Testing the Re-Engineered Hospital Discharge

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00252057
First received: November 10, 2005
Last updated: April 13, 2009
Last verified: April 2009
Results First Received: February 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: ALL
Intervention: Behavioral: Re-Engineered Discharge

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants were recruited between January 1, 2006 and October 16, 2007, from the general medical floors at Boston Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The baseline interview was conducted after enrollment and prior to group assignment, but it did not affect this assignment or lead to exclusion from the study for any participant. All participants who gave consent and agreed to be in the study were assigned to a group

Reporting Groups
  Description
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.
Standard Hospital Discharge Participants received the routine, standard hospital discharge.

Participant Flow:   Overall Study
    Re-engineered Hospital Discharge     Standard Hospital Discharge  
STARTED     373     376  
COMPLETED     370     368  
NOT COMPLETED     3     8  
Withdrawal by Subject                 2                 5  
Death                 1                 2  
Participant previously enrolled                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Standard Hospital Discharge Participants received the routine, standard hospital discharge.
Total Total of all reporting groups

Baseline Measures
    Re-engineered Hospital Discharge     Standard Hospital Discharge     Total  
Number of Participants  
[units: participants]
  373     376     749  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     312     314     626  
>=65 years     61     62     123  
Age  
[units: years]
Mean ± Standard Deviation
  50.1  ± 15.1     49.6  ± 15.3     49.9  ± 15.2  
Gender  
[units: participants]
     
Female     178     199     377  
Male     195     177     372  
Region of Enrollment  
[units: participants]
     
United States     373     376     749  



  Outcome Measures

1.  Primary:   Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.   [ Time Frame: 30 days after discharge ]

2.  Secondary:   Adverse Events One Month After Discharge   [ Time Frame: 30 days after discharge ]
Results not yet posted.   Anticipated Posting Date:   08/2009   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events
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No Other Adverse Events Entered.


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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