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| Sponsor: | Boston University |
|---|---|
| Information provided by: | Boston University |
| ClinicalTrials.gov Identifier: | NCT00252057 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
ALL |
Behavioral: Re-Engineered Discharge |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Testing the Re-Engineered Hospital Discharge |
| Enrollment: | 749 |
| Study Start Date: | December 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Boston Medical center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Brian Jack, MD | Boston Medical Center - Family Medicine |
More Information
| Responsible Party: | Ellen Jamieson, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00252057 History of Changes |
| Other Study ID Numbers: | IU18HS015905-01, RFA-HS-05-012 |
| Study First Received: | November 10, 2005 |
| Results First Received: | February 10, 2009 |
| Last Updated: | April 13, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
rehospitalization readmission adverse events discharge |