Outcome Following Severe TBI: Bridging the Gaps Between Evidence, Practice and Policy
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1 Outcome Following Severe TBI: Bridging the Gaps Between Evidence, Practice and Policy Joseph T. Giacino, PhD Director of Rehabilitation Neuropsychology Spaulding Rehabilitation Hospital Associate Professor, Harvard Medical School Spaulding-Harvard TBIMS Severe TBI Stakeholder Summit U.S. Access Board Washington, DC May 16-17, 2016 Department of Physical Medicine & Rehabilitation Harvard Medical School Spaulding Rehabilitation Hospital Massachusetts General Hospital Brigham & Women s Hospital
2 Disclosure Dr. Giacino has no significant financial relationship with any commercial or proprietary entity that produces health-related products and/or services relevant to the content of this presentation. Dr. Giacino occasionally receives honoraria for conducting CRS-R training seminars. Dr. Giacino receives grant funding from the National Institute of Neurological Disorders and Stroke, the National Institute on Disability, Independent Living and Rehabilitation Research, U.S. Department of Defense and the James S. McDonnell Foundation.
3 Gaps between evidence, practice and policy
4 Why gaps matter (Photo and name used with permission)
5 High Stakes Decisions Key Drivers Surrogate substituted judgment Physician attitudes Intensity of Aggressive Withdrawal of
6 Mortality associated with withdrawal of life-sustaining therapy for patients with severe TBI: A Canadian multicenter cohort study (Turgeon, et al., CMAJ, 2011)
7 High Stakes Decisions Key Drivers Surrogate substituted judgment Physician attitudes Intensity of Aggressive Withdrawal of Survival Death Key Drivers Physician recommendation Surrogate judgment Authorization guidelines Type of Specialized inpatient rehab SNF/Nursing home
8 CMS Authorization Guidelines for Inpatient Rehabilitation The patient must reasonably be expected to actively participate in, and benefit significantly from, the intensive rehabilitation therapy program The patient can only be expected to benefit significantly from the intensive rehabilitation therapy program if the patient s condition and functional status are such that the patient can reasonably be expected to make measurable improvement (that will be of practical value to improve the patient s functional capacity or adaptation to impairments) and if such improvement can be expected to be made within a prescribed period of time
9 Interpretation of CMS Guideline as per InterQual Criteria 11. McKesson consultants agree that a Rancho Level of III or greater is required to ensure the patient can cognitively participate in a 3-hour therapy program 15. Full participation requires the patient to be medically-stable, cognitively-capable, and willing to participate in an intensive program...
10 High Stakes Decisions Intensity of Aggressive Withdrawal of Survival Death Type of Specialized inpatient rehab SNF/Nursing home??
11 Aims of Inpatient Rehabilitation (Edlow, Wu, et al) Specialized diagnostic and prognostic assessment Standardized neurobehavioral metrics Advanced neuroimaging studies Treatment trials Pharmacologic Physical medicine
12 SNF/custodial settings Broad mix of patients with different treatment needs Focus on common long-term needs with limited attention to the unique needs of persons with stbi. Staff lack training required to conduct specialized assessment and treatment procedures. No mechanism to fluently upgrade rehab intensity if clinical condition improves.
13 High Stakes Decisions Key Drivers Surrogate substituted judgment Physician attitudes Intensity of Aggressive Withdrawal of Survival Death Key Drivers Physician recommendation Authorization guidelines CMS/InterQual Type of Specialized inpatient rehab SNF/Nursing home Length of Key Drivers Rehab team recommendation Insurance authorization Extend specialized Downgrade to lower-intensity
14 Answer Choices Responses Q6: Did your insurance plan cover all the services you need related to your brain injury? Yes No 35.14% % 120 Total 185 BIAA Consumer Survey Related to Brain Injury Coverage Under the ACA (Survey Monkey: Since 11/13/2014)
15 Q8: Why was coverage for your brain injury services denied? (select all that apply) Answer Choices My injury happened too long ago. I have used all my allowable benefits. I will no longer improve with additional services. The services I need are not covered under my health plan. The services are not available in the provider network. I was unable to afford the copayments. Responses 14.13% % % % % % 24 Total Respondents: 92
16 Continuity of Private Health Insurance Coverage After Traumatic Brain Injury Enrollees with TBI were more likely to change coverage than those without and to demonstrate accelerated coverage change. The severity of the TBI was associated with accelerated coverage change in a dose-response manner; compared with patients without TBI, patients with TBI who had an AIS score of 2 demonstrated 8% shorter coverage, patients with TBI who had an AIS score of 3 demonstrated 19% shorter coverage, patients with TBI who had an AIS score of 4 demonstrated 23% shorter coverage, and patients with TBI who had an AIS score of 5 to 6 demonstrated 44% shorter coverage (145 vs 258 days). (Lin JA, Canner JK, Schneider EB. JAMA Surg 2016 )
17 Day 8 Day 44 Day 198 Day 366 (Edlow, Giacino, et al, Neurocrit Care, 2013) Day 744
18 How unusual is Dylan? Longitudinal outcome of patients with prolonged disorders of consciousness in the NIDRR TBI Model Systems: Sample: 337 patients not following commands on admission to rehab w/ at least 1 f-u between 1 and 5 yrs post-injury Results: (Nakase-Richardson, Whyte, Giacino, et al, J Neurotrauma, 2011) Functionally-independent = 20% (n=66) Employable = 23% (n=63)
19 Percentage of Patients Independent Functional Recovery Over 5 Years in Patients Admitted to Inpatient Rehab Not Following Commands 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% n=108 Discharge 1 YR F/U 2 YR F/U 5 YR F/U (Whyte, Nakase-Richardson, Giacino, et al, APM&R, 2013)
20 Gaps in need of closure Belief: Functional recovery after stbi with prolonged DoC is rare and the window of opportunity closes after 12 mths Truth: 20% of persons with stbi and prolonged DoC regain functional independence with meaningful changes evident out to 5 years Belief: Active participation is required to benefit from intensive rehabilitation Truth: There is no evidence of differential improvement in outcome from active v. passive rehabilitation
21 Gaps in need of closure Belief: It is possible to accurately project the duration of time needed to achieve functional milestones at the single-case level Truth: All established prognostic markers have very wide confidence intervals Belief: days of insurance coverage is sufficient to meet the basic health needs of persons with stbi Truth: Most persons with stbi experience late complications requiring medical intervention and experience chronic needs
22 Acknowledgements Spaulding Rehabilitation Hospital: Cornell-Weill Medical School -Yelena Guller, PhD - Nicholas Schiff, MD -Therese O Neil-Pirozzi, PhD - Joseph Fins, MD - Mel Glenn, MD - Ron Hirschberg, MD Boston University Medical School - Matt Doiron, BA - Douglas Katz, MD - Cecilia Carlowicz, BA - Sabrina Taylor, PhD - Ross Zafonte, DO Brigham and Women s Hospital: Moss Rehabilitation Research Institute - Emily Stern, MD - John Whyte, MD, PHD - Hong Pan, PhD - Martha Shenton, PhD James A. Haley Veterans Medical Center - Sylvain Boiux, PhD - Risa Nakase-Richardson, PhD - Ben Fuchs, BA - Courtney Chaley, BA Mt. Sinai Medical Center - Emilia Bagiella, PhD Massachusetts General Hospital: Imaging - Brian Edlow, MD Athinoula A. Martinos Center for Biomedical - Ona Wu
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