Collaborative community-based brain rehabilitation research: Clinical trials designed for implementation

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1 Collaborative community-based brain rehabilitation research: Clinical trials designed for implementation NASHIA: Building Bridges for a Better Future September 26, 2018 Des Moines, IA 2018 MFMER slide-1

2 Allen W. Brown, MD Consultant, Division of Brain Rehabilitation Department of Physical Medicine and Rehabilitation, Mayo Clinic Rochester, MN Professor of Physical Medicine and Rehabilitation Mayo Clinic College of Medicine and Science Principal Investigator, Project Director Mayo Clinic Traumatic Brain Injury Model System Center 2018 MFMER slide-2

3 Disclosure Relevant Financial Relationships None Off-Label Investigational Uses None 2018 MFMER slide-3

4 Outline Epidemiology Models of Care Testing Interventions Pragmatic Clinical Trials at Mayo Clinic Future: attributing outcomes to TBI 2018 MFMER slide-4

5 Main Points Concussive traumatic brain injury dominates its epidemiology Integrated models of care are associated with superior outcomes over time Design of clinical interventions should be informed by those receiving them and tested in the communities in which they will be used Risk of developing degenerative brain conditions following TBI is unknown 2018 MFMER slide-5

6 Epidemiology Case Definition Classification Incidence Cost Survival 2018 MFMER slide-6

7 Rochester Epidemiology Project Olmsted County, Minnesota, (2010 census population, 144,248) The Mayo Clinic/Hospitals, Olmsted Medical Center/Hospital provide all care Since 1907, every patient has been assigned a unique identifier and record All information types and from every setting Identify population-based controls Melton LJ. Mayo Clin Proc 1996;71: MFMER slide MFMER slide-7

8 Case Definition of TBI External mechanical force Brain dysfunction 2018 MFMER slide-8

9 Classification Glasgow Coma Scale score (3-15) Eye, motor, verbal responses Mild (13-15); Moderate (9-12); Severe (3-8) Mild versus not-mild Loss of consciousness > 30 minutes Post-traumatic amnesia > 24 hours Complicated mild No alteration of consciousness CT abnormalities including skull fracture 2018 MFMER slide-9

10 Classification Consider all positive evidence in record that meets case definition Incorporate existing accepted injury severity classification criteria J Neurotrauma 2007;24: MFMER slide-10

11 Mayo TBI Classification System A. Classify as Definite TBI if one or more of the following criteria apply: 1. Death due to this TBI 2. Loss of consciousness of 30 minutes or more 3. Post-traumatic anterograde amnesia of 24 hours or more 4. Worst Glasgow Coma Scale full score in first 24 hours < 13 (unless invalidated upon review, e.g., attributable to intoxication, sedation, systemic shock) 5. Intracranial CT scan abnormality B. If none of Criteria A apply, classify as Probable TBI if one or more of the following criteria apply: 6. Loss of consciousness of momentary to less than 30 minutes 7. Post-traumatic anterograde amnesia of momentary to less than 24 hours 8. Depressed, basilar or linear skull fracture (dura intact) C. If none of Criteria A or B apply, classify as Possible TBI if one or more of the following symptoms are present: Blurred vision Confusion (mental state changes) Dazed Dizziness Focal neurologic symptoms Headache Nausea 2018 MFMER slide MFMER slide-11

12 Incidence Population-based Medical record review Full spectrum of disease J Neurotrauma 2012;29: MFMER slide-12

13 Incidence of TBI by Injury Classification Category Total = 558/100 K Definite = 47 Probable = 215 Possible = 297 Olmsted County, 1 January 1987 to 31 December MFMER slide-13

14 Estimated incidence 579/100,000 population Faul M, et al. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths Atlanta (GA): Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; MFMER slide MFMER slide-14

15 Cost: TBI-associated medical cost Study period 1985 to 1999 Population-based matched controls Controlled for pre-existing conditions, non-brain trauma J Neurotrauma 2012;29: MFMER slide-15

