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临床试验/NCT07159932
NCT07159932尚未招募不适用

Poland Integrated Medicines Management (PL-IMM) - Randomized Controlled Trial Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients in the Polish Healthcare System

Wroclaw Medical University2 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
610
试验地点
2
主要终点
Additional episodes of care

研究概览

简要总结

The aim of the study is to assess whether the involvement of a clinical pharmacist in patient care at every stage of hospitalization, from admission to discharge, will improve the quality of healthcare services provided in clinical and economic terms. As part of the research study, we will randomly assign you to two different groups.

Within one group, a pharmacist will be involved in the process of caring for you throughout your hospital stay. The pharmacist will participate in medical rounds, verify medications upon admission to the hospital, check current test results and medical orders regarding pharmacotherapy, verify medications upon discharge and provide advice on the use of medications. All activities will be carried out in consultation with other medical staff. The aim is to check whether such a model of patient care increases safety and leads to improved pharmacotherapy for patients, and also has a positive effect on patient satisfaction and compliance with therapeutic recommendations. Additionally, the opinion of the medical staff and the economic aspects of this solution will be assessed. Within the second group, you will receive standard care offered by the hospital. In the case of both groups, after the hospitalization is completed, the pharmacist will contact you after 1, 3, 6 months to verify your health condition - he or she will ask about any hospitalizations, complications, side effects, and additional visits to the doctor.

详细描述

Despite the benefits of clinical pharmacy services demonstrated in numerous publications and their implementation in many countries around the world, Poland has still not achieved nationwide implementation. There is also a lack of scientific data at the national level showing the benefits of including a pharmacist in the patient facing activities. Therefore, this RCT aimes to determine if pharmacist input at each stage of hospitalization, from admission to discharge, can result in an enhanced level of patient care when compared to standard care as measured by a number of clinical and economic outcomes. Given the aforementioned, the objective of this research is to:

  1. Primary outcome: Determine the incidence of hospital, emergency department and other unscheduled visits after discharge from hospital during the 6 months follow-up period.
  2. Secondary outcome: Assess the length of stay (LoS) in hospital.
  3. Additional outcomes:
  • Evaluate the service by determining the frequency and type of interventions performed, their acceptance and influence on the quality of pharmacotherapy.
  • Assess the perception of the service by patients.
  • Assess the perception of the service by healthcare professionals.
  • Estimate the potential financial benefits of the service.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients meeting the following inclusion criteria:
  • ≥18 years old and an acute admission to the hospital fulfilling at least one of the following criteria:
  • taking ≥4 medicines
  • taking high risk medicines listed in the medicines reconciliation standard of Polish Society of Clinical Pharmacy (….)
  • medicine related admission to the hospital within last 12 months
  • chronic kidney or liver disease
  • after solid organ transplantation

排除标准

  • age below 18 years old
  • pregnancy
  • resident of long-term care facility
  • unable to express informed consent to participate in the research
  • expected survival less than 6 months

结局指标

主要结局

Additional episodes of care

时间窗: 1, 3 and 6 months after discharge

incidence of hospital, emergency department and other unscheduled visits after discharge from hospital during the 6 months follow-up period

次要结局

  • LoS(Periprocedural)

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kamila Urbańczyk

MPharm

Wroclaw Medical University

研究点 (2)

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