Clinical trial NCT04326062: Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study
Official title: Supporting Prescribing in Irish Primary Care: a Non-Randomised Pilot Study of a General Practice Pharmacist (GPP) Intervention to Optimise Prescribing in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Multimorbidity
Keywords: Polypharmacy
Multimorbidity
General Practice
Pharmacist
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive, Ireland
name: University of Dublin, Trinity College
First posted: 2020-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the number of medicines patients were prescribed.
timeFrame: Six months.
measure: Prevalence of potentially inappropriate prescribing.
timeFrame: Six months.
Secondary outcomes:
measure: Patients' self-rated health-related quality of life.
timeFrame: Six months.
measure: Self-rated attitudes of patients towards deprescribing of their medications.
timeFrame: Six months.
measure: Patients' self-rated treatment burden.
timeFrame: Six months.
measure: Patients' self-rated beliefs about medicines
timeFrame: Six months.
measure: Patients' self-rated health-related quality of life (VAS).
timeFrame: Six months.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Royal College of Surgeons in Ireland
Study officials:
affiliation: Royal College of Surgeons in Ireland
name: Susan M Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: