'd rather not discuss my chances of being laid off.

I would try to think which employees in my department the supervisor might have thought had done the worst job.

I would continue doing my work as if nothing special was happening.

4. Vividly imagine that you are on an airplane, thirty minutes from your destination, when the plane unexpectedly goes into a deep dive and then suddenly levels off. After a short time, the pilot announces that nothing is wrong, although the rest of the ride may be rough. You, however, are not convinced that all is well.

Check all of the statements that might apply to you.

I would carefully read the information provided about safety features in the plane and make sure I knew where the emergency exits were.

I would make small talk with the passenger beside me.

I would watch the end of the movie, even if I had seen it before.

I would call for the flight attendant and ask what exactly the problem was.

I would order a drink from the flight attendant or take a tranquilizer.

I would listen carefully to the engines for unusual noises and would watch the crew to see if their behaviour was out of the ordinary.

I would talk to the passenger beside me about what might be wrong.

I would settle down and read a book or magazine or write a letter.

This is the end of the questionnaire. Thank you very much for taking the time to fill it in.

Could you now please give the questionnaire back to the researcher via email or post.

Again, thank you for your time.

Sonia Dalkin [contact details] Questionnaire validation Results from an MBSS validation study showed that coping-style scores accurately predicted informational strategy, particularly with the monitoring dimension (Miller, 1987).

Appendix 32 - Correspondence with Dr. Miller

Hi:

I have been on travel and facing deadlines.

I am most interested in your study and would love to hear more.

I am ccing my assistant who will answer your questions.

Generally it is stable over time, if the situation remains consistent. So, yes it is a trait.



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