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临床试验/NCT01600677
NCT01600677终止不适用

Determining the Impact of a Medication Delivery Unit on Medication Adherence Immediately Following Hospitalization of Adults With Common Cardiac Conditions

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
Medication Adherence

研究概览

简要总结

The research study is a randomized controlled trial (RCT). The primary endpoint is to compare medication adherence of adult patients recently hospitalized with a diagnosis of common cardiac conditions who require medication assistance either by receiving usual care or by using a medication delivery unit. The overall study will last a total of 12 months. Each subject will be enrolled for a period of 90 days.

详细描述

Care transition interventions have been successful in reducing medication-related problems and associated rehospitalization primarily by focusing on medication reconciliation conducted by trained healthcare professionals. Programs to improve the medication reconciliation process have largely been effective but have limitations, including: the expenses associated with recruiting, training, and retaining care transition healthcare professionals; the ability to provide services within a finite geographic area; and the retrospective nature of the reconciliation process, which usually occurs in the home following hospital discharge.

Our short-term objective is to determine the impact of the INRange Systems Electronic Medication Management Assistant (EMMA) medication delivery unit (MDU) for adults that require medication assistance in their home immediately following an acute hospitalization with a diagnosis of a common cardiac condition. As part of this study, we will determine: (1) Medication adherence rates (# doses/doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts at days 1, 45 and 90 (control)); (2) Health service utilization; (3) Health economic assessment from health plan and societal perspectives; (4) Medication administration errors; (5) Patient experience and satisfaction; (6) Medication reconciliation errors (using medication discrepancy tool); (7) 30-day readmission rates; and (8) Factors related to continued use of the EMMA MDU.

Study Overview and Design: The research study design associated with this proposal is a randomized controlled trial (RCT) design. The primary endpoint is to compare medication adherence of adult patients recently hospitalized with a diagnosis of congestive heart failure who require medication assistance either by receiving usual care (i.e., the control group; take medications as they had before hospitalization) or by using a medication delivery unit (i.e., the intervention group; take medications only from the device, which will always differ from the usual way in which medications were taken prior to hospitalization).

Study duration: The overall study will last a total of 12 months. Each subject will be enrolled for a period of 90 days regardless of unit of randomization (i.e., control/usual care vs. intervention).

Subject Recruitment: One-hundred and sixty patients > 18 years old who are admitted to UPMC Presbyterian Hospital will be considered as potential study participants. Records of these patients will be pre-screened within 24 hours of admittance using inclusion and exclusion criteria that can be assessed without direct patient contact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

  • Patients > 18 years of age.
  • Admitted during the study period for a nonpsychiatric condition to UPMC Presbyterian Hospital.
  • Documented in their medical record with a common cardiac condition.
  • Prescribed > 3 and < 20 regularly scheduled (i.e., non-PRN) prescription medications.
  • Be from and return to a home setting (not to an assisted living or skilled nursing facility, or to a program for all-inclusive care of the elderly, etc).
  • Reside within a predefined geographic radius of the hospital (specifically, Allegheny, Beaver, Butler, Fayette, Washington or Westmoreland Counties).
  • Have a working telephone.
  • Be English-speaking.
  • Have an informal caregiver or support person.
  • Evidence of unintentional medication non-adherence

排除标准

  • Have an active prescription for narcotic analgesic.
  • Enrolled in or plan to enroll into hospice care.
  • Plans to travel during the next 90 days following discharge for >/= 14 consecutive days.
  • Participating in another research protocol.
  • Have evidence in the chart of a diagnosis of active delirium.
  • Have evidence in the chart of a diagnosis of dementia.
  • Have evidence in the chart of legal blindness.
  • Unable to demonstrate appropriate use of the EMMA medication delivery unit.
  • Unable to receive ATT wireless service data plan based on physical address.
  • Evidence of intentional medication non-adherence.

结局指标

主要结局

Medication Adherence

时间窗: 90-day

Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))

次要结局

  • Medication-reconciliation Errors During Transition From Hospital to Home(90-day)
  • Hospital Readmission Rates(30 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven M Handler, MD, PhD

Assistant Professor

University of Pittsburgh

研究点 (2)

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