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Sponsor study identifier
interventional
246
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. 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 NIA's goals to improve transition outcomes, we will evaluate a novel intervention designed to improve the effectiveness of transition support for older adults with common chronic conditions via three mechanisms of action: (a) direct tailored communication to patients via regular automated calls post discharge, (b) support for informal caregivers living outside of the patient's household 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 21, 2012
Actual (reported)August 24, 2012
Actual (reported)October 2016
Actual (reported)October 2016
Actual (reported)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 lower readmission rates, emergency department visits, and improved patient functional status.
Outcomes will be measured at 30- and 90-days post discharge.
Specific Aim 2
To evaluate the impact of the intervention on process measures of transition quality (e.g., attendance at post-discharge appointments and patients' understanding of their personal health record), as well as on patients' medication-related self-management (e.g., adherence and medication beliefs).
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 caregivers' stress and increases their activation levels (e.g., by increasing their disease-specific communication with the patient and successful problem solving).
Outcomes will be measured at 30- and 90-days post discharge.
Telemonitoring plus self-management support
Usual Care
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Piette JD, Striplin D, Aikens JE, Lee A, Marinec N, Mansabdar M, Chen J, Gregory LA, Kim CS. Impacts of Post-Hospitalization Accessible Health Technology and Caregiver Support on 90-Day Acute Care Use and Self-Care Assistance: A Randomized Clinical Trial. Am J Med Qual. 2021 May-Jun 01;36(3):145-155. doi: 10.1177/1062860620943673.
John D. Piette, Ph.D.
VA Center for Clinical Management Research & the University of Michigan
246 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
November 7, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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