Acute Coronary Syndrome Clinical Trial
Official title:
A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome: An Intervention Cohort Study
Verified date | August 2018 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal
and is associated with poor clinical outcomes. Patients' beliefs about medications have been
shown to predict poor adherence and may be targetable for intervention. Findings novel ways
to improve adherence is an important area of research with widespread clinical implications.
Pharmacists may currently be underutilised in promoting and monitoring medication-taking
behaviour. There have been few effective interventions led by pharmacists to support
medication adherence in patients with ACS.
Objectives This study follows on from a feasibility and acceptability study recently
conducted (NCT02967588). The primary objective is to pilot a pharmacist-led hospital-based
intervention to support medication adherence following an ACS.
Methods This study will adopt a non-randomised intervention cohort design (i.e. controlled
before-and-after (CBA) study). Patients admitted to hospital with an ACS will be recruited
for this study. Patients must be prescribed medicines for secondary prevention. The study
will be delivered by hospital pharmacists over two sessions and will target both intentional
(Session 1) and unintentional (Session 2) adherence barriers. Session 1 will involve
eliciting and challenging patients' erroneous beliefs about medications. Session 2 will
involve formulating specific action plans to encourage medication-taking habit formation.
Outcome Outcome data will be collected at two time points - 6 week and 12 week follow up. The
primary outcome of this proposed study will be treatment beliefs, measured using the Beliefs
about Medicines Questionnaire-Specific (BMQ-S) (Horne, Weinman & Hankin, 1999). Our secondary
outcome will be self-reported medication adherence measured using the Medication Adherence
Report Scale (MARS-5) (Horne & Weinman, 2002). Depression, medicines-related self-efficacy
and satisfaction with medicines information provision will also be measured.
Study timeline Control cohort ('before' group): eligible patients will receive treatment as
usual (TAU) and will complete all outcome measures (i.e. treatment beliefs, medication
adherence). Pharmacists will then be trained to deliver the intervention. Intervention cohort
('after' group): eligible patients will receive the pharmacist-led intervention and will
complete all outcome measures.
Status | Completed |
Enrollment | 56 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 18 years and over - Clinical diagnosis of ACS* - ACS primary reason for hospitalisation - Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, ß-blockers) - Sufficient spoken English to participate in the study Exclusion Criteria: - Under 18 years of age - Developed ACS* as a secondary condition (i.e. perioperative MI) - Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, ß-blockers) - Non-English speaking - Medical notes indicate cognitive impairment *ACS is defined as patients diagnosed with a myocardial infarction or unstable angina (European Society of Cardiology Clinical Practice Guidelines (Roffi et al., 2015; Steg et al., 2012)). - Non-ST-segment elevated myocardial infarction (NSTEMI) - Myocardial ischaemia with elevated cardiac biomarkers (i.e. troponin) in the absence of ST-segment elevation identified via electrocardiogram (ECG). - ST-segment elevated myocardial infarction (STEMI) - Myocardial ischaemia with elevated cardiac biomarkers (i.e. troponin) and ST-segment elevation identified via electrocardiogram (ECG). - Unstable angina - Myocardial ischaemia at rest or minimal exertion in the absence of cardiomyocyte necrosis and significantly elevated cardiac biomarkers (i.e. troponin). All diagnoses will be made by the patients' clinical team. The research team will play no part in this process. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's & St Thomas' NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment beliefs | Beliefs about Medication Questionnaire-Specific (BMQ-S) | 12 week follow up | |
Secondary | Treatment beliefs | Beliefs about Medication Questionnaire-Specific (BMQ-S) | 6 week follow up | |
Secondary | Medication adherence | Medication Adherence Report Scale-5 (MARS-5) | 12 week follow up | |
Secondary | Medication adherence | Medication Adherence Report Scale-5 (MARS-5) | 6 week follow up | |
Secondary | Depression | Patient Health Questionnaire-2 (PHQ-2) | 12 week follow up | |
Secondary | Medicines-related self-efficacy | Self-Efficacy for Appropriate Medication Use Scale (SEAMS) | 12 week follow up |
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