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临床试验/NCT03728855
NCT03728855终止不适用

A Multicentre Study on the Effects of Self-administration of Medication During Hospitalization on Medication Safety, Adherence, and Patient Satisfaction in Dutch Hospitals

Radboud University Medical Center8 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
193
试验地点
8
主要终点
Proportion of medication administration errors

研究概览

简要总结

During hospitalization, medication administration errors (MAEs) occur daily in health care and can lead to serious harm. Improvement of medication safety is a major concern to policymakers and health care workers. Inpatient self-administration of medication (SAM) during hospital admission could be a way to reduce MAEs. Therefore the aim of this study is to determine the effect of inpatient self-administration of medication on the number of medication administration errors during hospitalization.

详细描述

Objective: the main objective of this study is to determine the effect of inpatient self-administration of medication on the number of medication administration errors during hospitalization. The secondary objectives of this study are to determine:

  1. The effect of inpatient self-administration of medication on the severity of medication administration errors during hospitalization
  2. The effect of inpatient self-administration on medication adherence after hospitalization
  3. The effect of inpatient self-administration of medication on patient satisfaction during hospitalization
  4. The effect of inpatient self-administration of medication on staff satisfaction during hospitalization

Study design: multicentre prospective quasi-experimental study with a pre-post design

Study population: hospitalized ≥ 16 years old patients

Intervention: the implementation of self-administration of medication by hospitalized patients. SAM will be compared to standard care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The subject, staff and investigators are aware of which method of medication administration the patient is given, SAM or standard care. Only the data analysis is blinded by anonymizing and coding all data. Furthermore, an independent person will perform the data analyses.

入排标准

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

入选标准

  • •All patients (≥ 16 years old) admitted to the ward who use medication or will be using medication at home after hospital discharge and are able to administer (part of) this medication themselves

排除标准

  • •Not providing informed consent
  • •The use of a medication box without original medication boxes
  • •The use of medication pre-packaged by automated dispensing system
  • •The need of homecare support to administer medication
  • •The need of an informal caretaker to help with medication administration
  • •Admitted from a nursing home and medication is under supervision of the staff
  • •Not understanding the Dutch language, written or spoken
  • •The subject is not capable of managing SAM (due to mental or physical state)

研究组 & 干预措施

Standard care

No Intervention

Based on an (electronic) order placed by a physician, nurses collect medication and provide patients with the ordered medication in a timely matter. Nurses document the administration either in an electronic medical record or on paper.

Self-administration of medication (SAM)

Experimental

During SAM medication is stocked at the patient's bedside. When medication is scheduled to be administered, patients collect those form their own stock, administer, and document the administration by themselves. Once daily nurses check whether patients succeeded in administration for all prescriptions of the last 24 hours. Each day, patients are qualified for SAM. In the case patients do not meet the criteria of SAM, they will be excluded from SAM.

干预措施: Self-administration of medication (SAM) (Behavioral)

结局指标

主要结局

Proportion of medication administration errors

时间窗: 2 weeks

The doctor's prescriptions as noted in the CPOE system will be compared to the observed medication administration and any discrepancy will be marked as an MAE. The number of erroneous medication administrations (containing 1 or more errors) will be divided by the number of observed drug administrations plus the number of omissions (concept of opportunities).

次要结局

  • Patient satisfaction during hospitalization(7 days)
  • Severity of MAEs(2 weeks)
  • Medication adherence after hospitalization(1 year)
  • Staff satisfaction(1 year)
  • Medication adherence after hospitalization(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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