The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients (MOR)

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

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Medicines Optimisation Review toolkit; Other: Standard of Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Brighton & Sussex University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOR Toolkit; Medicines Optimisation Review consultation + My clinical companion (patient questionnaire about their medications)	Other: Medicines Optimisation Review toolkit; 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.
Active Comparator: Standard of Care; Current standard of care for patients with HIV receiving antiretroviral therapy, which consists of a phamacists review of ART prescriptions.	Other: Standard of Care; Pharmacist review of ART medications

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Jaime Vera, MD, University of Sussex

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MOR study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No