Clinical trial NCT05899114: Less is More: Optimized Pharmacotherapy with Improved CoNtinuity of CarE in HospitaLized OLder PeOple
Official title: Less is More: Optimized Pharmacotherapy with Improved CoNtinuity of CarE in HospitaLized OLder PeOple
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polypharmacy
Medication Review
Keywords: Polypharmacy
Medication Review
Aged
Deprescribing
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Amsterdam UMC, location AMC
name: Amphia ziekenhuis
name: Catharina Ziekenhuis Eindhoven
name: Deventer Ziekenhuis
name: Diakonessenhuis, Utrecht
name: Erasmus Medical Center
name: HagaZiekenhuis
name: Leiden University Medical Center
name: Meander Medisch Centrum
name: University Medical Center Groningen
name: UMC Utrecht
name: Zaans Medisch Centrum
name: Ziekenhuisgroep Twente
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Zorgevaluatie Nederland
name: Canisius Wilhelmina Ziekenhuis (CWZ)
First posted: 2023-06-12
Enrollment: 2576
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Drug Related Readmissions in the first 30 days after index hospitalisation
timeFrame: 30 days after index hospitalisation
Secondary outcomes:
measure: Number of Drug Related Readmissions at 3 and 12 months after index hospitalisation
timeFrame: 3 and 12 months after index hospitalisation
measure: Duration of hospitalisation of Drug Related Readmission
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Time to first Drug Related Readmission
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Number of Emergency Department visits
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Number of all-cause hospital readmissions
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Healthcare costs
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Quality of Life measured with EQ-5D-5L
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Cost-effectiveness
timeFrame: During the 12 month follow-up
measure: Number of regular medications
timeFrame: At discharge from index hospitalisation and 30 days, 3 months and 12 months after index hospitalisation
measure: Number and type of recommendations in the intervention group
timeFrame: At discharge from index hospitalisation
measure: Number of implemented recommendations
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Activities of Daily Living
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Number of patients living independently
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Number of falls
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
measure: Mortality
timeFrame: 30 days, 3 months and 12 months after index hospitalisation
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: Noord Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - location VUMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC- location AMC
state: Noord-Holland
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
state: Noord-Holland
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
state: Overijssel
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum Amersfoort
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Rotterdam
state: Zuid Holland
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leiden Universitair Medisch Centrum
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Kees Kramers, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: