A Trial of the C-TraC Intervention for Dementia Patients
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|ClinicalTrials.gov Identifier: NCT02388711|
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Other: C-TraC Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Usual Care with C-TraC Intervention
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
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.
No Intervention: Usual Care
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.
- Change from baseline in rehospitalizations at 14, 30 and 90-days [ Time Frame: 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.
- Increase in patient delirium prevention/resolution [ Time Frame: 14, 30 and 90-days ]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.
- Patient functional maintenance/recovery [ Time Frame: 14, 30 and 90-days ]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.
- Patient falls prevention [ Time Frame: 14, 30 and 90-days ]Caregivers will be asked to report the presence and dates of any patient falls since discharge.
- Decrease caregiver stress [ Time Frame: 14, 30 and 90-days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388711
|Contact: Amy J Kind, MD, PhD||(608) email@example.com|
|United States, Wisconsin|
|University of Wisconsin Hospital||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Amy J Kind, MD, PhD||University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine|