Clinical trial NCT02967588: An Intervention to Support Medication Adherence Following Acute Coronary Syndrome
Official title: Development and Feasibility of a Brief Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Medication adherence
Behavioural intervention
Acute coronary syndrome
Medication beliefs
Implementation intentions
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2016-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal and is associated with poor clinical outcomes. Non-adherence can be considered intentional or unintentional. Findings ways to improve adherence is an important area of research with widespread clinical implications, however, previous interventions have generally been ineffective. The investigators propose an intervention that challenges both intentional and unintentional non-adherence in patients hospitalised following ACS.

Objectives The objective of this study is to determine the feasibility of a hospital-based intervention aimed at supporting medication adherence in patients following an ACS.

Methods Patients admitted to hospital with an ACS will be recruited for this study. The study will target both intentional and unintentional non-adherence over two sessions through challenging treatment beliefs and formulating specific action plans to encourage habit formation. Patients will be asked to provide in-depth feedback around the acceptability of the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will not be collected.

Dissemination If this study seems to be practical to deliver and acceptable to patients then it will inform the design of a future randomized-controlled pilot study to test the effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e. medication adherence).

Detailed description: Intervention details

* All stages of the intervention will take place during hospitalization.
* Firstly, patients will complete a questionnaire based on the Beliefs about Medication Questionnaire-Specific (BMQ-S) (Horne \& Weinmen, 1999).
* Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. The aim is to identify any negative or erroneous beliefs patients have that may prevent them from taking their medicines after they leave the hospital.
* 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'. The aim is to make taking their medicines as much a part of their daily routine as possible.
* Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications.
* Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting (i.e. hospital-based), timing (i.e. straight after an ACS), content (i.e. targeting both intentional and unintentional non-adherence) and interventionist (i.e. PhD candidate) seem to be acceptable to patients.
* Feedback will be gathered after completion of the intervention and also during a follow up phone call 2-3 weeks after discharge.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ACS
* ACS primary reason for hospitalization
* 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

Primary outcomes:
measure: Treatment beliefs
timeFrame: During index hospitalisation, within two days of admission.
Secondary outcomes:
measure: Initial patient study feedback
timeFrame: During index hospitalisation, within two days of admission.
measure: Detailed patient study feedback
timeFrame: Within three weeks post-discharge
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References: