Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

Cardiovascular Diseases Clinical Trial

Official title:

A RCT to Reduce Cardiopulmonary Rehospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217867
• Other study ID #: H-25057
• Secondary ID: R01HL081307
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: July 26, 2017
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization		Measured at 30 days
Secondary	Subject satisfaction with intervention and hospital experience		Measured at discharge and 30 days
Secondary	Subject readiness for discharge		Measured at 30 days