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Completed

NCT Number: NCT05454644

Effectiveness of a Person-centred Prescription Model 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

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Key information

Conditions

End-Of-Life Death Deprescriptions Geriatrics Inappropriate Prescribing Palliative Medicine Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matia Foundation

Donostia / San Sebastian, Gipuzkoa, 20018, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Person-Centred Prescription Model

Other

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

Primary outcomes

  1. Change between admission and discharge in the number of regular medications.

    Time frame: 3 months

Secondary outcomes

  1. Change between admission and discharge in the STOPP Frail Criteria

    Time frame: 3 months

  2. Change between admission and discharge in the Drug Burden Index (DBI)

    Time frame: 3 months

  3. Change between admission and discharge in the total drug-drug interactions

    Time frame: 3 months

  4. Change between admission and discharge in the Medication Regimen Complexity Index (MRCI)

    Time frame: 3 months

  5. Change in the 28-day cost of prescriptions in €

    Time frame: 3 months

  6. Number of patients who have had a new emergency department presentation.

    Time frame: 3 months

  7. Number of patients who have had unplanned hospital readmission

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Matia Foundation

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

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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