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

Primary Purpose

End-Of-Life, Inappropriate Prescribing, Deprescriptions

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Person-Centred Prescription Model
Sponsored by
Matia Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-Of-Life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Matia Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Pharmaceutical Care

Person-Centred Prescription Model

Arm Description

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.

An interdisciplinary medicine-optimisation strategy is implemented in people at the end of life (EOL) based on the person-centred prescription (PCP).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change between admission and discharge in the STOPP Frail Criteria
Change between admission and discharge in the Drug Burden Index (DBI)
Change between admission and discharge in the total drug-drug interactions
Change between admission and discharge in the Medication Regimen Complexity Index (MRCI)
Change in the 28-day cost of prescriptions in €
Number of patients who have had a new emergency department presentation.
Number of patients who have had unplanned hospital readmission

Full Information

First Posted
June 30, 2022
Last Updated
July 7, 2022
Sponsor
Matia Foundation
Collaborators
University of the Basque Country (UPV/EHU), Universidad de León
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1. Study Identification

Unique Protocol Identification Number
NCT05454644
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Matia Foundation
Collaborators
University of the Basque Country (UPV/EHU), Universidad de León

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Of-Life, Inappropriate Prescribing, Deprescriptions, Palliative Medicine, Geriatrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Pharmaceutical Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Person-Centred Prescription Model
Arm Type
Experimental
Arm Description
An interdisciplinary medicine-optimisation strategy is implemented in people at the end of life (EOL) based on the person-centred prescription (PCP).
Intervention Type
Other
Intervention Name(s)
Person-Centred Prescription Model
Intervention Description
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 Outcome Measure Information:
Title
Change between admission and discharge in the number of regular medications.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change between admission and discharge in the STOPP Frail Criteria
Time Frame
3 months
Title
Change between admission and discharge in the Drug Burden Index (DBI)
Time Frame
3 months
Title
Change between admission and discharge in the total drug-drug interactions
Time Frame
3 months
Title
Change between admission and discharge in the Medication Regimen Complexity Index (MRCI)
Time Frame
3 months
Title
Change in the 28-day cost of prescriptions in €
Time Frame
3 months
Title
Number of patients who have had a new emergency department presentation.
Time Frame
3 months
Title
Number of patients who have had unplanned hospital readmission
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Matia Foundation
City
Donostia
State/Province
Gipuzkoa
ZIP/Postal Code
20018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21622981
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.
Results Reference
background
PubMed Identifier
28476211
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.
Results Reference
background
PubMed Identifier
30315745
Citation
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.
Results Reference
background
PubMed Identifier
1474400
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. doi: 10.1016/0895-4356(92)90144-c.
Results Reference
background
PubMed Identifier
28119312
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.
Results Reference
background
PubMed Identifier
26446832
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.
Results Reference
background
PubMed Identifier
15266038
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. doi: 10.1345/aph.1D479. Epub 2004 Jul 20.
Results Reference
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PubMed Identifier
17452540
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.
Results Reference
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PubMed Identifier
26942907
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.
Results Reference
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PubMed Identifier
36262221
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.
Results Reference
derived

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

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