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IVR-Enhanced Care Transition Support for Complex Patients

Primary Purpose

Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVR-Enhanced Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congestive Heart Failure focused on measuring care transitions, information technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital and UAB Highlands

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

CHF patients, IVR-Enhanced Care

COPD patients, IVR-Enhanced Care

CHF patients, Usual Discharge Care

COPD patients, Usual Discharge Care

Arm Description

Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.

Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.

Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).

Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).

Outcomes

Primary Outcome Measures

Re-hospitalizations

Secondary Outcome Measures

Rehospitalizations at 90 Days
Community Tenure
The number of days a patient spends in the home versus the hospital at 30 days.

Full Information

First Posted
June 1, 2010
Last Updated
May 31, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
University of California, San Francisco, US Department of Veterans Affairs, University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01135381
Brief Title
IVR-Enhanced Care Transition Support for Complex Patients
Official Title
E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of California, San Francisco, US Department of Veterans Affairs, University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
care transitions, information technology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF patients, IVR-Enhanced Care
Arm Type
Experimental
Arm Description
Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
Arm Title
COPD patients, IVR-Enhanced Care
Arm Type
Experimental
Arm Description
Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
Arm Title
CHF patients, Usual Discharge Care
Arm Type
No Intervention
Arm Description
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
Arm Title
COPD patients, Usual Discharge Care
Arm Type
No Intervention
Arm Description
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
Intervention Type
Behavioral
Intervention Name(s)
IVR-Enhanced Care
Other Intervention Name(s)
e-Coach, IVR, IVRS, IVR Care Transition Support, Interactive voice response-supported system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Re-hospitalizations
Time Frame
During the 30days after discharge
Secondary Outcome Measure Information:
Title
Rehospitalizations at 90 Days
Time Frame
90 days
Title
Community Tenure
Description
The number of days a patient spends in the home versus the hospital at 30 days.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine S Ritchie, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas K Houston, MD, MSPH
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joshua Richman, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital and UAB Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22922245
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.
Results Reference
background
PubMed Identifier
27339715
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.
Results Reference
derived

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IVR-Enhanced Care Transition Support for Complex Patients

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