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

NCT ID: NCT04617340

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

827 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2024-09-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Drug-Related Side Effects and Adverse Reactions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

Multifaceted clinical pharmacy intervention

Intervention Type OTHER

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.

Interventions

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Multifaceted clinical pharmacy intervention

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jos Tournoy, prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 31919802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35842106 (View on PubMed)

Other Identifiers

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S64758

Identifier Type: -

Identifier Source: org_study_id

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