NCT01135381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 3, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

June 1, 2010

Results QC Date

April 10, 2013

Last Update Submit

May 31, 2013

Conditions

Keywords

care transitionsinformation technology

Outcome Measures

Primary Outcomes (1)

  • Re-hospitalizations

    During the 30days after discharge

Secondary Outcomes (2)

  • Rehospitalizations at 90 Days

    90 days

  • Community Tenure

    30 days

Study Arms (4)

CHF patients, IVR-Enhanced Care

EXPERIMENTAL

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

Behavioral: IVR-Enhanced Care

COPD patients, IVR-Enhanced Care

EXPERIMENTAL

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

Behavioral: IVR-Enhanced Care

CHF patients, Usual Discharge Care

NO INTERVENTION

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

COPD patients, Usual Discharge Care

NO INTERVENTION

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

Interventions

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.

Also known as: e-Coach, IVR, IVRS, IVR Care Transition Support, Interactive voice response-supported system
CHF patients, IVR-Enhanced CareCOPD patients, IVR-Enhanced Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHF/COPD patients
  • English-speaking
  • Medicare beneficiaries
  • Recruited non-Medicare eligible beneficiaries

You may not qualify if:

  • Prognosis of 6 months or less
  • Cognitive impairment with no available proxy/caregiver
  • No possession of a phone
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital and UAB Highlands

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • 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.

    PMID: 22922245BACKGROUND
  • 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.

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations include generalizability. Our single healthcare system likely has unique characteristics. Readmission to the hospital is also a limited quality measure. There is currently no way to deem if readmissions are appropriate or avoidable.

Results Point of Contact

Title
Dr. Christine Ritchie
Organization
University of California San Francisco (UCSF); University of Alabama at Birmingham (UAB)

Study Officials

  • Christine S Ritchie, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
  • Thomas K Houston, MD, MSPH

    University of Massachusetts, Worcester

    STUDY DIRECTOR
  • Joshua Richman, MD, PhD

    University of Alabama at Birmingham

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 2, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 3, 2013

Results First Posted

June 3, 2013

Record last verified: 2013-05

Locations