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

July 7, 2022 updated by: Alexander Ferro Uriguen, Matia Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Gipuzkoa
      • Donostia, Gipuzkoa, Spain, 20018
        • Matia Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Pharmaceutical Care
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
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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matia Foundation

Collaborators

University of the Basque Country (UPV/EHU)
Universidad de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCP-EOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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