Coronary Heart DiseasePharmacycareNCT01920009
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
A study testing Pharmacist counselling session with a motivational interview in people with Coronary Heart Disease, run by University College, London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Pharmacist counselling session with a motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Coronary Heart Disease
- Being tested
- Pharmacist counselling session with a motivational interview
- Keywords
- pharmacy care, adherence, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist counselling session with a motivational interviewBehavioural
Also called Two counseling sessions including a motivational interview, Medication usage review session including a motivational interview, New medicine service session including 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"
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy care group | Active comparator | patients in this group will receive two counseling sessions with a motivational interview. Receives: Behavioral: Pharmacist counselling session with a motivational interview |
| Controlgroup | No intervention | patients in this group will receive usual care by pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to cardiovascular medication
Measured: Change in adherence from baseline assessed at 6 months and 12 months.
Secondary outcomes (2)
Change in blood pressure and LDL-C.
Measured: Change in blood pressure and LDL-C from baseline assessed at 6 months and 12 months.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Felicity Smith, Professor, Study director, UCL-School of PharmacyDavid Taylor, Professor, Study chair, UCL-School of PharmacyConsultant Pharmacist Sotiris Antoniou, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920009
- Sponsor's protocol ID
- 13/0064
- Acronym
- Pharmacycare
- Status last verified
- Apr 2015
- First submitted
- 5 Aug 2013
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19707097Jackevicius 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.
PubMed 18299512Gupta 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.
PubMed 16801466M 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.
PubMed 31156861
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01920009
- Acronym / sponsor ID
- Pharmacycare / 13/0064
- Conditions
- Coronary Heart Disease
- Keywords
- pharmacy care, adherence, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacy care group | Active comparator | Behavioral: Pharmacist counselling session with a motivational interviewpatients in this group will receive two counseling sessions with a motivational interview. |
| Controlgroup | No intervention | –patients in this group will receive usual care by pharmacists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist counselling session with a motivational interviewAlso: Two counseling sessions including a motivational interview, Medication usage review session including a motivational interview, New medicine service session including a motivational interviewThe 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" | Behavioural | Pharmacy care group |
Primary outcome
Change in adherence to cardiovascular medication
Time frame: Change in adherence from baseline assessed at 6 months and 12 months.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Background: PubMed 19707097Garavalia 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.
- Background: PubMed 18299512Jackevicius 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.
- Background: PubMed 16801466Gupta 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.
- Derived from this study: PubMed 31156861M 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicity Smith, Professor study director
UCL-School of Pharmacy
David Taylor, Professor study chair
UCL-School of Pharmacy
Consultant Pharmacist Sotiris Antoniou principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist counselling session with a motivational interview in people with Coronary Heart Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to cardiovascular medication (time frame: Change in adherence from baseline assessed at 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920009, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.