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

NCT01672398 | Completed DMC

• 1 other identifier: R18HS019625-01A1
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-discharge

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Specific Aim 1

  To determine the extent to which the CarePartner model for supporting effective transitions from hospital to home improves outcomes of care, including short-term readmission rates, emergency department visits, and patients' functional status.

  Outcomes will be measured at 30- and 90-days post discharge.

• Specific Aim 2

  To evaluate the impact of the CarePartner intervention on process measures of transition quality and on patients' medication-related self-management.

  Outcomes will be measured at 30- and 90-days post discharge.

• Specific Aim 3

  To determine the extent to which the intervention increases the quality and quantity of support for patients' self-care using a mixed methods approach to identify whether the service reduces stress and increases activation levels among CarePartners.

  Outcomes will be measured at 30- and 90-days post discharge.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Telemonitoring plus self-management support

Other: Telemonitoring plus self-management support

Usual Care Group

NO INTERVENTION

Usual Care

Interventions

Telemonitoring plus self-management support 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.

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John D. Piette, Ph.D.

  VA Center for Clinical Management Research & the University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VA Senior Research Career Scientist and Professor of Internal Medicine

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)