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

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.

Study Overview

• Status: Recruiting
• Conditions: Drug-Related Side Effects and Adverse Reactions
• Intervention / Treatment: Other: Multifaceted clinical pharmacy intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 828
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Hias, PharmD; Phone Number: +3216343080; Email: julie.1.hias@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • University Hospitals Leuven
    • Contact: Julie Hias, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jos Tournoy, prof, Department of Public Health and Primary care, KU Leuven, Leuven

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Older patients; Inappropriate prescribing; Clinical pharmacy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: S64758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No