Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

NCT ID: NCT00217867

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cardiovascular Diseases Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Animated character intervention with telephone follow-up

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian Jack

faculty member, BMC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Jack, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL081307

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-25057

Identifier Type: -

Identifier Source: org_study_id

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