Clinical trial NCT00217867: Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization
Official title: A RCT to Reduce Cardiopulmonary Rehospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-22
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Rehospitalization
timeFrame: Measured at 30 days
Secondary outcomes:
measure: Subject satisfaction with intervention and hospital experience
timeFrame: Measured at discharge and 30 days
measure: Subject readiness for discharge
timeFrame: Measured at 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Brian Jack, MD
role: PRINCIPAL_INVESTIGATOR
References: