Trial Outcomes & Findings for IVR-Enhanced Care Transition Support for Complex Patients (NCT NCT01135381)
NCT ID: NCT01135381
Last Updated: 2013-06-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
During the 30days after discharge
Results posted on
2013-06-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
CHF Patients, Usual Discharge Care
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
|
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.
|
COPD Patients, Usual Discharge Care
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
189
|
185
|
69
|
68
|
|
Overall Study
COMPLETED
|
168
|
178
|
65
|
67
|
|
Overall Study
NOT COMPLETED
|
21
|
7
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IVR-Enhanced Care Transition Support for Complex Patients
Baseline characteristics by cohort
| Measure |
CHF Patients, IVR-Enhanced Care
n=168 Participants
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.
|
CHF Patients, Usual Discharge Care
n=178 Participants
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
|
COPD Patients, IVR-Enhanced Care
n=65 Participants
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.
|
COPD Patients, Usual Discharge Care
n=67 Participants
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Age Continuous
|
62 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
63 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
62 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
61 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
63 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=5 Participants
|
178 participants
n=7 Participants
|
65 participants
n=5 Participants
|
67 participants
n=4 Participants
|
478 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the 30days after dischargeOutcome measures
| Measure |
CHF Patients, IVR-Enhanced Care
n=168 Participants
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.
|
CHF Patients, Usual Discharge Care
n=178 Participants
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
|
COPD Patients, IVR-Enhanced Care
n=65 Participants
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.
|
COPD Patients, Usual Discharge Care
n=67 Participants
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
|
|---|---|---|---|---|
|
Re-hospitalizations
|
27 participants
|
26 participants
|
8 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
CHF Patients, IVR-Enhanced Care
n=168 Participants
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.
|
CHF Patients, Usual Discharge Care
n=178 Participants
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
|
COPD Patients, IVR-Enhanced Care
n=65 Participants
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.
|
COPD Patients, Usual Discharge Care
n=67 Participants
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
|
|---|---|---|---|---|
|
Rehospitalizations at 90 Days
|
54 participants
|
48 participants
|
22 participants
|
26 participants
|
SECONDARY outcome
Timeframe: 30 daysThe number of days a patient spends in the home versus the hospital at 30 days.
Outcome measures
| Measure |
CHF Patients, IVR-Enhanced Care
n=168 Participants
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.
|
CHF Patients, Usual Discharge Care
n=178 Participants
Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
|
COPD Patients, IVR-Enhanced Care
n=65 Participants
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.
|
COPD Patients, Usual Discharge Care
n=67 Participants
Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
|
|---|---|---|---|---|
|
Community Tenure
|
1.62 days
Standard Deviation 4.6
|
1.48 days
Standard Deviation 4.1
|
0.52 days
Standard Deviation 1.8
|
1.6 days
Standard Deviation 3.5
|
Adverse Events
CHF Patients, IVR-Enhanced Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHF Patients, Usual Discharge Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD Patients, IVR-Enhanced Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD Patients, Usual Discharge Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christine Ritchie
University of California San Francisco (UCSF); University of Alabama at Birmingham (UAB)
Phone: 415-514-0605
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place