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

NCT ID: NCT05454644

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2021-02-28

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

Detailed Description

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Conditions

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End-Of-Life Inappropriate Prescribing Deprescriptions Palliative Medicine Geriatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Person-Centred Prescription Model

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role collaborator

Universidad de León

OTHER

Sponsor Role collaborator

Matia Foundation

OTHER

Sponsor Role lead

Responsible Party

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Alexander Ferro Uriguen

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Matia Foundation

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21622981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28476211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30315745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1474400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28119312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26446832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15266038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17452540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26942907 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36262221 (View on PubMed)

Other Identifiers

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PCP-EOL

Identifier Type: -

Identifier Source: org_study_id

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