NCT03178513

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

June 5, 2017

Last Update Submit

August 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • New or worsening symptoms

    "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 Outcomes (9)

  • Total cost, 30-days post discharge

    Day of discharge to 30 days later

  • Total reimbursement, 30-days post discharge

    Day of discharge to 30 days later

  • 3-item Care Transition Measure, score

    30 days after discharge

  • Primary care provider follow-up within 14 days, y/n

    Day of discharge to 14 days later

  • Ability to carry out the discharge plan, score

    30 days after discharge

  • +4 more secondary outcomes

Other Outcomes (31)

  • Global satisfaction with care, score

    30 days after discharge

  • Days at home since discharge, #

    30 days after discharge

  • All-cause 30-day readmission(s) after index hospitalization, y/n

    30 days after discharge

  • +28 more other outcomes

Study Arms (2)

Home visit

EXPERIMENTAL

A participant in this arm will receive a home visit after discharge from the hospital.

Other: Home visit

Usual Care

NO INTERVENTION

A participant in this arm will not receive a home visit after discharge from the hospital.

Interventions

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

Home visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Undomiciled
  • In police custody
  • Domestic violence screen positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (6)

  • 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.

    PMID: 17431881BACKGROUND
  • 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.

    PMID: 19217498BACKGROUND
  • 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.

    PMID: 9400040BACKGROUND
  • 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.

    PMID: 23978408BACKGROUND
  • 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.

    PMID: 27631713BACKGROUND
  • 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.

    PMID: 19786916BACKGROUND

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Jeffrey Schnipper, MD MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 7, 2017

Study Start

June 6, 2017

Primary Completion

January 20, 2018

Study Completion

January 20, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations