Clinical trial NCT01672398: Trial of the CarePartner Program for Improving the Quality of Transition Support
Official title: Trial of the CarePartner Program for Improving the Quality of Transition Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-discharge
Keywords: CarePartner
informal caregiver
interactive voice response
transition
post-discharge
chronic illness
readmission
self-care
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 271
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Patients hospitalized with complex chronic conditions frequently experience preventable short-term readmissions due to inadequate transition support. Although structured discharge planning with telephone follow-up improves transition outcomes, these services often are unavailable, and proactive outreach is often inadequate once the patient returns home. Informal caregivers are invaluable for ensuring successful transitions, but many patients live alone, have an in-home caregiver who is struggling with competing demands, or live at a distance from adult children or other potential sources of support. New models are needed for transition support that include low-cost technologies and more structured assistance for patients' informal caregiving network, while providing patients' clinical teams with the information they need to avert health crises.

Objectives: Consistent with Agency for Healthcare Research and Quality goals to improve transitions using accessible health IT, we will evaluate a novel intervention designed to improve the effectiveness of transition support for common chronic conditions via three mechanisms of action: (a) direct tailored communication to patients via automated calls post discharge, (b) support for informal caregivers via structured feedback about the patient's status and advice about how they can help, and (c) support for proactive care management including a web-based disease management tool, automated alerts about potential problems, and the capacity for asynchronous communication with patients and their caregivers. Specifically, the trial will determine: 1) whether the CarePartner intervention improves patients' readmission risk and functional status; 2) the impact of the intervention on patients' self-care behaviors and the quality of the transition process; and 3) whether the intervention improves caregiver burden and stress levels.

Detailed description: Methods: 422 adults with complex chronic conditions will be identified upon admission to a university-based acute care general medical service. Patients will be asked to identify a CarePartner (CP) living outside their household; CPs will be spouses, adult children, and others in their social network willing to play an active role in their transition support. Patients will be randomized to the intervention or usual care. Intervention patients will receive automated assessment and behavior change calls, and their CPs will receive structured feedback and advice following each assessment. Patients' clinical team will have access to patients' assessment results via the web, will receive automated reports about urgent health problems, and will be able to communicate asynchronously with patients and CPs using a secure web page and a specially designed voicemail service. Patients will complete surveys at baseline, 30- and 90- days post discharge; utilization data will be obtained from hospital records. CPs and clinicians will be interviewed to evaluate intervention effects on processes of self-care support, caregiver stress and communication, and the intervention's potential for broader implementation. The primary outcome will be 30 day readmission rates; 2ndary outcomes include functional status, self-care behaviors, and mortality risk.

Eligibility criteria: Inclusion Criteria:

* Being discharged from study site with any diagnoses that indicate a chronic condition with a high risk of short-term readmission, for example: stroke, heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, peripheral vascular disease, deep venous thrombosis, pulmonary embolism, pneumonia, diabetes, urinary tract infection, cellulitis, gastroenteritis, fevers, and other infections
* At least 21 years of age

Exclusion Criteria:

* Serious mental illness, e.g., psychosis
* Are in hospice care
* Do not speak English
* Are unable to use a telephone
* Have a non-health system-affiliated primary care provider
* Are unable to nominate a potentially eligible CarePartner
* Are cognitively impaired as determined by a validate screener

Primary outcomes:
measure: Specific Aim 1
timeFrame: Outcomes will be measured at 30- and 90-days post discharge.
measure: Specific Aim 2
timeFrame: Outcomes will be measured at 30- and 90-days post discharge.
measure: Specific Aim 3
timeFrame: Outcomes will be measured at 30- and 90-days post discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: VA Center for Clinical Management Research & the University of Michigan
name: John D. Piette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: