A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT03218813|
Recruitment Status : Completed
First Posted : July 17, 2017
Last Update Posted : August 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Behavioral: Intervention cohort ('after' group)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will adopt a non-randomised prospective intervention cohort design (i.e. controlled before-and-after (CBA) study). Two cohorts of patients will be recruited from a single NHS site over two recruitment periods. Pharmacists will be trained between these recruitment periods to deliver an intervention, thus creating two comparable groups (control/'before' group vs. intervention/'after' group).|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome: An Intervention Cohort Study|
|Actual Study Start Date :||December 12, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||October 31, 2018|
No Intervention: Control cohort ('before' group)
Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures.
Experimental: Intervention cohort ('after' group)
Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.
Behavioral: 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').
- Treatment beliefs [ Time Frame: 12 week follow up ]Beliefs about Medication Questionnaire-Specific (BMQ-S)
- Treatment beliefs [ Time Frame: 6 week follow up ]Beliefs about Medication Questionnaire-Specific (BMQ-S)
- Medication adherence [ Time Frame: 12 week follow up ]Medication Adherence Report Scale-5 (MARS-5)
- Medication adherence [ Time Frame: 6 week follow up ]Medication Adherence Report Scale-5 (MARS-5)
- Depression [ Time Frame: 12 week follow up ]Patient Health Questionnaire-2 (PHQ-2)
- Medicines-related self-efficacy [ Time Frame: 12 week follow up ]Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218813
|Guy's & St Thomas' NHS Foundation Trust|
|London, United Kingdom|