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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
Sponsor:
Information provided by (Responsible Party):
Brian Jack, Boston University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition All
Intervention Behavioral: Re-Engineered Hospital Discharge
Enrollment 749
Recruitment Details All participants were recruited between January 1, 2006 and October 16, 2007, from the general medical floors at Boston Medical Center.
Pre-assignment Details 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
Arm/Group Title Re-engineered Hospital Discharge Standard Hospital Discharge
Hide Arm/Group Description 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. Participants received the routine, standard hospital discharge.
Period Title: Overall Study
Started 373 376
Completed 370 368
Not Completed 3 8
Reason Not Completed
Withdrawal by Subject             2             5
Death             1             2
Participant previously enrolled             0             1
Arm/Group Title Re-engineered Hospital Discharge Standard Hospital Discharge Total
Hide Arm/Group Description 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. Participants received the routine, standard hospital discharge. Total of all reporting groups
Overall Number of Baseline Participants 373 376 749
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 376 participants 749 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
312
  83.6%
314
  83.5%
626
  83.6%
>=65 years
61
  16.4%
62
  16.5%
123
  16.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 376 participants 749 participants
50.1  (15.1) 49.6  (15.3) 49.9  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 376 participants 749 participants
Female
178
  47.7%
199
  52.9%
377
  50.3%
Male
195
  52.3%
177
  47.1%
372
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 373 participants 376 participants 749 participants
373 376 749
1.Primary Outcome
Title Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.
Hide Description 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.
Time Frame 30 days after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Re-engineered Hospital Discharge Standard Hospital Discharge
Hide Arm/Group Description:
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.
Participants received the routine, standard hospital discharge.
Overall Number of Participants Analyzed 370 368
Measure Type: Number
Unit of Measure: Total number of rehospitalizations
116 166
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Re-engineered Hospital Discharge Standard Hospital Discharge
Hide Arm/Group Description 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. Participants received the routine, standard hospital discharge.
All-Cause Mortality
Re-engineered Hospital Discharge Standard Hospital Discharge
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Re-engineered Hospital Discharge Standard Hospital Discharge
Affected / at Risk (%) Affected / at Risk (%)
Total   0/373 (0.00%)   0/376 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Re-engineered Hospital Discharge Standard Hospital Discharge
Affected / at Risk (%) Affected / at Risk (%)
Total   0/373 (0.00%)   0/376 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brian Jack PI
Organization: Boston Medical Center
Phone: 617-414-44675
Responsible Party: Brian Jack, Boston University
ClinicalTrials.gov Identifier: NCT00252057     History of Changes
Other Study ID Numbers: H-24858
First Submitted: November 10, 2005
First Posted: November 11, 2005
Results First Submitted: February 10, 2009
Results First Posted: April 13, 2009
Last Update Posted: March 28, 2017