NCT05899114

Brief Summary

The goal of this cluster randomized controlled trial is to compare transitional multidisciplinary pharmacotherapeutic care (TMPC) with usual care in patients aged 70 years or older with polypharmacy, admitted to the hospital via the emergency department for longer than 24 hours and that have an elevated risk of drug related readmissions. The primary aims of the study are:

  • To assess whether TMPC leads to a decrease in number of DRreAs compared to usual care during the first 30 days after index hospitalisation.
  • To assess whether TMPC is cost-effective Participants will receive TMPC in hospitals allocated to the intervention. TMPC will be executed by a pharmacotherapeutic team, it consists of the following four elements:
  • pharmacotherapeutic analysis
  • transitional multidisciplinary discussion
  • pharmacotherapeutic care interview and discussion with the patient
  • discharge note with the pharmacotherapeutic care plan Researchers will compare TMPC with usual care to assess the effect and cost-effectiveness of TMPC.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2026

Completed
Last Updated

August 11, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

May 23, 2023

Last Update Submit

August 5, 2025

Conditions

PolypharmacyMedication Review

Keywords

PolypharmacyMedication ReviewAgedDeprescribing

Outcome Measures

Primary Outcomes (1)

  • Number of Drug Related Readmissions in the first 30 days after index hospitalisation

    Whether readmission is drug related will be assessed with AT-HARM10

    30 days after index hospitalisation

Secondary Outcomes (15)

  • Number of Drug Related Readmissions at 3 and 12 months after index hospitalisation

    3 and 12 months after index hospitalisation

  • Duration of hospitalisation of Drug Related Readmission

    30 days, 3 months and 12 months after index hospitalisation

  • Time to first Drug Related Readmission

    30 days, 3 months and 12 months after index hospitalisation

  • Number of Emergency Department visits

    30 days, 3 months and 12 months after index hospitalisation

  • Number of all-cause hospital readmissions

    30 days, 3 months and 12 months after index hospitalisation

  • +10 more secondary outcomes

Study Arms (2)

Transitional Multidisciplinary Pharmacotherapeutic Care (TMPC)

EXPERIMENTAL

The participants in hospitals allocated to the intervention arm will receive TMPC, which will be executed by a Pharmacotherapy-team and will take place during the index hospital stay. This Pharmacotherapy-team will be composed of a physician and a hospital pharmacist, preferably registered as clinical pharmacologists.

Other: Transitional Multidisciplinary Pharmacotherapeutic Care

Usual care

NO INTERVENTION

The comparator in this study is usual care, which refers to the entire spectrum of medication-related interventions by different healthcare providers (physician, pharmacist, nurse etc.) which the patient undergoes during hospital admission.

Interventions

Transitional Multidisciplinary Pharmacotherapeutic CareOTHER

A structured medication review with improved transitional care and multidisciplinary collaboration. TMPC consists of the following four elements: 1. A structured pharmacotherapeutic analysis 2. A transitional multidisciplinary discussion.The treating physician in the hospital will be involved. The general practitioner and community pharmacist will be consulted. 3. An interview and discussion with the patient and/or legal representative by a member of the Pharmacotherapy-team, which will be performed before the patient is discharged from the hospital. 4. A discharge note with the pharmacotherapeutic care plan. This will be sent to the community pharmacist and the general practitioner.

Also known as: TMPC
Transitional Multidisciplinary Pharmacotherapeutic Care (TMPC)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • Polypharmacy, the use of 5 or more regular medications, defined as authorised medications with registration numbers, used for more than 30 days. Topical preparations are excluded from this definition.
  • Admitted to hospital through the ED (which comprises both the general emergency department and the cardiac emergency department)
  • Length of hospitalisation more than 24 hours
  • Completed medication verification
  • DRA prediction percentage of 23.0% or higher

You may not qualify if:

  • No informed consent by patient or a legal representative
  • Participation in an interfering clinical trial
  • Elective hospital admission
  • A life expectancy of less than 3 months, which includes patients with palliative treatment at home, direct admission to palliative care or palliative care planned within 24 hours after index hospital admission.
  • Patient or legal representative not able to speak Dutch.
  • Follow-up of patient primarily by secondary caregivers. This refers to situations where the secondary caregiver is in the lead of the medication list of the patient instead of the GP or elderly care physician, for example in the following patient groups:
  • patients receiving intensive oncologic therapy
  • patients in an organ- or stem cell transplantation procedure
  • patients receiving intensive (chronic) psychiatric care, such as patients admitted to a medical psychiatric unit
  • patients on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands

Location

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Amphia ziekenhuis

Breda, North Brabant, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Location

Amsterdam UMC - location VUMC

Amsterdam, North Holland, Netherlands

Location

Amsterdam UMC- location AMC

Amsterdam, North Holland, Netherlands

Location

Zaans Medisch Centrum

Zaandam, North Holland, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Overijssel, Netherlands

Location

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

Location

Leiden Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Location

Erasmus Medisch Centrum Rotterdam

Rotterdam, South Holland, Netherlands

Location

Haga Ziekenhuis

The Hague, South Holland, Netherlands

Location

Meander Medisch Centrum Amersfoort

Amersfoort, Utrecht, Netherlands

Location

Diakonessenhuis

Utrecht, Utrecht, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Utrecht, Netherlands

Location

Related Publications (1)

  • Cooijmans S, Engelen EMC, Wuyts SCM, Kramers C, van Agtmael MA, van den Bemt PMLA, Bouvy ML, Amouch H, Autar RS, Benoist GE, van Berlo-van de Laar IRF, Derijks-Engwegen JYMN, van den Elsen G, Engelaer FM, Gombert-Handoko KB, Jansen DRM, Kerskes MHM, Kruik-Kolloffel WJ, Kuijvenhoven MA, van der Kuy HM, Labots G, van Poelgeest EP, Sablerolles R, Sallevelt BTG, van Stiphout F, Storm BN, Taks M, Teeuwisse PJI, Uiterwijk J, Vondeling A, de Vries M, Wesselink E, Wiggers NML, de Wit HAJM, Schers HJ, Adang EMM, van Wely M, van Herwaarden N, Knol W. Less Is More: Optimized pharmacotherapy with improved coNtinuity of CarE in hospitaLized oLder peOple (LIMONCELLO): study protocol of a cluster randomized controlled trial. BMC Geriatr. 2025 Dec 24;25(1):1034. doi: 10.1186/s12877-025-06533-0.

    PMID: 41444867DERIVED

Related Links

Study Officials

  • Kees Kramers, Prof. Dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor, assessing whether a readmission is drug related will be masked. Masking the patients, care provider or investigator is not possible in this study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 12, 2023

Study Start

June 5, 2023

Primary Completion

April 1, 2025

Study Completion

January 17, 2026

Last Updated

August 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Anonymized data will be shared in a repository, published under restricted access.

Time Frame
All collected data will be stored for 15 years
Access Criteria
It will be shared in a repository. The data will be published under restricted access. Requests for access will be checked, by a data access committee (DAC) formed by the consortium.

Locations

NL(16)