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

Drug-Related Side Effects and Adverse Reactions Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04617340
• Other study ID #: S64758
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 827
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• Multifaceted clinical pharmacy intervention
Assessing patient and caregiver preferences Medication reconciliation on admission Performing a comprehensive medication review before discharge 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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	General practitioners contacts	Number of general practitioners contacts	Up to six months after discharge
Secondary	Mortality	Death date	Up to six months after discharge
Secondary	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
Secondary	Drug-related readmissions	Number of drug related readmissions	Up to six months after discharge
Secondary	Fall incidents	Number of falls	Up to one month after discharge
Secondary	Patient reported drug related problems	Number of drug related problems	Up to one month after discharge
Secondary	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
Secondary	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
Secondary	Medications	Number of medications	On admission, at discharge and one month after discharge
Secondary	Medication adherence	BAASIS tool	On admission and one month after discharge
Secondary	Potentially inappropriate medications	RASP tool	On admission, at discharge and one month after discharge
Secondary	Cost-effectiveness	Healthcare related costs and Medicine productivity costs	Up to six months after discharge