The sampling process

A purposive approach to sampling was adopted in which participants were recruited on the basis of characteristics which were relevant to the research question (Mason 2006). A fixed purposive sampling strategy was used to ensure the study’s conduct remained within the parameters of Research Ethics Committee approval (Teddlie & Yu 2007).

Detailed inclusion and exclusion criteria were developed to ensure the recruitment of participants with relevant characteristics (see table 4.4 below).The criteria were established on the basis of research evidence relating to patients’ use of medicines (see Chapter 3) and knowledge of the field of non-medical prescribing (see Chapter 2). The study therefore involved patients taking medicines on a regular basis for a long–term condition together with nurses and pharmacists practising as independent prescribers.

Any exclusion criteria were restricted to factors which had particular implications for the nature of any findings. Patients who had a mental health condition or who were under the age of 18 years were therefore excluded due to the specific issues involved in their use of medicines (Nunes et al 2009). Patients requiring an interpreter were also excluded due to the lack of available resources.

A sample size of 10 nurse/pharmacist prescribers and three patients per prescriber was initially sought i.e. a total of 30 patients and 10 nurse/pharmacist prescribers. As discussed in section 4.6.1 below, recruitment was lower than anticipated and, in particular, there was no recruitment of pharmacist prescribers.

Table 4.4: Sample selection: Inclusion and exclusion criteria Sample group Inclusion criteria Exclusion criteria Patients Any patient who:

Is an adult aged over 18 years

Has a condition for which they need to take one or more medications on a long- term basis

Is judged, by the nurse or pharmacist prescriber, as being capable to give consent to participate

Patients who require an interpreter to participate in the study due to the significant resources necessary to provide the appropriate formal

interpretation services and the confidentiality issues involved should a family member act as interpreter Patients who take medication on a regular basis for a mental health condition only. It is recognised that there are many distinct issues involved in enabling the use of medication in people with a long-term mental health condition (Nunes et al 2009). Patients who are under the age of 18 years as there are specific issues involved in supporting the use of medicines in children with a long-term condition (Nunes et al 2009)

Nurse and pharmacist prescribers

A registered nurse or pharmacist who has an additional qualification as an independent/supplementary prescriber and is thus able to prescribe for patients within the limits of their competence (DoH 2006)

Has responsibility for the care and management of people with a long-term condition, including the prescription of any required medication Works within a hospital or primary care setting

Nurses and pharmacists who are not qualified prescribers

Nurses and pharmacists who supply and administer medicines to patients via a patient group direction

4.6.1 Recruitment of sample

A summary of the sample recruitment process is outlined in a flowchart at the end of the section (figure 4.1). Each stage of the recruitment process is explored in detail below.

4.6.1(i) Negotiating access to research sites

Permission to conduct the study was sought initially from the non-medical prescribing director of one English strategic health authority who then contacted the prescribing leads within each National Health Service Trust within the authority to request participation in the study. The email request included a summary of the study. Prescribing leads from four secondary care Trusts and one primary care Trust responded to this request. Further discussion of the study took place with each Lead and their role in the research process was clarified. Permission from the prescribing lead was also obtained to identify him/her as the principal investigator in the application for Research and Development (R&D) approval (DoH 2005b). Further contact with the non-medical prescribing leads occurred as necessary via email and/or telephone to respond to any queries and to provide information about progress in obtaining ethical clearance and R& D approval. (See appendix 1 for details of communication with Trust leads)

4.6.1(ii) Recruitment of sample: prescribers

Following R & D approval, prescribing leads were asked to circulate letters of invitation and participant information sheets to all of the nurse and pharmacist prescribers within their Trust. It was recognised that the prescribing leads, in their role as gatekeeper, might create the expectation that the prescribers must participate and, to avoid any coercion, both the letters and the participant information sheets therefore stressed the voluntary nature of participation (Walls et al 2010). (See appendix 2 for details of communication with prescribers)

Whilst the research study sought to recruit both nurse and pharmacist prescribers, no pharmacists volunteered to participate. As noted in Chapter 2 there were relatively few pharmacist independent prescribers at the time of data collection which may have contributed to this situation. Three of the non-medical prescribing leads also pointed out that, whilst their hospital Trust employed pharmacist prescribers, none of the pharmacists assumed responsibility for the independent management of patients with a long-term condition as required by the research protocol. Their prescribing role was instead undertaken in ward settings, where they worked closely with medical staff to review and, where necessary, change in-patient medication.

