ALL, AdultOPenNCT05928104
Optimising Pharmacist-led Medication Reviews in Primary Care
An observational study of ALL, Adult, run by University of East Anglia at 3 sites in United Kingdom.
Trial summary
An increasing number of people are diagnosed with long-term conditions and are prescribed medicines to manage these conditions. Medication reviews (MRs) are used to optimise medicines, improve health outcomes, and decrease medicines related problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALL, Adult
- What is being tested?
- Medication review
- How many people
- 15 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Sep 2023to 31 Jan 2024
- Phase
- Observational
- 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
Study population: Patients will be recruited from the general practice sites that are recruited to participate in the study. These sites will be located in Norfolk, Suffolk and North East Essex
Who may be able to join
- Aged ≥ 18 years
- Due for a medication review by the practice pharmacist
- Effectively communicate in English
- Provide informed consent
Who cannot join
- Have no access to telephone/ internet
- Recently received a medication review
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Toftwood surgery
Dereham, Norflok, NR19 1LD
North Elmham surgery
Dereham, Norfolk, NR20 5JS
Sheringham Medical Practice
Sheringham, Norfolk, NR26 8RT
About this study
Official title: Optimising Pharmacist-led Medication Reviews in Primary Care (OPen): a Qualitative Study to Co-design and Test an Optimised Medication Review for Patients With Long-term Conditions.
An increasing number of people are diagnosed with long-term conditions and are prescribed medicines to manage these conditions. Medication reviews (MRs) are used to optimise medicines, improve health outcomes, and decrease medicines related problems.
Although medication reviews are widely used in health care settings, there has not been a dramatic change in the the rate at which patients experience poor medicines outcomes such as adverse drug reactions and hospitalisations.
Read more
This research wants to understand how medication reviews by pharmacists are delivered in GP surgeries and community pharmacies. The research team plans to test a co-designed document, which outlines what pharmacists should do in a MR, in a small number of GP surgeries, on a limited number of patients.
Pharmacists and patients who have used this document will be interviewed to understand their thoughts and feelings about the process.
Read the detailed description
Approximately 15 million people in England have a long-term condition (LTC) or chronic disease, such as heart disease, asthma, diabetes, for which there is currently no cure. Long-term conditions are mostly managed by medicines with 1.12 billion prescription items dispensed in England in 2019 at a total cost of £9.08 billion. Recent government reports have identified that prescribing too many or inappropriate medicines can lead to more medicines related problems and poor patient outcomes, such as drug interactions, adverse drug reactions, reduced quality of life, and hospitalisations.
Medication reviews are used to support patients with their medicines and to reduce the risk of over and inappropriate prescribing. Desired outcomes for medication reviews include optimising medicines, improving health outcomes, and decreasing medicines related problems. It has become more common for medication reviews to be used by doctors, nurses, and pharmacists in the last ten years, but the rate at which patients experience poor medicines outcomes such as adverse drug reactions and hospitalisations because of medicines use has not changed much in this time.
Pharmacists are considered to be medicines experts, so many organisations are encouraging them to be involved with the delivery of medication reviews. Pharmacists currently undertake various types of medication reviews in general practitioner (GP) surgeries, Primary Care Networks (PCN), and community pharmacies.
When interventions are introduced to address problems such as overprescribing, it is important to better understand how they have been designed and delivered. The Medical Research Council (MRC) has provided guidance on the process evaluation of complex interventions (of which medication reviews are an example).
This states that the key steps in evaluating complex interventions are:
- Understanding how and what is delivered Understanding how the intervention produces change
- Understanding how context affects implementation and outcomes
To understand the evidence for pharmacist-led medication reviews, a scoping review was undertaken with the aim of describing the existing, extensive literature in this field. This scoping review identified numerous systematic reviews that included a significant quantity of primary research from a wide range of countries. It concluded that overall evidence for effectiveness for medication reviews is uncertain (no strong evidence for or against their effect on patient outcomes). In addition, it identified that most reviews did not describe in depth what is delivered and how the intervention produces change. Therefore, it is difficult to know, from the existing systematic review literature, which elements of the medication review are likely to benefit the patient and the health service.
As a follow-up to this scoping review a systematic review was undertaken to explore what is delivered (the core components of pharmacist-led medication reviews), and whether and how they link to outcomes in different contexts. In addition to extracting data about context, implementation, outcomes, and mechanisms of impact (how intervention produces change), this systematic review also extracted information about actions that affect patients' medicines taking behaviour and implementation strategies (activities that describe how an intervention was delivered).
The output from the systematic review was a draft programme theory. A programme theory describes how an intervention is expected to lead to its effects and under what conditions. The programme theory for pharmacist-led medication reviews shows how the intervention may achieve patient and health service outcomes
The literature reviews have established what has been reported in previous studies, and the evidence for pharmacist-led medication reviews. The next step is to find out what is happening in practice. The current GP and community pharmacy contracts provide some guidance to the provision of medication reviews. However, these documents lack details on why elements have been included and how they will benefit the patient. Focus groups with patients and practitioner (pharmacists, GPs and practice nurses) were undertaken to establish what is happening is practice and the key uncertainties (unknown or incomplete essential details relating to the content and implementation of medication reviews) are. The results from the focus groups, combined with the outcomes from the systematic review were used to design an optimised, evidence-informed pharmacist-led medication review, with the help of stakeholders, such as pharmacists, patients, and GPs.
