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Completed

NCT Number: NCT01135381

IVR-Enhanced Care Transition Support for Complex Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital and UAB Highlands

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVR-Enhanced Care

Behavioral

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.

Other names: e-Coach, IVR, IVRS, IVR Care Transition Support, Interactive voice response-supported system

Primary outcomes

  1. Re-hospitalizations

    Time frame: During the 30days after discharge

Secondary outcomes

  1. Rehospitalizations at 90 Days

    Time frame: 90 days

  2. Community Tenure

    Time frame: 30 days

    The number of days a patient spends in the home versus the hospital at 30 days.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • US Department of Veterans Affairs
  • University of California, San Francisco
  • University of Massachusetts, Worcester

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2010
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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