- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178513
Post-Acute Physician Home Visit Program
Post-Acute Physician Home Visits: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02130
- Brigham and Women's Faulkner Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home visit
A participant in this arm will receive a home visit after discharge from the hospital.
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The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:
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No Intervention: Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New or worsening symptoms
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-item Care Transition Measure, score
Time Frame: 30 days after discharge
|
30 days after discharge
|
|
Total cost, 30-days post discharge
Time Frame: Day of discharge to 30 days later
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Day of discharge to 30 days later
|
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Total reimbursement, 30-days post discharge
Time Frame: Day of discharge to 30 days later
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Day of discharge to 30 days later
|
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Primary care provider follow-up within 14 days, y/n
Time Frame: Day of discharge to 14 days later
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Day of discharge to 14 days later
|
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Ability to carry out the discharge plan, score
Time Frame: 30 days after discharge
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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
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Change in medication list due to home visit, y/n
Time Frame: Day of home visit
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Physician-initiated medication change during home visit
|
Day of home visit
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Receipt of prescribed medicines following discharge, y/n
Time Frame: 30 days after discharge
|
Pharmacy confirmation
|
30 days after discharge
|
Unplanned 30-day readmission(s) after index hospitalization, y/n
Time Frame: 30 days after discharge
|
30 days after discharge
|
|
Unplanned 30-day readmission(s) after index hospitalization, #
Time Frame: 30 days after discharge
|
30 days after discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global satisfaction with care, score
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Days at home since discharge, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
All-cause 30-day readmission(s) after index hospitalization, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
All-cause 30-day readmission(s) after index hospitalization, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Emergency Department (ED) observation stay(s) after index hospitalization, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Emergency Department (ED) visit(s) after index hospitalization, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Emergency Department (ED) visit(s) after index hospitalization, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Imaging, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Imaging, y/n
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
|
Lab orders, #
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
|
Lab orders, y/n
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
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Physician visits, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Physician visits, #
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
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Home health utilization, days
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
|
Home health utilization, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
All cause 30-day mortality, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
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Unplanned 30-day mortality, y/n
Time Frame: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
Change in medication list due to error at discharge, y/n
Time Frame: Visit date
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Exploratory
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Visit date
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Pneumococcal vaccination if appropriate, y/n
Time Frame: 30 days after discharge
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Exploratory
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30 days after discharge
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Influenza vaccination if appropriate, y/n
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
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Smoking cessation counseling if appropriate, y/n
Time Frame: 30 days after discharge
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Exploratory
|
30 days after discharge
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Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
Time Frame: 30 days after discharge
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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
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Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time Frame: 30 days after discharge
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Heart failure patients only; Exploratory
|
30 days after discharge
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Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time Frame: 30 days after discharge
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Heart failure patients only; Exploratory
|
30 days after discharge
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Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time Frame: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
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Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
Time Frame: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
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Smoking status post-discharge
Time Frame: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
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Use of inappropriate medications in the elderly, y/n
Time Frame: 30 days after discharge
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Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
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30 days after discharge
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Time between discharge and visit, days
Time Frame: Date of home visit
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Exploratory
|
Date of home visit
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Duration of physician visit, minutes
Time Frame: Date of home visit
|
Exploratory
|
Date of home visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Schnipper, MD MPH, Brigham and Women's Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P000719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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