- Conditions
- ALL, Adult
- Being tested
- Medication review
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
Pharmacist-led medication review in primary care using a co-designed document
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient feasibility and acceptability
Patients will be interviewed to assess their thoughts and feelings after receiving the medication review
Measured: 3 months
Pharmacist feasibility and acceptability
Pharmacists will be interviewed to assess their thoughts and feelings after delivering medication reviews using the service specification
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Sep 2023
- Primary completion22 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, AdultStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928104
- Sponsor's protocol ID
- IRAS 313644
- Acronym
- OPen
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Pharmacist-led Medication Reviews in Primary Care (OPen): a Qualitative Study to Co-design and Test an Optimised Medication Review for Patients With Long-term Conditions.
- ClinicalTrials.gov ID
- NCT05928104
- Acronym / sponsor ID
- OPen / IRAS 313644
- Conditions
- ALL, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 3 Jul 2023 (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.
An increasing number of people are diagnosed with long-term conditions and are prescribed medicines to manage these conditions. Medication reviews (MRs) are used to optimise medicines, improve health outcomes, and decrease medicines related problems.
Although medication reviews are widely used in health care settings, there has not been a dramatic change in the the rate at which patients experience poor medicines outcomes such as adverse drug reactions and hospitalisations.
This research wants to understand how medication reviews by pharmacists are delivered in GP surgeries and community pharmacies. The research team plans to test a co-designed document, which outlines what pharmacists should do in a MR, in a small number of GP surgeries, on a limited number of patients.
Pharmacists and patients who have used this document will be interviewed to understand their thoughts and feelings about the process.
Detailed description
Approximately 15 million people in England have a long-term condition (LTC) or chronic disease, such as heart disease, asthma, diabetes, for which there is currently no cure. Long-term conditions are mostly managed by medicines with 1.12 billion prescription items dispensed in England in 2019 at a total cost of £9.08 billion. Recent government reports have identified that prescribing too many or inappropriate medicines can lead to more medicines related problems and poor patient outcomes, such as drug interactions, adverse drug reactions, reduced quality of life, and hospitalisations.
Medication reviews are used to support patients with their medicines and to reduce the risk of over and inappropriate prescribing. Desired outcomes for medication reviews include optimising medicines, improving health outcomes, and decreasing medicines related problems. It has become more common for medication reviews to be used by doctors, nurses, and pharmacists in the last ten years, but the rate at which patients experience poor medicines outcomes such as adverse drug reactions and hospitalisations because of medicines use has not changed much in this time.
Pharmacists are considered to be medicines experts, so many organisations are encouraging them to be involved with the delivery of medication reviews. Pharmacists currently undertake various types of medication reviews in general practitioner (GP) surgeries, Primary Care Networks (PCN), and community pharmacies.
When interventions are introduced to address problems such as overprescribing, it is important to better understand how they have been designed and delivered. The Medical Research Council (MRC) has provided guidance on the process evaluation of complex interventions (of which medication reviews are an example).
This states that the key steps in evaluating complex interventions are:
- Understanding how and what is delivered Understanding how the intervention produces change
- Understanding how context affects implementation and outcomes
To understand the evidence for pharmacist-led medication reviews, a scoping review was undertaken with the aim of describing the existing, extensive literature in this field. This scoping review identified numerous systematic reviews that included a significant quantity of primary research from a wide range of countries. It concluded that overall evidence for effectiveness for medication reviews is uncertain (no strong evidence for or against their effect on patient outcomes). In addition, it identified that most reviews did not describe in depth what is delivered and how the intervention produces change. Therefore, it is difficult to know, from the existing systematic review literature, which elements of the medication review are likely to benefit the patient and the health service.
As a follow-up to this scoping review a systematic review was undertaken to explore what is delivered (the core components of pharmacist-led medication reviews), and whether and how they link to outcomes in different contexts. In addition to extracting data about context, implementation, outcomes, and mechanisms of impact (how intervention produces change), this systematic review also extracted information about actions that affect patients' medicines taking behaviour and implementation strategies (activities that describe how an intervention was delivered).
The output from the systematic review was a draft programme theory. A programme theory describes how an intervention is expected to lead to its effects and under what conditions. The programme theory for pharmacist-led medication reviews shows how the intervention may achieve patient and health service outcomes
The literature reviews have established what has been reported in previous studies, and the evidence for pharmacist-led medication reviews. The next step is to find out what is happening in practice. The current GP and community pharmacy contracts provide some guidance to the provision of medication reviews. However, these documents lack details on why elements have been included and how they will benefit the patient. Focus groups with patients and practitioner (pharmacists, GPs and practice nurses) were undertaken to establish what is happening is practice and the key uncertainties (unknown or incomplete essential details relating to the content and implementation of medication reviews) are. The results from the focus groups, combined with the outcomes from the systematic review were used to design an optimised, evidence-informed pharmacist-led medication review, with the help of stakeholders, such as pharmacists, patients, and GPs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the general practice sites that are recruited to participate in the study. These sites will be located in Norfolk, Suffolk and North East Essex
Key inclusion criteria (4 listed)
- Aged ≥ 18 years
- Due for a medication review by the practice pharmacist
- Effectively communicate in English
- Provide informed consent
Key exclusion criteria (2 listed)
- Have no access to telephone/ internet
- Recently received a medication review
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 |
|---|---|---|
| Medication reviewPharmacist-led medication review in primary care using a co-designed document | Other | – |
Primary outcome
Patient feasibility and acceptability
Time frame: 3 months
Patients will be interviewed to assess their thoughts and feelings after receiving the medication review
Pharmacist feasibility and acceptability
Time frame: 3 months
Pharmacists will be interviewed to assess their thoughts and feelings after delivering medication reviews using the service specification
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 13 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALL, Adult, run by University of East Anglia at 3 sites 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 2 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Patient feasibility and acceptability (time frame: 3 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 13 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.