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临床试验/NCT01115608
NCT01115608已完成不适用

Development of a Standardized Clinical Pharmacist Service for Patients Discharged From Hospital. Measurement of Drug Prescribing Quality in Secondary Prevention of Coronary Heart Disease Utilizing a Medication Assessment Tool (MAT-CHDsp)

Hospital Pharmacy of North Norway Trust2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
2
主要终点
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)

研究概览

简要总结

Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls.

Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P < 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients.

No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.

详细描述

Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • established coronary heart disease
  • age 18 - 80 years
  • patients living in the three nearby communities Tromsoe, Balsfjord and Karlsoey, this because they need to see the pharmacist personally.

排除标准

  • patients living in nursing homes
  • patients included in NORstent, another trial including patients at the same department
  • patients already receiving pharmaceutical follow-up elsewhere
  • cancer patients

结局指标

主要结局

Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)

时间窗: After one year (both arms)

MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.

次要结局

  • Hospitalisation(After one year)
  • Drug related problems(At inclusion, after three months and after one year.)

研究者

发起方
Hospital Pharmacy of North Norway Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beate Hennie Garcia, PhD

Associate Professor

Hospital Pharmacy of North Norway Trust

研究点 (2)

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