IVR-Enhanced Care Transition Support for Complex Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135381
• Other study ID #: 1R18HS017786
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: May 31, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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.

Locations

Country	Name	City	State
United States	University Hospital and UAB Highlands	Birmingham	Alabama

Sponsors (4)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University of California, San Francisco, University of Massachusetts, Worcester, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ritchie C, Richman J, Sobko H, Bodner E, Phillips B, Houston T. The E-coach transition support computer telephony implementation study: protocol of a randomized trial. Contemp Clin Trials. 2012 Nov;33(6):1172-9. doi: 10.1016/j.cct.2012.08.007. Epub 2012 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-hospitalizations		During the 30days after discharge	Yes
Secondary	Rehospitalizations at 90 Days		90 days	No
Secondary	Community Tenure	The number of days a patient spends in the home versus the hospital at 30 days.	30 days	No