Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
Conditions
Keywords
care transitions, information technology
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-hospitalizations | During the 30days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalizations at 90 Days | 90 days | — |
| Community Tenure | 30 days | The number of days a patient spends in the home versus the hospital at 30 days. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
757 were discharged prior to completing their enrollment, and 304 did not meet other inclusion criteria. Thus, a total of 511 patients were enrolled and randomly assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| CHF Patients, IVR-Enhanced Care Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
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. | 168 |
| CHF Patients, Usual Discharge Care Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention). | 178 |
| COPD Patients, IVR-Enhanced Care Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
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. | 65 |
| COPD Patients, Usual Discharge Care Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). | 67 |
| Total | 478 |
Baseline characteristics
| Characteristic | CHF Patients, Usual Discharge Care | COPD Patients, IVR-Enhanced Care | CHF Patients, IVR-Enhanced Care | COPD Patients, Usual Discharge Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 89 Participants | 32 Participants | 74 Participants | 29 Participants | 224 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 33 Participants | 94 Participants | 38 Participants | 254 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 13.4 | 62 years STANDARD_DEVIATION 13.4 | 62 years STANDARD_DEVIATION 12.5 | 61 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 178 participants | 65 participants | 168 participants | 67 participants | 478 participants |
| Sex: Female, Male Female | 82 Participants | 38 Participants | 86 Participants | 21 Participants | 227 Participants |
| Sex: Female, Male Male | 96 Participants | 27 Participants | 82 Participants | 46 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 168 | 0 / 178 | 0 / 65 | 0 / 67 |
| serious Total, serious adverse events | 0 / 168 | 0 / 178 | 0 / 65 | 0 / 67 |
Outcome results
Re-hospitalizations
Time frame: During the 30days after discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHF Patients, IVR-Enhanced Care | Re-hospitalizations | 27 participants |
| CHF Patients, Usual Discharge Care | Re-hospitalizations | 26 participants |
| COPD Patients, IVR-Enhanced Care | Re-hospitalizations | 8 participants |
| COPD Patients, Usual Discharge Care | Re-hospitalizations | 14 participants |
Community Tenure
The number of days a patient spends in the home versus the hospital at 30 days.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHF Patients, IVR-Enhanced Care | Community Tenure | 1.62 days | Standard Deviation 4.6 |
| CHF Patients, Usual Discharge Care | Community Tenure | 1.48 days | Standard Deviation 4.1 |
| COPD Patients, IVR-Enhanced Care | Community Tenure | 0.52 days | Standard Deviation 1.8 |
| COPD Patients, Usual Discharge Care | Community Tenure | 1.6 days | Standard Deviation 3.5 |
Rehospitalizations at 90 Days
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHF Patients, IVR-Enhanced Care | Rehospitalizations at 90 Days | 54 participants |
| CHF Patients, Usual Discharge Care | Rehospitalizations at 90 Days | 48 participants |
| COPD Patients, IVR-Enhanced Care | Rehospitalizations at 90 Days | 22 participants |
| COPD Patients, Usual Discharge Care | Rehospitalizations at 90 Days | 26 participants |