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Testing the Re-Engineered Hospital Discharge

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ClinicalTrials.gov Identifier: NCT00252057
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : April 13, 2009
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):
Brian Jack, Boston University

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.

Condition or disease Intervention/treatment Phase
All Behavioral: Re-Engineered Hospital Discharge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 749 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Testing the Re-Engineered Hospital Discharge
Study Start Date : December 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
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.
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

No Intervention: Standard hospital discharge
Participants received the routine, standard hospital discharge.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252057

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United States, Massachusetts
Boston Medical center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
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Principal Investigator: Brian Jack, MD Boston Medical Center - Family Medicine
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Jack, PI, Boston University
ClinicalTrials.gov Identifier: NCT00252057    
Other Study ID Numbers: H-24858
First Posted: November 11, 2005    Key Record Dates
Results First Posted: April 13, 2009
Last Update Posted: March 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Brian Jack, Boston University:
adverse events