An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Gainesville、Florida、アメリカ、32608
- UF Health
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Jacksonville、Florida、アメリカ、32209
- UF Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Physical Function Between Baseline and 60 Days Post-ED Visit
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Donna L Carden, MD, MPH、University of Florida
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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