Clinical trial NCT05454644: Effectiveness of a Person-centred Prescription Model at the End of Life
Official title: Effectiveness of a Person-centred Prescription Model in Hospitalised Geriatric Patients at the End of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Of-Life
Inappropriate Prescribing
Deprescriptions
Palliative Medicine
Geriatrics
Lead sponsor: Matia Foundation
Sponsor class: OTHER
Collaborators: name: University of the Basque Country (UPV/EHU)
name: Universidad de León
First posted: 2022-07-12
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change between admission and discharge in the number of regular medications.
timeFrame: 3 months
Secondary outcomes:
measure: Change between admission and discharge in the STOPP Frail Criteria
timeFrame: 3 months
measure: Change between admission and discharge in the Drug Burden Index (DBI)
timeFrame: 3 months
measure: Change between admission and discharge in the total drug-drug interactions
timeFrame: 3 months
measure: Change between admission and discharge in the Medication Regimen Complexity Index (MRCI)
timeFrame: 3 months
measure: Change in the 28-day cost of prescriptions in €
timeFrame: 3 months
measure: Number of patients who have had a new emergency department presentation.
timeFrame: 3 months
measure: Number of patients who have had unplanned hospital readmission
timeFrame: 3 months
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Matia Foundation
state: Gipuzkoa
Study officials:
References:
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citation: 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.
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citation: 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.
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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. doi: 10.1001/archinte.167.8.781.
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.
citation: 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.