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Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse

2019年6月25日 更新者:Kathy Goggin、Children's Mercy Hospital Kansas City
Antibiotic overuse and misuse contributes to the development of antibiotic resistant infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of these prescriptions are unnecessary. The most important factor that leads to overprescribing is inadequate parent-provider communication. This study will recruit providers and eligible parents of children 1-5 years of age. Parents in both arms will receive identical brief antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. Parent data will be collected via a tablet computer RedCap survey administered in the exam room prior and immediately following the child's visit. Additional data will be garnered from the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with parents (re-visits and adverse drug reactions).

研究概览

详细说明

Significance: Antibiotic overuse and misuse contribute to the development of antibiotic resistant infections that kill at least 23,000 Americans and cause an additional 2 million infections annually. If left unchecked, antibiotic resistant infections are estimated to cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department visits annually.

The majority of all antibiotic prescribing occurs in outpatient settings where children receive 49 million prescriptions annually. Over 70% of these are for respiratory infections and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to overprescribing, but chief among them is inadequate parent-provider communication.

Innovation: This study is the first US multi-site randomized controlled trial comparing the effectiveness an education vs. communication skills provider intervention to stimulate high quality parent-provider communication and judicious use of antibiotics.

Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will be enrolled and exposed to one of the interventions based on the provider they see for their visit. English and Spanish speaking parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical brief negatively behavioral framed antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing. Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits and adverse drug reactions. Data will be collected via a tablet computer administered RedCap survey administered in the exam room prior and immediately following the child's visit. Additional data will be garnered from the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with parents (re-visits and adverse drug reactions).

Public Health Impact: This study could have significant public health implications and meet the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which seeks to slow the emergence of resistant bacteria and prevent the spread of resistant infections through the judicious and appropriate use of antibiotics.

研究类型

介入性

注册 (实际的)

1600

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kansas
      • Kansas City、Kansas、美国、66109
        • Heartland Primary Care
      • Lenexa、Kansas、美国、66227
        • Heartland Primary Care
    • Missouri
      • Kansas City、Missouri、美国、64111
        • Children's Mercy Pediatric Care Clinic

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria: \

  • Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking

Exclusion Criteria:

  • Parents of children who require hospitalization
  • Received antibiotics in the last 30 days
  • Have concurrent bacterial infection, an immune compromising condition or chronic medical condition

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:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Education
All providers will receive identical training on the appropriate prescribing of antibiotics for ARTIs in a 20 minute presentation. Follow up refresher video clips will also be available for all providers to view at their convenience throughout the study. Parents in both arms will receive identical high quality education on the pros and cons of antibiotics and tips for communicating with their provider.
The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections. This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.
有源比较器:Communication Skills
Providers randomized to the communication intervention will receive additional training on communication skills in a 40 minute communication skills training session. This training session will include good and bad communication examples, training on positive and negative behavioral framing, and education regarding key drivers of patient satisfaction.
The second intervention is an education plus communication skills training intervention. This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction. Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.

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
Inappropriate antibiotic use
大体时间:18 months
Patient medical records will be reviewed 2 weeks after the visit to determine the clinical diagnosis and whether or not antibiotics were given. Determination will be made regarding the appropriateness of the diagnosis and prescribing using current clinical practice guidelines.
18 months

次要结果测量

结果测量
措施说明
大体时间
Revisits
大体时间:18 months
All parents will be called 2 weeks following the initial visit to determine if any revisits to the same office or to another health care facility were made after the initial visit for either clinical worsening or lack of clinical improvement, or due to an adverse drug reaction.
18 months
Adverse drug reactions
大体时间:18 months
All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.
18 months
Shared decision-making
大体时间:18 months
Parents will rate the quality of the shared decision-making using validated survey instruments
18 months
Parent Satisfaction with visit
大体时间:18 months
Parents will rate the their satisfaction with the visit using validated measures.
18 months

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。

调查人员

  • 首席研究员:Jason G. Newland, MD、Washington University School of Medicine
  • 首席研究员:Kathy Goggin, PhD、Childrens Mercy Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2017年3月3日

初级完成 (实际的)

2019年3月20日

研究完成 (实际的)

2019年4月30日

研究注册日期

首次提交

2017年1月27日

首先提交符合 QC 标准的

2017年1月30日

首次发布 (估计)

2017年1月31日

研究记录更新

最后更新发布 (实际的)

2019年6月26日

上次提交的符合 QC 标准的更新

2019年6月25日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • PCORI150731759

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the final year of funding. Prior to data sharing, we will remove or convert all identifying information (date of birth will be converted to age and other identifiers will be removed). There may remain the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users under a data-sharing agreement.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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