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临床试验/NCT03079375
NCT03079375已完成不适用

The Impact of Pharmaceutical Medication Review, Medication Interview Before Discharge and Follow-up: A Randomized Controlled Trial

Lene V. Ravn-Nielsen0 个研究点目标入组 1,499 人开始时间: 2013年9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
1,499
主要终点
Emergency Department Visits

研究概览

简要总结

Background

It is well known that the transfer of a patient from hospital to the general practitioner is related with mistakes in the medication of the patient. A report from 2006 measure the number of drug related admissions in Denmark to be 69.000 to 162.000 per year. To reduce these mistakes, more and better communication between the health professionals are suggested. Furthermore medication reviews made by pharmacist seems to reduce the number of drug related readmissions and other drug related issues, which can lead to an economic cost reduction.

Objective

The aim of this study is to investigate the impact of medication review and better communication between the health professionals after discharge of a patient from hospital to the general practitioner. The effect is measured as reducing the number of readmissions and number of visits at the emergency department 30 days and six month after inclusion of the patient.

Method

This study was estimated to include 1500 participants. The patients were randomized to one of three groups; usual care, basic intervention or extended intervention. The usual care received the normal care following the Danish standard procedure. The basic intervention had a medication review by a clinical pharmacist during admission.

The extended interventions group was similar to the basic intervention group plus follow-up with the patient, the general practitioner and if relevant the nursing home and pharmacy one week and six month after discharge by interview with the clinical pharmacist.

详细描述

The aim of this study is to determine if a multifaceted pharmacist intervention based on medication review, medication interview and follow up with patient, general practitioner and pharmacy can reduce the number of readmissions and death and or if the time to next admission can be postponed. The combination of the full pharmacist intervention is compared with medication review alone in comparison to non-intervention.

Pharmacist intervention:

Usual care group: the patients received no intervention by the clinical pharmacist.

Basic intervention group: A structured, patient centered medication review (MR) was conducted by the clinical pharmacist. The following was considered during MR: Were there untreated diagnoses, has the goal of treatment been reached, was the treatment compliant with current national guidelines regarding dose, choice of drug and time of treatment. Focus was at certain drugs most commonly implicated in causing admission. Furthermore, all drugs on the medication list were assessed according to the following: Indication for treatment, drug dose, considering i.e. kidney insufficiency, age, etc., adverse drug events, therapeutic duplication, dosage time and interval, drug formulation and strength, interactions, contraindications, precautions and specific patient characteristics.

Advice on drug selection, dosages, monitoring needs and possibly side effects were given to the physician in charge of the patient, and written in the electronic patient journal (EPJ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

The study is double blinded. The pharmacist do not know, whether the patient is randomized to the basic or to the extended intervention before they conduct the medication review. That is why the patients in the intervention group are randomized two times.

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

  • Usual medicine of five drugs or above
  • Speak and understand Danish
  • Admitted via the Acute Medicine Admission Ward
  • Are able to give informed consent

排除标准

  • Patients included in a similar study
  • Declared terminal
  • In custody
  • Isolated at the hospital
  • Im- and/or expressive aphasia
  • Severe dementia

结局指标

主要结局

Emergency Department Visits

时间窗: 180 days

number of patients who have emergency department visits

Composite Endpoint, Admissions or Emergency Department Visits

时间窗: 180 days

number of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month

Readmissions

时间窗: 30 days

number of patients who have been readmitted

Admissions

时间窗: 180 days

number of patients who have been admitted

次要结局

  • Drug Related Mortality(180 days after the inclusion date)
  • Percentage of Medication Changes Accepted by GPs(up to 180 days)
  • Drug-related Readmissions(30 days after the inclusion date)
  • Drug-related Admissions(180 days after the inclusion date)
  • Medication Review Changes Accepted by Physicians (in Hospital)(1 month)
  • Mortality(180 days after the inclusion date)

研究者

发起方
Lene V. Ravn-Nielsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lene V. Ravn-Nielsen

Clinical pharmacist

Odense University Hospital

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