Elsevier

Contemporary Clinical Trials

Volume 33, Issue 6, November 2012, Pages 1172-1179
Contemporary Clinical Trials

The E-Coach transition support computer telephony implementation study: Protocol of a randomized trial

https://doi.org/10.1016/j.cct.2012.08.007Get rights and content

Abstract

Background

Patients requiring complex care are at high risk during the transition from one setting of care to another. Effective interventions to support care transitions have been designed but are very resource intensive. Telemonitoring has been considered as an approach to enhance care transition support, but many telemonitoring systems require special equipment or web-based interfaces to interact with patients and caregivers.

Methods/design

In this paper we report our protocol for developing and testing E-Coach, an interactive voice response (IVR)-enhanced care transition intervention that monitors patients at home using their personal phone. The elements described include 1) development of an IVR monitoring system that will be based on Coleman's four pillars of care transition support; 2) development of a web-based “dashboard” of IVR responses that alert care transition nurses (CTN) of patient/caregiver concerns after discharge and allow documentation by the CTN when patients/caregivers are called; 3) pilot testing of the IVR system by patients and providers with refinement of the system based on patient/provider input; and 4) a pragmatic protocol for formal testing through a randomized controlled trial (RCT) of the E-Coach intervention in congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) patients admitted to a large tertiary hospital. Trial Registration: CT.gov#: NCT01135381.

Introduction

Patients with complex care needs experience increased vulnerability when transitioning from one setting of care to another. In particular, the transition from the hospital setting to home places complex patients in jeopardy of adverse events and increases their risk for loss of community tenure. Approximately 20% of recently discharged patients experience adverse events, [1], [2] often precipitated by ineffective communication. Among over 15,000 hospitalized patients, 11.9% reported new or worsening symptoms within 3 to 5 days of leaving the hospital [3]. One-quarter of post-hospitalization Medicare beneficiaries experienced one or more transfers from lower- to higher-intensity care environments within the first 30 days post-discharge meeting the definition of a complicated care transition. Eight percent of these care transitions resulted in death during the 30-day post hospitalization time period [4].

Interventions have been tested to improve care transitions for complex hospitalized patients. Coleman and colleagues designed the Care Transitions Model based on focus groups demonstrating gaps in 4 domains at discharge: 1) medication self-management, 2) lack of a patient-centered health record owned and maintained by the patient to facilitate cross-site information transfer, 3) inconsistent follow-up with primary or specialty care, and 4) lack of knowledge by the patient or caregiver regarding warning signs and symptoms indicative of a worsening condition and instructions on how to respond to them. Coleman's intervention was coordinated by a transition nurse coach and included an in-hospital meeting with the patient prior to discharge, then patient follow-up, first by home visit and then by telephone 3 times during a 28-day post hospitalization discharge period. In a randomized controlled trial, the intervention reduced rehospitalization rates by 30% and 26% at 30 and 90 days respectively. Although the intervention reduced hospital costs compared to the control ($2058 vs. $2546), the intervention required intensive resource allocation, due to the requirement that the transition coach make home visits and proactive phone calls, and therefore could only take care of 24 to 28 patients at any given time [6].

Interactive voice response (IVR) systems allow interaction between patients and databases using a standard telephone. IVR systems can obtain information from patients and deliver recorded telephone messages, instructions, reminders, or tailored education. IVR systems have the distinct advantage of being accessible around the clock without geographic restriction [5], [7], [8]. IVR systems have been extensively studied for monitoring of chronic conditions and to support health behavior change [5]. Despite the flexibility of this technology, use of IVR to support health care transitions remains relatively underdeveloped [9]. Using the core elements of the Care Transition Model, we developed the “E-Coach” interactive voice response (IVR) system, an IVR-enhanced coaching and monitoring program. We chose this model because it utilizes the telephone, a means of communication more ubiquitous than the Internet that is not limited by geographic distance. Further, the use of this system facilitated efficient use of care transition nurse resources, because it gathered relevant clinical information to prompt transition nurses to call only those patients with concerns and need for transitional support, while providing a mechanism to monitor patients who are doing well without necessitating a personal follow-up call.

In this report we present the general study protocol for E-Coach, a pragmatic clinical trial. We also present preliminary data from pilot testing of the system and subsequent system refinements. This trial is pragmatic in several aspects, including a strong partnering and co-funding relationship with our collaborating Health Care System. In light of recent interest in pragmatic trials from the NIH Director's office, we focus on the pragmatic aspects of our study using the pragmatic–explanatory continuum indicator summary (PRECIS) [10] tools to visually demonstrate where we view this protocol on the continuum.

Section snippets

Study design

E-Coach is a multi-phase study that includes 1) development of an IVR monitoring system that is based on Coleman's four pillars of care transition support; 2) development of a web-based “dashboard” for care transition nurses, with alerts of patient/caregiver concerns after discharge; 3) pilot testing of the IVR system by patients and providers with refinement of the system based on patient/provider input; and 4) formal testing through a randomized controlled trial (RCT) of the E-Coach

Discussion

Care transitions are complex and require creative solutions to address the need for cost-effective post-discharge monitoring and support, especially for patients spanning a broad geographic area. We describe our protocol for the development and testing of a care transition support system that relies only on the nearly-ubiquitous telephone for monitoring, education and triaged coaching support.

As noted, our trial varies on the dimensions of the PRECIS tool (Fig. 3). We are most pragmatic in the

List of abbreviations

    IVR

    interactive voice response

    RCT

    randomized controlled trial

    CHF

    congestive heart failure

    COPD

    chronic obstructive pulmonary disease

    UAB

    University of Alabama at Birmingham

    LVAD

    left ventricular assist device

Authors' contributions

CR: conception of study and oversight of all study activities, preparation of manuscript; JR: participation in study oversight, study design and statistical analyses, review of manuscript; HS: involvement in IVR design, focus groups, IVR content development, study implementation, review of manuscript; EB: design and programming of systems, data management, review of manuscript; TH: conception of study and co-oversight of all study activities, preparation of manuscript.

Acknowledgments

This project is supported by an Agency for Healthcare Research and Quality Care of Complex Patients grant # R18-HS017786-02.

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