The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients

NCT03340077 | Completed DMC

• 1 other identifier: MOR study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The number of unresolved medication related problems

  6 months

• Drug and Drug interactions:

  baseline, 6 and 12 months

Study Arms (2)

MOR Toolkit

EXPERIMENTAL

Medicines Optimisation Review consultation + My clinical companion (patient questionnaire about their medications)

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.

Other: Standard of Care

Interventions

Medicines Optimisation Review toolkit OTHER

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.

MOR Toolkit

Standard of Care OTHER

Pharmacist review of ART medications

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have had a MOR conducted by an HIV pharmacist using the proposed tool within the previous 6 months
• Patients \< 18 years old

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Brighton & Sussex University Hospitals NHS Trust

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jaime Vera, MD

  University of Sussex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 13, 2017
• Study Start: February 6, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)