Does Arthritis Self-management Help? A Randomised Controlled Trial of an Arthritis Self-Management Programme in Primary Care
The  Trial <ul><li>Grant Holders: </li></ul><ul><li>Marta Buszewicz,   Greta Rait, Mark Griffin     University College Lon...
Contents of Presentation   <ul><li>Background to the DASH trial </li></ul><ul><li>Study design </li></ul><ul><li>Working w...
Background <ul><li>Osteoarthritis is a common & chronic condition, causing: </li></ul><ul><ul><li>Pain & functional disabi...
Previous results from studies examining arthritis self- management programmes in the USA & UK <ul><li>Improvements in anxi...
Arthritis Self-Management Programmes (ASMPs) <ul><li>Developed in the USA – started pragmatically, but theoretical basis i...
“ Challenging Arthritis”   (ASMP delivered by Arthritis Care) <ul><li>Six, weekly, structured group sessions  </li></ul><u...
‘ Expert Patients’ Initiative <ul><li>UK government initiative to address living with chronic diseases – first introduced ...
Study Objectives <ul><li>To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis: </li></u...
Study Design <ul><li>Randomised controlled trial   </li></ul><ul><ul><li>Intervention:  Challenging Arthritis course     +...
Inclusion  &  Exclusion Criteria <ul><li>Age 50 years or above </li></ul><ul><li>GP diagnosis of osteo-arthritis of knees ...
Outcomes to be Measured <ul><li>Measured at baseline, 4 & 12 months  </li></ul><ul><li>1 0   Quality of Life  (SF 36) </li...
Patient Identification  & Recruitment <ul><li>Nurse computer searches </li></ul><ul><ul><ul><li>Read code diagnoses </li><...
Qualitative methodology <ul><li>Sample of the intervention group interviewed </li></ul><ul><ul><li>Baseline, 4 & 12 months...
Collaboration with  the Voluntary Sector <ul><li>DASH was the first MRC trial working with the voluntary sector  </li></ul...
Arthritis Care   <ul><li>Structure of organisation </li></ul><ul><ul><li>Initially centralised & hierarchical </li></ul></...
Analysis Plan <ul><li>Participants analysed in randomisation group originally assigned to (ITT), with imputation of missin...
Results - recruitment
Results – baseline characteristics   Intervention   n=406 Control   n=406 Age  (yrs)  Mean  (S.D.)   68.4 (8.2 ) 68.7  (8....
Results – Challenging Arthritis course attendance <ul><ul><li>219 people in the intervention group (56 %) attended >= 4 in...
OUTCOMES Adjusted difference in means & (95% C.I.) at 4 months Adjusted difference in  means & (95% C.I.) at  12 months SF...
Outcome plots   - positive difference in means favours treatment SF 36 Mental Health SF 36 Physical Health
Outcome plots continued ASE Pain ASE Other
Outcome plots   - negative difference in means favours treatment HADS Anxiety HADS Depression
Outcome plots continued WOMAC Pain WOMAC Stiffness WOMAC Physical Functioning
12 Month Results - Summary <ul><li>Small non significant change in SF-36 mental health scale  </li></ul><ul><li>Significan...
Economic Evaluation <ul><li>No significant differences between groups at 12 months in: </li></ul><ul><ul><li>Costs to stat...
Summary / Discussion (1) <ul><ul><li>Does arthritis self-management work? </li></ul></ul><ul><ul><li>Statistically signifi...
Summary / Discussion (2) <ul><li>How does the intervention work? </li></ul><ul><ul><li>How might the intervention impact o...
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DASH - does arthritis self-management help?

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This lecture was given by Dr Marta Buszewicz, General Practitioner from North London and Senior Lecturer in Community Based Teaching & Research at UCL, to the North British Pain Association Spring Scientific Meeting in Edinburgh on Friday 18th May, 2007. Her lecture forms part of a conference "Blurring the Boundaries - Managing Pain in Primary Care and Secondary Care".

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  • Thanks for invite Introduce the recently funded DASH trial RCT of ASMP in primary care
  • DASH - does arthritis self-management help?

    1. 1. Does Arthritis Self-management Help? A Randomised Controlled Trial of an Arthritis Self-Management Programme in Primary Care
    2. 2. The Trial <ul><li>Grant Holders: </li></ul><ul><li>Marta Buszewicz, Greta Rait, Mark Griffin University College London </li></ul><ul><li>Andy Haines London School of Hygiene & Tropical Medicine Julie Barlow University of Coventry </li></ul><ul><li>Project Manager: Angela Atkinson UCL </li></ul><ul><li>Health Economists: Jeni Beecham, Anita Patel </li></ul><ul><li>Centre for the Economics of Mental Health </li></ul><ul><li>Intervention provided by Arthritis Care </li></ul><ul><li>RCT funded by the MRC </li></ul>
    3. 3. Contents of Presentation <ul><li>Background to the DASH trial </li></ul><ul><li>Study design </li></ul><ul><li>Working with the voluntary sector </li></ul><ul><li>Results </li></ul><ul><li>Discussion points </li></ul>
    4. 4. Background <ul><li>Osteoarthritis is a common & chronic condition, causing: </li></ul><ul><ul><li>Pain & functional disability </li></ul></ul><ul><ul><li>Anxiety & depression </li></ul></ul><ul><ul><li>Lowered quality of life </li></ul></ul><ul><li>It is associated with high direct (medical) & indirect (social & community costs </li></ul><ul><ul><li>Estimated total cost of £ 5.5 billion in 1999-2000 </li></ul></ul><ul><li>Perception that ‘medical’ treatments do not address many problems patients have </li></ul>
    5. 5. Previous results from studies examining arthritis self- management programmes in the USA & UK <ul><li>Improvements in anxiety & depression, exercise taken, sense of control over arthritis & better communication with doctors (reduced pain in some studies) </li></ul><ul><li>Sustained use of self-management techniques </li></ul><ul><li>Decrease in visits to doctors (in some studies) </li></ul><ul><li>Results so far with volunteer patients only </li></ul><ul><li>Recent systematic reviews raise some queries about methodology and effect sizes </li></ul>
    6. 6. Arthritis Self-Management Programmes (ASMPs) <ul><li>Developed in the USA – started pragmatically, but theoretical basis in Bandura’s self-efficacy theory </li></ul><ul><li>People with arthritis are a resource – have innate problem solving skills </li></ul><ul><li>Effective self-management techniques are taught by trained volunteers who have arthritis </li></ul><ul><li>Key component is building on small experiences of mastery with peers </li></ul>
    7. 7. “ Challenging Arthritis” (ASMP delivered by Arthritis Care) <ul><li>Six, weekly, structured group sessions </li></ul><ul><li>Education about condition & its management </li></ul><ul><li>Help individual to develop individual behavioural and cognitive strategies </li></ul><ul><li>Aim to improve communication with family & health professionals </li></ul><ul><li>Quality assured </li></ul>
    8. 8. ‘ Expert Patients’ Initiative <ul><li>UK government initiative to address living with chronic diseases – first introduced in 2002 </li></ul><ul><ul><li>Expert Patients’ Programme </li></ul></ul><ul><li>Generic self-management programmes </li></ul><ul><ul><li>Based on Lorig’s US self management programmes </li></ul></ul><ul><li>Funded initially by the government via PCTs </li></ul><ul><ul><li>National roll-out before pilot evaluations complete </li></ul></ul><ul><ul><li>No clear evidence of cost-effectiveness </li></ul></ul><ul><ul><li>Recent RCT results very similar to ours for ASMP </li></ul></ul>
    9. 9. Study Objectives <ul><li>To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis: </li></ul><ul><li>participation in ‘Challenging Arthritis’ groups improves quality of life (1o outcome) </li></ul><ul><li>participation affects pain, function, control over symptoms, anxiety or depression (2o outcomes) </li></ul><ul><li>the intervention is cost-effective </li></ul><ul><li>(also a qualitative arm led by team in Coventry) </li></ul>
