A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
NCT ID: NCT03218813
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
56 participants
INTERVENTIONAL
2017-12-12
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
NCT00493337
Impact of Care Transition on Medication Adherence in Cardiac Patients
NCT02481024
Improving Adherence to Pharmacological Treatment
NCT00848224
A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction
NCT03621111
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
NCT01920009
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control cohort ('before' group)
Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures.
No interventions assigned to this group
Intervention cohort ('after' group)
Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.
Intervention cohort ('after' group)
The intervention will take place during hospitalisation. Patients will complete the BMQ-S and their responses will form the basis of what will be discussed in Session 1. Pharmacists will elicit patients' thoughts and opinions about their medicines and highlight the need to take them. Any erroneous treatment beliefs will be discussed and any concerns will be addressed.
After Session 1, patients will be given a planning sheet and will be asked to think about their usual daily routine and how taking medicines may fit into it. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention cohort ('after' group)
The intervention will take place during hospitalisation. Patients will complete the BMQ-S and their responses will form the basis of what will be discussed in Session 1. Pharmacists will elicit patients' thoughts and opinions about their medicines and highlight the need to take them. Any erroneous treatment beliefs will be discussed and any concerns will be addressed.
After Session 1, patients will be given a planning sheet and will be asked to think about their usual daily routine and how taking medicines may fit into it. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis of ACS\*
* ACS primary reason for hospitalisation
* Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
* Sufficient spoken English to participate in the study
Exclusion Criteria
* Developed ACS\* as a secondary condition (i.e. perioperative MI)
* Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
v1 30-06-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.