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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jos Tournoy, prof, Principal Investigator, Department of Public Health and Primary care, KU Leuven, Leuven
  • Overall Contact(s)
    • Julie Hias, PharmD, +3216343080, julie.1.hias@uzleuven.be

References

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. Review.

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