GPs information sheet, invitation letters and interview questions

2.1
Lay summary
Please provide a summary of the project in non-specialist terms, which includes a description of the scientific background to the study (existing knowledge), the scientific questions the project will address and a justification of these. Please note that the description must be sufficient for the committee to take a reasonable view on the likely scientific rigour and value of the project.

Background to the research
Currently there are two General Practice (GP) practices within Slough Clinical Commissioning Group (CCG) that have the second and fourth highest rates of hypnotic prescribing in the area, which are above local and national averages. Pharmacists working within Slough CCG are independent prescribers who have been delivering medication review services to a range of patients within GP settings. One particular service that was delivered with success in 2013/14 involved an audit of hypnotic prescribing followed by an action plan to reduce prescribing and a further re-audit. The service, which could be described as a brief intervention, was reported to reduce the prescribing of hypnotics within the participating GP practice. There is evidence in the literature that brief interventions can address the prescribing of hypnotics. For example, research has shown that a simple letter intervention reduces benzodiazepine use in patients who have been using them long-term. In addition, a literature review pooling GP’s views on hypnotic prescribing has identified a range of barrier. These barriers, which can be thought of as determinants of behaviour change, span the sources of behaviour according to the ‘capability-opportunity-motivation’ model of behaviour change (COM-B). An existing pharmacist-led service model described below is going to be implemented in the two GP practices within Slough as describe above. The service is akin to a brief intervention and usesa template that was successfully delivered in 2013/14 to one GP practice within East Berkshire CCG.This project is a service evaluation of putting into place this existing service within these two practices.
Two GP practices that are currently prescribing hypnotics above the local and national rates have been identified by the CCG Lead Prescribing Support Pharmacist for Slough CCG to take part in this service evaluation. A practice meeting will be arranged with all prescribers within each setting. This would be in order to provide clear information about the rationale for the project as well as the detail relating to the project including the duration, the processes and the evaluation.
The service being implemented involves:
o Dispatch of a letter to patients meeting inclusion criteria:
? Explaining concern over the patient’s long-term use of named hypnotic
? Highlighting potential side effects relating to long-term use of named hypnotic
? Asking the patient to consider a reduction in their use
? Including advice on how to gradually reduce or cease use in a matter that is feasible and will decrease the likelihood of withdrawal symptoms
? Inviting the patient to discuss the issue further by booking into a pharmacist-led clinic or speaking with their own GP
o For patients receiving a letter and responding by seeing a practitioner:
? moving the medication from ‘repeat’ to ‘acute’ on the prescribing system
? limiting the hypnotic prescription to 56 days’ supply
o For patients receiving the letter but not responding:
? sending a short reminder letter three months after the initial letter
? informing the patient that the maximum length of supply was now 30 days in line with CD regulations
o Preparatory work within GP clinics:
? informing reception staff / prescription clerks’ fully about the study.
? running a poster campaign detailing the risks of long-term use of hypnotics
? agreeing initiation and prescribing policy for the prescribing of hypnotics to new patients supported by a leaflet
? making available a full range of support leaflets and hypnotic reduction schedules in all consulting rooms
o Pharmacist-led monthly clinics within GP practice:
? offering 20-minute appointments to patients responding to the letter described above
? ensuring clinics are led by a pharmacist independent prescriber in line with the benzodiazepine learning module via the MHRA Training and Continuing Professional Development.
o Preparatory work within local community pharmacies:
? raising awareness within local community pharmacies by providing self-help leaflets and posters
• Inclusion criteria: all adult patients prescribed hypnotic medication on a long-term basis (but see exclusion criteria)
• Exclusion criteria: Housebound, care/nursing home (reviewed separately by care home pharmacist & responsible GP) and palliative care patients; one off supplies e.g. for back spasm, fear of flying and for epilepsy treatment.
Focus of service evaluation
This is a non-interventional service evaluation of the provision of a pharmacist-led clinic addressing long-term hypnotic prescribing.The focus is to investigate the impact of a brief intervention service aimed at reducing the prescribing of hypnotics in two GP settings in Slough CCG within a before and after audit study that examines the process as well as the outcomes of this service.Primarily to examine the prescribing rate of hypnotics within the two GP practices. In addition, to investigate the processes involved and gain the views of patients and GP staff in relation to the service and the determinants of behaviours relating to hypnotic prescribing.
(This box may be expanded as required)
2.2
Procedure
Please briefly describe what the study will involve for your participants and the procedures and methodology to be undertaken (you may expand this box as required).
This is a mixed-methods service evaluation study.
The prescribing of hypnotics will be quantified using hypnotic Average Daily Quantity (ADQ) data per STAR-PUs (Specific Therapeutic Group Age-sex weightings Related Prescribing Units) and compared at a local and national level at baseline, during and after the study period.
The views of patients and practice staff will be obtained using qualitative interview and will be examined using thematic analysis.In order to gain the views of patients and GP staff in relation to the service and the determinants of behaviours relating to hypnotic prescribing, staff and patients will be invited to interviews from 3 months after the service has been initiated within the clinics. An initial letter of invitation and consent form will be sent to potential participants to invite them to interviews with a PhD student (xxx). A key NHS contact (the CCG Lead Prescribing Support Pharmacist for Slough CCG) will send the initial invitation letter to both potential sets of participants. The interviews will be audio-recorded and transcribed into word documents. The transcripts of the interviews will be analysed using thematic analysis and will be represented using diagrams or tables as appropriate.
(Note: All questionnaires or interviews should be appended to this application)
2.3
Where will the project take place?

