Less Is More: Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple
NCT ID: NCT05899114
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2576 participants
INTERVENTIONAL
2023-06-05
2026-01-17
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Masking the patients, care provider or investigator is not possible in this study.
Study Groups
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Transitional Multidisciplinary Pharmacotherapeutic Care (TMPC)
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.
Transitional Multidisciplinary Pharmacotherapeutic Care
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.
Usual care
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.
No interventions assigned to this group
Interventions
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Transitional Multidisciplinary Pharmacotherapeutic Care
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
70 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Amsterdam UMC, location AMC
OTHER
Amphia ziekenhuis
UNKNOWN
Catharina Ziekenhuis Eindhoven
OTHER
Deventer Ziekenhuis
OTHER
Diakonessenhuis, Utrecht
OTHER
Erasmus Medical Center
OTHER
HagaZiekenhuis
OTHER
Leiden University Medical Center
OTHER
Meander Medisch Centrum
OTHER
University Medical Center Groningen
OTHER
UMC Utrecht
OTHER
Zaans Medisch Centrum
OTHER
Ziekenhuisgroep Twente
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Zorgevaluatie Nederland
UNKNOWN
Canisius Wilhelmina Ziekenhuis (CWZ)
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kees Kramers, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands
Amphia ziekenhuis
Breda, North Brabant, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Amsterdam UMC - location VUMC
Amsterdam, North Holland, Netherlands
Amsterdam UMC- location AMC
Amsterdam, North Holland, Netherlands
Zaans Medisch Centrum
Zaandam, North Holland, Netherlands
Ziekenhuisgroep Twente
Almelo, Overijssel, Netherlands
Deventer Ziekenhuis
Deventer, Overijssel, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, Netherlands
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Erasmus Medisch Centrum Rotterdam
Rotterdam, South Holland, Netherlands
Haga Ziekenhuis
The Hague, South Holland, Netherlands
Meander Medisch Centrum Amersfoort
Amersfoort, Utrecht, Netherlands
Diakonessenhuis
Utrecht, Utrecht, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Utrecht, Netherlands
Countries
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Related Links
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LIMONCELLO website in collaboration with "Zorgevaluatie Nederland"
Other Identifiers
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10330032010002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL82393.091.22
Identifier Type: -
Identifier Source: org_study_id
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