Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899114
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-05-23
Brief Title:
Less Is More Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Less Is More Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMONCELLO
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
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 2576 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
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 2576 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10330032010002 | OTHER_GRANT | ZonMw | None |