The data relating to the prescribing within the two GP settings will be anonymised and provided to the PhD student (xxxxx) by the NHS contact. Interviews with patients and practice staff will be completed within the practice settings.
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2.4
Funding
Is the research supported by funding from a research council or other external sources (e.g. charities, business)? No
The researcher is supported by a full-time scholarship provided by the Saudi Arabian Cultural Bureau in London.
Please note that all projects (except those considered as low risk, which would be the decision of the School’s internal review committee and require Head of Department approval) require approval from the University Research Ethics Committee.
2.5
Ethical Issues
Could this research lead to any risk of harm or distress to the researcher, participant or immediate others? Please explain why this is necessary and how any risk will be managed.

This is a non-interventional service evaluation of the provision of a pharmacist-led clinic addressing long-term hypnotic prescribing. No ethical difficulties are foreseen. In terms of consent to take part in interviews, participants will be consented to take part in interviews within the remit of this service evaluation. All interviews will take place within a private office either at the GP practices or at the University of Reading (if more convenient to patients). For the prescribing data, this will be analysed anonymously (not linked to patient details) as part of the service evaluation.

(this box may be expanded as required)

2.7
Payment
Will you be paying your participants for their involvement in the study? Yes
If yes, please specify and justify the amount paid

This study will be able to compensate the participants by offering a £50 Amazon voucher for the time spent by each staff participant in the interview. We have taken the decision to offer this amount based on the inconvenience participants face, as busy professionals, in giving up their lunch hour or other free time to participate in the research and believe this is reasonable to achieve the recruitment required. However, we are willing to take suggestions from the committee if this amount is deemed excessive. Patients will be offered a £10 Amazon voucher which is in line with past experience with recruiting patients to interview studies.

