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

Polypharmacy Clinical Trial

— LIMONCELLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899114
• Other study ID #: NL82393.091.22
• Secondary ID: 10330032010002
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Medication Review
• Polypharmacy

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

External Links

•   LIMONCELLO website in collaboration with "Zorgevaluatie Nederland"