Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma
2014年3月3日 更新者：Children's Hospital of Philadelphia
A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial
The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.
研究概览
详细说明
Inner-city children are particularly at risk for poor asthma treatment outcomes and frequently obtain their asthma care in the ED. Prior studies have had limited success in improving primary care follow-up, quality of care, and long-term outcomes after a pediatric ED visit for asthma. Prior ED-based interventions have been designed to address barriers to follow-up with a primary care provider (PCP) such as an inability to obtain a follow-up appointment or lack of transportation. Focus groups and surveys of inner-city families have found that beliefs about the benefits of follow-up care and the role of preventive asthma medications have a strong impact on adherence to therapy.
This study will develop a brief educational video about the benefits of follow-up asthma care using a multi-disciplinary panel of experts at the Children's Hospital of Philadelphia and focus groups of parents of children with asthma. This educational video will then be combined into an intervention along with symptom screening and a reminder phone call that has been demonstrated to improve follow-up rates in a previous study. The combined intervention will be tested using a randomized trial design to determine its efficacy on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an ED visit. The research is conducted as part of a research career development award.
研究类型
介入性
注册 (实际的)
439
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
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
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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
1年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 1-18 years
- History of Asthma:
- At least 2 prior episodes of bronchodilator treatment
- No underlying cardiac disease
- No other chronic lung disease
- Residence within Philadelphia city limits
- Discharged from ED after treatment for asthma
Exclusion Criteria:
- Prior study enrollment
- Parent unable to speak English
- No telephone to be reachable for follow-up calls
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control Subjects
These subjects will receive standard discharge instructions that recommend follow-up with a PCP within 3-5 days.
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实验性的：Intervention Subjects
As part of the intervention, the family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups.
For children reporting persistent asthma symptoms, a letter will be given to the family to bring to their PCP stating that screening revealed symptoms that may require further treatment with controller medications.
A mailed reminder to schedule a follow-up appointment will be sent to the family.
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The subject's family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups; a mailed reminder will be sent to the family to schedule a follow-up appointment.
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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 |
|---|---|---|
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Follow-up with a Primary Care Physician (PCP)
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects will complete the Parental Impressions of the Benefits (pros) and barriers (cons) of Follow-Up Care Scale (24-item instrument designed to measure perceived benefits and barriers to follow-up after an ED visit).
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about the number of asthma-related follow-up visits which have been made to the Primary Care Physician.
Information provided by families will be verified by medical record review.
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4 weeks, 3 months and 6 months after Emergency Department visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Return to the Emergency Department for an asthma-related visit.
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit.
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Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about the number of asthma-related visits which have been made to the Emergency Department.
Information provided by families will be verified by medical record review.
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4 weeks, 3 months and 6 months after Emergency Department visit.
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Persistent asthma symptoms
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects will complete a screening instrument to assess the symptoms of persistent asthma (including cough, wheeze, shortness of breath).
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about asthma symptoms and information will be compared to baseline.
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4 weeks, 3 months and 6 months after Emergency Department visit
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Asthma Controller prescriptions by Primary Care Physician (PCP)
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies.
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about the number of asthma controller medication prescriptions made by their Primary Care Physician.
Information provided by families will be verified by medical record review.
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4 weeks, 3 months and 6 months after Emergency Department visit
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Asthma controller medication use
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies.
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about current asthma controller controller medication use.
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4 weeks, 3 months and 6 months after Emergency Department visit
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Days of school/work missed
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects will complete a screening interview which will assess asthma history.
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about the number of missed work/school days due to asthma-related reasons.
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4 weeks, 3 months and 6 months after Emergency Department visit
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Peak expiratory flow
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, all subjects over the age of 6 will receive a peak expiratory flow meter and instruction as per standard care in the Emergency Department.
Follow-up telephone contact will be made by the Primary Investigator or a research assistant.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about peak expiratory flow meter testing since the initial Emergency Department visit.
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4 weeks, 3 months and 6 months after Emergency Department visit
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Quality of life
大体时间：4 weeks, 3 months and 6 months after Emergency Department visit
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At baseline, parents will be asked to complete the Integrated Therapeutics Group Child Asthma Short Form (8-item asthma-related quality of life questionnaire).
Follow-up telephone contact will be made by the Primary Investigator or a research assistant.
The person making the call will be unaware of the subjects group assignment (control or intervention).
Families will be asked about the asthma-related quality of life since the initial Emergency Department visit.
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4 weeks, 3 months and 6 months after Emergency Department visit
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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：Joseph J. Zorc、Children's Hospital of Philadelphia
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
2003年9月1日
初级完成 (实际的)
2006年6月1日
研究完成 (实际的)
2006年6月1日
研究注册日期
首次提交
2005年6月9日
首先提交符合 QC 标准的
2005年6月9日
首次发布 (估计)
2005年6月10日
研究记录更新
最后更新发布 (估计)
2014年3月4日
上次提交的符合 QC 标准的更新
2014年3月3日
最后验证
2014年3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.
Intervention Subjects的临床试验
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人