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Completed

NCT Number: NCT02388711

A Trial of the C-TraC Intervention for Dementia Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-TraC Intervention

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2015
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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