Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya, Central, Sri Lanka
South Asian Clinical Toxicology Research Collaboration (SACTRC), Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
BMJ Open. 2023 Feb 9;13(2):e059413. doi: 10.1136/bmjopen-2021-059413.
Ensuring quality use of medicines (QUM) through clinical pharmacy services can improve therapeutic outcomes of patients diagnosed with acute coronary syndrome (ACS). The major objective of this study is to demonstrate the added value of a clinical pharmacist to the medical and nursing team providing care to patients with ACS on the continuation of quality use of the patients' medicine after discharge.
This protocol outlines a prospective, non-blinded, non-randomised, controlled interventional study.
The study will be conducted at the professorial medical wards of a tertiary care teaching hospital in Sri Lanka.
Sample size will be 746 patients in both control and intervention arms. Patients diagnosed with ACS who are 18 years old or above and expected to visit the hospital for their routine clinic follow-ups after discharge will be recruited and randomised 1:1 to either the intervention group or the control group. Patients who are diagnosed and suffering from psychological disorders will be excluded from this study.
The planned interventions that will be delivered at discharge include review and optimisation of medications, assessing patient adherence and providing discharge medication counselling. Data will be collected at recruitment, 1 month, 3 months and 6 months' time intervals in both groups. Improvement of patients' medication adherence, reduction of hospital readmissions, reduction of drug-related problems, the attitude of doctors and nurses towards clinical pharmacy services and the cost-effectiveness of the clinical pharmacy services will be the major outcomes of this study.
Ethical approval for this study has been obtained from the ethics review committee, Faculty of Medicine, University of Peradeniya (2019/EC/26) and the trial is registered at the Sri Lanka Clinical Trials Registry. The results of this study will be disseminated via conference proceedings, journal publications and thesis presentations.
SLCTR/2019/039.
通过临床药学服务确保药品的合理使用（QUM）可以改善急性冠状动脉综合征（ACS）患者的治疗效果。本研究的主要目的是展示临床药师对医疗和护理团队在患者出院后继续合理使用患者药物方面的附加价值，为 ACS 患者提供护理。
本方案概述了一项前瞻性、非盲、非随机、对照干预研究。
该研究将在斯里兰卡一家三级护理教学医院的教授级医疗病房进行。
对照组和干预组各有 746 名患者。将招募年龄在 18 岁及以上、预计在出院后到医院进行常规门诊随访的 ACS 确诊患者，并将其随机分为干预组和对照组，每组各 373 名。本研究将排除诊断为心理障碍并正在接受治疗的患者。
出院时计划实施的干预措施包括审查和优化药物、评估患者的依从性并提供出院药物咨询。将在招募时、第 1 个月、第 3 个月和第 6 个月收集两组的数据。该研究的主要结果是患者药物依从性的提高、住院再入院率的降低、药物相关问题的减少、医生和护士对临床药学服务的态度以及临床药学服务的成本效益。
这项研究已获得佩拉德尼亚大学医学院伦理审查委员会的伦理批准（2019/EC/26），试验已在斯里兰卡临床试验注册处注册。本研究的结果将通过会议论文集、期刊发表和论文演讲等方式进行传播。
SLCTR/2019/039。
