The Adherence to Oral Anticoagulants and Statins Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Charge from baseline adherence rates at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Researcher will be blinded to participants with pseudonymised data being collected for analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Charge from baseline adherence rates at 6 months
时间窗: baseline, 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.
Frequency of reported adherence barriers
时间窗: immediately after the intervention
Commonly reported and less commonly reported barriers as a percentage of all responses
次要结局
- Response rate, demographic and geographic variation(immediately after intervention)