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临床试验/NCT02582463
NCT02582463已完成不适用

Development of the Medicines Optimisation Assessment Tool (MOAT) - Targeting Hospital Pharmacists' Input to Reduce Risks and Improve Patient Outcomes

University College, London1 个研究点 分布在 1 个国家目标入组 1,552 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,552
试验地点
1
主要终点
Number of MRPs experienced by study participants

研究概览

简要总结

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.

详细描述

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs).

The MOAT will be developed following recommendations of the PROGnosis RESearch Strategy (PROGRESS) partnership. A prospective cohort study of 1,500 patients will be used to develop the MOAT from the medical wards of two UK hospitals. Data will be collected on prognostic factors (selected based on a review of published literature and expert opinion) for each patient, together with details of MRPs that occur. All MRPs will be reviewed by an expert panel who will grade for severity and preventability using recognised criteria. Multivariable logistic regression models will be used to determine the relationship between potential risk factors such as polypharmacy, renal impairment, and the use of 'high risk' medicines, and the study outcome of preventable medication related problems that are at least moderate in severity. Bootstrapping will be used to adjust the MOAT for optimism, and predictive performance will be assessed using calibration and discrimination. A simplified scoring system will also be developed, which will be assessed for sensitivity and specificity.

The intention of this research is to develop a prediction-tool (the MOAT), which has the potential to be adopted widely into clinical practice. If the initial research is successful in producing a prediction-tool with good predictive performance further research will be carried out to assess how feasible it would be to use the MOAT in practice, the potential efficiency savings, and an assessment of clinical risk to patients through use of the MOAT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the study sites

排除标准

  • subject admitted for investigation-only
  • subject not prescribed medication
  • subject both admitted and subsequently discharged outside of core pharmacy working hours

结局指标

主要结局

Number of MRPs experienced by study participants

时间窗: Through study completion (discharge from hospital), an average of 6 days

The outcome measure (i.e. all MRPs) will be graded for severity and preventability, then multivariate analysis such as logistic regression models will be used to determine the relationship between predictors (prognostic factors) and the outcome (MRPs which are at least moderate in severity and preventable). The objective will be to find the best combinations of predictors that are highly sensitive for detecting the outcome measure while achieving the maximum possible specificity.

次要结局

  • Feasibility of using the MOAT (content validity and ease of use)(18 months)
  • Potential efficiency savings(18 months)
  • Potential clinical risk to patients through use of the MOAT(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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