Less is More: Optimized Pharmacotherapy with Improved CoNtinuity of CarE in HospitaLized OLder PeOple

Not Applicable

Recruiting

• Conditions: Polypharmacy; Medication Review
• Interventions: Other: Transitional Multidisciplinary Pharmacotherapeutic Care

• Registration Number: NCT05899114
• Lead Sponsor: Radboud University Medical Center

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.

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 Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-02
• Study Start: 2023-06-05
• Study First Posted: 2023-06-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2576

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transitional Multidisciplinary Pharmacotherapeutic Care (TMPC)	Transitional Multidisciplinary Pharmacotherapeutic Care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of falls	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)
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
Activities of Daily Living	30 days, 3 months and 12 months after index hospitalisation	Measured with Katz-6 ADL questionnaire
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
Number of all-cause hospital readmissions	30 days, 3 months and 12 months after index hospitalisation
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
Number of patients living independently	30 days, 3 months and 12 months after index hospitalisation
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
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
Mortality	30 days, 3 months and 12 months after index hospitalisation

Trial Locations

Locations (16)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

Amphia ziekenhuis; 🇳🇱 Breda, Noord Brabant, Netherlands

Leiden Universitair Medisch Centrum; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Gelderland, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

Amsterdam UMC- location AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Amsterdam UMC - location VUMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Zaans Medisch Centrum; 🇳🇱 Zaandam, Noord-Holland, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Overijssel, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Overijssel, Netherlands

Erasmus Medisch Centrum Rotterdam; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Meander Medisch Centrum Amersfoort; 🇳🇱 Amersfoort, Utrecht, Netherlands

Haga Ziekenhuis; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands