Clinical trial NCT01920009: Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
Official title: Feasibility and Potential Impact of Community Pharmacy Care Including Motivational Interviews on Adherence to Secondary Prevention Medication in Patients With Coronary Heart Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: pharmacy care
adherence
coronary heart disease
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2013-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in adherence to cardiovascular medication
timeFrame: Change in adherence from baseline assessed at 6 months and 12 months.
Secondary outcomes:
measure: Change in blood pressure and LDL-C.
timeFrame: Change in blood pressure and LDL-C from baseline assessed at 6 months and 12 months.
measure: Cost of the intervention.
timeFrame: 6 months
Other outcomes:
measure: Patient satisfaction/feedback on the pharmacist intervention
timeFrame: 6 months
Locations:
city: London
country: United Kingdom
facility: The London Chest Hospital
Study officials:
affiliation: UCL-School of Pharmacy
name: Felicity Smith, Professor
role: STUDY_DIRECTOR
affiliation: UCL-School of Pharmacy
name: David Taylor, Professor
role: STUDY_CHAIR
affiliation: Barts & The London NHS Trust
name: Consultant Pharmacist Sotiris Antoniou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Gupta M, Singh N, Verma S. South Asians and cardiovascular risk: what clinicians should know. Circulation. 2006 Jun 27;113(25):e924-9. doi: 10.1161/CIRCULATIONAHA.105.583815. No abstract available.
citation: M A Jalal ZS, Smith F, Taylor D, Finlay K, Patel H, Antoniou S. Impact of pharmacy care upon adherence to cardiovascular medicines: a feasibility pilot controlled trial. Eur J Hosp Pharm. 2016 Sep;23(5):250-256. doi: 10.1136/ejhpharm-2015-000790. Epub 2016 Feb 2.