The prescribing leads were asked if there were any meetings of non-medical prescribers held within the Trust when the research could be presented to enhance

recruitment. Unfortunately, such meetings had either just taken place and would not be held again for several months or were no longer held within the Trust.

Prescribing leads in all Trusts were asked to re-circulate the email and study information six weeks later as no responses had been received from prescribers. Email responses were then received from nurse prescribers working in three of the hospital Trusts and the primary care Trust. There were no responses from one hospital Trust and no responses at all from pharmacist prescribers, reflecting similar difficulties in pharmacist recruitment noted in other studies (Weiss et al 2013, Weiss et al 2014).

Nurse prescribers expressing an interest in participation were contacted and a meeting was arranged with each nurse to answer any queries and obtain signed, informed consent. In total, seven nurse prescribers agreed to participate.

The non-medical prescribing lead in the remaining hospital Trust agreed to circulate the email and supporting information one further time, six weeks after the initial reminder. It was agreed however that this would be the final email sent to the prescribers to avoid any perceptions of harassment regarding their participation. No responses were received and therefore this Trust did not participate in the study.

The size of the prescriber sample was therefore smaller than anticipated which, in turn, meant that fewer patient participants could be recruited. The appropriate size of a sample is however a focus for significant debate in qualitative research (e.g. Baker & Edwards 2012, Gobo 2004, Morse 2000). In a review of the number of qualitative interviews required, the conclusion reached was that ‘it depends’ (Baker & Edwards 2012:6) on a number of factors including, amongst others, the availability of resources, methodological and epistemological perspectives and the breadth of the study. Whilst there is an emphasis on data saturation, when no new findings are emerging, there are practical challenges in achieving it, particularly when ethical approval is based on a stated sample size (Baker & Edwards 2012). Although the sample size in the current study was smaller than planned it allowed the emergence of a rich dataset and consistent themes and enabled an in-depth analysis of the data, factors which are important in justifying sample size in qualitative studies (Kelly 2010). It is therefore difficult to state definitively that the sample is too small although its size should be taken into account when considering the relevance of the findings.

There was however significant variation within the group of nurse prescribers in terms of their site of practice and clinical speciality. It is acknowledged however that the patients and prescribers recruited were mostly of white British origin which under-represents the ethnic variation found within both the national population (Office of National Statistics 2011) and the nursing population (Wood & Cracknell 2013).

The purposive sampling strategy used within the study does not however seek a representative sample rather one which could make a meaningful contribution to the study’s findings. Patients in the study were living with a wide range of long-term conditions and all were required to use at least one medicine on a regular basis. The sample of nurse prescribers demonstrated similar characteristics to those in other studies in terms of their seniority and length of experience (e.g. Latter et al 2007, Courtenay et al 2009a, 2009b). All of the participants were therefore able to make a rich contribution to the study.

4.6.1 (iii) Recruitment of sample: patients

Nurse prescribers who gave consent to taking part in the study were asked to provide a letter of invitation and participant information to patients in their care who took medication for a long-term condition on a regular basis. They were asked to approach only those patients who, in their opinion, were well enough to participate in the study and had the capacity to give informed consent. Patient information sheets and letters of invitation were circulated to patients by the nurse prescribers. A total of 21 patients informed the nurse prescribers that they would take part in the study.

Further discussion of the study took place with patients immediately before their appointment and written consent to participate in the study was obtained. (See appendix 3 for details of communication with patients). Patient participants were asked to consent to one of the following:

 Participation in the observation only  Participation in the interview only

 Participation in both the observation and interview.

A flowchart of the sample recruitment process is outlined in figure 4.1 below and participant characteristics are described in section 4.6.2.

Fig. 4.1 Summary of sample recruitment process

Invitation to participate sent by SHA lead to all NMP leads in hospital and primary care Trusts

Positive responses received from the following Trust leads

H1 H3 H4 P Care CCCa reca H2

Participant information sheet sent by NMP Lead to all NMPs meeting inclusion criteria and working in Trust

No responses received despite 2 further invitations H1 1 NPx H2 3 NPx H3 2 NPx P Care 1 NPx

Participant information sheet sent by nurse prescribers to all patients meeting inclusion criteria

Positive responses received from the following patients Positive responses received from the following nurse prescribers

(NPx) None received from pharmacist prescribers

P Care 3 patients H3 6 patients H2 9 patients H1 3 patients

Total sample: 21 patients