Note: excessive payment may be considered coercive and therefore unethical. Travel expenses need not to be declared.
2.8
Data protection and confidentiality
What steps will be taken to ensure participant confidentiality? How will the data be stored?
Confidentiality and privacy will be ensured for all participants and the information gathered will be only used for scientific purposes. Participants will be asked for their permission to record the interviews. The researcher will use a digital audio-recorder to record the conversation. Each interview will be recorded and then stored securely on USB sticks away from the main audio-recorder. Recordings will not be stored on a public or personal computer. Afterwards, transcripts will be made from these records on Microsoft word documents (by ‘’The Transcription Agency’’ which is an approved University of Reading supplier for transcribing services) without containing any names or any information that might identify the participants. All the information will be anonymised to prevent association of interviewees to defined quotes. As well as that, non-identifiable codes will be used throughout when coding for interviews. At the end of the study the audio-taped records will be destroyed.
Data reporting will ensure that the participants remain anonymous and their right ofconfidentiality respected. To achieve this, their names, addresses and other details will be excluded from the research. Finally, the electronic or paper files will be destroyed after the end of writing the thesis.

2.9
Consent
Please describe the process by which participants will be informed about the nature of the study and the process by which you will obtain consent
All potential participants will receive an email with a pack that includes; information sheet (inviting them to take part in the study and giving them full information about the study) and a consent form. The participants will have at least 24 hours to decide whether they want to participate in the study or not. When an initial interest has been shown, the time and location of the interview will be identified and agreed. The information sheet and the consent form will be given to the participant again before the interview to re-read and for them to sign the consent form. The researcher will explain verbally prior to each interview the study again to ensure that the participants understand everything that they are consenting to and all questions posed by potential participants will be answered prior to the start of the interviews. In addition, the researcher will explain to the participants their rights to not any questions that cause any distress to them or to withdraw from the study at any time (if so their information will be destroyed and not used in the research) without giving a reason to the researcher. All questions posed by potential participants will be answered prior to the start of the interviews. Then, a written consent form will be obtained before starting the interview and each participant will be given a copy of the signed consent form.

Please note that a copy of consent forms and information letters for all participants must be appended to this application.

2.10
Genotyping
Are you intending to genotype the participants? Which genotypes will be determined?
No

Please note that a copy of all information sheets on the implications of determining the specific genotype(s) to be undertaken must be appended to this application.
SECTION 3: PARTICIPANT DETAILS
3.1
Sample Size
How many participants do you plan to recruit? Please provide a suitable power calculation demonstrating how the sample size has been arrived at or a suitable justification explaining why this is not possible/appropriate for the study.
Population Studied:Two GP practices within Slough CCG identified by the CCG Lead Prescribing Support Pharmacist for Slough CCG will be offered the service. Patients under the care of the GPs in these practices who meet the inclusion criteria will receive letters as described above. Staff and patients who are included in the service will be invited to interview. In line with other qualitative studies, a sample size of approximately 30 participants is predicted. As this is ‘service evaluation’ numbers are an estimate only and will depend on analytical saturation (i.e. more participants might be recruited if data saturation not reached through thematic analysis of interviews).
Statistical Rationale (including power calculation): This is a pragmatic study of the impact of pharmacist-led clinics on the prescribing of hypnotics in a before and after design. In quantitative studies, the aim of calculating the sample size, is to work on the basis of likely effect sizes (and therefore estimate the sample sizes needed) for detection of statistically significant changes in outcome measures being quantified. Given that this is a pragmatic service evaluation study, it is reasonable to specify a time period for data collection post introduction of the service to enable comparison of data with baseline. This time period is suggested to be 6 months after the first set of letters are sent.
For the interviews, given the nature of the paradigm sample size calculations follow a pragmatic approach. A proposed total of approximately 30 participants will be recruited. The data collected will be analysed using a thematic qualitative analysis which provides large material as data without the need for a large sample size. Qualitative samples are usually small in size. There are three main reasons for this. First, if the data are properly analysed, there will come a point where very little new evidence or information is obtained from each additional participant recruited (this is called research/data saturation). There is therefore a point of diminishing return where increasing the sample size no longer contributes new evidence. Second, the type of information that qualitative studies yield is rich in detail. There will therefore be many ‘bites’ of information from each unit of data collection. Third, definitive statements about incidence or prevalence are not the concern of qualitative research, although qualitative research can shed light on how incidence or prevalence might be measured in a further study. There is therefore no requirement to ensure that the sample is of sufficient scale to provide estimates, or to determine statistically significant discriminatory variables. As a result, sample sizes need to be kept on a reasonably small scale. A very final note is that qualitative research is highly intensive in terms of research resources it requires. It would therefore simply be unmanageable to conduct and analyse hundreds of interviews or observations unless the researcher intends to spend several years doing so.
In this way, it is anticipated that from a total of 30 participants recruited we would obtain a broad range of possible viewpoints or extremes of opinion to build the in-depth data to enable the completion of this investigation. The purpose of the interview study is to collate and examine views about the prescribing of hypnotics and also to examine the determinants and mechanisms of prescribing behaviour change.

