Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03340077 |
| Other study ID # |
MOR study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2018 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
Brighton and Sussex University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit
(intervention) with standard pharmaceutical care (control)
Description:
The aim of this study is to evaluate the utility, acceptability and feasibility of
incorporating pharmacist Medicines Optimisation Reviews (MORs) into routine HIV outpatient
care. Medicines reviews are a fundamental role of clinical pharmacists and, although
availability of complete medication lists has been shown to reduce the number of DDIs per
patient, evidence of medication reviews reducing medication related problems in PLWH is still
limited. The British HIV Association (BHIVA) Standards of Care for People Living with HIV
mandate that "A complete medication review should be undertaken at least annually by the
specialist team, taking into consideration adherence, any difficulties with medication and
DDIs". However, in most clinics formal medication reviews are not routinely performed on an
annual basis, and a full drug history is not routinely documented, due to capacity
constraints and the lack of an effective and feasible tool for routine medicines reviews in
PLWH.
The Medicines Management Optimisation Review (MOR) toolkit was developed by HIV specialist
pharmacists (including the co-investigator, Heather Leake Date) representing a range of
clinics across the UK, in collaboration with Merck Sharp and Dohme (MSD). The core objective
of the toolkit is to enhance patient safety by identifying and reviewing all patients at
higher risk of polypharmacy or DDIs in the HIV outpatient setting. In the view of the HIV
Specialist pharmacists that developed the toolkit, it represents the "Gold Standard" in what
should be performed at outpatient appointments.
The tools consist of two items. 'My Clinic companion' and 'MOR consultation form'. 'My clinic
companion' is a patient-orientated questionnaire that promotes self-review of medications and
adherence and will facilitate the pharmacist consultation. The 'MOR consultation form' is
designed to aid a structured patient consultation using available information from local
databases, GP medication histories as well as that obtained directly from the patient. The
form also identifies key care providers involved in the patient case, including prior consent
to contact with information if required. It also identifies health care interventions such as
smoking cessation.
To date, evidence of the utility, acceptability and cost-benefit of the MOR toolkit is
missing and with this project we aim to demonstrate that implementation of MORs in a sample
of UK HIV clinics using the MOR toolkit developed by NHS healthcare professionals supported
and funded by MSD is effective, feasible and cost-effective. By 2020 it is estimated that
more than 50% of the UK's HIV population will be over 50 years old, with a corresponding
increase in co-morbidities, DDIs and MRPs, underlining the potential importance of regular
medication reviews. This work will have important implications for the commissioning of HIV
specialist pharmacy services in England (particularly in relation to work across the
primary/secondary care interface, and the development of Sustainability and Transformation
Plans), as it will demonstrate whether MORs can be incorporated into routine practice and if
they are a cost-effective use of pharmacist's time.
