Outcome Following Severe TBI: Bridging the Gaps Between...

www.mghcme.org/spauldingtbi

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

Outcome Following Severe TBI: Bridging the Gaps Between Evidence, Practice and Policy


Disclosure

Dr. Giacino has no significant financial relationship with any

commercial or proprietary entity that produces healthcare-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.


Gaps between evidence, practice and policy

Why gaps matter

(Photo and name used with permission)

Intensity of care

Aggressive care

Withdrawal of care

High Stakes Decisions

Key Drivers • Surrogate substituted judgment • Physician attitudes


Mortality associated with withdrawal of life-sustaining therapy for patients with severe TBI: A Canadian multicenter cohort study

(Turgeon, et al., CMAJ, 2011)

Intensity of care

Aggressive care

Survival

Type of care

Specialized inpatient

rehab

SNF/Nursing home

Death

Withdrawal of care



Key Drivers • Physician recommendation • Surrogate judgment • Authorization guidelines


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…”


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...”

Intensity of care

Aggressive care

Survival

Type of care


rehab

SNF/Nursing home

Death

Withdrawal of care


??


(Edlow, Wu, et al)

Aims of Inpatient

Rehabilitation

• Specialized diagnostic and prognostic assessment

• Standardized neurobehavioral metrics • Advanced neuroimaging studies

• Treatment trials • Pharmacologic • Physical medicine


SNF/custodial care settings

• Broad mix of patients with different treatment needs

• Focus on common long-term care 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.

Intensity of care

Aggressive care

Survival

Type of care


rehab

Length of care

Extend specialized

care

Downgrade to lower-intensity

care

SNF/Nursing home

Death

Withdrawal of care



Key Drivers • Rehab team recommendation • Insurance authorization

Key Drivers • Physician recommendation • Authorization guidelines

• CMS/InterQual


Q6: Did your insurance plan cover all the services you need related to your brain injury?

Answer Choices Responses

Yes 35.14%

65

No 64.86%

120

Total 185

BIAA Consumer Survey Related to Brain Injury Coverage Under the ACA

(Survey Monkey: Since 11/13/2014)


Q8: Why was coverage for your brain injury services denied? (select all that apply)

Answer Choices Responses

–My injury happened too long ago. 14.13% 13

–I have used all my allowable benefits. 22.83% 21

–I will no longer improve with additional services.

16.30% 15

–The services I need are not covered under my health plan.

64.13% 59

–The services are not available in the provider network.

29.35% 27

–I was unable to afford the co-payments.

26.09% 24

Total Respondents: 92


“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).”

Continuity of Private Health Insurance Coverage After Traumatic Brain Injury

(Lin JA, Canner JK, Schneider EB. JAMA Surg 2016 )


Day 8 Day 44 Day 198 Day 366

(Edlow, Giacino, et al, Neurocrit Care, 2013)

Day 744


Sample: • 337 patients not following commands on admission to rehab w/ at

least 1 f-u between 1 and 5 yrs post-injury

Results:

• Functionally-independent = 20% (n=66) • Employable = 23% (n=63)

Longitudinal outcome of patients with prolonged disorders of consciousness in the NIDRR TBI Model Systems:

(Nakase-Richardson, Whyte, Giacino, et al, J Neurotrauma, 2011)

How unusual is Dylan?


Functional Recovery Over 5 Years in Patients Admitted to Inpatient Rehab Not Following Commands

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pe

rce

nta

ge o

f P

atie

nts

In

de

pe

nd

en

t

Discharge

1 YR F/U

2 YR F/U

5 YR F/U

n=108

(Whyte, Nakase-Richardson, Giacino, et al, APM&R, 2013)


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

Gaps in need of closure

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


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: 30-60 days of insurance coverage is sufficient to meet the basic healthcare needs of persons with sTBI

Truth: Most persons with sTBI experience late complications requiring medical intervention and experience chronic care needs


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: Athinoula A. Martinos Center for Biomedical Imaging - Brian Edlow, MD - Ona Wu

Outcome Following Severe TBI: Bridging the Gaps Between...

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