16 Conclusions Entire period: TBI cost $4,906/case vs. control 1 day to 6 months: Definite $22,838; Probable $983; Possible $189 Year 1 to 6 years: Definite < control; Probable $1,016; Possible $4, MFMER slide MFMER slide-16

17 Total incremental costs for TBI by classification* *over 6 years, compared to control 2018 MFMER slide-17

18 Total = $8.545 billion Possible = $4.540 billion 2018 MFMER slide MFMER slide-18

19 Survival Many reports show reduced survival after TBI J Head Trauma Rehabil 2014;29:E MFMER slide-19

20 Survival after TBI TBI can be associated with other injuries These other injuries may affect survival Research questions: Does TBI increase risk for death? Does non-brain trauma contribute to risk of death? 2011 MFMER slide MFMER slide-20

21 Comparisons Controls 2 for each matched case Controlled for non-head trauma Special cases and their controls Three time periods Injury to follow-up Injury to 6 months 6 months to follow-up 2011 MFMER slide MFMER slide-21

22 Table 6. Risk of death using Regular vs. Special controls: All ages, all TBI severity categories Time period Injury to follow-up Injury to 6 months 6 months to follow-up Control HR Lower Upper Regular Special Regular Special Regular Special HR = hazard ratio; 95% upper and lower confidence intervals 2011 MFMER slide MFMER slide-22

23 Conclusions TBI increases risk for death This risk exists only during the first 6 months after injury 6-month survivors retain life-span Accounting for non-brain trauma substantially affects accuracy 2011 MFMER slide MFMER slide-23

24 Main Points Concussive ( Possible ) traumatic brain injury dominates its epidemiology Possible classification has the weakest evidence that a TBI occurred Population-based epidemiological study is gold standard Controlling for non-brain trauma has a substantial affect on the accuracy of estimating risk for death 2018 MFMER slide-24

25 2011 MFMER slide MFMER slide-25

26 Models of Care Service Line Integration Traumatic Brain Injury Model System Outcomes 2018 MFMER slide-26

27 International Classification of Functioning, Disability, and Health ICD-9/10 Impairment Impairment Roles Restriction to Participation Activity Limitations 2018 MFMER slide-27

28 Service Line Integration Acquired brain disorders service line Specialty brain rehabilitation services integrated into acute hospital care Rehabilitation becomes a primary medical need soon after admission Rehabilitation services provide longitudinal care 2018 MFMER slide-28

29 2018 MFMER slide-29

30 2018 MFMER slide-30

31 2018 MFMER slide-31

32 2018 MFMER slide-32

33 2018 MFMER slide-33

34 Mayo Clinic Hospital Saint Marys Campus 2018 MFMER slide-34

35 Acquired Disorders Service Line Brain Rehabilitation Continuum of Care Mayo Clinic Hospital Saint Marys Campus Brain Rehabilitation Unit Service Neurosurgery Brain Rehabilitation Consultation Service Trauma Neurology Critical Care Brain Rehabilitation Clinic Mayo Clinic Mayo Clinic Midwest MCCN 2018 MFMER slide-35

Patient & Family Coping Skills Patient and

36 Brain Rehabilitation Clinic Cognitive Rehabilitation Speech and Language Therapy Neuromuscular Therapy Brain physiatrist Neuropsychology and testing Brain Rehabilitation Nursing Vocational Case Coordinator Clinical Social Services Patient & Family Coping Skills Patient and Family Education Secretarial/Appointment/Administrative Support Brain Rehabilitation Research Mayo Clinic s TBI Model System Center 2018 MFMER slide-36

37 Mayo Clinic TBI Model System Center 2018 MFMER slide-37

38 2018 MFMER slide-38

39 2018 MFMER slide-39

40 TBIMS Center Activities Contribute subjects to the TBI National Data Base; follow up 1, 2, 5 and every 5 years thereafter Participate in collaborative research with other funded centers Carry out one site specific study 2018 MFMER slide-40

