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临床试验/NCT03169868
NCT03169868终止不适用

A Pilot Prospective, Randomized Controlled Trial Assessing Enhanced Medication Reconciliation With a Clinical Decision Support Tool in Patients With Serious Mental Illness.

Precera Bioscience, Inc.2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
26
试验地点
2
主要终点
Medical record accuracy

研究概览

简要总结

The purpose of this study is to evaluate the clinical utility of a decision support tool, the Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication reconciliation and identification of drug-related problems in patients with serious mental illness.

详细描述

Lack of adherence to medications is an identifiable and growing problem in the United States and can result in disease progression, disease complications, treatment failure, a lower quality of life, and increased morbidity and mortality. Medication-related problems and medication nonadherence have been estimated to cost $177 billion annually in total direct and indirect U.S. health care costs. Moreover, medication adherence rates are poor for individuals diagnosed with chronic conditions such as diabetes, depression, and schizophrenia, which require long-term therapy. Recent publications have estimated that nearly 50% of patients in the U.S. being treated for chronic conditions are non-adherent to their medication regimens. Although increased medication adherence may lead to increased spending on drug therapy, it is associated with greatly reduced total health care costs and usage, and better patient outcomes.

Persons diagnosed with serious mental illness (SMI) such as schizophrenia and bipolar disorder are at higher risk than the general population for medication nonadherence, cardiovascular mortality, and medical co-morbidities such as diabetes, hypertension, dyslipidemia, obesity, nicotine dependence, and coronary heart disease. Poor adherence to complex medication regimens, decreased access to care, and uncoordinated care between psychiatry and medical care teams, have been identified as key contributors to the disparities experienced by this patient population.

The United States healthcare system is complex and healthcare is fragmented, particularly for those with serious mental illness who are often prescribed multiple medications from numerous providers. One unifying piece of information that is of critical importance for optimizing patient care is the patient medication list. Unfortunately, appropriate medication reconciliation to obtain the correct medication list and information about medication adherence is a complex and imperfect process. Using patient pharmacy records, electronic health record (EHR), and patient interviews, discrepancies have been found with over one third of patients upon hospital admission. Therefore, it can be expected that most polypharmacy patients (defined as taking five or more medications) have errors in their medical record.

National and world health associations have identified several opportunities for health professionals to provide services that aim to increase medication adherence and decrease medication related problems. Several of the recommendations emphasize the use of coordinated multidisciplinary efforts to provide patients with the most access to care and the highest quality education about their medications. Pharmacists are among the most accessible health care professionals and have specialized training to identify, prevent, and resolve drug-related problems (DRPs). As medication experts, pharmacists are important members of the multidisciplinary team and are uniquely positioned to impact medication-related health outcomes through accurate medication reconciliation, comprehensive mediation reviews (CMR), and interventions to improve medication safety and adherence.

An objective measure of what medications patients are actually taking would enable healthcare teams to better identify and tailor interventions to each specific patient situation. Using a novel therapeutic drug monitoring assay and empirical clinical decision support tool, Sano has shown that errors in patient medication lists are prevalent and poorly reflect patient adherence to the intended medication regimen and actual medication exposure. For example, in a cohort of psychiatry patients, only 37% were fully adherent to all medications in their treatment regimen and roughly one in five medications detected was not in the medical record. We anticipate that when medication reconciliation is performed by a pharmacist using Sano's clinical decision support tool, medication adherence will improve and more drug therapy problems will be identified and resolved. As a result, we expect to see an improvement in patient outcomes and a reduction in healthcare spending (i.e. post-hospitalization unplanned healthcare utilization).

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current insurer is UPMC Health Plan
  • Currently active in CRS clinic
  • Prescribed four or more medications as indicated by pre-study Health Plan Medication List
  • Able to provide informed consent for present study

排除标准

  • Not competent to give informed consent in the opinion of the investigator
  • Having had a previous medication reconciliation by the clinical pharmacist

研究组 & 干预措施

Enhanced Medication reconciliation

Experimental

Medication reconciliation with pharmacist using electronic health records, pharmacy dispensing data and Sano Patient Medication Profile(TM)

干预措施: Sano Patient Medication Profile (Diagnostic Test)

Standard Medication reconciliation

No Intervention

Medication reconciliation with pharmacist using electronic health records and pharmacy dispensing data only

结局指标

主要结局

Medical record accuracy

时间窗: 3 months

The "Final Medication List" (medications in EHR at final visit) will be compared to the detected medications as summarized in the Patient Medication Profile at final visit (approx 3 months). For each patient, the proportion of detected medications that are not in the medication list will be calculated, excluding OTC medications from the analysis. Medical record accuracy in the intervention and control groups will be compared.

次要结局

  • Drug Related Problem Identification and resolution(3 months)
  • Adherence to prescribed medications(3 months)
  • Automated vs. manual pharmacist-led medication reconciliation(0 months)

研究者

发起方
Precera Bioscience, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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