Open Access Study protocol

Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

Daniel DL Bernal1*, Leanne Stafford1, Luke RE Bereznicki1, Ronald L Castelino1, Patricia M Davidson2 and Gregory M Peterson1

Author Affiliations

1 Unit for Medication Outcomes Research and Education (UMORE), School of Pharmacy, University of Tasmania (UTAS), Sandy Bay Campus, Tasmania 7001, Australia

2 Centre for Cardiovascular and Chronic Care, Faculty of Nursing, Midwifery and Health, University of Technology Sydney (UTS), Sydney 2007, Australia

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Trials 2012, 13:30  doi:10.1186/1745-6215-13-30

Published: 2 April 2012

Abstract

Background

Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service.

Methods/Design

We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality.

Discussion

As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible limitations to the success of the trial intervention include general practitioner approval of the intervention, general practitioner acceptance of pharmacists' recommendations, and pharmacists' ability to make appropriate recommendations. A detailed monitoring process will detect any barriers to the success of the trial. Given that poor medication persistence following acute coronary syndrome is a worldwide problem, the findings of our study may have international implications for the care of this patient group.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12611000452998

Keywords:
Acute coronary syndrome; Home medicines review; Medication adherence