TY - JOUR
T1 - Less Is More
T2 - Optimized pharmacotherapy with improved coNtinuity of CarE in hospitaLized oLder peOple (LIMONCELLO): study protocol of a cluster randomized controlled trial
AU - Cooijmans, Sjacky
AU - Engelen, Eline M C
AU - Wuyts, Stéphanie C M
AU - Kramers, Cornelis
AU - van Agtmael, Michiel A
AU - van den Bemt, Patricia M L A
AU - Bouvy, Marcel L
AU - Amouch, Hayat
AU - Autar, Reshma S
AU - Benoist, Guillemette E
AU - van Berlo-van de Laar, Inge R F
AU - Derijks-Engwegen, Judith Y M N
AU - van den Elsen, Geke
AU - Engelaer, Frouke M
AU - Gombert-Handoko, Kim B
AU - Jansen, David R M
AU - Kerskes, Marieke H M
AU - Kruik-Kollöffel, Willemien J
AU - Kuijvenhoven, Marianne A
AU - van der Kuy, Hugo M
AU - Labots, Geert
AU - van Poelgeest, Eveline P
AU - Sablerolles, Roos
AU - Sallevelt, Bastiaan T G
AU - van Stiphout, Feikje
AU - Storm, Bert N
AU - Taks, Margot
AU - Teeuwisse, Patty J I
AU - Uiterwijk, Jonne
AU - Vondeling, Ariël
AU - de Vries, Merijn
AU - Wesselink, Elsbeth
AU - Wiggers, Nikki M L
AU - de Wit, Hugo A J M
AU - Schers, Henk J
AU - Adang, Eddy M M
AU - van Wely, Madelon
AU - van Herwaarden, Noortje
AU - Knol, Wilma
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/12/24
Y1 - 2025/12/24
N2 - BACKGROUND: Polypharmacy is associated with negative health outcomes including drug-related hospital admissions, particularly in older patients. Approximately half of drug-related (re)admissions are potentially preventable, and are therefore a target for healthcare interventions. Several studies have investigated the effects of in-hospital medication reviews on clinically relevant outcome measures, such as drug-related readmissions (DRAs). The identified factors for success of the intervention were multicomponent interventions, multidisciplinary approaches, attention to transitional care and the selection of high-risk patients. In the present study, the impact of transitional multidisciplinary pharmacotherapeutic care (TMPC) on DRAs in a high-risk population is assessed.METHODS: Less Is More: Optimized pharmacotherapy with improved coNtinuity of CarE in hospitaLized oLder peOple (LIMONCELLO) is a cluster randomized controlled trial. A cluster is defined at the hospital level, and each cluster is randomly allocated (1:1) to the intervention or control group stratified by university or general hospitals. Patients aged 70 years and older with polypharmacy, a current non-elective hospital admission, completed medication reconciliation, and an increased risk of a DRA, as determined by the use of a DRA prediction model, are selected. TMPC consists of four elements: a pharmacotherapeutic analysis, a transitional multidisciplinary discussion, a pharmacotherapeutic care interview including shared decision-making with the patient, and a discharge letter with the pharmacotherapeutic plan sent to the general practitioner and community pharmacist. The comparator is usual care provided in the participating control hospitals. The primary outcome is the proportion of patients with DRA in the first 30 days after discharge. The secondary outcomes include cost-effectiveness, quality of life, and mortality.DISCUSSION: The novelty of this study lies in the selection of a patient group expected to be at high risk for DRAs, on the basis of an evidence-based prediction model, as well as in the combination of components used in the intervention. By selecting high-risk patients and applying a multicomponent approach, this study is expected to increase current knowledge on the effects of TMPC on clinically relevant outcomes and cost-effectiveness in hospitalized older patients.TRIAL REGISTRATION: Clinicaltrials.gov: NCT05899114, prospective submission, registration June 02 2023 (first inclusion June 5 2023).
AB - BACKGROUND: Polypharmacy is associated with negative health outcomes including drug-related hospital admissions, particularly in older patients. Approximately half of drug-related (re)admissions are potentially preventable, and are therefore a target for healthcare interventions. Several studies have investigated the effects of in-hospital medication reviews on clinically relevant outcome measures, such as drug-related readmissions (DRAs). The identified factors for success of the intervention were multicomponent interventions, multidisciplinary approaches, attention to transitional care and the selection of high-risk patients. In the present study, the impact of transitional multidisciplinary pharmacotherapeutic care (TMPC) on DRAs in a high-risk population is assessed.METHODS: Less Is More: Optimized pharmacotherapy with improved coNtinuity of CarE in hospitaLized oLder peOple (LIMONCELLO) is a cluster randomized controlled trial. A cluster is defined at the hospital level, and each cluster is randomly allocated (1:1) to the intervention or control group stratified by university or general hospitals. Patients aged 70 years and older with polypharmacy, a current non-elective hospital admission, completed medication reconciliation, and an increased risk of a DRA, as determined by the use of a DRA prediction model, are selected. TMPC consists of four elements: a pharmacotherapeutic analysis, a transitional multidisciplinary discussion, a pharmacotherapeutic care interview including shared decision-making with the patient, and a discharge letter with the pharmacotherapeutic plan sent to the general practitioner and community pharmacist. The comparator is usual care provided in the participating control hospitals. The primary outcome is the proportion of patients with DRA in the first 30 days after discharge. The secondary outcomes include cost-effectiveness, quality of life, and mortality.DISCUSSION: The novelty of this study lies in the selection of a patient group expected to be at high risk for DRAs, on the basis of an evidence-based prediction model, as well as in the combination of components used in the intervention. By selecting high-risk patients and applying a multicomponent approach, this study is expected to increase current knowledge on the effects of TMPC on clinically relevant outcomes and cost-effectiveness in hospitalized older patients.TRIAL REGISTRATION: Clinicaltrials.gov: NCT05899114, prospective submission, registration June 02 2023 (first inclusion June 5 2023).
KW - Cluster randomized controlled trial
KW - Drug-related readmissions
KW - Inappropriate prescribing
KW - Medication review
KW - Older persons
KW - Polypharmacy
UR - https://www.scopus.com/pages/publications/105025809883
U2 - 10.1186/s12877-025-06533-0
DO - 10.1186/s12877-025-06533-0
M3 - Article
C2 - 41444867
SN - 1471-2318
VL - 25
JO - BMC Geriatrics
JF - BMC Geriatrics
IS - 1
M1 - 1034
ER -