Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study

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

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.

Study Overview

• Status: Completed
• Conditions: Multimorbidity; Polypharmacy
• Intervention / Treatment: Other: Main Study; Other: PROM Study

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 2
    • Royal College of Surgeons in Ireland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main Study; A pharmacist will join the practice team for six months.	Other: Main Study; 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.
Experimental: PROM Study; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: University of Dublin, Trinity College; Health Service Executive, Ireland
• Investigators: Principal Investigator: Susan M Smith, PhD, Royal College of Surgeons in Ireland

Publications and helpful links

Helpful Links

• Protocol for study

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Polypharmacy; General Practice; Pharmacist; Multimorbidity
• Other Study ID Numbers: GPP2071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be available from study PI on study completion
• IPD Sharing Time Frame: Following publication final papers
• IPD Sharing Access Criteria: Researchers requesting access to anonymised study data can contact the PI and access will be provided once all papers published from the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No