Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05928104 |
| Other study ID # |
IRAS 313644 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2023 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of East Anglia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
