Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

July 26, 2017 updated by: Brian Jack, Boston Medical Center

A RCT to Reduce Cardiopulmonary Rehospitalization

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

832

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rehospitalization
Time Frame: Measured at 30 days
Measured at 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject satisfaction with intervention and hospital experience
Time Frame: Measured at discharge and 30 days
Measured at discharge and 30 days
Subject readiness for discharge
Time Frame: Measured at 30 days
Measured at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brian Jack, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-25057
  • R01HL081307 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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