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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02388711
Enrollment
584
Registered
2015-03-17
Start date
2015-03-31
Completion date
2019-10-11
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Dementia, Transitional Care, Caregiver

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.

Interventions

OTHERC-TraC Intervention

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in rehospitalizations at 14, 30 and 90-days14, 30 and 90-daysThe presence of any rehospitalization will be assessed through a combination of 14, 30 and 90 day structured phone calls directly to patients/caregivers, a detailed review of medical records associated with any of these caregiver/patient reported rehospitalizations, and a detailed review of the patient's UWHC medical records after all phone calls are completed.

Secondary

MeasureTime frameDescription
Increase in patient delirium prevention/resolution14, 30 and 90-daysTo assess for delirium, the Family Confusion Assessment Method (FAM-CAM) will be used - an 11-item tool designed to detect delirium from the observations of family caregivers.
Patient functional maintenance/recovery14, 30 and 90-daysTo assess function, the investigators will use the Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL). ADCS-ADL is a 23 item tool which offers detailed descriptions of each functional activity and asks caregivers to describe the patient's observed actions or behaviors.
Patient falls prevention14, 30 and 90-daysCaregivers will be asked to report the presence and dates of any patient falls since discharge.
Decrease caregiver stress14, 30 and 90-daysTo measure caregiver stress the 22-item Zarit Caregiver Burden Scale and the 6-item Caregiver Activation Survey (CAS) will be used. The Zarit Caregiver Burden Scale is used as a measure of caregiver psychological stress and the CAS is used as a measure of time spent caregiving. The investigators will also assess caregiver stress using the 9-item Patient Health Questionnaire (PHQ-9) and the 3-item Care Transitions Measure (CTM-3). The PHQ-9 is used to establish provisional depressive disorder diagnoses as well as grade the severity of depressive symptoms. The CTM-3 has been modified to be given to caregivers discussing their experience with coordinating their loved ones care after hospital discharge. The statements ask about when the loved one was in the hospital, when they were preparing to leave the hospital and about their medications.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026