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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
|
|
Active Comparator: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Total Healthcare Cost Avoidance per Participant
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Medications Deprescribed per Participant
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Medication-Related Problems Identified and Resolved
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- 188/2026
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .