Effectiveness of a Person-centred Prescription Model at the End of Life

Study Overview
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Brief Summary
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This study's main objective is to investigate whether the application of an adapted person-centred prescription model during a hospital stay would reduce the use of inappropriate or futile regular medications in older people at the end of life, improving their clinical/health statuses and reducing the expense associated with pharmacological treatment. We hypothesised that applying this modified method could optimise pharmacotherapeutic indicators and the expense associated with the pharmacological treatment of hospitalised patients

Official Title
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Effectiveness of a Person-centred Prescription Model in Hospitalised Geriatric Patients at the End of Life

Conditions
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End-Of-Life, Inappropriate Prescribing, Deprescriptions, Palliative Medicine, Geriatrics

Intervention / Treatment
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* Other: Person-Centred Prescription Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the geriatric convalescence unit and identified as having a non-oncological advanced chronic disease and being in need of palliative care, with a limited survival prognosis according to the necessity of palliative care (NECPAL) test. Exclusion Criteria: Patients with hospital stays of less than 72 hours. Patients transferred to other hospitals or units. Patients with imminently terminal patients.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of person-centred prescription model application versus standard pharmaceutical care alone. The intervention is applied randomly during hospital stay in hospitalised older people at the end of life. The primary outcome is the mean change between admission and discharge in the number of regular medications.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Pharmaceutical Care<br>Patients in the control arm receive usual pharmaceutical care in hospital. Reconciliation of the medication at hospital admission and a validation of the treatment modifications during the hospitalisation is carried out. | |
| Experimental: Person-Centred Prescription Model<br>An interdisciplinary medicine-optimisation strategy is implemented in people at the end of life (EOL) based on the person-centred prescription (PCP). | Other: Person-Centred Prescription Model<br>* Step 1: Identify patients with advanced chronic condition and limited life expectancy. Step 2: Interview with patients or closes caregiver. Step 3: Medication Review The clinical pharmacist conduct a structured medication review based on the medication appropriateness index (MAI): Indication/effectiveness: Product information, STOPPFrail (Screening Tool of Older Persons' Prescriptions in Frail adults with limited life expectancy) criteria and Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Dosage adjustment: Product Information and Lexi-Comp's Geriatric Dosage Handbook. Correct and practical directions: Medication Regimen Complexity Index (MRCI). Drug-drug interactions: Bot Plus/Beers Criteria and drug burden index (DBI), which measures dose-dependent anticholinergic and sedative loads. Drug-disease interactions: Beers Criteria. Duplication, duration and cost-effectiveness: Product information. Step 4: Treatment Plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between admission and discharge in the number of regular medications. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between admission and discharge in the STOPP Frail Criteria |  | 3 months | 
| Change between admission and discharge in the Drug Burden Index (DBI) |  | 3 months | 
| Change between admission and discharge in the total drug-drug interactions |  | 3 months | 
| Change between admission and discharge in the Medication Regimen Complexity Index (MRCI) |  | 3 months | 
| Change in the 28-day cost of prescriptions in € |  | 3 months | 
| Number of patients who have had a new emergency department presentation. |  | 3 months | 
| Number of patients who have had unplanned hospital readmission |  | 3 months |