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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| US Department of Veterans Affairs | FED |
| University of Massachusetts, Worcester | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF patients, IVR-Enhanced Care | Experimental | Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention. |
|
| COPD patients, IVR-Enhanced Care | Experimental | Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVR-Enhanced Care | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-hospitalizations | During the 30days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalizations at 90 Days | 90 days | |
| Community Tenure | The number of days a patient spends in the home versus the hospital at 30 days. | 30 days |
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Inclusion Criteria:
Amendment to Inclusion Criteria:
Exclusion Criteria:
Amendments to exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital and UAB Highlands | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22922245 | Background | 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. | |
| 27339715 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | CHF Patients, Usual Discharge Care | Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention). |
| FG002 | 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. |
| FG003 | COPD Patients, Usual Discharge Care | Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Re-hospitalizations | Posted | Number | participants | During the 30days after discharge |
|
Adverse event data were collected throughout the study period (2 years)
There were no serious adverse events (SAE) or other adverse events as a result of the intervention. Any adverse events that occurred were expected outcomes, given the baseline health level of the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Ritchie | University of California San Francisco (UCSF); University of Alabama at Birmingham (UAB) | 415-514-0605 | christine.ritchie@ucsf.edu; critchie@uab.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
|
| BG001 | CHF Patients, Usual Discharge Care | Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention). |
| BG002 | 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. |
| BG003 | COPD Patients, Usual Discharge Care | Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
| OG003 | COPD Patients, Usual Discharge Care | Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). |
|
|
| Secondary | Rehospitalizations at 90 Days | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Community Tenure | The number of days a patient spends in the home versus the hospital at 30 days. | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| 0 |
| 168 |
| 0 |
| 168 |
| EG001 | CHF Patients, Usual Discharge Care | Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention). | 0 | 178 | 0 | 178 |
| EG002 | 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. | 0 | 65 | 0 | 65 |
| EG003 | COPD Patients, Usual Discharge Care | Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention). | 0 | 67 | 0 | 67 |
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |