The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients

Study Overview
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Brief Summary
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Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control)

Detailed Description
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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.

Official Title
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A Multicentre Randomised Controlled Open Study of the Utility and Acceptability of the Medicines Optimisation Review (MOR) Toolkit Compared With Standard Pharmaceutical Care in HIV Outpatients

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: Medicines Optimisation Review toolkit
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients currently receiving cART who are ≥50 years old Patients <50 years old who are currently receiving cART and have documented comorbidities in the medical notes or the UKCHIC database that may require treatment with medicines. Exclusion Criteria: Patients who have had a MOR conducted by an HIV pharmacist using the proposed tool within the previous 6 months Patients < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOR Toolkit<br>Medicines Optimisation Review consultation + My clinical companion (patient questionnaire about their medications) | Other: Medicines Optimisation Review toolkit<br>* The Review tool consist of two items. 'My Clinic companion' and 'MOR consultation form'. 'My clinic companion' (see appendix 1) is a patient-orientated questionnaire that promotes self-review of medications and adherence and will facilitate the pharmacist consultation. The 'MOR consultation form' (see appendix 2), 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.<br>|
| Active Comparator: Standard of Care<br>Current standard of care for patients with HIV receiving antiretroviral therapy, which consists of a phamacists review of ART prescriptions. | Other: Standard of Care<br>* Pharmacist review of ART medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the number of medication related problems | The difference in the number each potential Medication Related Problems between the intervention group and control group at baseline, 6 and 12 months | baseline, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of unresolved medication related problems | The number of Medication Related Problems that remain unresolved 6 months after the intervention in the intervention arm | 6 months | 
| Drug and Drug interactions: | differences in the number of DDIs identified in the intervention group compared to the control group. | baseline, 6 and 12 months |