An Intervention to Support Medication Adherence Following Acute Coronary Syndrome

Development and Feasibility of a Brief Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: Intervention group

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

Behavioral: Intervention group; All stages of the intervention will take place during hospitalization. Patients will complete a questionnaire about their personal beliefs about medicines. Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. Any negative beliefs or concerns will be discussed and beliefs about drug necessity will be encouraged. 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'). 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, timing, content and delivery method seem to be acceptable to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment beliefs	Beliefs about medications will be compared pre-post intervention using responses from the BMQ-S, Separate necessity and concerns scores will be calculated (5-items each, total scores ranging 5-25) along with the BMQ differential (necessity score - concerns score) (Gujral et al., 2014).	During index hospitalisation, within two days of admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial patient study feedback	Patients will complete a study feedback questionnaire which will determine its acceptability to patients (setting, timing, content, delivery method).	During index hospitalisation, within two days of admission.
Detailed patient study feedback	Detailed patient feedback will be gathered 2-3 weeks after discharge via a phone call. A brief semi-structured interview will be undertaken and study acceptability will be assessed (setting, timing, content, delivery method). The follow up call will be audio recorded, transcribed and used to evaluate the intervention.	Within three weeks post-discharge

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Medication adherence; Implementation intentions; Behavioural intervention; Medication beliefs
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: v1 06-09-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No