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Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance

19 luglio 2026 aggiornato da: Dr. Juhaina Al Maqbali, Sultan Qaboos University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

260

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control Arm: Usual Care
Altro: 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.
Comparatore attivo: Intervention Arm: Clinical Pharmacist-Led Bundled Care
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Healthcare Cost Avoidance per Participant
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Medications Deprescribed per Participant
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Medication-Related Problems Identified and Resolved
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sultan Qaboos University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

12 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 188/2026

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Control Arm (Usual Care)

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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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