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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted clinical pharmacy intervention | Other |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General practitioners contacts | Number of general practitioners contacts | Up to six months after discharge |
| Mortality | Death date | Up to six months after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jos Tournoy, prof | Department of Public Health and Primary care, KU Leuven, Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31919802 | Background | 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. | |
| 41619153 | Derived | 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. |
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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
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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Randomized controlled trial
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| Other types of hospital visits | Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions | Up to six months after discharge |
| Drug-related readmissions | Number of drug related readmissions | Up to six months after discharge |
| Fall incidents | Number of falls | Up to one month after discharge |
| Patient reported drug related problems | Number of drug related problems | Up to one month after discharge |
| 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) | on admission, one month after discharge and six months after discharge |
| Differences in pain | Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain | Up to one month after discharge |
| Medications | Number of medications | On admission, at discharge and one month after discharge |
| Medication adherence | BAASIS tool | On admission and one month after discharge |
| Potentially inappropriate medications | RASP tool | On admission, at discharge and one month after discharge |
| Cost-effectiveness | Healthcare related costs and Medicine productivity costs | Up to six months after discharge |
| 35842106 | Derived | 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. |