Dataset Information

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.

SUBMITTER: Bernal DD

PROVIDER: S-EPMC3349589 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Bernal Daniel D L DD Stafford Leanne L Bereznicki Luke R E LR Castelino Ronald L RL Davidson Patricia M PM Peterson Gregory M GM

Trials 20120402

<h4>Background</h4>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 lette ...[more]

PMID: 22463733

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Project description:Introduction: Exercise training with well-known health benefits is a key element in the self-management of coronary artery disease (CAD). Although current guidelines for patients with CAD recommend daily exercise training, most of the patients do not follow the guidelines. We tested the hypothesis that an exercise training program guided by a novel technology used at home will improve adherence to exercise training. Methods: One to three weeks after percutaneous coronary intervention (PCI), acute coronary syndrome patients (n = 50) were randomized into traditional (age 65 ± 8 years) and novel technology-guided (age 60 ± 8 years) exercise rehabilitation groups. The novel technology included a tablet computer with a virtual autonomous physiotherapy agent (VAPA group) for every patient at home; it was used to guide exercise training time, volume, and intensity. Traditional rehabilitation was performed by exercise training prescriptions, phone calls, and diaries (control group). The duration of the rehabilitation program was 6 months for both groups. Exercise capacity and 24-h heart rate variability were measured at baseline and at the end of the program. Adherence to exercise was measured over 6 months as the percentage of realized training. Results: None of the patients dropped out from the VAPA group, while three patients dropped out from the control group. Adherence to exercise was higher in the VAPA group than in the control group for resistance training (141% ± 56% vs. 50% ± 20%, p < 0.0001), and there were no differences between the groups for aerobic training (144% ± 45% vs. 119% ± 65%, p = 0.22). Exercise capacity increased in both the groups (time p < 0.001, time × group interaction p = ns). High-frequency power of R-R intervals (lnHF) increased in the VAPA group but remained unchanged in the control group (natural logarithm of lnHF power from 5.5 ± 0.7 to 5.8 ± 0.9 ms2 and from 5.3 ± 0.8 to 5.2 ± 0.7 ms2, respectively, time × group interaction p = 0.014). Conclusion: Compared with the use of traditional methods, the use of novel technology at home results in better adherence to exercise, particularly in resistance training, in acute coronary syndrome patients. Second, the VAPA group showed improved cardiac vagal regulation, documented by increased vagally mediated R-R interval fluctuation, compared with the traditional training group (ClinicalTrials.gov identifier: NCT03704025).

Project description:BackgroundDrug-eluting stents (DES) are increasingly used for treatment of acute coronary syndrome (ACS). However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.MethodsA search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs) which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES]) versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES]) in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.ResultA total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR] = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09). However, the rate of target lesion revascularization (TLR) significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005). There were no significant differences in the incidence of major adverse cardiac events (MACEs), all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10). The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06) and a beneficial effect on reducing stent thrombosis episodes (p = 0.009), while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02) and TLR (p = 0.003).ConclusionSecond-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary interventional therapy, DES class should be adequately considered in order to maximize clinical benefit of DES implantation in these specific subjects.

Project description:Inconsistent results exist regarding the treatment effectiveness of immediate versus deferred percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). This meta-analysis aimed to evaluate the efficacy and safety of immediate versus deferred PCI in ACS patients. PubMed, EMBASE, and Cochrane Library electronic databases were systematically searched from their inception up to August 2019. Random-effects models were employed to calculate pooled relative risks (RRs) and weight mean differences (WMDs) with 95% confidence intervals (CIs). A total of 10 randomized controlled trials (RCTs) that recruited 3350 patients were selected for inclusion in the final meta-analysis. Four trials included patients with non-ST elevation ACS (NSTEACS), whereas the remaining six trials included patients with ST elevation myocardial infarction (STEMI). There were no significant differences between immediate versus deferred PCI for the risk of major adverse cardiovascular events (NSTEACS patients: RR, 0.76, 95%CI, 0.33-1.75, P = 0.513; STEMI patients: RR, 1.24, 95%CI, 0.80-1.92, P = 0.335), myocardial infarction (NSTEACS patients: RR, 0.88, 95%CI, 0.27-2.81, P = 0.826; STEMI patients: RR, 0.86, 95%CI, 0.43-1.74, P = 0.678), all-cause mortality (NSTEACS patients: RR, 0.85, 95%CI, 0.38-1.88, P = 0.686; STEMI patients: RR, 1.16, 95%CI, 0.82-1.66, P = 0.407), target vessel revascularisation (NSTEACS patients: RR, 1.26, 95%CI, 0.29-5.43, P = 0.756; STEMI patients: RR, 1.01, 95%CI, 0.51-1.97, P = 0.988), or major bleeding (NSTEACS patients: RR, 0.99, 95%CI, 0.64-1.54, P = 0.972; STEMI patients: RR, 0.90, 95%CI, 0.45-1.77, P = 0.753). Although patients who underwent immediate PCI may experience increased incidences of cardiac death (RR, 1.19, 95%CI, 0.69-2.07, P = 0.525) and no or slow reflow (RR, 1.60, 95%CI, 0.91-2.84, P = 0.105), these increases were not statistically significant. We noted that immediate versus deferred PCI was associated with a reduced incidence of myocardial brush grade 3 (RR, 0.70, 95%CI, 0.56-0.88, P = 0.002); however, no significant differences were observed between immediate and deferred PCI for TIMI III flow (RR, 0.98, 95%CI, 0.93-1.03, P = 0.453), complete ST-segment resolution (RR, 0.93, 95%CI, 0.75-1.17, P = 0.548), and ejection fraction (WMD, -1.05, 95%CI, -2.58 to 0.49, P = 0.182). The findings of this study suggested that deferred PCI did not yield significant benefits for clinical endpoints. Further large-scale RCTs should be conducted to verify the findings of this study.

Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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