NCT05816967

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

May 24, 2022

Last Update Submit

April 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (17)

  • 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.

    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.

    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

    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)

    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

  • +12 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

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.

Intervention group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients not speaking Dutch
  • Patients admitted for end of life care
  • Patients not taking any drugs on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Julie Hias, Pharm D

    UZ Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

April 18, 2023

Study Start

October 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations