Post-Acute Physician Home Visit Program
2019年8月9日 更新者：Jeffrey L. Schnipper, MD.,MPH.、Brigham and Women's Hospital
Post-Acute Physician Home Visits: A Randomized Controlled Trial
New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission.
These rates are higher than desired and costly to patients, payers, and providers.
Many interventions have unsuccessfully attempted to reduce readmissions, but few have provided in-home personnel to patients transitioning from acute care back to ambulatory care.
Still fewer have involved a physician in the home.
We therefore will test the effect of a physician home visit to a patient's home who was discharged in the last 4 days.
研究概览
地位
完全的
干预/治疗
研究类型
介入性
注册 (实际的)
51
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
-
-
Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02130
- Brigham and Women's Faulkner Hospital
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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:
- Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
- Has capacity to consent to study
- >=18 years old
Exclusion Criteria:
- Undomiciled
- In police custody
- Domestic violence screen positive
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：支持治疗
- 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：Home visit
A participant in this arm will receive a home visit after discharge from the hospital.
|
The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:
|
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无干预：Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.
|
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 |
|---|---|---|
|
New or worsening symptoms
大体时间：30 days after discharge from hospital
|
"Since you got home from the hospital, have you had any symptoms at all?" If no, stop. If yes, continue. "I'm going to read off a list of symptoms, and I want you to tell me if that symptom is new or has gotten worse since you left the hospital. Please don't include symptoms that have stayed the same since you were in the hospital." For each affirmative, double check if the symptom is new or has gotten worse since getting out of the hospital. Only if new or worse, mark yes. |
30 days after discharge from hospital
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
3 项护理过渡措施，得分
大体时间：出院后30天
|
出院后30天
|
|
|
Total cost, 30-days post discharge
大体时间：Day of discharge to 30 days later
|
Day of discharge to 30 days later
|
|
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Total reimbursement, 30-days post discharge
大体时间：Day of discharge to 30 days later
|
Day of discharge to 30 days later
|
|
|
Primary care provider follow-up within 14 days, y/n
大体时间：Day of discharge to 14 days later
|
Day of discharge to 14 days later
|
|
|
Ability to carry out the discharge plan, score
大体时间：30 days after discharge
|
I would like to ask you about some more problems that you might have faced after you left the hospital one month ago.
I will read some statements and ask if you agree or disagree.
|
30 days after discharge
|
|
Change in medication list due to home visit, y/n
大体时间：Day of home visit
|
Physician-initiated medication change during home visit
|
Day of home visit
|
|
Receipt of prescribed medicines following discharge, y/n
大体时间：30 days after discharge
|
Pharmacy confirmation
|
30 days after discharge
|
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Unplanned 30-day readmission(s) after index hospitalization, y/n
大体时间：30 days after discharge
|
30 days after discharge
|
|
|
Unplanned 30-day readmission(s) after index hospitalization, #
大体时间：30 days after discharge
|
30 days after discharge
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Global satisfaction with care, score
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Days at home since discharge, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
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All-cause 30-day readmission(s) after index hospitalization, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
All-cause 30-day readmission(s) after index hospitalization, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) observation stay(s) after index hospitalization, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) visit(s) after index hospitalization, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) visit(s) after index hospitalization, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Imaging, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Imaging, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Lab orders, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Lab orders, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Physician visits, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Physician visits, #
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Home health utilization, days
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Home health utilization, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
All cause 30-day mortality, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Unplanned 30-day mortality, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Change in medication list due to error at discharge, y/n
大体时间：Visit date
|
Exploratory
|
Visit date
|
|
Pneumococcal vaccination if appropriate, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Influenza vaccination if appropriate, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Smoking cessation counseling if appropriate, y/n
大体时间：30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography
|
30 days after discharge
|
|
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory
|
30 days after discharge
|
|
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory
|
30 days after discharge
|
|
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory
|
30 days after discharge
|
|
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory
|
30 days after discharge
|
|
Smoking status post-discharge
大体时间：30 days after discharge
|
Heart failure patients only; Exploratory
|
30 days after discharge
|
|
Use of inappropriate medications in the elderly, y/n
大体时间：30 days after discharge
|
Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
|
30 days after discharge
|
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Time between discharge and visit, days
大体时间：Date of home visit
|
Exploratory
|
Date of home visit
|
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Duration of physician visit, minutes
大体时间：Date of home visit
|
Exploratory
|
Date of home visit
|
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：Jeffrey Schnipper, MD MPH、Brigham and Women's 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。
一般刊物
- Epstein K, Juarez E, Loya K, Gorman MJ, Singer A. Frequency of new or worsening symptoms in the posthospitalization period. J Hosp Med. 2007 Mar;2(2):58-68. doi: 10.1002/jhm.170.
- Boling PA. Care transitions and home health care. Clin Geriatr Med. 2009 Feb;25(1):135-48, viii. doi: 10.1016/j.cger.2008.11.005.
- Meyer GS, Gibbons RV. House calls to the elderly--a vanishing practice among physicians. N Engl J Med. 1997 Dec 18;337(25):1815-20. doi: 10.1056/NEJM199712183372507.
- Wong FK, Chow SK, Chan TM, Tam SK. Comparison of effects between home visits with telephone calls and telephone calls only for transitional discharge support: a randomised controlled trial. Age Ageing. 2014 Jan;43(1):91-7. doi: 10.1093/ageing/aft123. Epub 2013 Aug 26.
- Branowicki PM, Vessey JA, Graham DA, McCabe MA, Clapp AL, Blaine K, O'Neill MR, Gouthro JA, Snydeman CK, Kline NE, Chiang VW, Cannon C, Berry JG. Meta-Analysis of Clinical Trials That Evaluate the Effectiveness of Hospital-Initiated Postdischarge Interventions on Hospital Readmission. J Healthc Qual. 2017 Nov/Dec;39(6):354-366. doi: 10.1097/JHQ.0000000000000057.
- Wolff JL, Meadow A, Boyd CM, Weiss CO, Leff B. Physician evaluation and management of Medicare home health patients. Med Care. 2009 Nov;47(11):1147-55. doi: 10.1097/MLR.0b013e3181b58e30.
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6月6日
初级完成 (实际的)
2018年1月20日
研究完成 (实际的)
2018年1月20日
研究注册日期
首次提交
2017年6月5日
首先提交符合 QC 标准的
2017年6月5日
首次发布 (实际的)
2017年6月7日
研究记录更新
最后更新发布 (实际的)
2019年8月13日
上次提交的符合 QC 标准的更新
2019年8月9日
最后验证
2019年8月1日
更多信息
与本研究相关的术语
其他研究编号
- P000719
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Home visit的临床试验
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Geisinger ClinicPatient-Centered Outcomes Research Institute; Penn State University; University of Nebraska; Iowa...完全的
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)招聘中
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University Health Network, TorontoSunnybrook Health Sciences Centre; University of Toronto完全的
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)完全的
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Universitair Ziekenhuis BrusselUniversity Ghent; Universiteit Antwerpen; Artevelde University of Applied Sciences; Odisee University...招聘中