How many RCTs in Stroke Rehab?

Transcription

1 Evidence Based Stroke Rehabilitation: Maximizing Recovery and Improving Outcomes Robert Teasell MD FRCPC Professor and Chair Chief Physical Medicine & Rehabilitation St. Joseph s Health Care London University of Western Ontario London, Ontario Objectives 1. Appreciate the importance of stroke rehabilitation in the continuum of stroke care 2. Understand the role of best practices in producing optimal stroke rehab outcomes

2 How many RCTs in Stroke Rehab? Stroke rehabilitation (n=8) Secondary stroke prevention (n=15) 12 th edition of SREBR: Number of RCTs / year The Importance of Rehabilitation in Stroke Strokes are Increasing First wave of baby boomers are now 6 years old and stroke is a disease of older people Primary prevention is expensive and difficult t PA treats anywhere from 5 1% of strokes and benefits about 1 in 5 7 (significant impact on 1 2% of all strokes) Demand for stroke rehabilitation is already increasing The Need for Stroke Rehabilitation Once a stroke occurs specialized interdisciplinary rehab offers best opportunity for improving outcomes Animal and clinical evidence (8 RCTs) have demonstrated benefit of stroke rehab in unravelling the blackbox of stroke rehab Evidence based stroke rehab saves money and improves lives Estimate 3% of stroke patients admitted to acute inpatient care should have access to organized stroke rehab

3 Reality Check Stroke rehab is complex and interdisciplinary, contained within a changing continuum of care with an increasingly sophisticated evidence base In Canada we have a system functioning on models over 4 5 decades old designed in an ad hoc fashion Outcomes in stroke rehab in Canada are stagnant or in decline even as research evidence increases Need to reinvest, rethink and reorganize stroke rehabilitation! Item Canada (CIHI 23, n=13) Mean Age 7.8 Lived alone Pre-Stroke 24.5% Mean Admission FIM 75.2 Mean/Median Stroke Onset to Rehab Admit (days) 26/14 Mean Rehab LOS (days) 38 Mean Discharge FIM 96.3 Mean Increase in FIM 21.1 FIM Efficiency (FIM gains/day).6 Number of Patients Home 75% 16,68 strokes hospitalized to acute care 25/26 2,293 died and 13,775 alive at discharge from acute care 2,958 admitted to inpatient rehabilitation (21%) of all strokes discharged from acute care Mean FIM admission 78 (median 8) Mean FIM discharge 12 (median 19)

4 Can We Do Better? PSROP (Post Stroke Rehabilitation Outcomes Project) Study of 7 stroke rehab centers (6 in United States, n=1161; 1 in New Zealand, n=13) Comprehensive study of stroke rehabilitation examining the black box Compare with CIHI Data of Canadian Centers (23) PROSP study, Archives of PM&R Dec 25 suppl Item US PSROP (n=1161) Canada (CIHI 23, n=13) Mean Age Lived alone Pre-Stroke 2.7% 24.5% Mean Admission FIM Median Stroke Onset to Rehab Admit (days) Mean Rehab LOS (days) Mean Discharge FIM Mean Increase in FIM FIM Efficiency (FIM gains/day) Variable 23/24 25/26 Stroke rehab 2,863 2,958 admissions Mean LOS 38.7 days 33.5 days Total rehab bed days 11,798 bed days 99,93 bed days Days from stroke onset to rehab admission 21.1 days 18.3 days Admission FIM LTC Admissions 2,248 3,43

5 What do the Americans do Differently? Best Rehab Units in the world do the basics well (Peter Langhorne) 1. Specialized Interdisciplinary Rehab Units 2. Get them in Early 3. Intensive and Stimulating Therapy 4. Strong Accountabilities 5. You can Never have enough Outpatients Americans apply best evidence carefully to achieve best outcomes and save $ #1 The Importance of Stroke Rehab Units Randomized Controlled Trial n = 251 stroke patients Acute stay 1 days randomized to treatment (inpatient rehab) or control (ad hoc community care) Rehab Unit LOS = 27.8 days Community Care 4% nursing home, 3% outpt therapy, 3% no formal rehab treatment

6 Results: 7 month follow up for all stroke patients Dependent (BI < 75) or dead 23% RU vs 38% CC (p=.1) 39% reduction in worse outcomes with stroke rehab Moderate to severe stroke (BI<5) (n=114): 62% CC vs 32% RU dead or dependent (p=.2) 48% reduction in bad outcomes Barthel Index scores 9 vs. 73 (p=.5) % Patients NS Death Dependent Dependent or Dead Median BI RU CR Stroke Rehab Units: Reality Check Specialized Interdisciplinary Stroke Rehab is the gold standard of care Several criteria: Dedicated stroke team members, geographic proximity, regular measure of outcomes and regular team communications 75% of Ontario stroke patients are sent to generalized rehabilitation units For the 25% who get stroke rehab unit care, care is often not well coordinated without the benefit of interdisciplinary team work

7 #2 4 Brain Reorganization The brain has significant capacity to reorganize itself to recover from loss of function following a stroke Reorganization depends on training or rehabilitation and will not occur spontaneously Rehabilitation training (enriched environments with animals) increases brain reorganization with subsequent functional recovery In animal studies key factors promoting recovery include increased activity and a complex, stimulating environment Lack of rehab causes decline in cortical representation and delays recovery Nudo RJ 1997 Post stroke lesion in squirrel monkey, rehab results in expansion of hand representation; no rehab results in contraction

8 Brain Reorganization The brain has significant capacity to reorganize itself to recover from loss of function following a stroke Reorganization depends on training or rehabilitation and will not occur spontaneously Key elements of stroke rehab should be increased activity and a complex and stimulating environment #2 The Earlier the Better The Earlier the Better Brain is primed to recover early in post stroke period Animal studies suggest there is a time window when brain is primed for maximal response to rehab therapies Delays are detrimental to recovery Clinical association between early admission to rehab and better outcomes

