Testing the Re-Engineered Hospital Discharge

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00252057
• Collaborator: (none)
• Enrollment: 749
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 34.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
All	Behavioral: Re-Engineered Hospital Discharge	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 749 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Testing the Re-Engineered Hospital Discharge
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 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.; Other Names: RED
No Intervention: Standard hospital discharge Participants received the routine, standard hospital discharge.

Outcome Measures

Primary Outcome Measures

1. Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Brian Jack, MD, Boston Medical Center - Family Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Agency for Healthcare Research and Quality
• Boston Medical Center

Publications

None provided.

• Responsible Party: Brian Jack, PI, Boston University
• ClinicalTrials.gov Identifier: NCT00252057
• Other Study ID Numbers: H-24858
• First Posted: Nov 11, 2005
• Last Update Posted: Mar 28, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Brian Jack, PI, Boston University: rehospitalization; readmission; adverse events; discharge

Study Results

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Re-engineered Hospital Discharge	Standard Hospital Discharge	Total
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 Participants	373	376	749
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (15.1)	49.6 (15.3)	49.9 (15.2)
Sex: Female, Male (Count of Participants)
Female	178 47.7%	199 52.9%	377 50.3%
Male	195 52.3%	177 47.1%	372 49.7%
Region of Enrollment (participants) [Number]
United States	373 100%	376 100%	749 100%

Outcome Measures

1. Primary Outcome

Title	Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Re-engineered Hospital Discharge	Standard Hospital Discharge
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.
Measure Participants	370	368
Number [Total number of rehospitalizations]	116	166

Adverse Events

Arm/Group Title	Re-engineered Hospital Discharge		Standard Hospital Discharge
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Re-engineered Hospital Discharge		Standard Hospital Discharge
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/373 (0%)		0/376 (0%)
Other (Not Including Serious) Adverse Events
	Re-engineered Hospital Discharge		Standard Hospital Discharge
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/373 (0%)		0/376 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.