Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

Sponsor

Boston Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00217867

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

832

Enrollment

Location

Arms

Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will use a comprehensive hospital discharge toolkit to implement up-to-date guidelines for cardiopulmonary diseases. The study will also include a computer-based patient-education program and a telephone-based post-discharge program, both designed for individuals with limited health literacy. The purpose of this study is to reduce early hospital readmission.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Heart Diseases	Behavioral: Animated character intervention with telephone follow-up	N/A

Detailed Description

BACKGROUND:

Limited health literacy is prevalent in America and has been identified as a cross-cutting priority area for transforming health care quality. This study will explore the effect of innovative patient-education and self-management systems on early rehospitalization for patients admitted to a general medical service.

DESIGN NARRATIVE:

This is a two-armed randomized study of patients with chronic cardiopulmonary diseases in three levels of health literacy. Patients will be tested with the 66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM) test to allow us to analyze the data according to literacy categories ( 6th grade, 7th-8th grade, and 9th grade). Patients will be randomized to one of the following groups: 1) standard discharge (control group); 2) a experimental group receiving both the case management intervention plus educational and self-management support by Embodied Conversational Agents (ECAs) and post-discharge reinforcement of the discharge plan using a computerized telephone system

Study Design

Study Type:

Interventional

Actual Enrollment :

832 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A RCT to Reduce Cardiopulmonary Rehospitalization

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Usual Care, defined as the usual hospital discharge process as delivered by nurses and doctors.
Experimental: 2 Use of animated computerized character to prepare subjects for discharge by reviewing information provided to subjects in a printed After Hospital Care Plan packet, followed by telephone system to reinforce the discharge.	Behavioral: Animated character intervention with telephone follow-up Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.

Arm

Intervention/Treatment

No Intervention: 1

Usual Care, defined as the usual hospital discharge process as delivered by nurses and doctors.

Experimental: 2

Use of animated computerized character to prepare subjects for discharge by reviewing information provided to subjects in a printed After Hospital Care Plan packet, followed by telephone system to reinforce the discharge.

Behavioral: Animated character intervention with telephone follow-up

Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.

Outcome Measures

Primary Outcome Measures

Rehospitalization [Measured at 30 days]

Secondary Outcome Measures

Subject satisfaction with intervention and hospital experience [Measured at discharge and 30 days]
Subject readiness for discharge [Measured at 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Admitted to the general medical service at Boston Medical Center (BMC)
Desires to be hospitalized in the future if there is a clinical need
Able to communicate in English with health providers

Exclusion Criteria:

Transferred from an outside hospital or a specialty services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry)
Requires hospice, nursing home, or other institutional settings
Vision that is inadequate to discern the computer-based education and self-management support system
Hearing that is inadequate to use a telephone
Unable to independently consent
Scheduled admission (e.g. for surgery)
Has sickle cell disease

Contacts and Locations

Locations

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

Sponsors and Collaborators

Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Brian Jack, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brian Jack, faculty member, BMC, Boston Medical Center

ClinicalTrials.gov Identifier:

NCT00217867

Other Study ID Numbers:

H-25057
R01HL081307

First Posted:

Sep 22, 2005

Last Update Posted:

Jul 28, 2017

Last Verified:

Jul 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Heart Diseases

Study Results

No Results Posted as of Jul 28, 2017