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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05899114
Other study ID # NL82393.091.22
Secondary ID 10330032010002
Status Recruiting
Phase N/A
First received
Last updated
Start date June 5, 2023
Est. completion date June 5, 2025

Study information

Verified date April 2023
Source Radboud University Medical Center
Contact Sjacky Cooijmans, MSc
Phone +31 (0)24 361 36 91
Email limoncello@zorgevaluatienederland.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2576
Est. completion date June 5, 2025
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transitional Multidisciplinary Pharmacotherapeutic Care
A structured medication review with improved transitional care and multidisciplinary collaboration. TMPC consists of the following four elements: A structured pharmacotherapeutic analysis A transitional multidisciplinary discussion.The treating physician in the hospital will be involved. The general practitioner and community pharmacist will be consulted. 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. A discharge note with the pharmacotherapeutic care plan. This will be sent to the community pharmacist and the general practitioner.

Locations

Country Name City State
Netherlands Ziekenhuisgroep Twente Almelo Overijssel
Netherlands Meander Medisch Centrum Amersfoort Amersfoort Utrecht
Netherlands Amsterdam UMC - location VUMC Amsterdam Noord-Holland
Netherlands Amsterdam UMC- location AMC Amsterdam Noord-Holland
Netherlands Amphia ziekenhuis Breda Noord Brabant
Netherlands Haga Ziekenhuis Den Haag Zuid-Holland
Netherlands Deventer Ziekenhuis Deventer Overijssel
Netherlands Catharina Ziekenhuis Eindhoven Noord Brabant
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Leiden Universitair Medisch Centrum Leiden Zuid-Holland
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen Gelderland
Netherlands Radboudumc Nijmegen Gelderland
Netherlands Erasmus Medisch Centrum Rotterdam Rotterdam Zuid Holland
Netherlands Diakonessenhuis Utrecht
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Netherlands Zaans Medisch Centrum Zaandam Noord-Holland

Sponsors (18)

Lead Sponsor Collaborator
Radboud University Medical Center Amphia ziekenhuis, Amsterdam UMC, location AMC, Amsterdam UMC, location VUmc, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven, Deventer Ziekenhuis, Diakonessenhuis, Utrecht, Erasmus Medical Center, HagaZiekenhuis, Leiden University Medical Center, Meander Medisch Centrum, UMC Utrecht, University Medical Center Groningen, Zaans Medisch Centrum, Ziekenhuisgroep Twente, ZonMw: The Netherlands Organisation for Health Research and Development, Zorgevaluatie Nederland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Drug Related Readmissions at 3 and 12 months after index hospitalisation Whether readmission is drug related will be assessed with AT-HARM10 3 and 12 months after index hospitalisation
Secondary Duration of hospitalisation of Drug Related Readmission Whether readmission is drug related will be assessed with AT-HARM10 30 days, 3 months and 12 months after index hospitalisation
Secondary Time to first Drug Related Readmission Whether readmission is drug related will be assessed with AT-HARM10 30 days, 3 months and 12 months after index hospitalisation
Secondary Number of Emergency Department visits 30 days, 3 months and 12 months after index hospitalisation
Secondary Number of all-cause hospital readmissions 30 days, 3 months and 12 months after index hospitalisation
Secondary Healthcare costs In euros, assessed with the iMTA Medical Consumption Questionnaire (iMCQ) 30 days, 3 months and 12 months after index hospitalisation
Secondary Quality of Life measured with EQ-5D-5L Measured by 5-level EuroQol-5 domains (EQ-5D-5L) questionnaire 30 days, 3 months and 12 months after index hospitalisation
Secondary Cost-effectiveness In euro per Quality Adjusted Life Year (QALY) gained, by combining costs and quality of life measurements During the 12 month follow-up
Secondary Number of regular medications Based on number of regular medications in the medication list At discharge from index hospitalisation and 30 days, 3 months and 12 months after index hospitalisation
Secondary Number and type of recommendations in the intervention group Based on documented recommendations made during TMPC At discharge from index hospitalisation
Secondary 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 30 days, 3 months and 12 months after index hospitalisation
Secondary Activities of Daily Living Measured with Katz-6 ADL questionnaire 30 days, 3 months and 12 months after index hospitalisation
Secondary Number of patients living independently 30 days, 3 months and 12 months after index hospitalisation
Secondary Number of falls 30 days, 3 months and 12 months after index hospitalisation
Secondary Mortality 30 days, 3 months and 12 months after index hospitalisation
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