Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study

NCT04326062 | Completed

• 1 other identifier: GPP2071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Multimorbidity

Keywords

Polypharmacy; Multimorbidity; General Practice; Pharmacist

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patients' self-rated health-related quality of life.

  Six months.

• Self-rated attitudes of patients towards deprescribing of their medications.

  Six months.

• Patients' self-rated treatment burden.

  Six months.

• Patients' self-rated beliefs about medicines

  Six months.

• Patients' self-rated health-related quality of life (VAS).

  Six months.

Study Arms (2)

Main Study

EXPERIMENTAL

A pharmacist will join the practice team for six months.

Other: Main Study

PROM Study

EXPERIMENTAL

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

Interventions

Main Study OTHER

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.

Main Study

PROM Study OTHER

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.

PROM Study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥1000 older patients (aged ≥65 years) on their patient panel.
• Aged ≥65 years
• Taking ≥10 repeat medications
• Able to attend their primary care practice and participate in data collection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Service Executive, Ireland: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland

Dublin, 2, Ireland

Location

Related Links

• Protocol for study

Study Officials

• Susan M Smith, PhD

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Susan M Smith

Model Details: Uncontrolled feasibility study based in general practices with a sub-set of patients completing a nested study collecting secondary patient reported outcome measures

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: March 30, 2020
• Study Start: June 14, 2017
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication final papers
• 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

Locations

IE (1)