Trial of the CarePartner Program for Improving the Quality of Transition Support

NCT ID: NCT01672398

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Post-discharge

Keywords

CarePartner; informal caregiver; interactive voice response; transition; post-discharge; chronic illness; readmission; self-care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

Telemonitoring plus self-management support

Group Type: EXPERIMENTAL

Telemonitoring plus self-management support

Intervention Type: OTHER

Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.

Usual Care Group

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telemonitoring plus self-management support

Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

John Piette

VA Senior Research Career Scientist and Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D. Piette, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Center for Clinical Management Research & the University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

R18HS019625-01A1

Identifier Type: AHRQ

Identifier Source: org_study_id

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