Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252057
Other study ID # IU18HS015905-01
Secondary ID RFA-HS-05-012
Status Completed
Phase Phase 2
First received November 10, 2005
Last updated January 14, 2016
Start date December 2005
Est. completion date October 2007

Study information

Verified date April 2009
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 749
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Boston Medical center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 30 days after discharge Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05016947 - Venetoclax Plus Inotuzumab for B-ALL Phase 1
Recruiting NCT05009537 - Optical Genome Mapping in Hematological Malignancies
Terminated NCT01230788 - Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia N/A
Completed NCT00333190 - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation N/A
Recruiting NCT05461625 - ACL Reconstruction With/Without ALL Reconstruction N/A
Recruiting NCT02990572 - Amish/Mennonite Research Contact Registry
Completed NCT02631993 - Photochemotherapy and Graft-versus-leukemia in Acute-leukemia N/A
Completed NCT00863148 - Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL) Phase 2
Recruiting NCT04601584 - GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL Phase 1/Phase 2
Not yet recruiting NCT05592470 - commd7 Gene Expression in ALL
Recruiting NCT02861209 - Collaborative Network to Take Responsibility for Oral Anticancer Therapy N/A
Completed NCT01012492 - Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT Phase 2
Recruiting NCT04644016 - Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders Phase 2
Recruiting NCT06131801 - Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Recruiting NCT05476770 - Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies Phase 1
Recruiting NCT03571321 - Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia Phase 1
Recruiting NCT05414162 - Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy
Active, not recruiting NCT03154346 - Project Baseline Health Study
Terminated NCT01532635 - A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives Phase 2
Completed NCT01319864 - POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients Phase 1