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Testing the Re-Engineered Hospital Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00252057
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : April 13, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Brian Jack, Boston University

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 11, 2005
Results First Submitted Date  ICMJE February 10, 2009
Results First Posted Date  ICMJE April 13, 2009
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2009)
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. [ Time Frame: 30 days after discharge ]
The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
rehospitaliazation rates at 1 month post discharge
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
adverse events at 1 month post discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing the Re-Engineered Hospital Discharge
Official Title  ICMJE Testing the Re-Engineered Hospital Discharge
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE All
Intervention  ICMJE Behavioral: Re-Engineered Hospital Discharge
The "Re-engineered Hospital Discharge" (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist.
Other Name: RED
Study Arms  ICMJE
  • Experimental: Re-engineered hospital discharge
    Participants received the "Re-Engineered Hospital Discharge", a set of 11 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: Behavioral: Re-Engineered Hospital Discharge
  • No Intervention: Standard hospital discharge
    Participants received the routine, standard hospital discharge.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2009)
749
Original Enrollment  ICMJE
 (submitted: November 10, 2005)
432
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00252057
Other Study ID Numbers  ICMJE H-24858
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Brian Jack, Boston University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Boston University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Jack, MD Boston Medical Center - Family Medicine
PRS Account Boston University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP