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Drug-Related Side Effects and Adverse ReactionsASPIRENCT04617340

Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE

A study testing Multifaceted clinical pharmacy intervention in people with Drug-Related Side Effects and Adverse Reactions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Multifaceted clinical pharmacy intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
827 participants
Where
1 siteBelgium
Study dates
25 Feb 2021to 27 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospitals Leuven

    Leuven

Other trials in Belgium

About this study

Official title: The Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE (ASPIRE): a Randomized Controlled Trial

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

Read the detailed description

Since drug-related harm remains persistently prevalent in older adults, there is an urgent and unmet clinical need to optimize pharmacotherapy both during hospital stay and after discharge Therefore, we aim to perform a randomized controlled trial in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes. The primary objective is to reduce all-cause unplanned hospital visits in geriatric inpatients. Secondary objective are to optimize drug therapy in geriatric inpatients and improve their health; To empower and educate patients, caregivers,community pharmacists and physicians regarding drug regimen decisions to maximize therapy adherence and the understanding of the (de)prescribing process and to enhance healthy ageing; To optimize transitional care from the hospital to primary care.

Being tested
Multifaceted clinical pharmacy intervention
Keywords
Older patients, Inappropriate prescribing, Clinical pharmacy
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifaceted clinical pharmacy interventionOther

    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.

Study groups in NCT04617340
Study groupRoleWhat they receive
Usual care groupNo interventionNo 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 groupExperimentalThe 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.
Receives: Other: Multifaceted clinical pharmacy intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to six months after discharge

Secondary outcomes (12)

  1. General practitioners contacts

    Number of general practitioners contacts

    Measured: Up to six months after discharge

  2. Mortality

    Death date

    Measured: Up to six months after discharge

  3. Other types of hospital visits

    Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions

    Measured: Up to six months after discharge

  4. Drug-related readmissions

    Number of drug related readmissions

    Measured: Up to six months after discharge

  5. Fall incidents

    Number of falls

    Measured: Up to one month after discharge

  6. Patient reported drug related problems

    Number of drug related problems

    Measured: Up to one month after discharge

  7. Change in Quality of life

    five-level version of the EuroQol five-dimensional (EQ5D) descriptive system (EQ-5D-5L) questionnaire. values will be tranformed using a value set to a score from 0 - 1 (a higher score indicating a better quality of life)

    Measured: on admission, one month after discharge and six months after discharge

  8. Differences in pain

    Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain

    Measured: Up to one month after discharge

  9. Medications

    Number of medications

    Measured: On admission, at discharge and one month after discharge

  10. Medication adherence

    BAASIS tool

    Measured: On admission and one month after discharge

  11. Potentially inappropriate medications

    RASP tool

    Measured: On admission, at discharge and one month after discharge

  12. Cost-effectiveness

    Healthcare related costs and Medicine productivity costs

    Measured: Up to six months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start25 Feb 2021
  3. Primary completion27 Sep 2024
  4. Study completion27 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
827 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617340
Sponsor's protocol ID
S64758
Acronym
ASPIRE
Status last verified
Apr 2025
First submitted
29 Oct 2020
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 31919802

  • 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 Mar;43(3):293-306. doi: 10.1007/s40266-026-01278-w. Epub 2026 Jan 31.

    PubMed 41619153

  • 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.

    PubMed 35842106

Questions about this trial

What is this clinical trial studying?

A study testing Multifaceted clinical pharmacy intervention in people with Drug-Related Side Effects and Adverse Reactions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to all-cause unplanned hospital visit after discharge. (time frame: up to six months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617340, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

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