Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study

Study Overview
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Brief Summary
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The aim of this pilot study is to develop and test an intervention (defined as the General Practice Pharmacist [GPP] intervention) involving pharmacists working with General Practitioners (GPs) to optimise prescribing in Ireland. The study will determine the costs and potential effectiveness of the GPP intervention and, through engagement with key stakeholders, will explore the potential for an RCT of the GPP intervention in Irish general practice settings.

Detailed Description
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Improving the quality and safety of prescribing for people with multiple chronic conditions and multiple medicines is a challenge for General Practitioners (GPs) and consequently, there has been an increased emphasis on ways to support GPs throughout this process. The integration of pharmacists into the general practice team is one approach being explored internationally and studies have shown that pharmacists, working as part of the general practice team, have influenced the safety and quality of prescribing. However, the evidence base is weak as there have been few high quality randomised controlled trials (RCTs) conducted and a range of modest effect sizes reported. Moreover, it is unclear whether such interventions can result in clinically significant improvements in patient outcomes. In Ireland, pharmacists are not integrated into general practice teams, therefore the feasibility of the integration of pharmacists into general practice warrants further exploration in the Irish primary care setting, prior to evaluation in a full scale RCT. The aim of this study is to develop and pilot test an intervention involving pharmacists, working within GP practices, to optimise prescribing in Ireland, which has a mixed public and private primary healthcare system.

Official Title
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Supporting Prescribing in Irish Primary Care: a Non-Randomised Pilot Study of a General Practice Pharmacist (GPP) Intervention to Optimise Prescribing in Primary Care

Conditions
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Polypharmacy, Multimorbidity

Intervention / Treatment
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* Other: Main Study
* Other: PROM Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for primary care practices: ≥1000 older patients (aged ≥65 years) on their patient panel. Inclusion criteria for patients: Aged ≥65 years Taking ≥10 repeat medications Able to attend their primary care practice and participate in data collection. Exclusion Criteria for patients: Psychiatric or psychological morbidity or cognitive impairment sufficient to impair the provision of informed consent Life-limiting illness likely to lead to death or major disability during the study follow-up period Patients who have already had a medication review/interacted with the pharmacist during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Uncontrolled feasibility study based in general practices with a sub-set of patients completing a nested study collecting secondary patient reported outcome measures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Study<br>A pharmacist will join the practice team for six months. | Other: Main Study<br>* The pharmacist will participate in the management of repeat prescribing and undertake medication reviews (which will address high risk prescribing and potentially inappropriate prescribing, deprescribing and cost-effective and generic prescribing) with adult patients. Pharmacists will also provide prescribing advice regarding the use of preferred drugs, undertake clinical audits, join practice team meetings and facilitate practice-based education. Throughout the six-month intervention period, anonymised practice-level medication (e.g. medication changes) and cost data will be collected.<br>|
| Experimental: PROM Study<br>A nested Patient Reported Outcome Measure (PROM) study will be undertaken during month four and five of the six-month intervention period to explore the impact of the intervention in older adults (aged ≥65 years). | Other: PROM Study<br>* For this, a sub-set of patients (n=200) aged ≥65 years on ≥10 repeat medicines will be recruited and invited to a medication review with the pharmacist. PROMs and healthcare utilisation data will be collected using patient questionnaires and a six-week follow-up review with these patients will also be conducted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the number of medicines patients were prescribed. | We recorded the number of medicines that were stopped, started or changed as a result of the pharmacist doing a medication review. | Six months. | 
| Prevalence of potentially inappropriate prescribing. | We recorded the prevalence of potentially inappropriate prescribing identified by the pharmacist using validated indicators STOPP (Screening Tool of Older People' Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). STOPP and START are validated, explicit criteria used to identify potentially inappropriate prescribing in older people (those aged 65+ years). | Six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' self-rated health-related quality of life. | We asked patients to rate their health-related quality of life using the European Quality of Life EQ5D-5L index score. | Six months. | 
| Self-rated attitudes of patients towards deprescribing of their medications. | We asked patients to rate their attitudes towards deprescribing of their medications using the revised Patients' attitudes towards deprescribing (rPATD) questionnaire. | Six months. | 
| Patients' self-rated treatment burden. | We asked patients to rate their experience of treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ). | Six months. | 
| Patients' self-rated beliefs about medicines | We asked patients to rate their beliefs about medicines using the Beliefs about Medicines Questionnaire. | Six months. | 
| Patients' self-rated health-related quality of life (VAS). | We asked patients to rate their health-related quality of life using the Visual Analogue Scale (range 0-100) | Six months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypharmacy, Multimorbidity, General Practice, Pharmacist