A Trial of the C-TraC Intervention for Dementia Patients

• ClinicalTrials.gov Identifier: NCT02388711
• Recruitment Status: Completed
• First Posted: March 17, 2015
• Last Update Posted: February 12, 2021
• Sponsor: University of Wisconsin, Madison
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dementia	Other: C-TraC Intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 584 participants
• Allocation: Randomized
• 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
• Actual Primary Completion Date: October 11, 2019
• Actual Study Completion Date: October 11, 2019

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin Hospital

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Amy J Kind, MD, PhD; University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine

More Information

Publications:

Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD, Pauly MV, Schwartz JS. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999 Feb 17;281(7):613-20. doi: 10.1001/jama.281.7.613.

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. Erratum In: J Am Geriatr Soc. 2004 Jul;52(7):1228.

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.

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.

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.

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.

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.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT02388711
• Other Study ID Numbers: 2014-1221; 2P50AG033514-06 ( U.S. NIH Grant/Contract ); A534255 ( Other Identifier: UW Madison ); SMPH\MEDICINE\GER-AD DEV ( Other Identifier: UW Madison ); Protocol Version 8/21/2018 ( Other Identifier: UW Madison )
• First Posted: March 17, 2015
• Last Update Posted: February 12, 2021
• Last Verified: February 2021

Keywords provided by University of Wisconsin, Madison:

Dementia; Transitional Care; Caregiver

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders