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首页> 外文期刊>Trials >Pharm-MD; an open-label, randomized controlled, phase II study to evaluate the efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients – study protocol for a randomized controlled trial
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Pharm-MD; an open-label, randomized controlled, phase II study to evaluate the efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients – study protocol for a randomized controlled trial

机译：药物-医学;一项开放标签，随机对照，II期研究，评估由药剂师管理的糖尿病诊所在高危糖尿病患者中的疗效-一项随机对照试验的研究方案

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Millions of Americans are currently living with diabetes and approximately 1.5 million cases are being diagnosed each year. Diabetes is now the seventh leading cause of death in the United States. In addition, the economic burden of the disease has resulted in billions of dollars in health care costs. In spite of these investments, the United States lags behind other developed countries on diabetes life expectancy and disease-related deaths. The purpose of this study is to assess the impact of a pharmacist-managed diabetes clinic (PMDC) model on diabetes core measures. Our hypothesis is that a PMDC would have a significant positive impact on the diabetes measures and will result in higher-quality care at a lower price. This study is a randomized, open-label, controlled, parallel-group trial which will be conducted in the outpatient clinic at Beaumont Hospital, Royal Oak, Michigan. Patients will be randomly assigned to one of two groups: standard of care (SOC) or standard of care plus PMDC (SOC?+?PMDC). Included in the study will be patients older than 18?years of age with a diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥?9%, who are established with a primary care resident and who have not been seen in the PMDC within the last 3?months. The primary outcome is the change in hemoglobin A1c, measured at 6 and 12?months. Secondary outcomes include the impact on all diabetes core measures, patient quality of life, harms, and cost impact related to the intervention. If the results of this trial are consistent with the previous retrospective analysis that a pharmacy clinic has a significant impact in controlling hemoglobin A1c levels as well as other diabetes core measures to improve clinical outcomes, it will constitute a scaffold for a future multicenter, randomized controlled trial. In addition, these results may influence future diabetes guidelines, leading to the inclusion of a PMDC as the standard of care. The impact of these results on the economic burden, life expectancy, and diabetes-related deaths are needed and have yet to be studied. ClinicalTrials.gov, ID: NCT03377127 . Protocol version: registered on 10 February 2018; version #1.
机译：当前有数百万的美国人患有糖尿病，每年被诊断出约150万例糖尿病。糖尿病现在是美国第七大死亡原因。此外，该疾病的经济负担还导致数十亿美元的医疗保健费用。尽管进行了这些投资，但美国在糖尿病的预期寿命和与疾病相关的死亡方面仍落后于其他发达国家。本研究的目的是评估药剂师管理的糖尿病诊所（PMDC）模型对糖尿病核心指标的影响。我们的假设是，PMDC将对糖尿病措施产生重大的积极影响，并将以较低的价格提供更高质量的护理。这项研究是一项随机，开放标签，对照，平行分组的试验，将在密歇根州皇家橡树市Beaumont医院的门诊进行。患者将被随机分为两组：护理标准（SOC）或护理标准加PMDC（SOC≥+ PMDC）。该研究将包括年龄在18岁以上且诊断为2型糖尿病且血红蛋白A1c≥9％的患者，这些患者是由初级保健住院医师建立的，并且未在PMDC内发现最近3个月。主要结果是在6和12个月时测得的血红蛋白A1c的变化。次要结果包括对所有糖尿病核心指标的影响，患者的生活质量，危害以及与干预措施相关的成本影响。如果该试验的结果与先前的回顾性分析一致，即药房诊所在控制血红蛋白A1c水平以及改善临床结局的其他糖尿病核心措施方面具有重大影响，则它将构成未来多中心，随机对照的支架试用。此外，这些结果可能会影响未来的糖尿病指南，导致将PMDC纳入护理标准。这些结果对经济负担，预期寿命以及与糖尿病相关的死亡的影响是需要的，尚待研究。 ClinicalTrials.gov，ID：NCT03377127。协议版本：2018年2月10日注册;版本＃1。

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