Medicines Gaps Study

Adherence, Medication Clinical Trial

— MeGa  

Official title:

The Adherence to Oral Anticoagulants and Statins Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332158
• Other study ID #: PH21/145969
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2022
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Emmanouela Kampouraki, PhD
• Phone: 0113 3926856
• Email: mymedsurvey.lth[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 30, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Anticoagulant Adverse Reaction
• Statin Adverse Reaction

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals Trust	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	Leeds Clinical Commissioning Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Frequency of reported adherence barriers	Commonly reported and less commonly reported barriers as a percentage of all responses	immediately after the intervention
Secondary	Response rate, demographic and geographic variation	Response rates in the integrated questionnaires within primary care systems	immediately after intervention