Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial

NCT02088099 | Completed

• 2 other identifiers: 12-008525NIDILRR
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

Mayo Clinic has been funded by the National Institute on Disability Independent Living \& Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes. Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are:

• Individuals recently hospitalized with TBI;
• Their families;
• Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors). The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities. The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Telehealth; ehealth; Mobile Health; social participation; patient participation; consumer participation; Patient Outcome Assessment

Outcome Measures

Primary Outcomes (4)

• Change in Traumatic Brain Injury - Quality of Life (TBI-QOL)

  TBI-QOL is a recently developed Computer Assisted Telephone Interview (CATI) tool that provides psychometrically sound and clinically relevant health-related patient-reported quality of life measurement specific to TBI. This scale is being used by the VA Research and Development Programs and will soon be a variable in the TBIMS National Database. TBI-QOL efficiently measures domains of depression, anxiety, fatigue and pain, using fewer items than scales measuring similar constructs. Responses for this scale will be obtained from subjects via a CATI.

  At enrollment, at 6 months, and at 18 months

• Change in measure of patient impression of Telemedicine (TMP-Q)

  Given that the entire complex intervention of this trial is delivered remotely, individual differences in its acceptance may influence outcome. The TMP-Q is a 17-item scale designed to assess impressions of the risks and benefits of home tele-care, and that has high levels of test-retest reliability and validity. Responses to a revised TMP-Q customized for the CONNECT trial will be obtained directly from subjects by phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.

  At enrollment, at 6 months, and at 18 months

• Change in Caregiver Appraisal Scale (CAS)

  The CAS will be used only for family members or care givers to measure caregiver burden. It contains 4 measurable factors: Perceived Burden, Caregiver Satisfaction, Caregiver Idealogy and Caregiver Mastery. It includes 35 questions each measured on a 5-point Likert scale. The CAS has high internal consistency when used to study burden in those caring for individuals with TBI. Responses for this scale will be obtained from family members and caregivers via phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.

  At enrollment, at 6 months, and at 18 months

• Change in Clinical Satisfaction and Competency Rating (CSCR)

  CSCR scales use a 5-point Likert method to measure satisfaction specific to individuals in each target population. They will be tested and refined in small groups of the target populations during Phase 1. The CSCR scale for individuals with TBI will focus on intervention quality, services, and progress. Satisfaction for family members will emphasize coping, communication, learning, and access. Questions to local providers will focus on their comfort, confidence, and competency in providing care to individuals with TBI. Responses for these scales will be obtained from individuals with TBI, their family members/caregivers, and their primary providers via phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.

  At enrollment, at 6 months, and at 18 months

Secondary Outcomes (2)

• Change in the Activity Measure for Post-Acute Care™ (AM-PAC™)

  At enrollment, at 6 months, and at 18 months

• Change in self-reported use of health care and other community support services

  Every 3 months after consenting until the end of study period at 18 months

Study Arms (2)

Complex clinical intervention

EXPERIMENTAL

Other: Complex clinical intervention

Treatment as usual

ACTIVE COMPARATOR

Other: Treatment as usual

Interventions

Complex clinical intervention OTHER

The complex intervention in CONNECT will be tested in 3 target populations: (1) Individuals hospitalized for TBI; (2) their family members; (3) their local health care providers. All intervention components will be delivered remotely: there will be no face-to-face interaction with the research subjects. The complex intervention tested in CONNECT is comprised of the clinical direction and advice to local providers, educational, and supportive services of the Mayo Brain Rehabilitation Clinic (BRC). The specific communication modes used to interact with individual study subjects, and the specific clinical and educational support services that are provided to an individual subject by these modes, will be determined by clinical need, individual preference, and technological capacity.

Complex clinical intervention

Treatment as usual OTHER

Participants in this arm will receive, experience, or provide the care that is usual and customary in their communities.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking individuals who are at least 18 years old
• Hospitalized for a minimum of 24 hours (no maximum) with TBI during the recruitment window in one of the following: 1) Hospital in state of Minnesota, 2) Hospital in state of Iowa, 3) Regional Health, 4) Altru Health System
• Individuals with TBI who have (or their LAR has) at least telephone communication technology

You may not qualify if:

• Non-English speaking individuals
• Individuals under a civil commitment order
• Individuals with TBI who are in coma or minimally conscious (not following commands)

Sponsors & Collaborators

• Mayo Clinic: lead
• Minnesota Department of Health: collaborator
• Iowa Department of Public Health: collaborator
• Rapid City Regional Hospital, Inc: collaborator
• Altru Health System: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Bergquist TF, Moessner AM, Mandrekar J, Ransom JE, Dernbach NL, Kendall KS, Brown AW. CONNECT: A pragmatic clinical trial testing a remotely provided linkage to service coordination after hospitalization for TBI. Brain Inj. 2022 Jan 28;36(2):147-155. doi: 10.1080/02699052.2022.2042601. Epub 2022 Feb 22.

  PMID: 35192438 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Patient Participation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

US (1)