A Trial of the C-TraC Intervention for Dementia Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Other: C-TraC Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Care with C-TraC Intervention<br>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. | Other: C-TraC Intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in rehospitalizations at 14, 30 and 90-days | The 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. | 14, 30 and 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in patient delirium prevention/resolution | To 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. | 14, 30 and 90-days | 
| Patient functional maintenance/recovery | To 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. | 14, 30 and 90-days | 
| Patient falls prevention | Caregivers will be asked to report the presence and dates of any patient falls since discharge. | 14, 30 and 90-days | 
| Decrease caregiver stress | To 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. | 14, 30 and 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Transitional Care, Caregiver