IVR-Enhanced Care Transition Support for Complex Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Congestive Heart Failure
• Interventions: Behavioral: IVR-Enhanced Care

• Registration Number: NCT01135381
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-04-10
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-31
• Last Update Submitted: 2013-05-31
• Results First Posted: 2013-06-03
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF patients, IVR-Enhanced Care	IVR-Enhanced Care	Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
COPD patients, IVR-Enhanced Care	IVR-Enhanced Care	Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.

Primary Outcome Measures

Name	Time	Method
Re-hospitalizations	During the 30days after discharge

Secondary Outcome Measures

Name	Time	Method
Rehospitalizations at 90 Days	90 days
Community Tenure	30 days	The number of days a patient spends in the home versus the hospital at 30 days.

Trial Locations

Locations (1)

University Hospital and UAB Highlands; 🇺🇸 Birmingham, Alabama, United States