Post-Acute Physician Home Visit Program

August 9, 2019 updated by: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Faulkner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:

  • Medical assessment
  • Psychosocial assessment
  • Medication reconciliation
  • Follow-up of inpatient primary team's specific recommendations
  • Follow-up, as needed, with primary care team or inpatient team
No Intervention: Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.

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
Day of discharge to 30 days later
Total reimbursement, 30-days post discharge
Time Frame: Day of discharge to 30 days later
Day of discharge to 30 days later
Primary care provider follow-up within 14 days, y/n
Time Frame: Day of discharge to 14 days later
Day of discharge to 14 days later
Ability to carry out the discharge plan, score
Time Frame: 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
Time Frame: Day of home visit
Physician-initiated medication change during home visit
Day of home visit
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
Exploratory
30 days after discharge
Lab orders, #
Time Frame: 30 days after discharge
Exploratory
30 days after discharge
Lab orders, y/n
Time Frame: 30 days after discharge
Exploratory
30 days after discharge
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
Home health utilization, days
Time Frame: 30 days after discharge
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
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
Exploratory
Visit date
Pneumococcal vaccination if appropriate, y/n
Time Frame: 30 days after discharge
Exploratory
30 days after discharge
Influenza vaccination if appropriate, y/n
Time Frame: 30 days after discharge
Exploratory
30 days after discharge
Smoking cessation counseling if appropriate, y/n
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Smoking status post-discharge
Time Frame: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Use of inappropriate medications in the elderly, y/n
Time Frame: 30 days after discharge
Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
30 days after discharge
Time between discharge and visit, days
Time Frame: Date of home visit
Exploratory
Date of home visit
Duration of physician visit, minutes
Time Frame: Date of home visit
Exploratory
Date of home visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey Schnipper, MD MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

January 20, 2018

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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