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A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention cohort ('after' group)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, β-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, 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.

Sites / Locations

  • Guy's & St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control cohort ('before' group)

Intervention cohort ('after' group)

Arm Description

Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures.

Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.

Outcomes

Primary Outcome Measures

Treatment beliefs
Beliefs about Medication Questionnaire-Specific (BMQ-S)

Secondary Outcome Measures

Treatment beliefs
Beliefs about Medication Questionnaire-Specific (BMQ-S)
Medication adherence
Medication Adherence Report Scale-5 (MARS-5)
Medication adherence
Medication Adherence Report Scale-5 (MARS-5)
Depression
Patient Health Questionnaire-2 (PHQ-2)
Medicines-related self-efficacy
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)

Full Information

First Posted
July 12, 2017
Last Updated
August 13, 2019
Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03218813
Brief Title
A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
Official Title
A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome: An Intervention Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control cohort ('before' group)
Arm Type
No Intervention
Arm Description
Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures.
Arm Title
Intervention cohort ('after' group)
Arm Type
Experimental
Arm Description
Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.
Intervention Type
Behavioral
Intervention Name(s)
Intervention cohort ('after' group)
Intervention Description
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').
Primary Outcome Measure Information:
Title
Treatment beliefs
Description
Beliefs about Medication Questionnaire-Specific (BMQ-S)
Time Frame
12 week follow up
Secondary Outcome Measure Information:
Title
Treatment beliefs
Description
Beliefs about Medication Questionnaire-Specific (BMQ-S)
Time Frame
6 week follow up
Title
Medication adherence
Description
Medication Adherence Report Scale-5 (MARS-5)
Time Frame
12 week follow up
Title
Medication adherence
Description
Medication Adherence Report Scale-5 (MARS-5)
Time Frame
6 week follow up
Title
Depression
Description
Patient Health Questionnaire-2 (PHQ-2)
Time Frame
12 week follow up
Title
Medicines-related self-efficacy
Description
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Time Frame
12 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, β-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, 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.
Facility Information:
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

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A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome

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