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

2026年7月19日 更新者: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.

研究概览

研究类型

介入性

注册 (估计的)

260

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
有源比较器: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Total Healthcare Cost Avoidance per Participant
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Number of Medications Deprescribed per Participant
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Number of Medication-Related Problems Identified and Resolved
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年7月12日

首先提交符合 QC 标准的

2026年7月19日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月19日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 188/2026

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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