HIV-1-infectionMORNCT03340077
The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients
A study testing Medicines Optimisation Review toolkit in people with HIV-1-infection, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Medicines Optimisation Review toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2018to 31 Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have had a MOR conducted by an HIV pharmacist using the proposed tool within the previous 6 months
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brighton & Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 5BE
About this study
Official title: 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)
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Medicines Optimisation Review toolkit, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicines Optimisation Review toolkitOther
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.
Standard of CareOther
Pharmacist review of ART medications
| Study group | Role | What they receive |
|---|---|---|
| MOR Toolkit | Experimental | Medicines Optimisation Review consultation + My clinical companion (patient questionnaire about their medications) Receives: Other: Medicines Optimisation Review toolkit |
| Standard of Care | Active comparator | Current standard of care for patients with HIV receiving antiretroviral therapy, which consists of a phamacists review of ART prescriptions. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 and 12 months
Secondary outcomes (2)
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
Measured: 6 months
Drug and Drug interactions:
differences in the number of DDIs identified in the intervention group compared to the control group.
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start6 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jaime Vera, MD, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340077
- Sponsor's protocol ID
- MOR study
- Acronym
- MOR
- Status last verified
- May 2021
- First submitted
- 12 Oct 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03340077
- Acronym / sponsor ID
- MOR / MOR study
- Conditions
- HIV-1-infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Nov 2017 (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.
Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control)
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOR Toolkit | Experimental | Other: Medicines Optimisation Review toolkitMedicines Optimisation Review consultation + My clinical companion (patient questionnaire about their medications) |
| Standard of Care | Active comparator | Other: Standard of CareCurrent standard of care for patients with HIV receiving antiretroviral therapy, which consists of a phamacists review of ART prescriptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who have had a MOR conducted by an HIV pharmacist using the proposed tool within the previous 6 months
- Patients < 18 years old
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 |
|---|---|---|
| Medicines Optimisation Review toolkitThe 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. | Other | MOR Toolkit |
| Standard of CarePharmacist review of ART medications | Other | Standard of Care |
Primary outcome
Differences in the number of medication related problems
Time frame: baseline, 6 and 12 months
The difference in the number each potential Medication Related Problems between the intervention group and control group at baseline, 6 and 12 months
2 secondary outcomes
The number of unresolved medication related problems
Time frame: 6 months
Drug and Drug interactions:
Time frame: baseline, 6 and 12 months
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 7 May 2021.
- 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.
Jaime Vera, MD principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicines Optimisation Review toolkit in people with HIV-1-infection, run by Brighton and Sussex University Hospitals NHS Trust at 1 site 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 2 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Differences in the number of medication related problems (time frame: baseline, 6 and 12 months). 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 7 May 2021.