A Trial of the C-TraC Intervention for Dementia Patients

A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients

Sponsors

Lead Sponsor: University of Wisconsin, Madison

Collaborator: National Institute on Aging (NIA)

Source University of Wisconsin, Madison
Brief Summary

The goal of the project is to conduct a prospective, randomized-controlled clinical trial to determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts transitional care quality, patient cognition/function, caregiver stress and 30-day rehospitalizations in patients with documented diagnoses of dementia discharged from the hospital to the community.

Detailed Description

Patients with dementia often experience poor quality transitions from the hospital to the community. In response, the investigators developed and piloted the Coordinated-Transitional Care (C-TraC) program--a low-cost, telephone-based intervention designed to improve care coordination and outcomes in hospitalized patients with dementia or other high-risk conditions discharged to community settings.

A single-blind, prospective, randomized-controlled trial will be used with participants being randomly assigned to receive usual (i.e. standard) care, or usual care plus the C-TraC intervention. Outcomes will be assessed via scheduled phone-calls at 14, 30, and 90 days post-hospitalization. A 45-day phone call will also be conducted to complete a brief satisfaction survey with the caregiver about their post-hospital experience.

Overall Status Suspended
Start Date March 2015
Completion Date March 31, 2022
Primary Completion Date March 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in rehospitalizations at 14, 30 and 90-days 14, 30 and 90-days
Secondary Outcome
Measure Time Frame
Increase in patient delirium prevention/resolution 14, 30 and 90-days
Patient functional maintenance/recovery 14, 30 and 90-days
Patient falls prevention 14, 30 and 90-days
Decrease caregiver stress 14, 30 and 90-days
Enrollment 1100
Condition
Intervention

Intervention Type: Other

Intervention Name: C-TraC Intervention

Description: C-TraC utilizes a nurse case manager to coordinate the patient's transitional care through active participation in inpatient multidisciplinary discharge rounds, a single brief protocol-driven inpatient encounter, and 1-4 protocol-driven post-hospital telephone calls with the patient/caregiver using spaced retrieval techniques.

Arm Group Label: Usual Care with C-TraC Intervention

Eligibility

Criteria:

Patient Inclusion Criteria:

- English-speaking

- Have a working telephone

- Hospitalized on medical inpatient wards at UWHC

- A documented pre-hospitalization diagnosis of dementia.

- Alzheimer's Disease Cooperative Study - Clinical Dementia Rating (ADCS-CDR) score of > 0

- Have a family member/informal caregiver who has regular contact with them in the community setting

Caregiver Inclusion Criteria:

- English-speaking

- Have a working telephone

- Have contact with patient a minimum of once per week

Patient Exclusion Criteria:

- Discharged to institutional settings

- No identified caregiver

- Discharged to hospice

- Followed by complex case management or any form of intensive case management (e.g. transplant, congestive heart failure, dialysis)

- Score moderate-high on modified ASSIST tool for alcohol

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Amy J Kind, MD, PhD Principal Investigator University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine
Location
Facility: University of Wisconsin Hospital
Location Countries

United States

Verification Date

March 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Usual Care with C-TraC Intervention

Type: Experimental

Description: Patients/caregivers randomized to this group will receive all routine hospital discharge education/materials (same as usual care group), but will also be enrolled in the C-TraC Program. C-TraC is a low-resource, telephone-based, protocol-driven program designed to reduce 30-day rehospitalizations and to improve care transitions during the early post-hospital period.

Label: Usual Care

Type: No Intervention

Description: Usual care group patients will receive all routine University of Wisconsin Hospital and Clinics (UWHC) discharge education/materials. This includes pharmacy-led medication teaching, physician discussions and routine nursing education. No post hospital education/contact is performed by these providers. Caregivers are sometimes, but not always, involved. Patients may receive home health services, depending on their physician's discharge plan.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov