Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines (Pharmacycare)
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|ClinicalTrials.gov Identifier: NCT01920009|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : May 1, 2015
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.
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.
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.
Both quantitative and qualitative data analysis will be performed.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Behavioral: Pharmacist counselling session with a motivational interview||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||November 2014|
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 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"
No Intervention: Controlgroup
patients in this group will receive usual care by pharmacists
- Change in adherence to cardiovascular medication [ Time Frame: Change in adherence from baseline assessed at 6 months and 12 months. ]
- 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. ]
- Cost of the intervention. [ Time Frame: 6 months ]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.
- Patient satisfaction/feedback on the pharmacist intervention [ Time Frame: 6 months ]This will be assessed by semi-structured telephone interviews conducted by the research pharmacist.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920009
|The London Chest Hospital|
|London, United Kingdom, E2 9JX|
|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|