IVR-Enhanced Care Transition Support for Complex Patients

Study Overview
=================
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.

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

Conditions
-----------------
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: IVR-Enhanced Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF patients, IVR-Enhanced Care<br>Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention. | Behavioral: IVR-Enhanced Care<br>* 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.<br>* Other names: Interactive voice response-supported system;|
| Experimental: COPD patients, IVR-Enhanced Care<br>Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention. | Behavioral: IVR-Enhanced Care<br>* 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.<br>* Other names: Interactive voice response-supported system;|
| No Intervention: CHF patients, Usual Discharge Care<br>Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention). | |
| No Intervention: COPD patients, Usual Discharge Care<br>Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
care transitions, information technology