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Completed

NCT Number: NCT00217867

Educational and Supportive Interventions to Prevent 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animated character intervention with telephone follow-up

Behavioral

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

Primary outcomes

  1. Rehospitalization

    Time frame: Measured at 30 days

Secondary outcomes

  1. Subject satisfaction with intervention and hospital experience

    Time frame: Measured at discharge and 30 days

  2. Subject readiness for discharge

    Time frame: Measured at 30 days

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

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

Registry information

Official study title

A RCT to Reduce Cardiopulmonary Rehospitalization

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2005
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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