IVR-Enhanced Care Transition Support for Complex Patients

NCT ID: NCT01135381

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-03-31

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.

Conditions

Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CHF patients, IVR-Enhanced Care

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

Group Type: EXPERIMENTAL

IVR-Enhanced Care

Intervention Type: 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.

COPD patients, IVR-Enhanced Care

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

Group Type: EXPERIMENTAL

IVR-Enhanced Care

Intervention Type: 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.

CHF patients, Usual Discharge Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

COPD patients, Usual Discharge Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IVR-Enhanced Care

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

e-Coach; IVR; IVRS; IVR Care Transition Support; Interactive voice response-supported system

Eligibility Criteria

Inclusion Criteria

• CHF/COPD patients
• English-speaking
• Medicare beneficiaries

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Christine Ritchie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine S Ritchie, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Thomas K Houston, MD, MSPH

Role: STUDY_DIRECTOR

University of Massachusetts, Worcester

Joshua Richman, MD, PhD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University Hospital and UAB Highlands

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22922245 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27339715 (View on PubMed)

Other Identifiers

1R18HS017786

Identifier Type: AHRQ

Identifier Source: org_study_id

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