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Medical and Resource Facilitation Intervention After Traumatic Brain Injury (MRFI)

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ClinicalTrials.gov Identifier: NCT03429322
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
Minnesota Brain Injury Alliance
Minnesota Department of Health
Information provided by (Responsible Party):
Allen Brown, Mayo Clinic

Brief Summary:

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs.

This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities.

Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.


Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Family Physician's Role Behavioral: Medical Care and Resource Facilitation Other: Usual Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Community-based randomized pragmatic clinical trial of a complex behavioral intervention delivered remotely
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing an Integrated Medical and Resource Facilitation Intervention After Traumatic Brain Injury: A Community-based Pragmatic Clinical Trial
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Medical Care and Resource Facilitation
All intervention components will be delivered remotely: there will be no face-to-face interaction with the participants. The intervention is comprised of the clinical, educational, and supportive services of Mayo's Brain Rehabilitation Clinic integrated with the MN BIA RF program.
Behavioral: Medical Care and Resource Facilitation
The intervention expands on an established web-based platform and uses other information and communication technology (ICT) devices, incorporating synchronous direct clinical care and asynchronous intervention. Participants will use their own devices and internet access for any and all interactions with Mayo Clinic providers. The specific ICT modes used and services provided to interact with participants will be determined by clinical need, individual preference, and technological capacity.
Active Comparator: Usual care
Individuals with TBI, their family members and PCPs assigned to the usual care group will receive care and provide services as usual in their communities. Individuals with TBI assigned to the usual care group will receive RF as routinely provided by MN BIA.
Other: Usual Care
Participants will receive and provide usual and customary care in their communities.



Primary Outcome Measures :
  1. Change in Mayo-Portland Participation Index (M2PI) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    A primary participation assessment and outcome measure for phone follow-up

  2. Change in Traumatic Brain Injury-Quality of Life (TBI-QOL) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Measures health-related patient-reported quality of life measurement specific to TBI

  3. Change in Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Measures long-term outcomes and function at the societal level


Secondary Outcome Measures :
  1. Change in Vocational Independence Scale [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Quantifies degree of vocational independence: 5-point ordinal scale which quantifies the degree of vocational independence, where level 1 is unemployed and level 5 is independent engagement in community-based work (at least 15 hours per week) without external supports.

  2. Change in Telemedicine Perception Questionnaire (TMP-Q) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Assesses impressions of the risks and benefits of home tele-care

  3. EQ-5D™ [ Time Frame: Assessed at study end (18 months) ]
    A measure of health outcome to be used in determining cost-effectiveness

  4. Change in Zarit Burden Inventory (ZBI) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Caregiver burden self-report measure

  5. Change in Family Needs Questionnaire (FNQ) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Assesses diverse family needs

  6. Change in Clinical Satisfaction and Competency Rating Scale (CSCRS) [ Time Frame: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months) ]
    Measures provider efficacy and mastery in caring for individuals with TBI: a 7 question format with each question rated in a 5-point scale with 1=disagree and 5=agree. The highest score of 35 indicates the best satisfaction and competency and the lowest score of 7 indicates the worst clinical satisfaction and competency.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age ≥ 18 years
  • Diagnosis of traumatic brain injury
  • Minnesota resident
  • Access to at least a telephone
  • Functional English speaker
  • Eligible for MN BIA Resource Facilitation participant

Exclusion criteria:

  • Age < 18 years
  • Diagnosis of acquired brain disorder other than traumatic brain injury
  • No telephone or on-line/internet access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429322


Contacts
Contact: Anne M Moessner, RN, MSN 507-255-5109 moessner.anne@mayo.edu
Contact: Nicole L Dernbach, CCRP 507-255-0718 dernbach.nicole@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Minnesota Brain Injury Alliance
Minnesota Department of Health
Investigators
Principal Investigator: Allen W Brown, MD Mayo Clinic

Responsible Party: Allen Brown, Professor of Physical Medicine and Rehabilitation, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03429322     History of Changes
Other Study ID Numbers: 17-009300
90DPTB0012-01-00 ( Other Grant/Funding Number: NIDILRR )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allen Brown, Mayo Clinic:
traumatic brain injury
pragmatic clinical trial
telemedicine
cost

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System