IVR-Enhanced Care Transition Support for Complex Patients

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Christine Ritchie, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01135381
First received: June 1, 2010
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Behavioral: IVR-Enhanced Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Re-hospitalizations [ Time Frame: During the 30days after discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rehospitalizations at 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Community Tenure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The number of days a patient spends in the home versus the hospital at 30 days.


Enrollment: 511
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • e-Coach
  • IVR
  • IVRS
  • 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:
  • e-Coach
  • IVR
  • IVRS
  • 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135381

Locations
United States, Alabama
University Hospital and UAB Highlands
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
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
  More Information

Publications:
Responsible Party: Christine Ritchie, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01135381     History of Changes
Other Study ID Numbers: 1-R18-HS017786
Study First Received: June 1, 2010
Results First Received: April 10, 2013
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
care transitions
information technology

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014