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

NCT05454644 | Completed

• 1 other identifier: PCP-EOL
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

End-Of-Life; Inappropriate Prescribing; Deprescriptions; Palliative Medicine; Geriatrics

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Usual Pharmaceutical Care

NO INTERVENTION

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.

Person-Centred Prescription Model

EXPERIMENTAL

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

Interventions

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

Person-Centred Prescription Model

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with hospital stays of less than 72 hours.
• Patients transferred to other hospitals or units.
• Patients with imminently terminal patients.

Sponsors & Collaborators

• Matia Foundation: lead
• University of the Basque Country (UPV/EHU): collaborator
• Universidad de León: collaborator

Study Sites (1)

Matia Foundation

Donostia / San Sebastian, Gipuzkoa, 20018, Spain

Location

Related Publications (10)

• 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.

  PMID: 21622981 BACKGROUND

• Espaulella-Panicot J, Molist-Brunet N, Sevilla-Sanchez D, Gonzalez-Bueno J, Amblas-Novellas J, Sola-Bonada N, Codina-Jane 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.

  PMID: 28476211 BACKGROUND

• Thompson W, Lundby C, Graabaek T, Nielsen DS, Ryg J, Sondergaard J, Pottegard 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.

  PMID: 30315745 BACKGROUND

• 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. doi: 10.1016/0895-4356(92)90144-c.

  PMID: 1474400 BACKGROUND

• 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.

  PMID: 28119312 BACKGROUND

• 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.

  PMID: 26446832 BACKGROUND

• 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. doi: 10.1345/aph.1D479. Epub 2004 Jul 20.

  PMID: 15266038 BACKGROUND

• 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. doi: 10.1001/archinte.167.8.781.

  PMID: 17452540 BACKGROUND

• 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.

  PMID: 26942907 BACKGROUND

• Ferro-Uriguen A, Beobide-Telleria I, Gil-Goikouria J, Pena-Labour PT, Diaz-Vila A, Herasme-Grullon AT, Echevarria-Orella E, Seco-Calvo J. Application of a person-centered prescription model improves pharmacotherapeutic indicators and reduces costs associated with pharmacological treatment in hospitalized older patients at the end of life. Front Public Health. 2022 Oct 3;10:994819. doi: 10.3389/fpubh.2022.994819. eCollection 2022.

  PMID: 36262221 DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 12, 2022
• Study Start: February 15, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2021
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)