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Evidence based rehabilitation Professor Cath Sackley PhD, MSc, MCSP, FCOT Rehabilitation Sciences, University of East Anglia Slide 2 A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care- homes. Cath Sackley, Marion Walker, Andrea Roalfe, Caroline Watkins, Chris Burton, Jonathan Mant, Karen Lett, Keith Wheatley, Bart Sheehan, Lesley Sharp, Katie Stant, Sheriden Bevan, Farzana Rashid, Joanna Fletcher Smith, Kerry Steel, Guy Peryer, Gina Sands, Joanna Briggs, Kate Wilde, Peter Sharp, Lisa Irvine, Garry Barton, Kath Mortimer, Max Feltham National Institute for Health Research. NIHR HTA Slide 3 Research Programme through clinical interest Slide 4 ~ 25% of all stroke survivors are unable to go home after their stroke Significant rise in the number of people living with stroke related disabilities between 1990 2010 Stroke survivors residing in care homes are more physically and cognitively impaired with high support needs compared to those living in the community Slide 5 UK MRC Framework for Evaluating Complex Interventions Continuum of increasing evidence Slide 6 Phase 1 A survey of immobility related complications Residents with stroke Contractures- 59 (48%) Pressure sores- 24 (20%) Shoulder pain-59 (48%) Falls- 80 (66%) Other pain- 59 (48%) Slide 7 Slide 8 How do residents spend their days? walking with assistance 1.7% walking without assistance 0.3% standing 1.0% Sitting (eyes open or closed) 97.0% Sackley C. et al. 2006. International Journal of Therapy and Rehabilitation, 13(8): 370-373. Slide 9 Phase 1 Staff Attitudes Staff feel they are employed to care Care viewed as doing for rather than maintaining independence Would like to know more about basic rehab Slide 10 Sackley C.M. et al. 2001. Age and Ageing, 30(6): 532-3. AHP provision in care homes: At best, patchy Rarely used qualified staff Inequality in access (particularly Occupational Therapy) Staff attitudes : Staff feel they are employed to care Care viewed as doing for rather than maintaining independence Staff showed an interest in learning about rehabilitation practices Care Home AHP provision Regional Survey Slide 11 Sackley C. et al. 2006. Stroke, 37(9):2336-41. Cluster RCT (n=118). Primary outcome: Barthel @ 3 months. Poor Outcome 20/63 (32%) were worse/dead in the intervention group compared with 31/55 (56%) in the control group. Group difference 25% (95% CI 51% to 1%), similar at 6 months. Self Care ADL BI score had increased by 0.6 (SD 3.9) in the intervention group and decreased by 0.9 (2.2) in the control group. Group difference 1.5 (95% CI 0.5 to 3.5). Mobility RMI score increased by 0.4 (3.0) in the intervention group decreased by 0.4 (1.9) in control. Group difference: 0.8 (95% CI 0.6 to 2.2). OTCH Phase II exploratory trial Slide 12 Standard mean difference (random) (95% Cl) Study Corr 19950.27 (-0.16 to 0.70) Gilbertson 20000.17 (-0.18 to 0.53) Chiu 20040.33 (-0.21 to 0.88) Walker 19960.10 (-0.66 to 0.86) Logan 19970.14 (-0.30 to 0.57) Walker 19990.38 (0.07 to 0.69) Sackley 20060.40 (0.00 to 0.80) Parker 2001-0.08 (-0.31 to 0.15) Total (95% Cl)0.18 (0.04 to 0.32) -0.500.5 1 Favours control Favours treatment Test for heterogeneity: x2=8.08, df=7, P=0.33, /2=13.3% Test for overall effect: z=2.45, P=0.01 Legg L.et al. 2007. BMJ, 335(7626):922. Meta-analysis: OT on personal activities of daily living Slide 13 OTCH Phase III Cluster RCT Care-home setting:Birmingham, Bangor, Portsmouth, Nottingham, Central Lancashire, Peninsula, West Midlands (n=228) Participants:1042 care home residents with a history of stroke or TIA Exclusion:Care home residents receiving end of life care. Inclusive:Includes those with communication and cognitive impairments. Primary outcome and timepoint: Independent assessment of Barthel @ 3 months. Secondary outcomes :Barthel @ 6 & 12 months. Rivermead Mobility, Depression (GDS-15), Quality of Life (EQ-5D). Analysis:Intention to treat Economic evaluation:Social perspective Slide 14 Randomised (228 homes, 1042 participants) Allocated to Occupational therapy 114 homes, average size= 5, 568 participants Allocated to Control 114 homes, average size= 42, 474 participants Received allocation= 545 Did not receive allocation = 23 Reasons: 16 died, 7 withdrawals Received allocation= 458 Did not receive allocation = 16 Reasons: 15 died, 1 withdrawal 3 month assessment= 491 (96% retention) Primary outcome completed = 479 (113 care homes) 3 incomplete, 9 missing, 48 died, 1 withdrawal, 3 ineligible, 2 lost to follow-up 3 month assessment= 416 ( 93% retention) Primary outcome completed= 391 (111 care homes) 12 incomplete, 13 missing, 37 died, 1 ineligible, 4 lost to follow-up 12 month assessment= 386 (84% retention) Primary outcome completed= 355 (104 care homes) 14 incomplete, 17 missing, 54 died, 3 withdrawals, 3 lost to follow-up 12 month assessment= 306 (83% retention) Primary outcome completed= 285 (100 care homes) 7 incomplete, 14 missing, 64 died, 5 withdrawals, 5 lost to follow-up 6 month assessment= 446 (90% retention) Primary outcome completed = 424 (111 care homes) 7 incomplete, 15 missing, 41 died, 4 withdrawals 4 lost to follow-up 6 month assessment= 380 (90% retention) Primary outcome completed= 369 (109 care homes) 2 incomplete, 9 missing, 33 died, 3 withdrawals, 4 lost to follow-up Slide 15 Interventions: Short term (3 month) targeted OT to improve mobility & self-care independence Information, advice & caregiver training Activity & mobility training Interventions 1 Slide 16 Control: Standard care (not a lot) Interventions 2 Interventions: Short term (3 month) targeted OT to improve mobility & self-care independence Assistive devices & adaptations Wheelchairs & seating reviewed Slide 17 Summary of OTCH Intervention Framework Employed a patient-centred goal-setting approach Treatment regime developed using consensus professional opinion 3-month intervention to improve mobility & self-care independence Staff training was a key component. Six Categories: - Assessment, Reassessment and Goal Planning - Communication - ADL training - Transfers and mobility (including wheelchairs) - Adaptive equipment (including seating) - Other (such as treating impairments) Slide 18 Barthel Index at Baseline Randomisation arm Barthel Index [0-20]Occupational therapyControl Very Severe [0-4]268 (47.7%)234 (50.1%) Severe [5-9]129 (23.0%)104 (22.3%) Moderate [10-14]91 (16.2%)76 (16.3%) Mild [15-19]64 (11.4%)46 (9.9%) Independent [20]10 (1.8%)7 (1.5%) Total562467 Slide 19 Intervention mean (sd) n Control mean (sd) n Sheffield [0 20] impaired [