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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05816967
Other study ID # S59694
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date September 2019

Study information

Verified date April 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Systematic evaluation of polypharmacy in geriatric patients, through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). A brief counseling session with the patient and/or his/her caregiver will be part of the intervention.


Description:

This project is focused on the systematic evaluation of polypharmacy in older patients admitted to the acute geriatric wards of a university hospital. Polypharmacy will be identified through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). Before hospital discharge the hospital pharmacist will have a brief counseling session with the patient and/or his/her caregiver in order to discuss the medication list and to enhance compliance.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Informed consent by the patient and/or his/her caregiver - Admission through the emergency department of patients coming from home or a residential care facility Exclusion Criteria: - Patients not speaking Dutch - Patients admitted for end of life care - Patients not taking any drugs on admission

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Medication review and discharge counseling
Medication reconciliation of home therapy will be performed by the clinical pharmacist through a standardized form. Next, the clinical pharmacist will perform a medication review, based on but not limited to the RASP list (Van der Linden 2014). The goal is optimization of therapy. Before discharge the clinical pharmacist will perform a second medication review, together with the treating physician and a medication reconciliation in orde to provide the best possible discharge medication list. The medication list will be provided 3 times: once for the patient and/or his/her caregiver, once for the general practitioner and once for the primary care pharmacist. Finally the clinical pharmacist will have a counseling session with the patient and/or his/her caregiver.

Locations

Country Name City State
Belgium UZLeuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. 1 month (30 days) after discharge
Primary Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. 3 month (90 days) after discharge
Secondary Number of drug intakes at discharge versus at admission. Number of drug intakes at discharge versus at admission. At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Secondary Number of drugs at discharge versus at admission. Number of drugs at discharge versus at admission. At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Secondary Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list. Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list. At discharge from the index hospitalization (as mentioned in the discharge medication scheme), compared to the medication list obtained on admission (this is, during the first 72 hours of the hospitalization)
Secondary Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge At discharge from the index hospitalisation (as mentioned in the discharge medication scheme) versus on admission (medication list obtained in the first 72 hours) of the index hospitalization
Secondary Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge) Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge) On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme), 1 (30 days) month after discharge, 3 months (90 days) after discharge
Secondary Mortality during admission Mortality during admission During the index hospitalization, from admission to the emergency ward until moment of death on the geriatric ward, assessed up to 72 hours after death.
Secondary Number of falls during hospitalization Number of falls during hospitalization During the index hospitalization, from admission on the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Secondary Number of fractures during hospitalization Number of fractures during hospitalization during the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Secondary Length of stay Length of stay During the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Secondary Readmission rate 3 months after discharge Readmission rate 3 months after discharge 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Secondary Number of fractures at 3 months after discharge Number of fractures at 3 months after discharge 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Secondary Number of falls 3 months after discharge Number of falls 3 months after discharge 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Secondary Mortality at 3 months after discharge Mortality at 3 months after discharge 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Secondary Category of potentially inappropriate medications identified through the RASP list on admission and at discharge Category of potentially inappropriate medications identified through the RASP list on admission and at discharge On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme)
Secondary Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list. Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list. During the course of the index hospitalization, defined as the period between discharge from the geriatric ward and admission to the geriatric department. The outcome parameter will be assessed within 72 hours of discharge.
Secondary Number of drugs at follow-up (1 month and 3 months after discharge) Number of drugs at follow-up (1 month and 3 months after discharge) 1 month (30 days) and 3 months (90 days) after the index hospitalization
Secondary Number of drug intakes at follow-up (1 month and 3 months after discharge) Number of drug intakes at follow-up (1 month and 3 months after discharge) 1 month (30 days) and 3 months (90 days) after the index hospitalization
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