9 Ontario Stroke Strategy did fund early rehabilitation in larger acute stroke centers with subsequent decrease in mortality Still takes over 2 weeks on average to get patients into inpatient rehabilitation units. Waiting lists negatively impact outcomes! #3 Therapy Intensity RCT of 146 middle band strokes to stroke unit (SU) or gen med (GM) unit Median BI = 4/2 initially in both Stroke Unit BI = 15 after 6 wks; discharged at 6 wks General Medical Unit BI = 12 after 12 wks; discharged at 2 wks Kalra et al. 1994

10 Mean Barthel 2 SRU 18 GMU Weeks % D/C SRU GMU Weeks Mean hrs/pt 2 1 * OT PT SRU GMW

11 Mean hrs/pt Kalra et al OT PT * 1 SRU GMW % D/C Mean Barthel 2 SRU 18 GMU Weeks 1 9 SRU 8 GMU Weeks In a therapeutic day >5% time in bed 28% sitting out of bed 13% in therapeutic activities Alone for 6% of the time (Inactive and alone, Bernhardt et al, Stroke 24) Contrary to the evidence that increased activity and environmental stimulation is important to neurological recovery Conclusions on Therapy Intensity More therapy results in improved outcomes Actual direct therapist patient time and time spent in activation activities is important Rehab in Canada has traditionally struggled providing adequate therapy time (average is a little over 1 hour/day U.S. has mandated minimum of 3 hours/day

12 #4 Greater Accountabilities Study compared motor and functional recovery after stroke between 4 European Rehab Centers Gross motor and functional recovery was better in Swiss and German than UK center with Belgian center in middle Time sampling study showed avg. daily direct therapy time of 6 min in UK, 12 min in Belgian, 14 min in German and 166 min in Swiss centers Differences in therapy time not attributed to differences in patient/staff ratio (similar staffing) De Wit et al. Stroke 27:38: Average daily direct therapy time 3 Hrs Therapy per day UK Belgium S witzerland Germany Hrs Therapy per day

13 % Time Spent in Therapeutic Activities No differences were found in the content of physiotherapy and occupational therapy In German and Swiss centers, the rehabilitation programs were strictly timed (therapists had less freedom), while in UK and Belgian centers they were organized on an ad hoc basis (therapists had more freedom to decide)! More formal management in the German center may have resulted in the most efficient use of human resources, which may have resulted in more therapy time for the patients De Wit et al. Stroke 27:38: U.S. Inpatient Stroke Rehabilitation is driven by Medicare which expects: 1.Participation ( the 3 Hour Rule ) 2.Progress (FIM Gain of 1 1.5/day) 3.Expedited Discharge Home or to SNF if progress is too slow or family unwilling/unable to take home

14 The 3 Hour Rule 3 hours/day of PT, OT & SLP 5 6 days/wk Psychol, RN, VR, TR don t count (TR=OT sometimes) 55 min one on one therapy sessions with PT, OT, SLP daily and if pt can t handle 55 min then 2x3 min is scheduled Patient: therapist ratio is 7:1 each day, supplemented with rehab techs (aids) In Addition 1 2 hrs daily of OT +/or PT group sessions Weekly Speech/Cognitive group therapy sessions TR, VR, Psychology, RD, RN education Family are engaged very early in the process with caregiver training Therapist must record face to face interactions with pt in 15 min increments Manager responsible at end of day to ensure patient received their full 3 hrs of therapy Any missed therapy must have a strong medical justification documented by MD and therapist Failure to deliver enough time means loss of payment

15 Therapy is Cheap; LOS is Not Core Therapies of PT, OT and SLP are most sensitive to intensity In Canada, < 2% of total inpatient rehab budget in subacute rehab is spent on core therapies Limited accountabilities for that time and missed therapy time is extremely common Not replaced when sick or absent A laissez faire attitude towards rehab therapies even though that is our core business 6% of costs are nursing meaning LOS drive costs #5 Where Did the Outpatients Go? Cochrane Review of OutPt Rehab 14 RCTs of 1,617 patients (Outpatient Trialists 23) involved in home based, day hospital and outpatient clinic Therapy reduced the odds of a poor outcome (death, deterioration or dependency) (OR.72; 95% CI.57.92; p=.9) Number needed to treat in order to spare one person from experiencing a poor outcome was 14 U.S. puts a lot of emphasis on Outpatient Programs

16 Outpatient Therapy Outpatient therapy improves short term functional outcomes Outpatient therapy is relatively inexpensive (1 PT/1 OT/.5 SLP/.5 SW = cost of 1 rehab inpt bed) Reduces rehospitalization and allows earlier discharge home Estimated savings is $2 for every $1 spent on outpatient therapies Reality First thing cut with budget pressures Stroke Rehab in Canada Current Canadian Stroke Rehab Proposed Goals Admission to Rehab 1 17 days post stroke onset 5 7 days post stroke onset Intensity of Therapy PT, OT or SLP average 2 25 minutes per day Weekend Therapy and Statutory Holidays No therapy (sometimes weekend LOAs) Therapy Time Regulation Little or no regulation therapists set their own times; accountabilities are often lax Rehab Length of Stay days 25 days Rehab FIM Efficiency.6.8 > 1. Outpatient Therapy System Designed for Who? Often wait list or not available Provider driven care 3 hours of therapy per day in some cases extending to weekends Active therapy every day Carefully regulated therapists time carefully accounted for; therapists replaced when off Well developed and more readily available Patient driven care The End