AzTrials
AzTrials

End-Of-LifeNCT05454644

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

A study testing Person-Centred Prescription Model in people with End-Of-Life and Inappropriate Prescribing, run by Matia Foundation at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Person-Centred Prescription Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteSpain
Study dates
15 Feb 2018to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Matia Foundation

    Donostia / San Sebastian, Gipuzkoa, 20018

Other trials in Spain

About this study

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

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

Being tested
Person-Centred Prescription Model
Medical subject headings
Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-Centred Prescription ModelOther

    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

Study groups in NCT05454644
Study groupRoleWhat they receive
Usual Pharmaceutical CareNo interventionPatients 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 ModelExperimentalAn interdisciplinary medicine-optimisation strategy is implemented in people at the end of life (EOL) based on the person-centred prescription (PCP).
Receives: Other: Person-Centred Prescription Model

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (7)

  1. Change between admission and discharge in the STOPP Frail Criteria

    Measured: 3 months

  2. Change between admission and discharge in the Drug Burden Index (DBI)

    Measured: 3 months

  3. Change between admission and discharge in the total drug-drug interactions

    Measured: 3 months

  4. Change between admission and discharge in the Medication Regimen Complexity Index (MRCI)

    Measured: 3 months

  5. Change in the 28-day cost of prescriptions in €

    Measured: 3 months

  6. Number of patients who have had a new emergency department presentation.

    Measured: 3 months

  7. Number of patients who have had unplanned hospital readmission

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start15 Feb 2018
  3. Primary completion28 Feb 2020
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05454644
Sponsor's protocol ID
PCP-EOL
Status last verified
Jul 2022
First submitted
30 Jun 2022
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21622981

  • 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.

    PubMed 28476211

  • 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.

    PubMed 30315745

  • 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.

    PubMed 1474400

  • 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.

    PubMed 28119312

  • 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.

    PubMed 26446832

  • 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.

    PubMed 15266038

  • 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.

    PubMed 17452540

  • 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.

    PubMed 26942907

  • 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.

    PubMed 36262221

Questions about this trial

What is this clinical trial studying?

A study testing Person-Centred Prescription Model in people with End-Of-Life and Inappropriate Prescribing, run by Matia Foundation at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change between admission and discharge in the number of regular medications. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05454644, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in