An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
研究概览
详细说明
Investigators will review the ED electronic medical record in real-time to determine ED patients' study eligibility. Older, chronically ill ED patients who are eligible and agree to participate in the study will be randomly assigned to a healthcare coach and Care Transition Intervention or usual, post-ED care.
At the time of enrollment, all subjects will be asked to provide informed consent for study investigators to request Medicare Claims to determine how many ED visits, hospital admissions and doctor office visits the subject had at least 30 days after the index ED visit. All research participants will be asked basic personal information such as age, race, sex, employment and marital status. All subjects will be asked to complete a baseline survey about their quality of life.
If the subject is assigned to the Care Transition Intervention, the healthcare coach will visit the subject at home within 3 days of the ED visit. The coach will talk with the subject about following up with a regular, personal doctor and symptoms that indicate a worsening health condition. The coach will help the subject understand their medicines and help the subject make a personal health record (PHR). The coach will tell the subject about the Area Agency on Aging. If the subject receives usual care, they but will be given the usual discharge instructions from the ED nurse and doctor. If the subject receives the Care Transition Intervention, the coach will also call the subject at least 3 times after the ED visit and review the same items listed above.
All enrolled subjects will be asked to complete a phone survey within 31-60 days of the ED visit. This survey will again ask subjects about their quality of life.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Gainesville、Florida、美国、32608
- UF Health
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Jacksonville、Florida、美国、32209
- UF Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 60 years of age or older
- Medicare beneficiaries
- Community dwelling
- Reside within defined geographical area (to enable home visits)
- Have a working telephone
- Have at least one of the following conditions documented in their electronic medical record: congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, diabetes, stroke, pneumonia, medical and surgical back conditions (predominantly spinal stenosis), hip fracture, peripheral vascular disease, cardiac arrhythmias, deep venous thrombosis, pulmonary embolism, peptic ulcer disease or hemorrhage
Exclusion Criteria:
- Current diagnosis of psychosis
- Cancer
- Dialysis
- History of organ transplantation
- Dementia without a live-in caregiver, or
- In hospice care
- Reside outside the defined geographical area
- Reside in a skilled nursing or assisted living facility
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
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实验性的：ED-to-home care transition intervention
The ED-to-home care transition intervention is a coaching intervention.
It is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and at least 3 follow-up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.
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The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver.
During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit.
2: Knowledge of Red Flag Symptoms.
3: Medication Reconciliation.
4: The Personal Health Record (PHR).
The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.
其他名称：
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实验性的：Usual Care
Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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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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Change in Physical Function Between Baseline and 60 Days Post-ED Visit
大体时间：Baseline up to 60 days after index ED Visit
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PROMIS Physical Function instruments measure self-reported capability.
Each of 7-items in the physical function instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Physical Function Instrument used is 7 and the maximum score is 35.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average.
A Physical Function T-score of 40 is one SD worse than average.
Change in Physical Function is the difference between baseline and 60 day T-score.
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Baseline up to 60 days after index ED Visit
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Change in Anxiety Between Baseline and 60 Days Post-ED Visit
大体时间：Baseline up to 60 days after index ED Visit
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PROMIS Anxiety instruments measure self-reported fear, anxious misery, and hyperarousal.
Each of 8-items in the Anxiety Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Anxiety Instrument used is 8 and the maximum score is 40.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average and an Anxiety T-score of 40 is one SD better than average.
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Baseline up to 60 days after index ED Visit
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Change in Informational Support Between Baseline and 60 Days Post-ED Visit
大体时间：Baseline up to 60 days after index ED Visit
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PROMIS Informational Support instruments measure perceived availability of helpful information or advice.
Each of 5-items in the Informational Support Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Informational Support Instrument used is 5 and the maximum score is 25.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Informational Support, a T-score of 60 is one SD better than average and a T-score of 40 is one SD worse than average.
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Baseline up to 60 days after index ED Visit
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Number of Participants With Outpatient Visit Claims
大体时间：Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an outpatient visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With ED Visit Claims
大体时间：Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an ED visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With In-patient Admission Claims
大体时间：Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for a hospitalization in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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合作者和调查者
调查人员
- 首席研究员：Donna L Carden, MD, MPH、University of Florida
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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