Clinical trial NCT01135381: IVR-Enhanced Care Transition Support for Complex Patients
Official title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: care transitions
information technology
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: US Department of Veterans Affairs
name: University of Massachusetts, Worcester
First posted: 2010-06-02
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Re-hospitalizations
timeFrame: During the 30days after discharge
Secondary outcomes:
measure: Rehospitalizations at 90 Days
timeFrame: 90 days
measure: Community Tenure
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital and UAB Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christine S Ritchie, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Thomas K Houston, MD, MSPH
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Joshua Richman, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Ritchie CS, Houston TK, Richman JS, Sobko HJ, Berner ES, Taylor BB, Salanitro AH, Locher JL. The E-Coach technology-assisted care transition system: a pragmatic randomized trial. Transl Behav Med. 2016 Sep;6(3):428-37. doi: 10.1007/s13142-016-0422-8.