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

Study Overview
=================
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.

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

Conditions
-----------------
Drug-Related Side Effects and Adverse Reactions

Intervention / Treatment
-----------------
* Other: Multifaceted clinical pharmacy intervention


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care group<br>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<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older patients, Inappropriate prescribing, Clinical pharmacy