“Evidence based rehabilitation”
Professor Cath Sackley PhD, MSc,
MCSP, FCOT
Rehabilitation Sciences, University
of East Anglia
A cluster randomised controlled trial of
an occupational therapy intervention for
residents with stroke living in UK carehomes.
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
Research Programme through clinical interest
~ 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
UK MRC Framework for
Evaluating Complex Interventions
Phase IV
Phase III
Phase II
Phase I
Pre-clinical
Theory
Modelling
Continuum of increasing evidence
Exploratory trial
Definitive RCT
Long term
implementation
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%)
How do residents spend their days?
walking with
assistance 1.7%
standing 1.0%
walking without
assistance 0.3%
Sitting (eyes
open or closed)
97.0%
Sackley C. et al. 2006. International Journal of Therapy and Rehabilitation, 13(8): 370-373.
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
Care Home AHP provision Regional Survey
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
Sackley C.M. et al. 2001. Age and Ageing, 30(6): 532-3.
OTCH Phase II exploratory trial
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).
Sackley C. et al. 2006. Stroke, 37(9):2336-41.
Meta-analysis: OT on personal activities of daily living
Standard mean difference
(random) (95% Cl)
0.27 (-0.16 to 0.70)
0.17 (-0.18 to 0.53)
0.33 (-0.21 to 0.88)
0.10 (-0.66 to 0.86)
0.14 (-0.30 to 0.57)
0.38 (0.07 to 0.69)
0.40 (0.00 to 0.80)
-0.08 (-0.31 to 0.15)
Study
Corr 1995
Gilbertson 2000
Chiu 2004
Walker 1996
Logan 1997
Walker 1999
Sackley 2006
Parker 2001
Total (95% Cl)
0.18 (0.04 to 0.32)
-1
-0.5
Favours
control
0
1
0.5
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.
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
Randomised (228 homes, 1042 participants)
Allocated to Occupational therapy
Allocated to Control
114 homes, average size= 5,
568 participants
114 homes, average size= 4·2,
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)
3 month assessment= 416 ( 93% retention)
Primary outcome completed = 479 (113 care homes)
3 incomplete, 9 missing, 48 died, 1 withdrawal, 3
ineligible, 2 lost to follow-up
Primary outcome completed= 391 (111 care homes)
12 incomplete, 13 missing, 37 died, 1 ineligible,
4 lost to follow-up
6 month assessment= 446
6 month assessment= 380 (90% retention)
(90% retention)
Primary outcome completed = 424 (111 care homes)
7 incomplete, 15 missing, 41 died, 4 withdrawals
4 lost to follow-up
Primary outcome completed= 369 (109 care homes)
2 incomplete, 9 missing, 33 died, 3 withdrawals, 4
lost to follow-up
12 month assessment= 386 (84% retention)
12 month assessment= 306 (83% retention)
Primary outcome completed= 355 (104 care homes)
14 incomplete, 17 missing, 54 died, 3 withdrawals,
3 lost to follow-up
Primary outcome completed= 285 (100 care homes)
7 incomplete, 14 missing, 64 died, 5 withdrawals,
5 lost to follow-up
Interventions 1
Interventions: Short term (3 month) targeted OT to improve mobility &
self-care independence
• Information, advice & caregiver training
• Activity & mobility training
Interventions 2
Interventions: Short term (3 month) targeted OT to improve mobility &
self-care independence
•
Assistive devices & adaptations
•
Wheelchairs & seating reviewed
Control: Standard care (not a lot)
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)
Barthel Index at Baseline
Randomisation arm
Barthel Index [0-20]
Occupational therapy
Control
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%)
562
467
Total
Additional Participant Characteristics at Baseline
Intervention
mean (sd)
n
Control
mean (sd)
n
Sheffield [0 – 20]
impaired [<15]
10.9 (7.1)
424
(58%)
11.9 (6.9)
374
(57%)
MMSE [0-30 ]
