Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines (Pharmacy care)

This study is currently recruiting participants.
Verified May 2013 by University College, London
Sponsor:
Collaborator:
Barts & The London NHS Trust
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01920009
First received: August 5, 2013
Last updated: October 24, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Behavioral: Pharmacist counselling session with a motivational interview

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Change in adherence to cardiovascular medication [ Time Frame: Change in adherence from baseline assessed at 6 months and 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood pressure and LDL-C. [ Time Frame: Change in blood pressure and LDL-C from baseline assessed at 6 months and 12 months. ] [ Designated as safety issue: No ]
  • Cost of the intervention. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Patient satisfaction/feedback on the pharmacist intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This will be assessed by semi-structured telephone interviews conducted by the research pharmacist.


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacy care group
patients in this group will receive two counseling sessions with a motivational interview.
Behavioral: Pharmacist counselling session with a motivational interview

The intervention:

The patient will be invited by the community pharmacist for two consultations the first 2 weeks after discharge and the second after 3 months.

The intervention group consultation:

Community pharmacy consultation around 2 weeks The consultation will take place in the pharmacy a face to face consultation for 20 minutes including; Motivational interview session, the pharmacists will incorporate the key motivational interview skills in their consultation "Express empathy, develop discrepancy, role with resistance, support self efficacy".

The sessions will aim to develop a partnership between the pharmacist with the patient and exchange information to facilitate an informed decision. Furthermore both the pharmacist and the patient will negotiate behaviour and reach an agreement. The goal is to access motivation and elicit commitment to change behaviour "in this case would be adherence to life saving medication"

Other Names:
  • Two counseling sessions including a motivational interview
  • Medication usage review session including a motivational interview
  • New medicine service session including a motivational interview
No Intervention: Controlgroup
patients in this group will receive usual care by pharmacists

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920009

Contacts
Contact: Zahraa Mohammedali Jalal, Msc. 07732051082 zahraa.ali.11@ucl.ac.uk

Locations
United Kingdom
The London Chest Hospital Recruiting
London, United Kingdom, E2 9JX
Contact: Sotiris Antoniou, MSc.         
Principal Investigator: Consultant Pharmacist Sotiris Antoniou, MSc.         
Principal Investigator: Pharmacist Zahraa Mohammedali Jalal, MSc.         
Sub-Investigator: University of Buckingham Katherine Finlay, Dr.         
Sub-Investigator: Mr.Hemant Patel North- East London Local Pharmaceutical Committee         
Sponsors and Collaborators
University College, London
Barts & The London NHS Trust
Investigators
Study Director: Felicity Smith, Professor UCL-School of Pharmacy
Study Chair: David Taylor, Professor UCL-School of Pharmacy
Principal Investigator: Consultant Pharmacist Sotiris Antoniou Barts & The London NHS Trust
  More Information

Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01920009     History of Changes
Other Study ID Numbers: 13/0064
Study First Received: August 5, 2013
Last Updated: October 24, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
pharmacy care
adherence
coronary heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014