41 TBI National Data Base Current n = 16, year follow-up n = 4, year n = 1, year n = MFMER slide-41

42 Outcomes 2018 MFMER slide-42

43 2018 MFMER slide-43

44 2011 MFMER slide MFMER slide-44

45 Testing Interventions Internal, external advisory and oversite Unmet Needs Pragmatic Clinical Trials Background Methodology 2018 MFMER slide-45

46 External Internal 2018 MFMER slide-46

47 Unmet Needs Literature in the field National and state needs assessments Informed by consultation consumers state and community agencies providing care and making policy research and clinical peers Drives research questions 2018 MFMER slide-47

48 Pragmatic Clinical Trials Background Methodology 2018 MFMER slide-48

49 Johnson KE et al. BMJ 2014;349: MFMER slide-49

50 Randomized Double-blind Placebo-controlle d Clinical Trials: Ideal conditions Randomized Pragmatic Clinical Trials: Real-world conditions Implementation research: study of barriers to/methods of promoting systematic application of research findings in practice, including in public policy. Cully JA et al. Implementation Science 2012;7: MFMER slide-50

51 Designed for Implementation Research question and methodology is informed by: Target populations Community-based collaborators Intervention is tested in community where it will used Intervention can be used without additional trials 2018 MFMER slide-51

52 Methodology Community-based randomized pragmatic clinical trial Designed for implementation Complex behavioral intervention 2018 MFMER slide-52

53 Craig P et al. BMJ 2008;337:a MFMER slide-53

54 Pragmatic Clinical Trials at Mayo Clinic Midwest Advocacy Project CONNECT MRFI 2018 MFMER slide-54

55 Midwest Advocacy Project Brain Inj. 2015;29(13-14): ClinicalTrials.gov Identifier: NCT MFMER slide-55

56 Midwest Advocacy Project Unmet needs Gaps in community services, low levels of public awareness Perceived needs unrecognized, barriers to receiving services, lack of advocacy Association between met needs and life satisfaction 2018 MFMER slide-56

57 Midwest Advocacy Project Focus on improving advocacy skills Self-advocacy: benefitting an individual or significant other Systems advocacy: system change benefitting individuals with TBI generally 2018 MFMER slide-57

58 Midwest Advocacy Project Research question: Is curriculum-based advocacy training superior to customary methods (support group) in improving advocacy skills Target population: individuals with TBI, their families/caregivers Hypothesis: superior outcomes with curriculum intervention 2018 MFMER slide-58

59 Study Design Collaboration with state Brain Injury Associations MN, IA, WI Sample: print, electronic BIA newsletter datasets, BIA-sponsored events, promotion Randomize: curriculum versus self-directed 2018 MFMER slide-59

60 Study Design Intervention: curriculum-based advocacy training course Alternative: self-directed support group One day/month, 4 consecutive months 2018 MFMER slide-60

61 Study Design Primary outcome measure: Advocacy Behavior Scale score Pre-post letter, video 2018 MFMER slide-61

62 Midwest Advocacy Project Hypotheses: Programmed advocacy training Demonstrate better advocacy skills Greater advocacy activity, behavior, perceived self-control Increase media attention, policy, regulation, legislative activity 2018 MFMER slide-62

63 MIDWEST ADVOCACY PROJECT 2018 MFMER slide-63

64 2011 MFMER slide MFMER slide-64

65 2011 MFMER slide MFMER slide-65

66 2011 MFMER slide MFMER slide-66

67 Midwest Advocacy Project Conclusions Curriculum-based advocacy training intervention not superior to self-directed approach When groups combined a significant improvement in advocacy skills was observed Key feature of improving advocacy skills is bringing together motivated individuals 2018 MFMER slide-67

68 CONNECT Trial 2018 MFMER slide-68

69 CONNECT Trial Individual with TBI Mayo Brain Rehabilitation Clinic Primary clinical providers Family/Caregivers 2018 MFMER slide-69

70 Upper Midwest states: high risk 2011 MFMER slide MFMER slide-70

71 2018 MFMER slide-71

72 2011 MFMER slide MFMER slide-72

73 CONNECT Trial Unmet need: lack of system capacity and limited access to specialty care 4 upper Midwest states: rural, elderly, Native American high risk 2011 MFMER slide MFMER slide-73

74 Methodology Community-based randomized pragmatic clinical trial Designed for implementation Complex behavioral intervention Provided remotely: increase access, capacity 2018 MFMER slide-74

75 Intervention Brain rehabilitation clinic resources Secure electronic web-based platform (CareHubs) Smart-phone, land line, Skype Clinical, educational, peer support, facilitation, coordination 2011 MFMER slide MFMER slide-75

76 Target populations Individuals with TBI hospitalized a minimum of one night Their family/caregivers Local clinical providers Target n = 250 individuals with TBI/group Mayo Clinic patients excluded 2011 MFMER slide MFMER slide-76

77 Process Sample MN, IA: statute connection ND, SD: practice collaboration Contact, consent, randomize Team staffing Customization of services, coordination, assistance Education, peer interaction, office hours, webinars 2011 MFMER slide MFMER slide-77

78 Measures Individuals with TBI Impairment, activity, participation, satisfaction (PROMIS, TBI-QOL) Family/caregivers Participation, satisfaction Primary clinical providers Confidence, comfort, satisfaction 2011 MFMER slide MFMER slide-78

79 Hypotheses Intervention will show greater improvement in participation outcomes Individuals with TBI, families in intervention group more satisfied with health care, medical care experience Local providers in intervention group will report greater satisfaction with experience caring for individuals with TBI and more capable 2011 MFMER slide MFMER slide-79

80 Collaborators Internal Center for Innovation (Mayo ICT since early 90 s) Center for Social Media External Minnesota Department of Health Iowa Department of Public Health Trinity Health, Minot, ND Regional Health, Rapid City, SD CareHubs 2011 MFMER slide MFMER slide-80

81 Preliminary Results Recruitment overall: 74% (n = 332) By state (% target): MN > IA > SD > ND Sample representative Gender Urban/rural Race/ethnicity 2011 MFMER slide MFMER slide-81

82 Lessons Learned Participants not always needy Broad geographic area limited intervention Intervention had medical bias Web-based community design Poor PCP participation 2011 MFMER slide MFMER slide-82

83 Integrated Medical and Resource Facilitation Intervention (MRFI) 2018 MFMER slide-83

84 Unmet Needs Ineffective connection to specialized resources in transition from hospital to community Limited access to TBI experts Inconsistent primary care provider (PCP) knowledge about complex needs 2018 MFMER slide-84

85 Unmet Needs Medical and social problems after TBI have a common cause and are intertwined Complex medical and social needs must be addressed holistically, considering all aspects of an individual s health and circumstances including their social context 2018 MFMER slide-85

86 Methodology Community-based randomized pragmatic clinical trial Designed for implementation Complex behavioral intervention Cost effectiveness analysis Formative review 2018 MFMER slide-86

87 Methodology Sample Individuals with TBI who enter MN BIA RF Families PCPs Intervention Mayo Brain Rehabilitation Clinic MN BIA Resource Facilitation (RF) Direct medical and rehabilitation care by telemedicine Mayo Clinic Connect online community 2018 MFMER slide-87

88 MRFI: Key Components Every participant will receive unique combination of services based on need, interest, technology Families, PCPs strategically engaged as part of integrated team All target populations receive services by various modes of remote ICT No face-to-face visits 2018 MFMER slide-88

89 MRFI: PCP engagement Free Mayo CME 18 credits Approach office staff, midlevels Ways/times to reach out Enlist help from participant/family PCP specific brochure 2018 MFMER slide-89

