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Completed

NCT Number: NCT04617340

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

A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.

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Key information

Conditions

Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifaceted clinical pharmacy intervention

Other
  • 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 outcomes

  1. Time to all-cause unplanned hospital visit after discharge.

    Time frame: up to six months after discharge

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

Secondary outcomes

  1. General practitioners contacts

    Time frame: Up to six months after discharge

    Number of general practitioners contacts

  2. Mortality

    Time frame: Up to six months after discharge

    Death date

  3. Other types of hospital visits

    Time frame: 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

    Time frame: Up to six months after discharge

    Number of drug related readmissions

  5. Fall incidents

    Time frame: Up to one month after discharge

    Number of falls

  6. Patient reported drug related problems

    Time frame: Up to one month after discharge

    Number of drug related problems

  7. Change in Quality of life

    Time frame: 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

    Time frame: 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

    Time frame: On admission, at discharge and one month after discharge

    Number of medications

  10. Medication adherence

    Time frame: On admission and one month after discharge

    BAASIS tool

  11. Potentially inappropriate medications

    Time frame: On admission, at discharge and one month after discharge

    RASP tool

  12. Cost-effectiveness

    Time frame: Up to six months after discharge

    Healthcare related costs and Medicine productivity costs

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ASPIRE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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