Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT07159932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients
Sponsor:
Wroclaw Medical University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PL-IMM
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: