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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05899114

Collaborator

Amsterdam UMC, location VUmc (Other), Amsterdam UMC, location AMC (Other), Amphia ziekenhuis (Other), Catharina Ziekenhuis Eindhoven (Other), Canisius-Wilhelmina Hospital (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 (Other)

2,576

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polypharmacy Medication Review	Other: Transitional Multidisciplinary Pharmacotherapeutic Care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2576 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized studyCluster randomized study

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 5, 2023

Anticipated Primary Completion Date :

Jul 5, 2024

Anticipated Study Completion Date :

Jun 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: TMPC
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

TMPC

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Number of Drug Related Readmissions in the first 30 days after index hospitalisation [30 days after index hospitalisation]
Whether readmission is drug related will be assessed with AT-HARM10

Secondary Outcome Measures

Number of Drug Related Readmissions at 3 and 12 months after index hospitalisation [3 and 12 months after index hospitalisation]
Whether readmission is drug related will be assessed with AT-HARM10
Duration of hospitalisation of Drug Related Readmission [30 days, 3 months and 12 months after index hospitalisation]
Whether readmission is drug related will be assessed with AT-HARM10
Time to first Drug Related Readmission [30 days, 3 months and 12 months after index hospitalisation]
Whether readmission is drug related will be assessed with AT-HARM10
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]
Healthcare costs [30 days, 3 months and 12 months after index hospitalisation]
In euros, assessed with the iMTA Medical Consumption Questionnaire (iMCQ)
Quality of Life measured with EQ-5D-5L [30 days, 3 months and 12 months after index hospitalisation]
Measured by 5-level EuroQol-5 domains (EQ-5D-5L) questionnaire
Cost-effectiveness [During the 12 month follow-up]
In euro per Quality Adjusted Life Year (QALY) gained, by combining costs and quality of life measurements
Number of regular medications [At discharge from index hospitalisation and 30 days, 3 months and 12 months after index hospitalisation]
Based on number of regular medications in the medication list
Number and type of recommendations in the intervention group [At discharge from index hospitalisation]
Based on documented recommendations made during TMPC
Number of implemented recommendations [30 days, 3 months and 12 months after index hospitalisation]
The number of differences between the pharmacotherapeutic plan composed by the P-team and the participant's current medication list at each time point
Activities of Daily Living [30 days, 3 months and 12 months after index hospitalisation]
Measured with Katz-6 ADL questionnaire
Number of patients living independently [30 days, 3 months and 12 months after index hospitalisation]
Number of falls [30 days, 3 months and 12 months after index hospitalisation]
Mortality [30 days, 3 months and 12 months after index hospitalisation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >27.9%

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kees Kramers, Prof. Dr., Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

LIMONCELLO website in collaboration with "Zorgevaluatie Nederland"

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT05899114

Other Study ID Numbers:

NL82393.091.22
10330032010002

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Radboud University Medical Center

Study Results

No Results Posted as of Jun 12, 2023