Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance
Impact of a Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance Among Hospitalized Adults in Oman: A Prospective Randomized Controlled Study
This study aims to evaluate whether a clinical pharmacist-led bundled care model can improve medication use and health outcomes in hospitalized adult patients with preventable polypharmacy. Preventable polypharmacy refers to the use of multiple medications when some may no longer be necessary, may be inappropriate, or may increase the risk of medication-related harm.
Participants will be randomly assigned to receive either the pharmacist-led bundled care intervention in addition to usual hospital care or usual hospital care alone. The intervention includes comprehensive medication reconciliation, assessment of medication appropriateness, identification of potentially inappropriate medications, individualized deprescribing recommendations when appropriate, patient and caregiver education, discharge medication reconciliation, and follow-up after hospital discharge.
The study will compare important clinical outcomes between the two groups, including hospital readmissions, emergency department visits, adverse drug events, medication appropriateness, quality of prescribing, and healthcare costs. The findings will help determine whether integrating a clinical pharmacist-led bundled care model into routine hospital practice can improve patient safety, optimize medication use, and reduce unnecessary healthcare utilization.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 years or older.
- Admitted under an adult medical specialty at one of the participating hospitals.
- Receiving five or more regular medications at the time of hospital admission.
- Expected hospital stay of at least 48 hours.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Admission under obstetric, pediatric, or psychiatric services.
- Admission to an intensive care unit.
- Terminal illness with an expected survival of less than three months.
- Unable to provide informed consent and without an available legal representative.
- Declines participation in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control Arm: Usual Care
|
Participants randomized to the control arm will receive usual hospital care provided according to the standard practices of the participating institutions.
This includes routine medical and nursing care, medication prescribing and review by the treating healthcare team, and standard discharge processes.
No structured clinical pharmacist-led bundled care intervention, standardized comprehensive medication review, protocol-driven deprescribing, or post-discharge pharmacist follow-up will be provided as part of the study.
Clinical pharmacy services that are routinely available at the participating hospitals may be provided as part of usual care but will not follow the standardized intervention protocol.
|
|
Comparateur actif: Intervention Arm: Clinical Pharmacist-Led Bundled Care
|
Participants randomized to the intervention arm will receive a structured clinical pharmacist-led bundled care model in addition to usual hospital care.
The intervention includes medication reconciliation at admission, comprehensive medication review, identification and resolution of medication-related problems, assessment of medication appropriateness using validated tools, deprescribing of potentially inappropriate medications when clinically indicated, dose optimization, evaluation of drug-drug interactions and medication safety, individualized pharmaceutical care planning, participation in multidisciplinary care with recommendations to the treating team, patient and caregiver medication counseling, discharge medication reconciliation, provision of an updated medication list, and post-discharge follow-up to reinforce medication adherence, identify medication-related problems, and optimize ongoing therapy.
All interventions will be delivered according to a standardized study protocol
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Healthcare Cost Avoidance per Participant
Délai: 90 days after hospital discharge
|
The difference between the intervention and control groups in total healthcare cost avoidance per participant associated with the clinical pharmacist-led bundled care model. Total cost avoidance will include direct medication and investigation cost reductions and indirect costs avoided through prevention of adverse drug events, reduced hospital length of stay, and reductions in unplanned hospital readmissions and emergency department visits. Cost avoidance will be calculated using institutional healthcare utilization and costing data and standardized cost-avoidance values for accepted pharmacist interventions. |
90 days after hospital discharge
|
|
Prevalence of Preventable Polypharmacy at Hospital Discharge
Délai: through study completion, an average of 1 week during admission
|
The proportion of participants with one or more unnecessary, inappropriate, duplicative, or potentially harmful medications at hospital discharge, compared between the pharmacist-led bundled care group and the usual-care group.
Preventable polypharmacy will be assessed using predefined clinical criteria, comprehensive medication review, and validated medication-appropriateness tools.
|
through study completion, an average of 1 week during admission
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Medications Deprescribed per Participant
Délai: through study completion, an average of 1 week during admission
|
The number of unnecessary, inappropriate, duplicative, or potentially harmful medications discontinued following medication review.
Only deprescribing recommendations accepted and implemented by the treating medical team will be counted.
|
through study completion, an average of 1 week during admission
|
|
Incidence of Adverse Drug Events
Délai: From hospital admission through 90 days after discharge
|
During the index hospitalization and at 90 days after hospital discharge
|
From hospital admission through 90 days after discharge
|
|
All-Cause Hospital Readmission
Délai: 30 days and 90 days after hospital discharge
|
The proportion of participants with at least one unplanned all-cause hospital readmission following discharge, compared between the intervention and control groups.
|
30 days and 90 days after hospital discharge
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Medication-Related Problems Identified and Resolved
Délai: through study completion, an average of 1 week during admission
|
The number and type of medication-related problems identified by clinical pharmacists and the proportion resolved following acceptance and implementation of pharmacist recommendations.
|
through study completion, an average of 1 week during admission
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 188/2026
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .