PolypharmacyNCT04326062
Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study
A study testing Main Study and PROM Study in people with Polypharmacy and Multimorbidity, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Polypharmacy, Multimorbidity
- What is being tested?
- Main Study and PROM Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 14 Jun 2017to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Polypharmacy, Multimorbidity
- Being tested
- Main Study, PROM Study
- Keywords
- Polypharmacy, Multimorbidity, General Practice, Pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Main StudyOther
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 StudyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Main Study | Experimental | A pharmacist will join the practice team for six months. Receives: 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). Receives: Other: PROM Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Six months.
Secondary outcomes (5)
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.
Measured: 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.
Measured: Six months.
Patients' self-rated treatment burden.
We asked patients to rate their experience of treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ).
Measured: Six months.
Patients' self-rated beliefs about medicines
We asked patients to rate their beliefs about medicines using the Beliefs about Medicines Questionnaire.
Measured: 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)
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start14 Jun 2017
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive, Ireland, University of Dublin, Trinity College
- Responsible party
- Principal investigator, Susan Smith, Royal College of Surgeons, Ireland
- Investigators
- Susan M Smith, PhD, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326062
- Sponsor's protocol ID
- GPP2071
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be available from study PI on study completion
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04326062
- Acronym / sponsor ID
- GPP2071
- Conditions
- Polypharmacy, Multimorbidity
- Keywords
- Polypharmacy, Multimorbidity, General Practice, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Health Service Executive, Ireland, University of Dublin, Trinity College
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Main Study | Experimental | Other: Main StudyA pharmacist will join the practice team for six months. |
| PROM Study | Experimental | Other: PROM StudyA 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Main StudyThe 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. | Other | Main Study |
| PROM StudyFor 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. | Other | PROM Study |
Primary outcome
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.
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).
5 secondary outcomes
Patients' self-rated health-related quality of life.
Time frame: Six months.
Self-rated attitudes of patients towards deprescribing of their medications.
Time frame: Six months.
Patients' self-rated treatment burden.
Time frame: Six months.
Patients' self-rated beliefs about medicines
Time frame: Six months.
Patients' self-rated health-related quality of life (VAS).
Time frame: Six months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Protocol for studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Will be available from study PI on study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Smith, PhD principal investigator
Royal College of Surgeons in Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Main Study and PROM Study in people with Polypharmacy and Multimorbidity, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of medicines patients were prescribed. (time frame: Six months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.