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

19. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

260

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Arm: Usual Care
Andet: 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.
Aktiv komparator: Intervention Arm: Clinical Pharmacist-Led Bundled Care
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Healthcare Cost Avoidance per Participant
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Medications Deprescribed per Participant
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Medication-Related Problems Identified and Resolved
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sultan Qaboos University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

12. juli 2026

Først indsendt, der opfyldte QC-kriterier

19. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 188/2026

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Medicin-relaterede problemer

Kliniske forsøg med Control Arm (Usual Care)

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Betingelser

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