AzTrials
AzTrials

PolypharmacyLIMONCELLONCT05899114

Less Is More: Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple

A study testing Transitional Multidisciplinary Pharmacotherapeutic Care in people with Polypharmacy and Medication Review, run by Radboud University Medical Center at 16 sites in Netherlands.

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

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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Polypharmacy, Medication Review
What is being tested?
Transitional Multidisciplinary Pharmacotherapeutic Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,241 participants
Where
16 sitesNetherlands
Study dates
5 Jun 2023to 17 Feb 2026
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 70 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

Who cannot join

  • No informed consent by patient or a legal representative
  • Participation in an interfering clinical trial
  • Elective hospital admission
  • Direct admission to the ICU (when medication verification as usual can't be executed, and therefore inclusion of patients as described in 10.2 is not possible)
  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Netherlands16 sites
  • Ziekenhuisgroep Twente

    Almelo, Overijssel

  • Meander Medisch Centrum Amersfoort

    Amersfoort, Utrecht

  • Amsterdam UMC - location VUMC

    Amsterdam, North Holland

  • Amsterdam UMC- location AMC

    Amsterdam, North Holland

  • Amphia ziekenhuis

    Breda, North Brabant

  • Deventer Ziekenhuis

    Deventer, Overijssel

  • Catharina Ziekenhuis

    Eindhoven, North Brabant

  • Universitair Medisch Centrum Groningen

    Groningen, Provincie Groningen

  • Leiden Universitair Medisch Centrum

    Leiden, South Holland

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Gelderland

  • Radboudumc

    Nijmegen, Gelderland

  • Erasmus Medisch Centrum Rotterdam

    Rotterdam, South Holland

  • Haga Ziekenhuis

    The Hague, South Holland

  • Diakonessenhuis

    Utrecht, Utrecht

  • Universitair Medisch Centrum Utrecht

    Utrecht, Utrecht

  • Zaans Medisch Centrum

    Zaandam, North Holland

Other trials in Netherlands

About this study

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:

Read more
  • 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.

Read the detailed description

Rationale: Polypharmacy poses an ongoing healthcare challenge, as it is associated with negative outcomes such as adverse drug events, lower quality of life and mortality. These risks are especially elevated for the frail and old, leading to high numbers of drug related admissions (DRAs) and unplanned emergency department visits. Approximately half of the DRAs are potentially preventable, and therefore a possible target point for interventions. Unfortunately, until now, despite multiple efforts to decrease drug related harm, the number of drug related admissions has not decreased. Several studies have previously investigated the effect of a structured medication review with varying success. Identified strengths were multicomponent approaches, multidisciplinary approaches and selection of specifically high-risk patients. The LIMONCELLO study will take this into account and will study a multidisciplinary multicomponent intervention with focus on transitional care in a patient population that is most likely to benefit from this intervention. It is hypothesised that transitional multidisciplinary pharmacotherapeutic care (TMPC) is superior in preventing drug related readmissions (DRreAs) compared to usual care.

Objective: The LIMONCELLO study aims to assess the effect and cost-effectiveness of TMPC compared to usual care.

Study design: This is a cluster randomised controlled trial, a cluster will be defined at the hospital level, with each cluster randomly allocated to the intervention or control group. Patients aged 70 years or older with polypharmacy, admitted to the hospital via the emergency department for longer than 24 hours, with completed medication verification and with an elevated risk of drug related readmissions (calculated by use of the DRA prediction model, an algorithm developed by the OPERAM study group) will be included. Participants in intervention hospitals will receive TMPC during index hospitalisation. TMPC consists of four elements: pharmacotherapeutic analysis, transitional multidisciplinary discussion, pharmacotherapeutic care interview and discussion with the patient, and a discharge note with the pharmacotherapeutic care plan. The comparator is usual care as is provided in the participating hospitals. Follow-up will be 1 year, participants will be called 30 days, 3 months and 12 months after index hospitalisation.

Statistical considerations: 16 clusters will participate in the study, requiring a total of 161 patients per cluster to be included, 2,576 participants in total. Results will be analysed by intention-to-treat analysis and per-protocol analysis. For the primary outcome, drug related readmissions, a generalized linear mixed model with a binomial distribution and logit link function will be used for the analysis on an individual level, adjusting for clustering.

Being tested
Transitional Multidisciplinary Pharmacotherapeutic Care
Keywords
Polypharmacy, Medication Review, Aged, Deprescribing

What participants receive

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

  • Transitional Multidisciplinary Pharmacotherapeutic CareOther

    Also called TMPC

    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.
Study groups in NCT05899114
Study groupRoleWhat they receive
Transitional Multidisciplinary Pharmacotherapeutic Care (TMPC)ExperimentalThe 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.
Receives: Other: Transitional Multidisciplinary Pharmacotherapeutic Care
Usual careNo interventionThe 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.

What is being measured

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

  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

    Measured: 30 days after index hospitalisation

Secondary outcomes (15)
  1. Number of Drug Related Readmissions at 3 and 12 months after index hospitalisation

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

    Measured: 3 and 12 months after index hospitalisation

  2. Duration of hospitalisation of Drug Related Readmission

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

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  3. Time to first Drug Related Readmission

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

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  4. Number of Emergency Department visits

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  5. Number of all-cause hospital readmissions

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  6. Healthcare costs

    In euros, assessed with the iMTA Medical Consumption Questionnaire (iMCQ)

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  7. Quality of Life measured with EQ-5D-5L

    Measured by 5-level EuroQol-5 domains (EQ-5D-5L) questionnaire

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  8. Cost-effectiveness

    In euro per Quality Adjusted Life Year (QALY) gained, by combining costs and quality of life measurements

    Measured: During the 12 month follow-up

  9. Number of regular medications

    Based on number of regular medications in the medication list

    Measured: At discharge from index hospitalisation and 30 days, 3 months and 12 months after index hospitalisation

  10. Number and type of recommendations in the intervention group

    Based on documented recommendations made during TMPC

    Measured: At discharge from index hospitalisation

  11. Number of implemented recommendations

    The number of differences between the pharmacotherapeutic plan composed by the P-team and the participant's current medication list at each time point

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  12. Activities of Daily Living

    Measured with Katz-6 ADL questionnaire

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  13. Number of patients living independently

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  14. Number of falls

    Measured: 30 days, 3 months and 12 months after index hospitalisation

  15. Mortality

    Measured: 30 days, 3 months and 12 months after index hospitalisation

Timeline

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

  1. First posted12 Jun 2023
  2. Study start5 Jun 2023
  3. Primary completion1 Apr 2025
  4. Study completion17 Feb 2026

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899114
Sponsor's protocol ID
NL82393.091.22
Other IDs
10330032010002
Acronym
LIMONCELLO
Status last verified
Jun 2026
First submitted
23 May 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be shared in a repository, published under restricted access.

Publications

  • 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.

    PubMed 41444867

Questions about this trial

What is this clinical trial studying?

A study testing Transitional Multidisciplinary Pharmacotherapeutic Care in people with Polypharmacy and Medication Review, run by Radboud University Medical Center at 16 sites in Netherlands.

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 6 inclusion and 11 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Netherlands. 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?

Number of Drug Related Readmissions in the first 30 days after index hospitalisation (time frame: 30 days after index hospitalisation). 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 NCT05899114, which also lists 1 linked publication.

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 1 Jul 2026.

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