An interventional study of IVR-Enhanced Care in Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-03.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research
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.
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.
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This study's enrollment of 511 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
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Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Amendment to Inclusion Criteria:
Exclusion Criteria:
Amendments to exclusion criteria:
Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
Behavioral: IVR-Enhanced Care
Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
Behavioral: IVR-Enhanced Care
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).
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
Re-hospitalizations
Time frame: During the 30days after discharge
Rehospitalizations at 90 Days
Time frame: 90 days
Community Tenure
The number of days a patient spends in the home versus the hospital at 30 days.
Time frame: 30 days
Patients were recruited from multiple clinical units in a large tertiary care clinical facility in Alabama with a geographically wide, mostly rural catchment area. Recruitment period: 2/2010 to 3/2012.
| Milestone | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care |
|---|---|---|---|---|
| Started | 189 | 185 | 69 | 68 |
| Completed | 168 | 178 | 65 | 67 |
| Not completed | 21 | 7 | 4 | 1 |
| participants | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care |
|---|---|---|---|---|
| Re-hospitalizations | 27 | 26 | 8 | 14 |
| participants | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care |
|---|---|---|---|---|
| Rehospitalizations at 90 Days | 54 | 48 | 22 | 26 |
The number of days a patient spends in the home versus the hospital at 30 days.
| days | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care |
|---|---|---|---|---|
| Community Tenure | 1.62 ± 4.6 | 1.48 ± 4.1 | 0.52 ± 1.8 | 1.6 ± 3.5 |
Collected over Adverse event data were collected throughout the study period (2 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHF Patients, IVR-Enhanced Care | — | 0/168 (0%) | 0/168 (0%) |
| CHF Patients, Usual Discharge Care | — | 0/178 (0%) | 0/178 (0%) |
| COPD Patients, IVR-Enhanced Care | — | 0/65 (0%) | 0/65 (0%) |
| COPD Patients, Usual Discharge Care | — | 0/67 (0%) | 0/67 (0%) |
A few patients were excluded from the final study groups. 6 patients died prior to discharge, 2 patients declined participation, and 4 patients became ineligible. After hospital discharge, 12 patients declined follow-up, we were unable to contact 5 for follow-up, and 4 became ineligible.
| Age, Categorical(Participants) | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 94 | 89 | 33 | 38 | 254 |
| >=65 years | 74 | 89 | 32 | 29 | 224 |
| Age Continuous(years) | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care | Total |
|---|---|---|---|---|---|
| Mean | 62 ± 12.5 | 63 ± 13.4 | 62 ± 13.4 | 61 ± 14.0 | 63 ± 12.4 |
| Sex: Female, Male(Participants) | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care | Total |
|---|---|---|---|---|---|
| Female | 86 | 82 | 38 | 21 | 227 |
| Male | 82 | 96 | 27 | 46 | 251 |
| Region of Enrollment(participants) | CHF Patients, IVR-Enhanced Care | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care | Total |
|---|---|---|---|---|---|
| United States | 168 | 178 | 65 | 67 | 478 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham