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

Geriatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454644
• Other study ID #: PCP-EOL
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2022
• Source: Matia Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Deprescriptions
• End-Of-Life
• Geriatrics
• Inappropriate Prescribing
• Palliative Medicine

Intervention

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

Locations

Country	Name	City	State
Spain	Matia Foundation	Donostia	Gipuzkoa

Sponsors (3)

Lead Sponsor	Collaborator
Matia Foundation	Universidad de León, University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Spain, 

References & Publications (9)

By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. doi: 10.1111/jgs.13702. Epub 2015 Oct 8. — View Citation

Espaulella-Panicot J, Molist-Brunet N, Sevilla-Sánchez D, González-Bueno J, Amblàs-Novellas J, Solà-Bonada N, Codina-Jané C. [Patient-centred prescription model to improve adequate prescription and therapeutic adherence in patients with multiple disorders]. Rev Esp Geriatr Gerontol. 2017 Sep - Oct;52(5):278-281. doi: 10.1016/j.regg.2017.03.002. Epub 2017 May 2. Spanish. — View Citation

George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. Epub 2004 Jul 20. — View Citation

Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992 Oct;45(10):1045-51. — View Citation

Hilmer SN, Mager DE, Simonsick EM, Cao Y, Ling SM, Windham BG, Harris TB, Hanlon JT, Rubin SM, Shorr RI, Bauer DC, Abernethy DR. A drug burden index to define the functional burden of medications in older people. Arch Intern Med. 2007 Apr 23;167(8):781-7. — View Citation

Lavan AH, Gallagher P, Parsons C, O'Mahony D. STOPPFrail (Screening Tool of Older Persons Prescriptions in Frail adults with limited life expectancy): consensus validation. Age Ageing. 2017 Jul 1;46(4):600-607. doi: 10.1093/ageing/afx005. — View Citation

O'Mahony D, O'Connor MN. Pharmacotherapy at the end-of-life. Age Ageing. 2011 Jul;40(4):419-22. doi: 10.1093/ageing/afr059. Epub 2011 May 28. — View Citation

Potter K, Flicker L, Page A, Etherton-Beer C. Deprescribing in Frail Older People: A Randomised Controlled Trial. PLoS One. 2016 Mar 4;11(3):e0149984. doi: 10.1371/journal.pone.0149984. eCollection 2016. — View Citation

Thompson W, Lundby C, Graabaek T, Nielsen DS, Ryg J, Søndergaard J, Pottegård A. Tools for Deprescribing in Frail Older Persons and Those with Limited Life Expectancy: A Systematic Review. J Am Geriatr Soc. 2019 Jan;67(1):172-180. doi: 10.1111/jgs.15616. Epub 2018 Oct 13. — View Citation

Outcome

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