Clinical trial NCT02388711: A Trial of the C-TraC Intervention for Dementia Patients
Official title: A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Transitional Care
Caregiver
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-03-17
Enrollment: 584
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in rehospitalizations at 14, 30 and 90-days
timeFrame: 14, 30 and 90-days
Secondary outcomes:
measure: Increase in patient delirium prevention/resolution
timeFrame: 14, 30 and 90-days
measure: Patient functional maintenance/recovery
timeFrame: 14, 30 and 90-days
measure: Patient falls prevention
timeFrame: 14, 30 and 90-days
measure: Decrease caregiver stress
timeFrame: 14, 30 and 90-days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine
name: Amy J Kind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.
citation: Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
citation: Marin DB, Dugue M, Schmeidler J, Santoro J, Neugroschl J, Zaklad G, Brickman A, Schnur E, Hoblyn J, Davis KL. The Caregiver Activity Survey (CAS): longitudinal validation of an instrument that measures time spent caregiving for individuals with Alzheimer's disease. Int J Geriatr Psychiatry. 2000 Aug;15(8):680-6. doi: 10.1002/1099-1166(200008)15:83.0.co;2-7.
citation: Hurd MD, Martorell P, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Aug 1;369(5):489-90. doi: 10.1056/NEJMc1305541. No abstract available.
citation: Bourgeois MS, Camp C, Rose M, White B, Malone M, Carr J, Rovine M. A comparison of training strategies to enhance use of external aids by persons with dementia. J Commun Disord. 2003 Sep-Oct;36(5):361-78. doi: 10.1016/s0021-9924(03)00051-0.
citation: Tractenberg RE, Schafer K, Morris JC. Interobserver disagreements on clinical dementia rating assessment: interpretation and implications for training. Alzheimer Dis Assoc Disord. 2001 Jul-Sep;15(3):155-61. doi: 10.1097/00002093-200107000-00007.