Medication AdherenceNCT03241498
General Practitioner (GP) Practice Based Pharmacist Input to Medicines Optimisation
A study testing Medicines optimisation in people with Medication Adherence, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Medicines optimisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2016to 31 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are included in the study if they have any of the following:
- Have had at least 1 unplanned hospital admission or 2 or more accident and emergency department (A\&E) attendances in the previous 12 months.
- Prescribed ≥ 6 regular oral/systemic, long term medicines.
- Has ≥ 2 long-term chronic conditions.
Who cannot join
- Patient is residing in a nursing home or a care home.
- Patient is considered unable to give written informed consent e.g. Alzheimer's disease.
- Palliative care patients.
- Patient has had ≥ 4 unplanned admissions to hospital in the previous 6 months.
- Patient is participating in another intervention research project within the practice.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern Health and Social Care Trust
Antrim, Northern Ireland
About this study
Official title: GP Practice Based Pharmacist Input to Medicines Optimisation
The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will engage with patients, thought to be at a higher risk of medication related problems, within their GP practice in order to help identify areas for improvement
Read the detailed description
Drug therapy is growing more complex as patients increasingly suffer from a number of co-morbidities. Accordingly, in clinical medicine, a wide range of medication related problems may arise (1). A medication related problem (MRP) is defined as "an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes" (2). These problems have been found to lead to more hospital admissions and thus increase the cost of healthcare provision (3, 4). For instance, Winterstein et al. carried out a meta-analysis of research in this area which showed that 7.1% of hospital admissions were attributable to a drug related problem, of which 59% appeared avoidable (5). Moreover, a large study in the United Kingdom showed that these admissions cost the National Health Service (NHS) up to £466 million annually, which is 0.59% of the British health care budget (6).
Medication related problems (MRPs) remain a serious concern particularly in primary care settings. A recent UK study found that one in 20 prescription items in general practice included an error, affecting 1 in 8 patients. Although the majority of these errors were described as being either mild or moderate in severity, 1 in 550 of all prescription items contained an error determined to be severe (7). In addition, significant medication wastage has been found within general practice settings in England with an estimated £300 million worth of prescribed medications being wasted each year in primary and community care (8). Optimisation of drug therapy and prevention of MRPs can reduce health care expenditure, potentially save lives and enhance patient quality of life (9-13).
Medicines optimisation is defined as 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines. Medicines optimisation applies to people who may or may not take their medicines effectively. Shared decision-making is an essential part of evidence-based medicine, seeking to use the best available evidence to guide decisions about the care of the individual patient, taking into account their needs, preferences and values' (14, 15, 16).
Medicines optimisation requires more patient engagement and professional collaboration within health and social care settings. It focuses on actions taken by all health and social care practitioners. To support the medicines optimisation agenda a guide on medicines optimisation has been produced by The Royal Pharmaceutical Society (RPS) the aim of which is to help patients make the most of their medicines (17). This guide involves four key principles for medicines optimisation in order to achieve improved patient outcomes (16). These principles are as follows:
(i) Aim to understand the patient's experience (ii) Evidence based choice of medicines (iii) Ensure medicines use is as safe as possible (iv) Make medicines optimisation part of routine practice
In order to support the implementation of the guiding principles, NHS England launched the prototype medicines optimisation dashboard in 2014. The dashboard aims to 'encourage Clinical Commissioning Groups (CCGs) and healthcare Trusts to think more about how well their patients are supported to use medicines and less about focusing on cost and volume of drugs' (16).
Primary care systems have started utilising a team based approach to care delivery. Pharmacists have been increasingly recognised as a part of the healthcare professional team within primary care settings in many countries (18). This integration of pharmacists into primary health care systems was found to have significant benefits that included reduction of errors, effective identification and resolution of medication related problems, improvements in medication adherence, improved patient outcomes, relief of work pressure on GPs, improved communication and cooperation between health professionals, and strengthened team working within primary care (18-22).
Despite the expansion of the role of pharmacists in the primary health care setting, limited research has been conducted to evaluate the impact of pharmacist input on health service utilisation and cost.
- Conditions
- Medication Adherence
- Being tested
- Medicines optimisation
- Keywords
- Medicines optimisation, Healthcare resource utilisation, HRQOL, Pharmacist-led, GP based
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicines optimisationOther
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | All patients allocated to the control group, who on checking meet the study entry criteria and who consent (written informed consent) to participate in the research, will be asked to complete the three study questionnaires (see below) and will be advised that repeat questionnaires will be distributed by post at the end of the study (6 months) for completion at home and return by post. The patients will continue to receive all services provided by the GP practice (normal care) but will not receive the bespoke clinical pharmacist intervention which is being evaluated in this research study. |
| Intervention arm | Experimental | Participants meeting all study entry criteria who are allocated to the intervention group will also be asked to complete the three study questionnaires. Having completed the questionnaires they will receive the medicines optimisation intervention by the clinical pharmacist. They will be asked to return for repeat appointments with the clinical pharmacist at 2 and 4 months and will be advised that they will be asked to complete the study questionnaires again at the end of the study (at home, via post at 6 months). Receives: Other: Medicines optimisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unplanned hospital admissions
Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients
Measured: Recruitment - 6 months post intervention
Number of A&E attendances
Number of attendance to the A\&E department over the follow-up period will be collected for both control and intervention patients
Measured: Recruitment - 6 months post intervention
Number of GP consultations
Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients
Measured: Recruitment - 6 months post intervention
Secondary outcomes (7)
Medication appropriateness index (MAI) score
MAI scores will be calculated at the beginning and end of the project for each patient recruited into the study
Measured: Recruitment - 6 months post intervention
Number of medication related problems
Number of medication related problems will be calculated at the beginning and end of the project for each patient recruited into the study
Measured: Recruitment - 6 months post intervention
Health-related quality of life (HRQOL)
HRQOL scores will be calculated using the EQ-5D tool at the beginning and end of the project for each patient recruited into the study
Measured: Recruitment - 6 months post intervention
Medication Adherence report scale (MARS)
MARS scores will be calculated at the beginning and end of the project for each patient recruited into the study
Measured: Recruitment - 6 months post intervention
Beliefs about medicines questionnaire (BMQ)
BMQ scores will be calculated at the beginning and end of the project for each patient recruited into the study
Measured: Recruitment - 6 months post intervention
Patient satisfaction with GP services
Patients will be asked to complete a bespoke satisfaction questionnaire in order to assess their satisfaction with the new service which has been provided
Measured: Recruitment - 6 months post intervention
Patient laboratory data relevant to medications being received
Pertinent laboratory data will be collected throughout the intervention period and follow-up
Measured: Recruitment - 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Dec 2016
- Primary completion31 Mar 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- A prospective, multi-centre, randomised intervention study will be conducted simultaneously in four different regions of the United Kingdom (UK), namely: 1. Northern Health and Social Care Trust (NHSCT) and Western Health and Social Care Trust (WHSCT), Northern Ireland 2. North West Coast Academic Health Science Network (AHSN), England 3. Wessex AHSN, England 4. Eastern AHSN, England Two GP practices will participate in the research in each of these four geographical areas. The pragmatic sample size at each site will be 50 intervention patients and 50 control patients completing a six month follow-up period i.e. a total of 800 patients (400 intervention and 400 control patients) across the eight participating GP practices. An over-recruitment of 20%, i.e. 60 each of both control and interventions patients per practice, will be recruited into the study to take account of patients who drop out of the study and/or are lost to follow up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Medicines Optimisation Innovation Centre (MOIC), Association of the British Pharmaceutical Industry (ABPI)
- Responsible party
- Principal investigator, James McElnay, Queen's University, Belfast
- Investigators
- James C McElnay, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241498
- Sponsor's protocol ID
- QUB B16/46
- Status last verified
- Dec 2019
- First submitted
- 2 Aug 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final results will be disseminated through relevant academic press
Publications
Syafhan NF, Al Azzam S, Williams SD, Wilson W, Brady J, Lawrence P, McCrudden M, Ahmed M, Scott MG, Fleming G, Hogg A, Scullin C, Horne R, Ahir H, McElnay JC. General practitioner practice-based pharmacist input to medicines optimisation in the UK: pragmatic, multicenter, randomised, controlled trial. J Pharm Policy Pract. 2021 Jan 4;14(1):4. doi: 10.1186/s40545-020-00279-3.
PubMed 33397509
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GP Practice Based Pharmacist Input to Medicines Optimisation
- ClinicalTrials.gov ID
- NCT03241498
- Acronym / sponsor ID
- QUB B16/46
- Conditions
- Medication Adherence
- Keywords
- Medicines optimisation, Healthcare resource utilisation, HRQOL, Pharmacist-led, GP based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Medicines Optimisation Innovation Centre (MOIC), Association of the British Pharmaceutical Industry (ABPI)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Aug 2017 (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 study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will engage with patients, thought to be at a higher risk of medication related problems, within their GP practice in order to help identify areas for improvement
Detailed description
Drug therapy is growing more complex as patients increasingly suffer from a number of co-morbidities. Accordingly, in clinical medicine, a wide range of medication related problems may arise (1). A medication related problem (MRP) is defined as "an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes" (2). These problems have been found to lead to more hospital admissions and thus increase the cost of healthcare provision (3, 4). For instance, Winterstein et al. carried out a meta-analysis of research in this area which showed that 7.1% of hospital admissions were attributable to a drug related problem, of which 59% appeared avoidable (5). Moreover, a large study in the United Kingdom showed that these admissions cost the National Health Service (NHS) up to £466 million annually, which is 0.59% of the British health care budget (6).
Medication related problems (MRPs) remain a serious concern particularly in primary care settings. A recent UK study found that one in 20 prescription items in general practice included an error, affecting 1 in 8 patients. Although the majority of these errors were described as being either mild or moderate in severity, 1 in 550 of all prescription items contained an error determined to be severe (7). In addition, significant medication wastage has been found within general practice settings in England with an estimated £300 million worth of prescribed medications being wasted each year in primary and community care (8). Optimisation of drug therapy and prevention of MRPs can reduce health care expenditure, potentially save lives and enhance patient quality of life (9-13).
Medicines optimisation is defined as 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines. Medicines optimisation applies to people who may or may not take their medicines effectively. Shared decision-making is an essential part of evidence-based medicine, seeking to use the best available evidence to guide decisions about the care of the individual patient, taking into account their needs, preferences and values' (14, 15, 16).
Medicines optimisation requires more patient engagement and professional collaboration within health and social care settings. It focuses on actions taken by all health and social care practitioners. To support the medicines optimisation agenda a guide on medicines optimisation has been produced by The Royal Pharmaceutical Society (RPS) the aim of which is to help patients make the most of their medicines (17). This guide involves four key principles for medicines optimisation in order to achieve improved patient outcomes (16). These principles are as follows:
(i) Aim to understand the patient's experience (ii) Evidence based choice of medicines (iii) Ensure medicines use is as safe as possible (iv) Make medicines optimisation part of routine practice
In order to support the implementation of the guiding principles, NHS England launched the prototype medicines optimisation dashboard in 2014. The dashboard aims to 'encourage Clinical Commissioning Groups (CCGs) and healthcare Trusts to think more about how well their patients are supported to use medicines and less about focusing on cost and volume of drugs' (16).
Primary care systems have started utilising a team based approach to care delivery. Pharmacists have been increasingly recognised as a part of the healthcare professional team within primary care settings in many countries (18). This integration of pharmacists into primary health care systems was found to have significant benefits that included reduction of errors, effective identification and resolution of medication related problems, improvements in medication adherence, improved patient outcomes, relief of work pressure on GPs, improved communication and cooperation between health professionals, and strengthened team working within primary care (18-22).
