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Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

2019年6月4日 更新者:Tim Emil Vejborg、Region Hovedstadens Apotek

Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.

Objective:

The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy increases patient satisfaction and sense of security regarding drug treatment after hospital discharge.

研究概览

地位

完全的

详细说明

Method and design:

This study was estimated to include 250 participants in a clinical randomized controlled trial. The participants were included from the Acute Medical Ward and the Department of Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized to one of two groups with unequal sizes: the control (50 participants) or intervention group (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25. The control group received the normal care following the Danish standard procedure. Participants in the intervention group also received the normal care but was also offered the possibility to contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Data for the primary outcome measures was collected 14 days after discharge through structured phone interviews. An interview guide with a semi-structured questionnaire and already validated questions were developed, pre-tested and optimized. The participants were asked to answer open-ended questions, closed-ended question and rate statements or questions on a five-point scale.

The participants in the control group were asked to answer 13 items (seven questions or statements on a five-point scale, four closed-ended questions and two open-ended questions).

The participants in the intervention group who did not make any queries were asked the same questions as the participants in the control group and additionally three closed-ended questions. A total of 16 items.

The participants in the intervention group who made queries were asked the same questions as the participants in the intervention group who did not make any queries and additionally five questions on a five-point scale, four closed-ended and one open-ended question. A total of 27 items.

The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical assessment in which it was assessed whether the drug counseling had potentially prevented a drug-related problem.

Quantitative data from the phone interviews will be analyzed in Microsoft excel with descriptive statistics and simple parametric statistics. An analysis will determine whether there is a difference in the primary outcome measures.

研究类型

介入性

注册 (实际的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • København NV
      • Copenhagen、København NV、丹麦、2400
        • Capital Regions Hospital Pharmacy

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients discharged from the acute medical ward and department of respiratory medicine at Bispebjerg Hospital.
  • Patients discharged to own home.
  • Can speak the danish language.
  • ≥18 years old.
  • Can be contacted by phone.

Exclusion Criteria:

  • Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other barriers that unable the participant to use the intervention service.
  • Patient does not answer phone within five attempts on five different days, when trying to conduct patient interview.
  • Cognitive and communicative problems that unable the participant to answer questions in the patient interview.
  • Deceased or readmitted before patient interview.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control group
Participants in the control group received the normal care following the Danish standard procedure.
有源比较器:Intervention group
Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sense of security regarding drug treatment and satisfaction with drug counseling.
大体时间:2-4 weeks after discharge.
The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.
2-4 weeks after discharge.

次要结果测量

结果测量
措施说明
大体时间
Number of medications by admission.
大体时间:Within one week after discharge.
Number of medications will be read in admission report.
Within one week after discharge.
Number of medications by discharge.
大体时间:Within one week after discharge.
Number of medications will be read in discharge report..
Within one week after discharge.
Number of patients that received medication review by pharmacist during admission.
大体时间:Within one week after discharge.
The patient's journal will be searched for a medication review.
Within one week after discharge.
Number of patients that received help with medication at home after discharge.
大体时间:Within one week after discharge.
The patient's journal will be searched for information regarding help with medication at home.
Within one week after discharge.
Number of enquiries.
大体时间:Directly after the patient received drug counseling.
Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.
Directly after the patient received drug counseling.
Number of potentially prevented drug-related problems.
大体时间:Directly after the patient received drug counseling.
The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.
Directly after the patient received drug counseling.
Cause of hospitalization.
大体时间:Within one week after discharge.
The patient's journal will be searched for cause of hospitalization.
Within one week after discharge.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tim E Vejborg, M.Sc.Pharm、Region Hovedstadens Apotek

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年7月12日

初级完成 (实际的)

2019年6月3日

研究完成 (实际的)

2019年6月3日

研究注册日期

首次提交

2019年1月22日

首先提交符合 QC 标准的

2019年2月1日

首次发布 (实际的)

2019年2月4日

研究记录更新

最后更新发布 (实际的)

2019年6月5日

上次提交的符合 QC 标准的更新

2019年6月4日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • H-18003889

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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