Medicines Gaps Study

NCT05332158 | Unknown DMC

• 1 other identifier: PH21/145969
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication; Statin Adverse Reaction; Anticoagulant Adverse Reaction

Keywords

adherence; barriers; anticoagulants; statins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Response rate, demographic and geographic variation

  immediately after intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

A single arm to administer questionnaires for patients barriers to adherence.

Behavioral: Questionnaires to report barriers to medication adherence

Interventions

Questionnaires to report barriers to medication adherence BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Leeds Clinical Commissioning Group: collaborator

Study Sites (1)

Leeds Teaching Hospitals Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Emmanouela Kampouraki, PhD

  Leeds Teaching Hospitals Trust

  STUDY CHAIR

Central Study Contacts

Emmanouela Kampouraki, PhD

CONTACT

0113 3926856; mymedsurvey.lth@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Researcher will be blinded to participants with pseudonymised data being collected for analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: April 18, 2022
• Study Start: May 30, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 30, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

GB (1)