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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04617340
Collaborator
(none)
828
1
2
26.1
31.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multifaceted clinical pharmacy intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
828 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE (ASPIRE): a Randomized Controlled Trial
Actual Study Start Date :
Feb 25, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Time to all-cause unplanned hospital visit after discharge. [up to six months after discharge]

    An unplanned hospital visit is defined as an unplanned hospital admission or an emergency department visit

Secondary Outcome Measures

  1. General practitioners contacts [Up to six months after discharge]

    Number of general practitioners contacts

  2. Mortality [Up to six months after discharge]

    Death date

  3. Other types of hospital visits [Up to six months after discharge]

    Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions

  4. Drug-related readmissions [Up to six months after discharge]

    Number of drug related readmissions

  5. Fall incidents [Up to one month after discharge]

    Number of falls

  6. Patient reported drug related problems [Up to one month after discharge]

    Number of drug related problems

  7. Change in Quality of life [on admission, one month after discharge and six months after discharge]

    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)

  8. Differences in pain [Up to one month after discharge]

    Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain

  9. Medications [On admission, at discharge and one month after discharge]

    Number of medications

  10. Medication adherence [On admission and one month after discharge]

    BAASIS tool

  11. Potentially inappropriate medications [On admission, at discharge and one month after discharge]

    RASP tool

  12. Cost-effectiveness [Up to six months after discharge]

    Healthcare related costs and Medicine productivity costs

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven Leuven Belgium

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04617340
Other Study ID Numbers:
  • S64758
First Posted:
Nov 5, 2020
Last Update Posted:
Mar 18, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021