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Testing the Re-Engineered Hospital Discharge

Testing the Re-Engineered Hospital Discharge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00252057
Enrollment
749
Registered
2005-11-11
Start date
2005-12-31
Completion date
2007-10-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All

Keywords

rehospitalization, readmission, adverse events, 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.

Interventions

BEHAVIORALRe-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.

Sponsors

Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.30 days after dischargeThe 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.

Countries

United States

Participant flow

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

Participants by arm

ArmCount
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.
373
Standard Hospital Discharge
Participants received the routine, standard hospital discharge.
376
Total749

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath12
Overall StudyParticipant previously enrolled01
Overall StudyWithdrawal by Subject25

Baseline characteristics

CharacteristicStandard Hospital DischargeRe-engineered Hospital DischargeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
62 Participants61 Participants123 Participants
Age, Categorical
Between 18 and 65 years
314 Participants312 Participants626 Participants
Age, Continuous49.6 years
STANDARD_DEVIATION 15.3
50.1 years
STANDARD_DEVIATION 15.1
49.9 years
STANDARD_DEVIATION 15.2
Region of Enrollment
United States
376 participants373 participants749 participants
Sex: Female, Male
Female
199 Participants178 Participants377 Participants
Sex: Female, Male
Male
177 Participants195 Participants372 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3730 / 376
serious
Total, serious adverse events
0 / 3730 / 376

Outcome results

Primary

Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 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.

Time frame: 30 days after discharge

ArmMeasureValue (NUMBER)
Re-engineered Hospital DischargeTotal Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.116 Total number of rehospitalizations
Standard Hospital DischargeTotal Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.166 Total number of rehospitalizations

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026