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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07159932
Acronym
PL-IMM
Enrollment
610
Registered
2025-09-08
Start date
2026-01-01
Completion date
2027-12-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Admitted Multimorbid Patients

Keywords

clinical pharmacy, integrated medicines managment, pharmacist interventions, clinical pharmacy services, medicines management, transfer of care, medicines review, medicines reconcilliation, patient education

Brief summary

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

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

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Additional episodes of care1, 3 and 6 months after dischargeincidence of hospital, emergency department and other unscheduled visits after discharge from hospital during the 6 months follow-up period

Secondary

MeasureTime frameDescription
LoSPeriproceduralthe length of stay (LoS) in hospital

Other

MeasureTime frameDescription
Patient opinionat hospital discharge before patient begins the 6 month follow-up periodThe perception of the service by patients based on PSPSQ 2.0 questionnaire
InterventionsPeriproceduralEvaluation of the service by determining the type of interventions performed based on classification of French Society of Clinical Pharmacy
Quality of pharmacotherapyPeriproceduralAssessment of quality of pharmacotherapy using PC-MAI
Healthcare team opinionduring the patient's 6 month follow-up periodThe perception of the service by healthcare professionals based on questionnaire prepared by research team
Economyfrom first patient enrollment at hospital admission until the end of 6 month follow-up period of the last patient enrolledEstimation of the potential financial benefits of the service

Countries

Poland

Contacts

Primary ContactKamila Urbańczyk, MPharm
kamila.urbanczyk@umw.edu.pl0048 71 32 70 427

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026