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Trial registered on ANZCTR

Registration number

ACTRN12611000322932

Ethics application status

Approved

Date submitted

24/03/2011

Date registered

28/03/2011

Date last updated

20/03/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

The role of a pharmacist supporting beliefs about medications in people who have experienced a heart attack

Scientific title

Community pharmacists supporting beliefs towards medicines in patients who have experienced an episode of acute coronary syndrome compared to routine pharmacy care improves adherence to medicines; a randomised controlled trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Coronary Syndrome

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will be interviewed at one, three and six months post discharge from hospital using the repertory grid technique to identify their opinions towards their medicines.
In the intervention group, the community pharmacist will provide usual care (information on how to take their medication, the potential side effects to look out for and what to do if they arise) and also establish how participants are coping with their medicines. The usual care should take place at approximately monthly intervals when the patient collects their prescription medicines for ACS and should last for five minutes. At one, three, six and twelve months after discharge from hospital, the pharmacist will have a longer discussion (maximum 10 minutes) with the participant about the medicines they are taking, and will also support the patients’ beliefs about their medicines for acute coronary syndrome. This will be done by enforcing positive health beliefs about medications for acute coronary syndrome and discussing the patient's own health beliefs generated from the interview with the student researcher using the repertory grid technique. The community pharmacist will also review the participants ACS medications for appropriateness and monitor adherence.
The researcher utilised the repertory grid technique at one, three and six months to explore participant’s opinions towards their ACS medicines. The repertory grid component of the interview asks participants to compare and contrast between their ACS medicines to generate statements that reflect their individual opinions. Participants were presented their ACS medicines in groups of three and asked; “which two medicines are similar in some way” and “how is the third one different to the others.” This generated two opposing poles of the individual’s opinions towards their medicines. The process was repeated for different combinations of their ACS medicines, creating a list of statements reflecting their individual opinion of their medicines. The process was repeated until all combinations of their ACS medicines were exhausted or no new statements were generated. A likert scale was placed between the two poles of the generated statements and the participant rated each of their medicines against each statement. The information generated for each individual patient formed a grid of data, with their statements of opinions as the rows and their medicines as the columns.

Intervention code [1]

Behaviour

Comparator / control treatment

In the control group, when a patient presents a prescription for their ACS medicines to a community pharmacist, they will provide usual care (information on how to take their medication, the potential side effects to look out for and what to do if they arise).

Control group

Active

Outcomes

Primary outcome [1]

Improved adherence measured by Medication Adherence Reporting Scale and Medication Possession ratio.

Timepoint [1]

12 months

Secondary outcome [1]

Beliefs towards medicines and the relationship to adherence, measured by the Beliefs About Medicines Questionnaire and the Repertory Grid Technique.

Timepoint [1]

6 months and 12 months

Secondary outcome [2]

Optimised medications as assessed from dispensing history

Timepoint [2]

12 months

Eligibility

Key inclusion criteria

Admitted to hospital with an episode of acute coronary syndrome with a diagnosis of STEMI or non-STEMI

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

People whose primary language is other than English (LOTE)
Children and/or young people (ie. <18 years)
People with an intellectual or mental impairment
Aboriginal and/or Torres Strait Islander peoples
Women who are pregnant

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Potential participants will be approached in hospital by the cardiac rehabilitation nurse and asked if they
would be willing to take part in the study. If the patient is willing to take part, they will be introduced to the
student researcher who will provide them with written information about the study for them to read. After the
patient has read the information sheet, the student researcher will explain the process of the study to them
to ensure that they have understood what is required.
The researcher will have a predetermined randmoisation sequence with which to allocate the participant.
Allocation was not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Will use an Excel data base to generate a permuted block randomisation sequence to ensure equal numbers of participants in both groups.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2009

Actual

2/10/2009

Date of last participant enrolment

Anticipated

Actual

9/08/2010

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Pharmacy Board of Queensland

Address [1]

Australian Health Practitioner Regulation Agency
G.P.O. Box 9958
Brisbane
QLD 4001

Country [1]

Australia

Primary sponsor type

Individual

Name

Neil Cottrell

Address

The School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Lisa Nissen

Address [1]

The School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Alexandra Hospital Human Research Ethics Committee

Ethics committee address [1]

Princess Alexandra Hospital Health Service District
Ipswich Road
Woolloongabba
QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2009

Approval date [1]

24/08/2009

Ethics approval number [1]

HREC/09/QPAH/175

Summary

Brief summary

The purpose of this project is to determine if a patient’s belief or views towards their medicines for heart attacks affects their decision on whether to take their medicines or not. This may help determine why some people choose not to take medications for their heart attack.

Aim:
To determine if patients’ belief towards medication for heart attacks is related to an optimised medication regimen as well as adherent behaviour, and whether this is influenced by review of their medication by a community pharmacist.

Hypotheses:
1. Patients with good adherence will have different beliefs towards their medication than those with poor adherence
2. Patients receiving regular interviews with their community pharmacist are more likely to be on the appropriate medications for ACS at optimised doses and have better adherence than those who do not have this intervention.
3. Patients with beliefs in regards to their medicines that match good adherence are more likely to be taking evidence-based medicines for ACS at 12 months.

Trial website

Trial related presentations / publications

2011 December 11-14; Adelaide. CP03-1Gujral G, Winckel K, Garrahy P, Nissen L, Cottrell WN. Pharmacists reinforcing patients’ beliefs about medications to improve adherence post myocardial infarction. In: Proceedings of the Australasian Pharmaceutical Science Association Annual Conference.

2011 December 11-14; Adelaide. Gujral G, Winckel K, Garrahy P, Nissen L, Cottrell WN. Changes in medication beliefs over time in adherent and non-adherent patients post myocardial infarction. In: Proceedings of the Australasian Pharmaceutical Science Association Annual Conference.

2011 December 4-8; New Orleans. Gujral G, Winckel K, Garrahy P, Nissen L, Cottrell WN. Does promoting patients’ personal understanding about medications for acute coronary syndrome improve adherence: use of the repertory grid technique. In: Proceedings of the 46th ASHP Midyear Clinical Meeting & Exhibition. 

2011 September 6-9; Brisbane. Gujral G, Winckel K, Garrahy P, Nissen L, Cottrell WN. Does Promoting Opinions About Medications In Patients With Acute Coronary Syndrome Improve Adherence: A Randomised Controlled Trial - six month interim results. In: Proceedings of the Princess Alexandra Hospital Health Symposium.

2010 August 23-26; Lisbon. Gujral G, Winckel K, Nissen L, Cottrell WN. Beliefs towards medications for acute coronary syndrome and their relation to adherence one month after hospital discharge. In: Proceedings of the 16th International Social Pharmacy Workshop. ISBN 1886-3655

2010 May 26-28; Melbourne. Gujral G, Cottrell WN, Nissen L, Winckel K. Medication beliefs in patients with acute coronary syndrome one month after discharge from hospital - a novel interview method using the repertory grid technique. In: Proceedings of the National Medicines Symposium

2009 December 8-11; Hobart. Gujral G, Cottrell WN, Nissen L, Winckel K. Patients' understanding towards medicines in acute coronary syndrome: development of a novel interview method using the repertory grid technique. In: Proceedings of the Australasian Pharmaceutical Science Association Annual Conference. ISBN 978-0-646-52257-0.

2007 December 8-11; Manly. Gujral G, Barras M, Cottrell WN. Comparison of Self Reported Myalgia in Individuals on High and Low to Moderate Dose Statin Therapy. In: Proceedings of the Australasian Pharmaceutical Science Association Annual Conference; ISBN 978-0-646-48458-7.

Public notes

Contacts

Principal investigator

Name

A/Prof Neil Cottrell

Address

The University of Queensland Pharmacy Australia Centre of Excellence Level 4, 20 Cornwall Street Woolloongabba, QLD, 4102

Country

Australia

Phone

61 7 3346 1977

Fax

n.cottrell@uq.edu.au

Contact person for public queries

Name

Gina Gujral

Address

The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102

Country

Australia

Phone

61 7 3346 1743

Fax

61 7 3346 1999

g.gujral@uq.edu.au

Contact person for scientific queries

Name

Gina Gujral

Address

The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102

Country

Australia

Phone

61 7 3346 0610

Fax

61 7 3346 1999

g.gujral@uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Interventions to improve adherence to lipid-lowering medication.	2016	https://dx.doi.org/10.1002/14651858.CD004371.pub4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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