A Trial of the C-TraC Intervention for Dementia Patients

NCT ID: NCT02388711

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-10-11

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

C-TraC Intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* English-speaking
* Have a working telephone
* Have contact with patient a minimum of once per week

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy J Kind, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine

Locations

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University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10029122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15086645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17000937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10960880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23902508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12927944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11522933 (View on PubMed)

Other Identifiers

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2P50AG033514-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534255

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\GER-AD DEV

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/21/2018

Identifier Type: OTHER

Identifier Source: secondary_id

2014-1221

Identifier Type: -

Identifier Source: org_study_id

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