Clinical trial NCT04617340: Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE
Official title: The Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE (ASPIRE): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug-Related Side Effects and Adverse Reactions
Keywords: Older patients
Inappropriate prescribing
Clinical pharmacy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 827
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to all-cause unplanned hospital visit after discharge.
timeFrame: up to six months after discharge
Secondary outcomes:
measure: General practitioners contacts
timeFrame: Up to six months after discharge
measure: Mortality
timeFrame: Up to six months after discharge
measure: Other types of hospital visits
timeFrame: Up to six months after discharge
measure: Drug-related readmissions
timeFrame: Up to six months after discharge
measure: Fall incidents
timeFrame: Up to one month after discharge
measure: Patient reported drug related problems
timeFrame: Up to one month after discharge
measure: Change in Quality of life
timeFrame: on admission, one month after discharge and six months after discharge
measure: Differences in pain
timeFrame: Up to one month after discharge
measure: Medications
timeFrame: On admission, at discharge and one month after discharge
measure: Medication adherence
timeFrame: On admission and one month after discharge
measure: Potentially inappropriate medications
timeFrame: On admission, at discharge and one month after discharge
measure: Cost-effectiveness
timeFrame: Up to six months after discharge
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Department of Public Health and Primary care, KU Leuven, Leuven
name: Jos Tournoy, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.