Regional Hospital in Wroclaw
Wroclaw, 51 124, Poland
Not Yet Recruiting
NCT Number: NCT07159932
Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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:
- Primary outcome: Determine the incidence of hospital, emergency department and other unscheduled visits after discharge from hospital during the 6 months follow-up period.
- Secondary outcome: Assess the length of stay (LoS) in hospital.
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
multidisciplinary treatment
BehavioralThe 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 outcomes
-
Additional episodes of care
Time frame: 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
Secondary outcomes
-
LoS
Time frame: Periprocedural
the length of stay (LoS) in hospital
Other outcomes
-
Interventions
Time frame: Periprocedural
Evaluation of the service by determining the type of interventions performed based on classification of French Society of Clinical Pharmacy
-
Economy
Time frame: from first patient enrollment at hospital admission until the end of 6 month follow-up period of the last patient enrolled
Estimation of the potential financial benefits of the service
-
Patient opinion
Time frame: at hospital discharge before patient begins the 6 month follow-up period
The perception of the service by patients based on PSPSQ 2.0 questionnaire
-
Healthcare team opinion
Time frame: during the patient's 6 month follow-up period
The perception of the service by healthcare professionals based on questionnaire prepared by research team
-
Quality of pharmacotherapy
Time frame: Periprocedural
Assessment of quality of pharmacotherapy using PC-MAI
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Wroclaw Medical University
Other
Registry information
Official study 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
Acronym: PL-IMM
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Sep 8, 2025
- Registry last updated
- Sep 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.