cognitive impairment [0-20]
13.6 (9.5)
398
(70%)
13.2 (9.0)
362
(73%)
Barthel [0-20]
6.5 (5.8)
562
6.3 (5.7)
467
Rivermead [0-15]
3.1 (3.8)
557
2.8 (3.7)
456
GDS [0-15]
6.8 (3.9)
498
6.4 (3.5)
415
EQ-5D (3L)
0.20 (0.38)
506
0.24 (0.36)
423
Therapy Time Distribution
• Visits = 2538 to N= 498 residents
• Mean = 5.1 (SD 3.04) visits/resident
• Median Duration = 30mins (IQR 15-60)
• Six Categories:
- Assessment and Goal Planning:
- Communication:
- ADL training:
- Transfers and mobility :
- Adaptive equipment :
- Other :
23%
49%
7%
8%
7%
6%
Primary & Secondary Outcomes @ 3 months
Randomisation arm
Occupational
Control
Therapy
Adj
n
Adj
n
mean*
mean*
(se)
(se)
Barthel
Rivermead
GDS-15
EQ-5D
5.47
(0.20)
539
2.74
(0.11)
465
6.09
(0.21)
383
0.24
(0.02)
409
5.29
(0.21)
436
2.73
(0.12)
382
6.30
(0.22)
324
0.23
(0.02)
338
ICC
Difference in
adjusted means
(95% CI)
P
value
0.09
0.19
0.48
(-0.33 to 0.70)
0.04
0.02
0.90
0.07
(-0.28 to 0.31)
-0.21
0.44
0.06
(-0.76 to 0.33)
0.01
0.65
(-0.04 to 0.06)
Process Evaluation Summary
• Embedded process evaluation to develop an explanatory account of how the
intervention was implemented within the trial.
• Interviews with trial therapists and critical incidents.
• Four overarching mechanisms which characterised implementation:
(1) Balancing research and professional requirements,
(2) Building rapport with care home staff,
(3) Re-engineering the personal environments of care home patients,
(4) Therapists’ learning about the intervention and its impacts over time.
• How these mechanisms operated was contingent on multiple factors such as
the prior experience of therapists, and the contexts characterising the care
homes included in the trial.
• Masterson-Algar , et al. Journal of Evaluation and Clinical Practice, submitted.
Health Economics Summary
• The intervention costs more than the NICE cost-effectiveness
threshold of £20,000/QALY across all analyses.
• Significant difference in cost /QALY between participants in
nursing homes (£63k/QALY) compared with residential care
(£28k/QALY).
• Based on current cost-effectiveness thresholds, we would not
endorse the OTCH programme.
Summary
• Neutral findings are deemed as robust .
• Participant baseline characteristics were representative of the
UK care home population, in regards to age, gender balance,
levels of frailty and support needed.
• The OT treatment offered to participants was similar to an NHS
intervention, indicated by the OTCH process evaluation.
• The evidence does not support the use of an OT package to
increase or maintain abilities in personal activities of daily living,
for an older care home population with stroke-related disabilities.
Conclusions
• These neutral findings are similar to those reported in other
recently reported RCTs conducted in a care-home population
(Underwood et al, 2013; Kerse et al, 2008).
• These studies assessed the influence of exercise on
depression ratings using the GDS, and the influence of functional
activity on quality of life / frequency of falls.
• Both trials reported either a neutral or a minimal effect,
mediated by levels of cognitive impairment.
• What are the next steps for research in this clinically complex
population with high incidence of depression, cognitive and
physical impairment?
OT Intervention with John
Some of the ‘perks’ of being involved in stroke research…
John was interviewed by local TV news and enjoyed his 15 minutes
of fame!
OT Intervention with John
Some of the ‘perks’ of being involved in stroke research…
John met HRH Princess Anne when she visited the research unit
OT Intervention with John
Some of the ‘perks’ of being involved in stroke research…
Notts County FC acknowledged his support with a lifetime season
ticket and merchandise
Acknowledgements