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Testing the Re-Engineered Hospital Discharge
This study is currently recruiting participants.
Verified by Boston University, April 2007
Sponsored by: Boston University
Information provided by: Boston University
ClinicalTrials.gov Identifier: NCT00252057
  Purpose

The purpose of this study is to determine if the "Re-Engineered Discharge" will decrease rehospitalization rates and adverse events of patients leaving Boston Medical Center.


Condition Intervention Phase
ALL
Behavioral: Re-Engineered Discharge
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Testing the Re-Engineered Hospital Discharge

Further study details as provided by Boston University:

Primary Outcome Measures:
  • rehospitaliazation rates at 1 month post discharge

Secondary Outcome Measures:
  • adverse events at 1 month post discharge

Estimated Enrollment: 432
Study Start Date: December 2005
Estimated Study Completion Date: September 2007
Detailed Description:

This project responds to the problems of non-standardized care and discontinuity at hospital discharge. Post-discharge adverse events are common and have been well documented. However, to date, there are no studies demonstrating the effectiveness of any procedures or tools designed to reduce them. This work builds on our "Safe Practices Implementation Challenge Grant" in which we developed the "Reengineered Hospital Discharge" tool, a set of 10 discrete, mutually reinforcing components. Hypotheses: The newly designed "Re-engineered Hospital Discharge" intervention will (1) reduce the percentage of patients experiencing a post-discharge adverse event, and (2) reduce subsequent hospital utilization (emergency department visits and rehospitalization) within 30 days following hospital discharge. Population Studied: Patients from a network of Community Health Centers discharged from a general medical service at an urban hospital. The subjects studied represent a low-income, ethnically diverse urban population. This study meets AHRQ guidelines for the inclusion of priority populations in research. Methods: 432 adult patients admitted to the general medical service of Boston Medical Center will be enrolled and randomized to (1) those receiving routine discharge as defined by our "Process Map" (Control Group); and (2) those receiving our "Re-engineered Hospital Discharge" intervention, a set of 10 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist (Intervention Group). Outcome Measures: The primary patient centered outcomes are: the combined 30-day subsequent hospital utilization (readmission and emergency department use), and health status as measured by the SF-12. Process outcomes include the number and severity of the adverse events related to the discharge 30 days after discharge. Although not a primary outcome, an economic analysis will be completed. Expected Results: This project will provide valuable information about whether the "Re-Engineered Discharge" will reduce adverse events related to discharge and decrease subsequent hospital utilization. Deliverables/Dissemination: An advisory committee of senior Boston Medical Center leaders will oversee the project and, if proven effective, will implement the intervention throughout our Academic Medical Center. The "Re-engineered Hospital Discharge" tool will be widely generalizable and widely disseminated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The Project Director will meet with the subject to determine if the patient meets inclusion or exclusion criteria.

Inclusion criteria include are patients who:

  1. are over 18 years old;
  2. are to be discharged to a community, non-institutionalized setting;
  3. report that they desire to be hospitalized in the future if there is a clinical need; and
  4. are admitted to Firm B of the BMC Inpatient Service.

Exclusion Criteria:

  1. admitted to non-general Medical services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry);
  2. requiring hospice, nursing home or other institutional settings upon discharge,
  3. who die during the admission,
  4. subjects who speak languages other than English;
  5. those who indicate that they have no access to a telephone or unable to give a contact telephone number; and
  6. those not competent to sign informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252057

Contacts
Contact: Brian Jack, MD 617-414-5956 brian.jack@bmc.org
Contact: Anna Johnson 617-414-6210 anna.johnson@bmc.org

Locations
United States, Massachusetts
Boston Medical center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Brian Jack, MD     617-414-5956     brian.jack@bmc.org    
Contact: Anna Johnson     617-414-6210     anna.johnson@bmc.org    
Principal Investigator: Brian Jack, MD            
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Brian Jack, MD Boston Medical Center - Family Medicine
  More Information

Agency for Healthcare Research and Quality  This link exits the ClinicalTrials.gov site
Boston Medical Center  This link exits the ClinicalTrials.gov site

Study ID Numbers: IU18HS015905-01, RFA-HS-05-012
Study First Received: November 10, 2005
Last Updated: April 3, 2007
ClinicalTrials.gov Identifier: NCT00252057  
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
rehospitaliazation
readmission
adverse events
discharge

ClinicalTrials.gov processed this record on January 14, 2009