Rationalisation of Polypharmacy by the RASP-instrument and Discharge Counselling of Geriatric Inpatients

Rationalisation of Polypharmacy by the RASP-instrument (Rationalisation of Home Medication by an Adjusted STOPP-list and Discharge Counselling of Geriatric Inpatients: a Prospective, Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Polypharmacy
• Intervention / Treatment: Procedure: Medication review and discharge counseling

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZLeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; In the monocentric interventional part of the study, the effect of discharge counseling on the acceptance of pharmacotherapeutic recommendations will be evaluated 1 and 3 months after discharge.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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
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
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.
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.
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.
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.
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
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
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
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
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)
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.
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
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Julie Hias, Pharm D, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: S59694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No