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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178513
Other study ID # P000719
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2017
Est. completion date January 20, 2018

Study information

Verified date August 2019
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 20, 2018
Est. primary completion date January 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • A Patient Discharged From an Acute-care Hospital Who Had an Acute Illness

Intervention

Other:
Home visit
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

Locations

Country Name City State
United States Brigham and Women's Faulkner Hospital Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Global satisfaction with care, score Exploratory 30 days after discharge
Other Days at home since discharge, # Exploratory 30 days after discharge
Other All-cause 30-day readmission(s) after index hospitalization, y/n Exploratory 30 days after discharge
Other All-cause 30-day readmission(s) after index hospitalization, # Exploratory 30 days after discharge
Other Emergency Department (ED) observation stay(s) after index hospitalization, y/n Exploratory 30 days after discharge
Other Emergency Department (ED) observation stay(s) after index hospitalization, # Exploratory 30 days after discharge
Other Emergency Department (ED) visit(s) after index hospitalization, # Exploratory 30 days after discharge
Other Emergency Department (ED) visit(s) after index hospitalization, y/n Exploratory 30 days after discharge
Other Imaging, # Exploratory 30 days after discharge
Other Imaging, y/n Exploratory 30 days after discharge
Other Lab orders, # Exploratory 30 days after discharge
Other Lab orders, y/n Exploratory 30 days after discharge
Other Physician visits, y/n Exploratory 30 days after discharge
Other Physician visits, # Exploratory 30 days after discharge
Other Home health utilization, days Exploratory 30 days after discharge
Other Home health utilization, y/n Exploratory 30 days after discharge
Other All cause 30-day mortality, y/n Exploratory 30 days after discharge
Other Unplanned 30-day mortality, y/n Exploratory 30 days after discharge
Other Change in medication list due to error at discharge, y/n Exploratory Visit date
Other Pneumococcal vaccination if appropriate, y/n Exploratory 30 days after discharge
Other Influenza vaccination if appropriate, y/n Exploratory 30 days after discharge
Other Smoking cessation counseling if appropriate, y/n Exploratory 30 days after discharge
Other Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n 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
Other Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n Heart failure patients only; Exploratory 30 days after discharge
Other Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n Heart failure patients only; Exploratory 30 days after discharge
Other Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n Heart failure patients only; Exploratory 30 days after discharge
Other Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n Heart failure patients only; Exploratory 30 days after discharge
Other Smoking status post-discharge Heart failure patients only; Exploratory 30 days after discharge
Other Use of inappropriate medications in the elderly, y/n Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria 30 days after discharge
Other Time between discharge and visit, days Exploratory Date of home visit
Other Duration of physician visit, minutes Exploratory Date of home visit
Primary 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 Total cost, 30-days post discharge Day of discharge to 30 days later
Secondary Total reimbursement, 30-days post discharge Day of discharge to 30 days later
Secondary 3-item Care Transition Measure, score 30 days after discharge
Secondary Primary care provider follow-up within 14 days, y/n Day of discharge to 14 days later
Secondary Ability to carry out the discharge plan, score 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
Secondary Change in medication list due to home visit, y/n Physician-initiated medication change during home visit Day of home visit
Secondary Receipt of prescribed medicines following discharge, y/n Pharmacy confirmation 30 days after discharge
Secondary Unplanned 30-day readmission(s) after index hospitalization, y/n 30 days after discharge
Secondary Unplanned 30-day readmission(s) after index hospitalization, # 30 days after discharge