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

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.

Figure 1

Trial protocol overview. ACS: Acute Coronary Syndrome; dHMR: Directed Home Medicines Review; GP: General Practitioner; AP: Accredited Pharmacist.

Figure 2

Summary of the Lemmens et al. framework [28]. This representation of the 'Evaluation model for disease-management programs' has been adjusted slightly from the originally produced model to better reflect the points of the framework that we consider relevant to the HMR service (shown in further detail through Figure 3). It is important to recognize that this framework highlights the importance of considering patient-related factors, professional-related factors, and health-system factors in both the design and evaluation of interventions targeted toward improving the management of chronic diseases. These considerations have been particularly important throughout the development of this trial.

Figure 3

How the proposed dHMR service addresses the specific components of the Lemmens et al. framework [28]. ACS: Acute Coronary Syndrome; dHMR: Directed Home Medicines Review; GP: General Practitioner; QOL: Quality Of Life. The blue text highlights the areas of the framework where we are investigating the effect of a dHMR with specific detail provided for clarification.

Figure 4

Evaluation of the professional-focused components of the intervention [28]. The blue text in this figure highlights where the professional focused components of the intervention fit into the Lemmens et al. framework. dHMR: Directed Home Medicines Review.

Figure 5

Evaluation of the health system's impact on the implementation of the intervention [28]. The blue text in this figure highlights how the local health-system structure may affect the implementation of the intervention described within this trial protocol. Again, the relevant points raised by the Lemmens et al. framework have been considered. dHMR: Directed Home Medicines Review.

Figure 6

Evaluation of the patient focused component of the intervention [28,40,49-54]. This figure highlights the comprehensive evaluation that we have designed for the patient-focused component of the intervention. IPQ: Illness Perception Questionnaire; PHRQ: Perceived Health Risk Questionnaire; BMQ: Beliefs About Medicines Questionnaire; TABS: Tool for Adherence Behavior Screening; MPR: Medication Possession Ratio.