IVR-Enhanced Care Transition Support for Complex Patients

May 31, 2013 updated by: Christine Ritchie, University of Alabama at Birmingham

E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients

For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events, including the experience of a medical error or loss of community tenure. Recent successful studies have used a Care Transition Intervention (CTI), using a nurse who conducts home visits, telephone follow-up, and provides assistance at and after discharge. Although successful, this model is costly and and not feasible in settings serving geographically dispersed populations. We propose a cost-efficient technological solution to the problems presented by the traditional CTI through "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention. We propose to develop and evaluate "e-Coach," by performing a randomized controlled trial of this intervention versus a usual care comparison group. Our Specific Aims are to: 1) Randomize 720 patients at high risk of transition-related errors (complex adult patients discharged alive after a hospitalization with congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD), from a geographically diverse area including many rural areas across Alabama and the South) to an IVR-supported care transition program ("e-Coach") versus a usual care comparison group. The IVR system will actively call patients at multiple intervals after discharge. In a stepped-care approach, the IVR will be further supported by a Care Transition nurse who monitors patient symptoms through the e-Coach IVR and supports patient self management through telephone-based interactions when needed, up to 3 months after discharge; 2) Evaluate use of the e-Coach by patients and healthcare providers; 3) Evaluate the impact of the e-Coach on patient outcomes, including 90 day rehospitalizations, successful community tenure over a 3 month period, medication discrepancies, and patient self-efficacy based on the previously validated Care Transition Measure; and 4) Quantify the cost associated with the e-Coach.

Study Type

Interventional

Enrollment (Actual)

511

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Hospital and UAB Highlands

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:

  • CHF/COPD patients
  • English-speaking
  • Medicare beneficiaries

Amendment to Inclusion Criteria:

  • Recruited non-Medicare eligible beneficiaries

Exclusion Criteria:

  • Prognosis of 6 months or less
  • Cognitive impairment with no available proxy/caregiver
  • No possession of a phone

Amendments to exclusion criteria:

  • heart or lung transplant recipients
  • dialysis patients
  • individuals already in the Cystic Fibrosis program or receiving intensive monitored care
  • individuals with a ventricular assist device (LVAD; RVAD; BiVAD)
  • individuals utilizing a pre-paid phone service

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CHF patients, IVR-Enhanced Care
Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
Behavioral: IVR-Enhanced Care
Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified.
Other Names:
  • IVRS
  • e-Coach
  • IVR
  • IVR Care Transition Support
  • Interactive voice response-supported system
EXPERIMENTAL: COPD patients, IVR-Enhanced Care
Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
Behavioral: IVR-Enhanced Care
Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified.
Other Names:
  • IVRS
  • e-Coach
  • IVR
  • IVR Care Transition Support
  • Interactive voice response-supported system
NO_INTERVENTION: CHF patients, Usual Discharge Care
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
NO_INTERVENTION: COPD patients, Usual Discharge Care
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Re-hospitalizations
Time Frame: During the 30days after discharge
During the 30days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehospitalizations at 90 Days
Time Frame: 90 days
90 days
Community Tenure
Time Frame: 30 days
The number of days a patient spends in the home versus the hospital at 30 days.
30 days

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

US Department of Veterans Affairs
University of California, San Francisco
University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Christine S Ritchie, MD, MSPH, University of Alabama at Birmingham
  • Study Director: Thomas K Houston, MD, MSPH, University of Massachusetts, Worcester
  • Study Chair: Joshua Richman, MD, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (ESTIMATE)

June 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18HS017786 (AHRQ)

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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