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

Post-discharge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672398
• Other study ID #: R18HS019625-01A1
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: November 4, 2016
• Start date: August 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Post-discharge

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No