Congestive Heart FailureNCT01135381
IVR-Enhanced Care Transition Support for Complex Patients
A study testing IVR-Enhanced Care in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- IVR-Enhanced Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHF/COPD patients
- English-speaking
- Medicare beneficiaries
- Amendment to Inclusion Criteria:
- Recruited non-Medicare eligible beneficiaries
Who cannot join
- Prognosis of 6 months or less
- Cognitive impairment with no available proxy/caregiver
- No possession of a phone
- Amendments to exclusion criteria:
- heart or lung transplant recipients
- dialysis patients
Show all 9Show fewer
- individuals already in the Cystic Fibrosis program or receiving intensive monitored care
- individuals with a ventricular assist device (LVAD; RVAD; BiVAD)
- individuals utilizing a pre-paid phone service
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital and UAB Highlands
Birmingham, Alabama, 35294
About this study
Official title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
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.
Read the 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.
- Being tested
- IVR-Enhanced Care
- Keywords
- care transitions, information technology
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR-Enhanced CareBehavioural
Also called e-Coach, IVR, IVRS, IVR Care Transition Support
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.
| Study group | Role | What they receive |
|---|---|---|
| CHF patients, IVR-Enhanced Care | Experimental | Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention. Receives: Behavioral: IVR-Enhanced Care |
| COPD patients, IVR-Enhanced Care | Experimental | Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention. Receives: Behavioral: IVR-Enhanced Care |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalizations
Measured: During the 30days after discharge
Secondary outcomes (2)
Rehospitalizations at 90 Days
Measured: 90 days
Community Tenure
The number of days a patient spends in the home versus the hospital at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, US Department of Veterans Affairs, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Christine Ritchie, University of Alabama at Birmingham
- Investigators
- Christine S Ritchie, MD, MSPH, Principal investigator, University of Alabama at BirminghamThomas K Houston, MD, MSPH, Study director, University of Massachusetts, WorcesterJoshua Richman, MD, PhD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135381
- Sponsor's protocol ID
- 1R18HS017786
- Status last verified
- May 2013
- First submitted
- 1 Jun 2010
- Last updated
- 3 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22922245Ritchie 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.
PubMed 27339715
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
- ClinicalTrials.gov ID
- NCT01135381
- Acronym / sponsor ID
- 1R18HS017786
- Keywords
- care transitions, information technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of California, San Francisco, US Department of Veterans Affairs, University of Massachusetts, Worcester
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 3 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHF patients, IVR-Enhanced Care | Experimental | Behavioral: IVR-Enhanced CarePatients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention. |
| COPD patients, IVR-Enhanced Care | Experimental | Behavioral: IVR-Enhanced CarePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CHF/COPD patients
- English-speaking
- Medicare beneficiaries
- Recruited non-Medicare eligible beneficiaries
Key exclusion criteria (9 listed)
- Prognosis of 6 months or less
- Cognitive impairment with no available proxy/caregiver
- No possession of a phone
- heart or lung transplant recipients
- dialysis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR-Enhanced CareAlso: e-Coach, IVR, IVRS, IVR Care Transition SupportThose 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. | Behavioural | CHF patients, IVR-Enhanced Care, COPD patients, IVR-Enhanced Care |
Primary outcome
Re-hospitalizations
Time frame: During the 30days after discharge
2 secondary outcomes
Rehospitalizations at 90 Days
Time frame: 90 days
Community Tenure
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22922245Ritchie 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.
- Derived from this study: PubMed 27339715Ritchie 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine S Ritchie, MD, MSPH principal investigator
University of Alabama at Birmingham
Thomas K Houston, MD, MSPH study director
University of Massachusetts, Worcester
Joshua Richman, MD, PhD study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR-Enhanced Care in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalizations (time frame: During the 30days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.