Clinical trial NCT03178513: Post-Acute Physician Home Visit Program
Official title: Post-Acute Physician Home Visits: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: A Patient Discharged From an Acute-care Hospital Who Had an Acute Illness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: New or worsening symptoms
timeFrame: 30 days after discharge from hospital
Secondary outcomes:
measure: Total cost, 30-days post discharge
timeFrame: Day of discharge to 30 days later
measure: Total reimbursement, 30-days post discharge
timeFrame: Day of discharge to 30 days later
measure: 3-item Care Transition Measure, score
timeFrame: 30 days after discharge
measure: Primary care provider follow-up within 14 days, y/n
timeFrame: Day of discharge to 14 days later
measure: Ability to carry out the discharge plan, score
timeFrame: 30 days after discharge
measure: Change in medication list due to home visit, y/n
timeFrame: Day of home visit
measure: Receipt of prescribed medicines following discharge, y/n
timeFrame: 30 days after discharge
measure: Unplanned 30-day readmission(s) after index hospitalization, y/n
timeFrame: 30 days after discharge
measure: Unplanned 30-day readmission(s) after index hospitalization, #
timeFrame: 30 days after discharge
Other outcomes:
measure: Global satisfaction with care, score
timeFrame: 30 days after discharge
measure: Days at home since discharge, #
timeFrame: 30 days after discharge
measure: All-cause 30-day readmission(s) after index hospitalization, y/n
timeFrame: 30 days after discharge
measure: All-cause 30-day readmission(s) after index hospitalization, #
timeFrame: 30 days after discharge
measure: Emergency Department (ED) observation stay(s) after index hospitalization, y/n
timeFrame: 30 days after discharge
measure: Emergency Department (ED) observation stay(s) after index hospitalization, #
timeFrame: 30 days after discharge
measure: Emergency Department (ED) visit(s) after index hospitalization, #
timeFrame: 30 days after discharge
measure: Emergency Department (ED) visit(s) after index hospitalization, y/n
timeFrame: 30 days after discharge
measure: Imaging, #
timeFrame: 30 days after discharge
measure: Imaging, y/n
timeFrame: 30 days after discharge
measure: Lab orders, #
timeFrame: 30 days after discharge
measure: Lab orders, y/n
timeFrame: 30 days after discharge
measure: Physician visits, y/n
timeFrame: 30 days after discharge
measure: Physician visits, #
timeFrame: 30 days after discharge
measure: Home health utilization, days
timeFrame: 30 days after discharge
measure: Home health utilization, y/n
timeFrame: 30 days after discharge
measure: All cause 30-day mortality, y/n
timeFrame: 30 days after discharge
measure: Unplanned 30-day mortality, y/n
timeFrame: 30 days after discharge
measure: Change in medication list due to error at discharge, y/n
timeFrame: Visit date
measure: Pneumococcal vaccination if appropriate, y/n
timeFrame: 30 days after discharge
measure: Influenza vaccination if appropriate, y/n
timeFrame: 30 days after discharge
measure: Smoking cessation counseling if appropriate, y/n
timeFrame: 30 days after discharge
measure: Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
timeFrame: 30 days after discharge
measure: Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: 30 days after discharge
measure: Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: 30 days after discharge
measure: Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: 30 days after discharge
measure: Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
timeFrame: 30 days after discharge
measure: Smoking status post-discharge
timeFrame: 30 days after discharge
measure: Use of inappropriate medications in the elderly, y/n
timeFrame: 30 days after discharge
measure: Time between discharge and visit, days
timeFrame: Date of home visit
measure: Duration of physician visit, minutes
timeFrame: Date of home visit
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey Schnipper, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.