Despite the expansion of the role of pharmacists in the primary health care setting, limited research has been conducted to evaluate the impact of pharmacist input on health service utilisation and cost.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multi-centre, randomised intervention study will be conducted simultaneously in four different regions of the United Kingdom (UK), namely: 1. Northern Health and Social Care Trust (NHSCT) and Western Health and Social Care Trust (WHSCT), Northern Ireland 2. North West Coast Academic Health Science Network (AHSN), England 3. Wessex AHSN, England 4. Eastern AHSN, England Two GP practices will participate in the research in each of these four geographical areas. The pragmatic sample size at each site will be 50 intervention patients and 50 control patients completing a six month follow-up period i.e. a total of 800 patients (400 intervention and 400 control patients) across the eight participating GP practices. An over-recruitment of 20%, i.e. 60 each of both control and interventions patients per practice, will be recruited into the study to take account of patients who drop out of the study and/or are lost to follow up.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –All patients allocated to the control group, who on checking meet the study entry criteria and who consent (written informed consent) to participate in the research, will be asked to complete the three study questionnaires (see below) and will be advised that repeat questionnaires will be distributed by post at the end of the study (6 months) for completion at home and return by post. The patients will continue to receive all services provided by the GP practice (normal care) but will not receive the bespoke clinical pharmacist intervention which is being evaluated in this research study. |
| Intervention arm | Experimental | Other: Medicines optimisationParticipants meeting all study entry criteria who are allocated to the intervention group will also be asked to complete the three study questionnaires. Having completed the questionnaires they will receive the medicines optimisation intervention by the clinical pharmacist. They will be asked to return for repeat appointments with the clinical pharmacist at 2 and 4 months and will be advised that they will be asked to complete the study questionnaires again at the end of the study (at home, via post at 6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had at least 1 unplanned hospital admission or 2 or more accident and emergency department (A\&E) attendances in the previous 12 months.
- Prescribed ≥ 6 regular oral/systemic, long term medicines.
- Has ≥ 2 long-term chronic conditions.
Key exclusion criteria (5 listed)
- Patient is residing in a nursing home or a care home.
- Patient is considered unable to give written informed consent e.g. Alzheimer's disease.
- Palliative care patients.
- Patient has had ≥ 4 unplanned admissions to hospital in the previous 6 months.
- Patient is participating in another intervention research project within the practice.
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 |
|---|---|---|
| Medicines optimisation | Other | Intervention arm |
Primary outcome
Number of unplanned hospital admissions
Time frame: Recruitment - 6 months post intervention
Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients
Number of A&E attendances
Time frame: Recruitment - 6 months post intervention
Number of attendance to the A\&E department over the follow-up period will be collected for both control and intervention patients
Number of GP consultations
Time frame: Recruitment - 6 months post intervention
Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients
7 secondary outcomes
Medication appropriateness index (MAI) score
Time frame: Recruitment - 6 months post intervention
Number of medication related problems
Time frame: Recruitment - 6 months post intervention
Health-related quality of life (HRQOL)
Time frame: Recruitment - 6 months post intervention
Medication Adherence report scale (MARS)
Time frame: Recruitment - 6 months post intervention
Beliefs about medicines questionnaire (BMQ)
Time frame: Recruitment - 6 months post intervention
Patient satisfaction with GP services
Time frame: Recruitment - 6 months post intervention
Patient laboratory data relevant to medications being received
Time frame: Recruitment - 6 months post intervention
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 17 Dec 2019.
- Derived from this study: PubMed 33397509Syafhan NF, Al Azzam S, Williams SD, Wilson W, Brady J, Lawrence P, McCrudden M, Ahmed M, Scott MG, Fleming G, Hogg A, Scullin C, Horne R, Ahir H, McElnay JC. General practitioner practice-based pharmacist input to medicines optimisation in the UK: pragmatic, multicenter, randomised, controlled trial. J Pharm Policy Pract. 2021 Jan 4;14(1):4. doi: 10.1186/s40545-020-00279-3.
- Individual participant dataSharing planned: No. Final results will be disseminated through relevant academic press
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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.
James C McElnay, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicines optimisation in people with Medication Adherence, run by Queen's University, Belfast at 1 site in United Kingdom.
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 5 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 17 Dec 2019. 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 United Kingdom. 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?
Number of unplanned hospital admissions (time frame: Recruitment - 6 months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241498, which also lists 1 linked publication.
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 17 Dec 2019.