Coronary Heart Disease Clinical Trial
— PharmacycareOfficial title:
Feasibility and Potential Impact of Community Pharmacy Care Including Motivational Interviews on Adherence to Secondary Prevention Medication in Patients With Coronary Heart Diseases
Verified date | April 2015 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Introduction:
In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial
infarction (MI) and will need secondary prevention medications. Longterm adherence to
secondary prevention therapies remains poor, nonadherence to medication in MI patients
ranges from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not
refill their cardiac medications (2). Strategies to tackle the burden of non adherence could
involve pharmacy care and The New Medicine Service (which is a service provided by community
pharmacists to help patients on long term medications for chronic diseases) with a
motivational interview incorporated as part of the counselling session of a community
pharmacist. Communication of health providers with patients and between health providers
could also be an important strategy to improve adherence.
Cardiovascular disease is high in all ethnic groups as well as in the general population;
however it is the South Asians who have the highest prevalence of coronary heart disease
(CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of
40 years (3).
Aim of this study:
This study is to investigate the feasibility and potential impact of a pharmacy care
intervention involving motivational interviews and referral to the New Medicine Service in
coronary heart disease patients on adherence to secondary prevention medication and on
outcomes of coronary heart disease.
Method:
The study is designed as a prospective, controlled feasibility/pilot, intervention study.
The study has two phases.
In the intervention phase a total of 200 coronary heart disease patients discharged from the
London Chest Hospital will be enrolled into the study and followed up for one year.
Pharmacies from up to six London Boroughs will be invited to take place in the study.
Pharmacies will be randomised using a table of random numbers into intervention site or
control site. The pharmacists working in the intervention pharmacies will be invited for
training on the delivery of the intervention and on motivational interviewing. The
intervention will be performed by community pharmacists. Recruitment of patients will take
place in the hospital. In the interview phase 20 patients from South Asian backgrounds will
be invited for a telephone interview to study the effect of their beliefs and cultural
backgrounds in regards to their adherence to cardiac medication.
Outcome measures:
The primary outcome measure is self report adherence with coronary artery disease medication
employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low
density lipoprotein cholesterol) in addition to data regarding the feasibility of the
intervention.
Analysis:
Both quantitative and qualitative data analysis will be performed.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18-yr-old. - Both Male/female. - Acute coronary syndromes; angina, NSTEMI (non-ST-segment elevation myocardial infarction) /unstable angina, STEMI (ST segment elevation myocardial infarction). - Patients included are from high risk group (hypertension , diabetes, hyperlipidemia), as well as patient from low risk group (developed MI with an unknown risk factor). - Patients medically treated for secondary prevention of coronary artery disease (dual antiplatelet therapy aspirin plus either clopidogrel, ticagrelor or prasugrel. Beta-blockers, or calcium channel blockers, ACE-inhibitors or ARBs (angiotensin II receptor blocker), and statins). - Patients living in the area around East London and who regularly refill prescriptions in the pharmacies involved in the study. Exclusion Criteria: - Congenital heart disease. - Complications of myocardial infarction: Arrhythmias, Congestive Heart Failure, Tamponade / Thromboembolic disorder, Rupture (Ventricle, septum, papillary muscle), Aneurysm (Ventricle), Pericarditis, Infection. - Patients who do not live in the area around East London and do not regularly refill prescriptions in the pharmacies involved in the study. - Patients who do not live independently (living or nursing home residence). - Patients with less than one year survival rate. - Patients unable to understand oral and written English. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United Kingdom | The London Chest Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | Barts & The London NHS Trust |
United Kingdom,
Garavalia L, Garavalia B, Spertus JA, Decker C. Exploring patients' reasons for discontinuance of heart medications. J Cardiovasc Nurs. 2009 Sep-Oct;24(5):371-9. doi: 10.1097/JCN.0b013e3181ae7b2a. — View Citation
Gupta M, Singh N, Verma S. South Asians and cardiovascular risk: what clinicians should know. Circulation. 2006 Jun 27;113(25):e924-9. Review. — View Citation
Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient satisfaction/feedback on the pharmacist intervention | This will be assessed by semi-structured telephone interviews conducted by the research pharmacist. | 6 months | No |
Primary | Change in adherence to cardiovascular medication | Change in adherence from baseline assessed at 6 months and 12 months. | No | |
Secondary | Change in blood pressure and LDL-C. | Change in blood pressure and LDL-C from baseline assessed at 6 months and 12 months. | No | |
Secondary | Cost of the intervention. | Cost of the intervention: This will include training of the community pharmacists on motivational interviews. Cost of the community pharmacist intervention in terms of time and material spent on counselling patients and establish if this can be accommodated into a daily schedule of a community pharmacy and how many sessions can one pharmacy manage per day. | 6 months | No |
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