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Completed

NCT Number: NCT04326062

Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal College of Surgeons in Ireland

Dublin, 2, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in the number of medicines patients were prescribed.

    Time frame: Six months.

    We recorded the number of medicines that were stopped, started or changed as a result of the pharmacist doing a medication review.

  2. Prevalence of potentially inappropriate prescribing.

    Time frame: Six months.

    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).

Secondary outcomes

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

    Time frame: Six months.

    We asked patients to rate their health-related quality of life using the European Quality of Life EQ5D-5L index score.

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

    Time frame: Six months.

    We asked patients to rate their attitudes towards deprescribing of their medications using the revised Patients' attitudes towards deprescribing (rPATD) questionnaire.

  3. Patients' self-rated treatment burden.

    Time frame: Six months.

    We asked patients to rate their experience of treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ).

  4. Patients' self-rated beliefs about medicines

    Time frame: Six months.

    We asked patients to rate their beliefs about medicines using the Beliefs about Medicines Questionnaire.

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

    Time frame: Six months.

    We asked patients to rate their health-related quality of life using the Visual Analogue Scale (range 0-100)

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Health Service Executive, Ireland
  • University of Dublin, Trinity College

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2020
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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