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临床试验/NCT03803033
NCT03803033已完成不适用

Cost-benefit Analysis of a Clinical Pharmacist Intervention in Preventing Adverse Drug Events in the General Chronic Diseases Outpatients

Applied Science Private University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Cost-benefit analysis

研究概览

简要总结

Clinical pharmacy services are vital in the prevention of adverse drug events (ADEs) in clinical practice, extending beyond the hospital to chronic disease management in outpatient settings. This study sought to evaluate the cost-benefit of a clinical pharmacy intervention in resolving treatment-related problems (TRPs) among hospital outpatients with chronic diseases. From the hospital system perspective, the cost-benefit analysis was based on a randomized clinical trial in the general outpatients of the major hospital in Jordan. Eligible patients were randomly assigned to either an intervention or a control group. TRPs were identified in both study groups, but interventions were delivered only to the intervention group via a home medication management review (HMMR) by a clinical pharmacist. A follow-up in both groups took place 3 months after recruitment. The total economic benefit was the sum of (i) cost savings due to intervention and (ii) cost avoidance associated with preventable ADEs. The primary outcome measures were the net benefit and benefit-to-cost ratio with the clinical pharmacist-based HMMR. Based on both of the annual net benefit and benefit-to-cost ratio, the study intervention demonstrated to be cost beneficial. Sensitivity analyses confirmed the robustness of results. The RCT-based cost-benefit evaluation provided evidence-based insight into the economic benefit of a clinical pharmacist-provided HMMR for preventing ADEs in the general chronic diseases outpatients. This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the healthcare hospital payer in Jordan.

详细描述

Economic evaluation The total economic benefit of the intervention was calculated as the sum of the cost savings and the cost avoidance associated with the intervention.

Cost savings Cost savings based on the intervention were the reduced cost of therapy associated with treatment changes due to the intervention. Cost savings were therefore calculated as (the reduced cost of therapy in the intervention arm) minus (the reduced cost of therapy in the control arm).

Cost avoidance Cost avoidance was the cost avoided by eliminating the occurrence of ADEs as a consequence of the pharmacist interventions.

  • Based on the method of Nesbit et al., utilizing an expert panel of four specialist clinical pharmacists, the likelihood of an ADE in the absence of the intervention was set. The intervention with the potential to prevent an ADE was assessed for cost avoidance.
  • The cost of an ADE was calculated on the assumption that an ADE in an outpatient will lead to a single admission to an internal medicine ward via an emergency department visit.
  • For each intervention with the potential to prevent an ADE, cost avoidance was calculated by multiplying the probability of an ADE in the absence of the intervention (calculated via the Nesbit method) by the average cost of an ADE. The overall cost avoidance was the sum of avoided cost with all interventions for TRPs.

Cost-benefit analysis The net benefit was calculated as (cost saving) + (cost avoidance). It was assumed that no intervention would increase the probability of a preventable ADE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

A prospective single-blind randomized control trial (RCT) for evaluating the economic impact of a clinical pharmacist's identifying and managing of TRPs as part of an home medication management review

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years old;
  • with at least one chronic disease, defined as a condition requiring prolonged management for a minimum of 3 months;
  • living in Jordan for the past year;
  • intention to remain in Jordan for the 3-month study duration;
  • met at least one of the following criteria:
  • taking ≥5 medications, taking ≥12 doses a day, discharged from the hospital within the past 4 weeks, exposed to significant changes in medication regimens within the past 3 months, demonstrating symptoms of potential adverse drug reactions, or demonstrating a poor therapeutic response to medication therapy. A significant change to medication regimen was defined as discontinuing a medication, starting new medications, or stepping up because of actual or potential therapy failure or guideline recommendations. A poor therapeutic response was defined as persistence of symptoms despite treatment.

排除标准

  • Patients who don't have a chronic disease
  • Cognitive or sensory impairment that may prevent conducting the interview
  • Pregnant patients
  • Patients who are planning to travel within the next 3 months after the baseline visit to the clinic

研究组 & 干预措施

Intervention

Experimental

The objective of the group was to introduce an experimental clinical pharmacy-based home medication review service in the outpatient clinic setting of the Jordan University Hospital in Amman, Jordan. The intervention under evaluation in the study is the pharmacy-based home medication review service.

干预措施: Clinical pharmacy-based home medication management review service (Other)

Control

No Intervention

The objective of the control group was to identify changes in treatment and associated costs that take place in patients as part of the usual practice, as compared to the intervention arm, regardless of the clinical pharmacist service intervention.

结局指标

主要结局

Cost-benefit analysis

时间窗: Three months

The benefit-to-cost ratio was the (sum of cost savings and cost avoidance) divided by (cost of the intervention). The net benefit of the intervention was the (sum of cost savings and cost avoidance) minus (cost of the intervention). The scope of this is limited to cost consequences of TRPs and interventions addressing them, and does not include humanistic and clinical outcomes of interventions. Net benefit and benefit-to-cost ratio with the clinical pharmacist-based home-based service.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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