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Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients

No phase Interventional Acute Admitted Multimorbid Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: multidisciplinary treatment.
Who it may be relevant to
Registry conditions: Acute Admitted Multimorbid Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral multidisciplinary treatment
    The pharmacist will conduct medication reconciliation at admission, perform medication reviews during the hospital stay and provide drug education to the patient before discharge, as well as written drug information

Primary outcome measures

  • Additional episodes of care [Time frame: 1, 3 and 6 months after discharge]
Secondary outcome measures (1)
  • LoS [Time frame: Periprocedural]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Poland · 1 center
  • Regional Hospital in Wroclaw — Wroclaw

Identifiers

NCT: NCT07159932 · KB 47O/2O23N

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