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IVR-Enhanced Care Transition Support for Complex Patients

E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135381
Enrollment
511
Registered
2010-06-02
Start date
2010-02-28
Completion date
2012-03-31
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

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

BEHAVIORALIVR-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.

Sponsors

University of California, San Francisco
CollaboratorOTHER
US Department of Veterans Affairs
CollaboratorFED
University of Massachusetts, Worcester
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Re-hospitalizationsDuring the 30days after discharge

Secondary

MeasureTime frameDescription
Rehospitalizations at 90 Days90 days
Community Tenure30 daysThe 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

ArmCount
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
Total478

Baseline characteristics

CharacteristicCHF Patients, Usual Discharge CareCOPD Patients, IVR-Enhanced CareCHF Patients, IVR-Enhanced CareCOPD Patients, Usual Discharge CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
89 Participants32 Participants74 Participants29 Participants224 Participants
Age, Categorical
Between 18 and 65 years
89 Participants33 Participants94 Participants38 Participants254 Participants
Age Continuous63 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 participants65 participants168 participants67 participants478 participants
Sex: Female, Male
Female
82 Participants38 Participants86 Participants21 Participants227 Participants
Sex: Female, Male
Male
96 Participants27 Participants82 Participants46 Participants251 Participants

Adverse events

Event typeEG000
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 / 1680 / 1780 / 650 / 67
serious
Total, serious adverse events
0 / 1680 / 1780 / 650 / 67

Outcome results

Primary

Re-hospitalizations

Time frame: During the 30days after discharge

ArmMeasureValue (NUMBER)
CHF Patients, IVR-Enhanced CareRe-hospitalizations27 participants
CHF Patients, Usual Discharge CareRe-hospitalizations26 participants
COPD Patients, IVR-Enhanced CareRe-hospitalizations8 participants
COPD Patients, Usual Discharge CareRe-hospitalizations14 participants
Secondary

Community Tenure

The number of days a patient spends in the home versus the hospital at 30 days.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
CHF Patients, IVR-Enhanced CareCommunity Tenure1.62 daysStandard Deviation 4.6
CHF Patients, Usual Discharge CareCommunity Tenure1.48 daysStandard Deviation 4.1
COPD Patients, IVR-Enhanced CareCommunity Tenure0.52 daysStandard Deviation 1.8
COPD Patients, Usual Discharge CareCommunity Tenure1.6 daysStandard Deviation 3.5
Secondary

Rehospitalizations at 90 Days

Time frame: 90 days

ArmMeasureValue (NUMBER)
CHF Patients, IVR-Enhanced CareRehospitalizations at 90 Days54 participants
CHF Patients, Usual Discharge CareRehospitalizations at 90 Days48 participants
COPD Patients, IVR-Enhanced CareRehospitalizations at 90 Days22 participants
COPD Patients, Usual Discharge CareRehospitalizations at 90 Days26 participants

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026