A Trial of the C-TraC Intervention for Dementia Patients

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388711
• Other study ID #: 2014-1221
• Secondary ID: 2P50AG033514-06A
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: October 11, 2019

Study information

• Verified date: February 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. Erratum in: J Am Geriatr Soc. 2004 Jul;52(7):1228. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient falls prevention	Caregivers will be asked to report the presence and dates of any patient falls since discharge.	14, 30 and 90-days
Secondary	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