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

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05816967
Collaborator
(none)
0
1
1
11
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medication review and discharge counseling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. [3 month (90 days) after discharge]

    Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.

Secondary Outcome Measures

  1. 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 drug intakes at discharge versus at admission.

  2. 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 at discharge versus at admission.

  3. 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)]

    Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.

  4. 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]

    Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge

  5. 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]

    Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge)

  6. 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.]

    Mortality during admission

  7. 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 falls during hospitalization

  8. 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.]

    Number of fractures during hospitalization

  9. 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.]

    Length of stay

  10. Readmission rate 3 months after discharge [3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90]

    Readmission rate 3 months after discharge

  11. 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 fractures at 3 months after discharge

  12. Number of falls 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

  13. Mortality at 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

  14. 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 potentially inappropriate medications identified through the RASP list on admission and at discharge

  15. 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.]

    Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.

  16. 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 drugs at follow-up (1 month and 3 months after discharge)

  17. 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]

    Number of drug intakes at follow-up (1 month and 3 months after discharge)

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZLeuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Julie Hias, Pharm D, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier:
NCT05816967
Other Study ID Numbers:
  • S59694
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Apr 18, 2023