NCT04617340

Brief Summary

A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
827

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

October 29, 2020

Last Update Submit

April 11, 2025

Conditions

Keywords

Older patientsInappropriate prescribingClinical pharmacy

Outcome Measures

Primary Outcomes (1)

  • Time to all-cause unplanned hospital visit after discharge.

    An unplanned hospital visit is defined as an unplanned hospital admission or an emergency department visit

    up to six months after discharge

Secondary Outcomes (12)

  • General practitioners contacts

    Up to six months after discharge

  • Mortality

    Up to six months after discharge

  • Other types of hospital visits

    Up to six months after discharge

  • Drug-related readmissions

    Up to six months after discharge

  • Fall incidents

    Up to one month after discharge

  • +7 more secondary outcomes

Study Arms (2)

Usual care group

NO INTERVENTION

No pharmacist will be actively involved in the medication review, counseling or discharge and post-discharge procedure. In both groups the best possible preadmission drug list will be compiled for inpatients within 72 hours after admission to the geriatric ward. If potentially dangerous or life-threatening drug errors are observed in the usual care group, this will be communicated to the treating physician

Intervention group

EXPERIMENTAL

The clinical pharmacist-collaborative service in the intervention group comprises six steps based on the clinical pharmacy intervention proposal of Van der Linden et al (Drugs Aging 2020). The first three steps focus on optimizing the drug therapy of geriatric inpatients. The remaining steps target a safe transition from the hospital to the community.

Other: Multifaceted clinical pharmacy intervention

Interventions

1. Assessing patient and caregiver preferences 2. Medication reconciliation on admission 3. Performing a comprehensive medication review before discharge 4. Promoting safe transition 4.a. Compiling a patient friendly medication list 4.b.Optimizing communication with healthcare providers in primary care: 4.b.i.Providing a copy of the medication list for the community pharmacist 4.b.ii. Contacting the general practitioner by phone 4.b.iii. Contacting, if applicable the home care nurse or the nurse from the nursing home by phone. 5.A motivation interview will take place before discharge with patients and caregivers 6.Post-discharge follow-up: 6.a.Follow-up call to discuss potential drug therapy issues, therapy adherence and to resolve any pending issues 6.b.A telepharmacology service will be provided to primary healthcare professionals as a means to consult the ward-based clinical pharmacists and/or research team after discharge.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to one of the study wards under supervision of a geriatrician
  • A written informed consent by the patient or his/her representative
  • Discharged from the hospital

You may not qualify if:

  • Admitted for a maximum of one day
  • Unable to understand Dutch
  • Being in a palliative stage as stated in their medical record with active withdrawal of drug therapy
  • Patients being discharged to another ward within the same hospital or to another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (3)

  • Van der Linden L, Hias J, Walgraeve K, Flamaing J, Tournoy J, Spriet I. Clinical Pharmacy Services in Older Inpatients: An Evidence-Based Review. Drugs Aging. 2020 Mar;37(3):161-174. doi: 10.1007/s40266-019-00733-1.

    PMID: 31919802BACKGROUND
  • Hellemans L, Blocquiaux L, Hias J, Walgraeve K, Liesenborghs A, Lammens A, Deschodt M, Tournoy J, Van der Linden L. Effect of a Multifaceted Pharmacist-Led Intervention on Medication Appropriateness and Medication Burden in Patients Admitted to an Acute Geriatric Ward: Results from the ASPIRE Trial. Drugs Aging. 2026 Jan 31. doi: 10.1007/s40266-026-01278-w. Online ahead of print.

  • Hias J, Hellemans L, Laenen A, Walgraeve K, Liesenborghs A, De Geest S, Luyten J, Spriet I, Flamaing J, Van der Linden L, Tournoy J. The effect of a trAnSitional Pharmacist Intervention in geRiatric inpatients on hospital visits after dischargE (ASPIRE): Protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Aug;119:106853. doi: 10.1016/j.cct.2022.106853. Epub 2022 Jul 14.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Jos Tournoy, prof

    Department of Public Health and Primary care, KU Leuven, Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 5, 2020

Study Start

February 25, 2021

Primary Completion

September 27, 2024

Study Completion

September 27, 2024

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

IPD will not be made available publicly due to privacy or ethical restrictions, but data that support the findings of this study will be available upon reasonable request

Locations