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

Primary Purpose

Drug-Related Side Effects and Adverse Reactions

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Multifaceted clinical pharmacy intervention
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug-Related Side Effects and Adverse Reactions focused on measuring Older patients, Inappropriate prescribing, Clinical pharmacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care group

Intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

General practitioners contacts
Number of general practitioners contacts
Mortality
Death date
Other types of hospital visits
Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions
Drug-related readmissions
Number of drug related readmissions
Fall incidents
Number of falls
Patient reported drug related problems
Number of drug related problems
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)
Differences in pain
Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain
Medications
Number of medications
Medication adherence
BAASIS tool
Potentially inappropriate medications
RASP tool
Cost-effectiveness
Healthcare related costs and Medicine productivity costs

Full Information

First Posted
October 29, 2020
Last Updated
January 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04617340
Brief Title
Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE
Acronym
ASPIRE
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Related Side Effects and Adverse Reactions
Keywords
Older patients, Inappropriate prescribing, Clinical pharmacy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
828 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multifaceted clinical pharmacy intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to all-cause unplanned hospital visit after discharge.
Description
An unplanned hospital visit is defined as an unplanned hospital admission or an emergency department visit
Time Frame
up to six months after discharge
Secondary Outcome Measure Information:
Title
General practitioners contacts
Description
Number of general practitioners contacts
Time Frame
Up to six months after discharge
Title
Mortality
Description
Death date
Time Frame
Up to six months after discharge
Title
Other types of hospital visits
Description
Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions
Time Frame
Up to six months after discharge
Title
Drug-related readmissions
Description
Number of drug related readmissions
Time Frame
Up to six months after discharge
Title
Fall incidents
Description
Number of falls
Time Frame
Up to one month after discharge
Title
Patient reported drug related problems
Description
Number of drug related problems
Time Frame
Up to one month after discharge
Title
Change in Quality of life
Description
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)
Time Frame
on admission, one month after discharge and six months after discharge
Title
Differences in pain
Description
Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain
Time Frame
Up to one month after discharge
Title
Medications
Description
Number of medications
Time Frame
On admission, at discharge and one month after discharge
Title
Medication adherence
Description
BAASIS tool
Time Frame
On admission and one month after discharge
Title
Potentially inappropriate medications
Description
RASP tool
Time Frame
On admission, at discharge and one month after discharge
Title
Cost-effectiveness
Description
Healthcare related costs and Medicine productivity costs
Time Frame
Up to six months after discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Hias, PharmD
Phone
+3216343080
Email
julie.1.hias@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos Tournoy, prof
Organizational Affiliation
Department of Public Health and Primary care, KU Leuven, Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Hias, PharmD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
31919802
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.
Results Reference
background
PubMed Identifier
35842106
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.
Results Reference
derived

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

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