Clinical trial NCT05332158: Medicines Gaps Study
Official title: The Adherence to Oral Anticoagulants and Statins Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherence, Medication
Statin Adverse Reaction
Anticoagulant Adverse Reaction
Keywords: adherence
barriers
anticoagulants
statins
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Leeds Clinical Commissioning Group
First posted: 2022-04-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Charge from baseline adherence rates at 6 months
timeFrame: baseline, 6 months
measure: Frequency of reported adherence barriers
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Response rate, demographic and geographic variation
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals Trust
state: West Yorkshire
Study officials:
affiliation: Leeds Teaching Hospitals Trust
name: Emmanouela Kampouraki, PhD
role: STUDY_CHAIR
References: