Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
2017年8月21日 更新者：Johns Hopkins Bloomberg School of Public Health
The aim of this study is to pilot test a web-based, patient-centered educational program that encourages the patient to have an informed discussion about pain medication options with their emergency department (ED) provider.
研究概览
详细说明
This multi-site, randomized trial will evaluate an m-health program designed to aid the patient in making an informed decision about their pain treatment.
Patients reporting to the ED with an injury-related chief complaint who agree to participate are randomized to receive the intervention program, My Healthy Choices, or an attention-matched control.
My Healthy Choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor.
Data are collected through surveys at three time points during the ED encounter (baseline, immediately after the intervention, and just before discharge), and at a 6-week follow-up survey.
The primary outcomes are whether the patient prefers an opioid pain reliever (OPR) and whether the patient takes an OPR.
The investigators hope this program will facilitate patient-provider communication, as well as reduce the number of prescriptions written for OPRs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.
研究类型
介入性
注册 (实际的)
123
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
-
-
Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins Hospital Emergency Department
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West Virginia
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Morgantown、West Virginia、美国、26506
- West Virginia University Emergency Department
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-
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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ED visit for an injury- or pain-related chief complaint
- 18 years of age or older
- speak English
- has a smart phone or email address that is used on a regular basis
- no previous medical care for the current complaint
- triage pain score between 7-10
Exclusion Criteria:
- allergy to pain medications
- have used a prescription pain medication for more than two days in the past month
- report renal problems or a history of dialysis
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：预防
- 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 |
|---|---|
|
实验性的：Intervention Group
MyHealthyChoices
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My Healthy Choices explains what opioid pain medications are, assesses and explains the patient's risk factors related to taking opioids, assesses patient preferences about pain medications, and produces a tailored patient report based on the answers.
The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain.
Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage, and disposal and access to an educational web portal that contains more information on prescription pain medications and safety.
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安慰剂比较：Control Group
Health Risk Assessment
|
The WellSource health risk assessment content focuses on general health promotion, and the participant's overall health and wellness.
A summary report based on the participants' answers is sent to their email address.
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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 |
|---|---|---|
|
Change in Self-Reported Preference for Opioid Pain Reliever
大体时间：Baseline and Immediate Post-test
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Assessed via questionnaire on a scale of 0-10.
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Baseline and Immediate Post-test
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications
大体时间：Baseline and 6 weeks
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Assessed with a 25-item questionnaire.
Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.
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Baseline and 6 weeks
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Self-Reported Prescription Drug Storage and Disposal Behaviors
大体时间：6 weeks
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Assessed via 5 items on a questionnaire.
Behaviors will be scored correct or incorrect and tabulated across study groups.
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6 weeks
|
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：Andrea C Gielen, ScD ScM、Johns Hopkins Bloomberg School of Public Health
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)
2016年9月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2016年12月13日
首先提交符合 QC 标准的
2017年1月4日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (实际的)
2017年8月22日
上次提交的符合 QC 标准的更新
2017年8月21日
最后验证
2017年8月1日
更多信息
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.