Medicines Gaps Study (MeGa)

The Adherence to Oral Anticoagulants and Statins Project

The adherence project aims to understand adherence rates and barriers to Direct oral anticoagulants (DOACs) and statins and improve awareness of healthcare professionals on adherence across Leeds.

During the first component of the project, the investigation of rates of non-adherence was classed as service evaluation. The second component of this project, which this IRAS application refers to, will look into patient perspectives and barriers to adherence. Currently, such information is not routinely collected and only requested as part of shorter or longer consultations depending on a pre-defined clinical agenda and with little attention to adherence. Two specific questionnaires have been designed and integrated within the primary care medical records systems. Following invitation for target patients on DOACs and/or statins to respond anonymously, responses to the questionnaire(s) will be stored in their medical records. Data will then be extracted from the two systems [SystmOne and Egton Medical Information Systems (EMIS)] using unique system identifiers, that will be pseudonymised at the time of extraction. All patient pseudonymised information (including medical records system identifiers and responses to the questionnaire) will be extracted by the LTHT Researcher-Pharmacist following access provided by each participating General Practitioner (GP) Practice, based on searches built centrally by the Data Quality Team of the Leeds Clinical Commissioning Group (CCG).

Apart from the dissemination of findings based on the questionnaire, a training package for health professionals will be designed and delivered. The aim of the training is to combine and disseminate all findings of the project, raise awareness on real-world non-adherence prevalence and the common barriers to adherence, demonstrate the usefulness of routine adherence estimation and suggest tools to address non-adherence in daily practice. The objectives of this training will also consider the training needs of healthcare professionals locally, as per the healthcare professionals survey that has been designed and circulated.

Study Overview

• Status: Recruiting
• Conditions: Adherence, Medication; Statin Adverse Reaction; Anticoagulant Adverse Reaction
• Intervention / Treatment: Behavioral: Questionnaires to report barriers to medication adherence

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanouela Kampouraki, PhD; Phone Number: 0113 3926856; Email: mymedsurvey.lth@nhs.net

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Recruiting
      • Leeds Teaching Hospitals Trust
      • Contact: Emmanouela Kampouraki, PhD; Phone Number: 0113 3926856; Email: mymedsurvey.lth@nhs.net

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:

• adult patients
• having an active repeat prescription for a DOAC and/or a statin for at least 6 months prior to the date of data extraction
• a diagnosis of atrial fibrillation (AF) for those on a DOAC and of hypercholesterolemia for those on a statin (to justify the preventive nature of the treatments)

Exclusion Criteria:

• Patients with an active repeat prescription for a DOAC and/or a statin for less than 6 months prior to the date of data extraction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; A single arm to administer questionnaires for patients barriers to adherence.	Behavioral: Questionnaires to report barriers to medication adherence; One questionnaire specific to DOACs and one specific to statins have been integrated within the medical records system and will be sent to eligible patients to respond to following written informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Charge from baseline adherence rates at 6 months	Barriers to DOAC and statin adherence that patients have chosen to disclose in the dedicated questionnaires. The rates of adherence based on repeat prescription data following the use of questionnaire(s) will also be compared with the individual rate before the use of questionnaire.	baseline, 6 months
Frequency of reported adherence barriers	Commonly reported and less commonly reported barriers as a percentage of all responses	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate, demographic and geographic variation	Response rates in the integrated questionnaires within primary care systems	immediately after intervention

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Leeds Clinical Commissioning Group
• Investigators: Study Chair: Emmanouela Kampouraki, PhD, Leeds Teaching Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: adherence; anticoagulants; statins; barriers
• Other Study ID Numbers: PH21/145969

Drug and device information, study documents

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