3.2
Will the research involve children or vulnerable adults (e.g. adults with mental health problems or neurological conditions)? No

If yes, how will you ensure these participants fully understand the study and the nature of their involvement in it and freely consent to participate?

(Please append letters and, if relevant, consent forms, for parents, guardians or carers). Please note: information letters must be supplied for all participants wherever possible, including children. Written consent should be obtained from children wherever possible in addition to that required from parents.
3.3
Will your research involve children under the age of 18 years? No
Will your research involve children under the age of 5 years? No
3.4
Will your research involve NHS patients, Clients of Social Services or will GP or NHS databases be used for recruitment purposes?Yes but please note that this is a service evaluation which does not need NRES ethics approval

Please note that if your research involves NHS patients or Clients of Social Services your application will have to be reviewed by the University Research Ethics Committee and by an NHS research ethics committee.
3.5
Recruitment
Please describe the recruitment process and append all advertising and letters of recruitment.
The principle aim of this study is to scientifically examine the outcome of the hypnotic prescribing service on prescribing rates and to investigate any mechanism of prescribing behaviour change through interviews.
Two GP practices that are currently prescribing hypnotics above the local and national rates have been identified by the CCG Lead Prescribing Support Pharmacist for Slough CCG to take part in the service evaluation. In order to gain the views of patients and GP staff in relation to the service, staff and patients will be invited to interviews from 3 months after the service has been initiated within the clinics. An initial letter of invitation and consent form will be sent to potential participants to invite them to interviews with a PhD student (Ali Dobia). A key NHS contact (the CCG Lead Prescribing Support Pharmacist for Slough CCG) will send the initial invitation letter to both potential sets of participants.
I need you to do
1- GPs information sheet only these three questions as the rest of them are already known ( what is the purpose of the study? Why have you been invited and what are the possible benefits of taking part? Please see my answers for patients information sheet
What is the purpose of the study?
The purpose of this study is to find out patients’ and prescribers’ views on a pharmacy service whichfocussed on hypnotic prescribing through one-to-one interviews.

Hypnotics are medicines prescribed for a range of reasons (e.g. to help people sleep better). They include medicines such as diazepam or zopiclone and other medicines described as ‘benzodiazepines’ or ‘z-drugs’. As part of the pharmacy service you would have received a letter about your prescription, information about how to reduce your usage of hypnotic medication as well as an invitation to speak with a pharmacist at your GP practice.

The aim of this study is to examine your experience with the pharmacy service, your satisfaction with it, your views about its benefits and downsides, if any, and suggestions for improvement of the service for the future. This research will form the basis of my PhD (xxxxxx). I am studying under the supervision of Drxxxxxx at the School of Pharmacy, University of xxxxx.

Why have you been invited?
You are being invited because we would like the view of everyone who was included in the service. You are invited as you match the study selection criteria: a patient who has been prescribed a hypnotic medication and who was invited to take part in the pharmacy service.
What are the possible benefits of taking part?
I cannot promise the study will help you in any specific way but you may find participating and reflecting on the topic helpful personally and of course the information we get from this study may help gain an understanding of views on this current topic, and could help improve pharmacy services in the future.

2- Invitation letter for Gps and patients
3- Interview questions for patents
4- Interview questions for GPs

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