90 Measures Individuals with TBI Impairment, activity, participation, satisfaction (PROMIS, TBI-QOL) Family/caregivers Participation, satisfaction Primary clinical providers Confidence, comfort, satisfaction 2011 MFMER slide MFMER slide-90

91 Study aims Specific Aim 1: Assess effectiveness of intervention provided remotely in improving participation outcomes of individuals with TBI Specific Aim 2: Test for differences in caregiver burden, quality of life in the families of individuals with TBI 2018 MFMER slide-91

92 Study aims Specific Aim 3: Measure differences in efficacy and mastery among PCPs in caring for individuals with TBI Specific Aim 4: Compare the cost-effectiveness of the integrated service intervention arm of the trial with the usual care arm 2018 MFMER slide-92

93 Mayo Clinic Collaborators Center for Connected Care Social Media Network Center for the Science of Health Care Delivery 2018 MFMER slide-93

94 Cost effectiveness analysis Costs between MRFI and Usual Care groups will be compared All Payer Claims Data (APCD) Consultants Stefan Gildemeister, Jon Roesler, Mark Kinde, MDH Bijan Borah, PhD and James Naessens, ScD, Mayo Clinic Science for the Delivery of Health Care 2018 MFMER slide-94

95 TBI Model System Centers National Hub-and-Spoke System of Brain Rehabilitation Care 2011 MFMER slide MFMER slide-95

96 2011 MFMER slide MFMER slide-96

97 Future: Attributing outcomes to TBI 2018 MFMER slide-97

98 Future: Attributing outcomes to TBI 2018 MFMER slide-98

99 2018 MFMER slide-99

100 Attributing outcomes to TBI The epidemiology of CTE is not yet known There are no studies of its incidence or prevalence All reports to date relate to biased samples 2018 MFMER slide-100

101 Attributing outcomes to TBI By definition, traumatic brain injury alters brain function The severity and duration of neurological impairment after TBI is related to injury severity Activity (functional) limitations and restriction to participation in roles after TBI can be influenced by neurological impairment and many other things 2018 MFMER slide-101

102 Attributing outcomes to TBI It is evident that TBI can lead to degenerative conditions associated with abnormal protein deposition in the brain (synucleinopathies, tauopathies) It is unclear the extent to which exposure (severity, frequency, duration of TBI) influences this risk, but it is generally considered that risk increases as exposure increases 2018 MFMER slide-102

103 Attributing outcomes to TBI Any risk imparted to an individual by TBI of any degree of exposure is unique to that individual and today cannot be predicted with any certainty Preventing TBI is an important community health priority The vast majority of individuals who are exposed to relatively mild TBI even multiple times develop no lasting or limiting brain-related neurological impairment 2018 MFMER slide-103

104 Attributing outcomes to TBI Health risks associated with a sedentary lifestyle for all ages are well established Known health benefits of physical activity and aerobic exercise are well established Related to sport-related concussive and sub-concussive events, we struggle making medical decisions which balance known health benefits of participation against the unknown but potential health risk of exposure to TBI 2018 MFMER slide-104

105 Attributing outcomes to TBI The vast majority of individuals with persistent symptoms after concussive TBI are unrelated to trauma-related neurological impairment Many advocate improving knowledge and awareness of coaches and athletes at all levels, refinement of rules of play and sport-specific technique to minimize exposure risk 2018 MFMER slide-105

106 Main Points Concussive traumatic brain injury dominates its epidemiology Integrated models of care are associated with superior outcomes over time Design of clinical interventions should be informed by those receiving them and tested in the communities in which they will be used Risk of developing degenerative brain conditions following TBI is unknown 2018 MFMER slide-106

107 Thank you 2018 MFMER slide-107

Expanding Access to Movement Disorders Care and Research. Kevin M. Biglan, MD, MPH Rochester, New York September 24, 2016.

Expanding Access to Movement Disorders Care and Research Kevin M. Biglan, MD, MPH Rochester, New York September 24, 2016 Disclosures Presbyterian Home of Central New York Susquehanna Nursing and Rehabilitation