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

NCT07719907 | Not Yet Recruiting

• 1 other identifier: 188/2026
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Medication-related Problems

Outcome Measures

Primary Outcomes (2)

• Total Healthcare Cost Avoidance per Participant

  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

  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

Secondary Outcomes (3)

• Number of Medications Deprescribed per Participant

  through study completion, an average of 1 week during admission

• Incidence of Adverse Drug Events

  From hospital admission through 90 days after discharge

• All-Cause Hospital Readmission

  30 days and 90 days after hospital discharge

Other Outcomes (1)

• Number of Medication-Related Problems Identified and Resolved

  through study completion, an average of 1 week during admission

Study Arms (2)

Control Arm: Usual Care

ACTIVE COMPARATOR

Other: Control Arm (Usual Care)

Intervention Arm: Clinical Pharmacist-Led Bundled Care

ACTIVE COMPARATOR

Other: Clinical Pharmacist-Led Bundled Care

Interventions

Clinical Pharmacist-Led Bundled Care OTHER

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

Intervention Arm: Clinical Pharmacist-Led Bundled Care

Control Arm (Usual Care) OTHER

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.

Control Arm: Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Specialist Pharmacist

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07