    10. 10. Study Design <ul><li>Randomised controlled trial </li></ul><ul><ul><li>Intervention: Challenging Arthritis course + education booklet </li></ul></ul><ul><ul><li>Comparison: Education booklet only </li></ul></ul><ul><li>Sample size </li></ul><ul><ul><li>1000 patients aimed for from power calculation </li></ul></ul><ul><ul><li>Recruited from the MRC GP Research Framework & other primary care research networks </li></ul></ul><ul><li>Selection of practices </li></ul><ul><ul><li>Availability of ‘Challenging Arthritis’ nationally </li></ul></ul>
    11. 11. Inclusion & Exclusion Criteria <ul><li>Age 50 years or above </li></ul><ul><li>GP diagnosis of osteo-arthritis of knees and / or hips </li></ul><ul><li>Problems for 1 year+ </li></ul><ul><li>Significant pain & disability in past month </li></ul><ul><li>Too immobile to attend course </li></ul><ul><li>Knee / hip pain under investigation </li></ul><ul><li>Referral for OA surgery </li></ul><ul><li>Neurological signs </li></ul><ul><li>Inability to complete questionnaires </li></ul>
    12. 12. Outcomes to be Measured <ul><li>Measured at baseline, 4 & 12 months </li></ul><ul><li>1 0 Quality of Life (SF 36) </li></ul><ul><li>2 0 </li></ul><ul><ul><li>Pain, Functional Disability (WOMAC) </li></ul></ul><ul><ul><li>Control over Symptoms (arthritis self-efficacy) </li></ul></ul><ul><ul><li>Anxiety and Depression (HADS) </li></ul></ul><ul><ul><li>Cost-effectiveness (CSRI) </li></ul></ul><ul><ul><li>Health Status (Euroquol) </li></ul></ul>
    13. 13. Patient Identification & Recruitment <ul><li>Nurse computer searches </li></ul><ul><ul><ul><li>Read code diagnoses </li></ul></ul></ul><ul><ul><ul><li>Repeat prescriptions for NSAIDs & analgesics </li></ul></ul></ul><ul><li>GP identification </li></ul><ul><ul><ul><li>Patients seen in surgery over 4-6 week period </li></ul></ul></ul><ul><li>Letter sent to potential participants inviting for : </li></ul><ul><li>Research nurse interview </li></ul><ul><ul><ul><li>Eligibility checked, consent & baseline questionnaires </li></ul></ul></ul><ul><li>Followed by contact with Project Manager </li></ul><ul><ul><ul><li>Telephone randomisation and course information sent </li></ul></ul></ul>
    14. 14. Qualitative methodology <ul><li>Sample of the intervention group interviewed </li></ul><ul><ul><li>Baseline, 4 & 12 months </li></ul></ul><ul><ul><li>Purposively sampled for age, gender, ASE score </li></ul></ul><ul><ul><li>Initially 30 patients – complete interviews on 17 </li></ul></ul><ul><li>Aims: </li></ul><ul><ul><li>To examine patients’ perceptions and attitudes towards the ‘Challenging Arthritis’ intervention </li></ul></ul><ul><ul><li>To explore how they felt about being referred to an ASMP via their general practice </li></ul></ul>
    15. 15. Collaboration with the Voluntary Sector <ul><li>DASH was the first MRC trial working with the voluntary sector </li></ul><ul><li>Arthritis Care is a national voluntary organisation supporting people with arthritis – activities include - </li></ul><ul><ul><li>Support, education and campaigning </li></ul></ul><ul><ul><li>Delivery of ‘Challenging Arthritis’ & other courses </li></ul></ul>
    16. 16. Arthritis Care <ul><li>Structure of organisation </li></ul><ul><ul><li>Initially centralised & hierarchical </li></ul></ul><ul><ul><li>Paid management & unpaid volunteers </li></ul></ul><ul><ul><li>Funding for Challenging Arthritis courses </li></ul></ul><ul><ul><ul><li>Aim to be self-funding, including ‘central costs’ </li></ul></ul></ul><ul><ul><ul><li>Contracts traditionally set up with HAs and other organisations </li></ul></ul></ul><ul><ul><ul><li>Aim to add to evidence in support of CA courses </li></ul></ul></ul>
    17. 17. Analysis Plan <ul><li>Participants analysed in randomisation group originally assigned to (ITT), with imputation of missing data </li></ul><ul><li>Primary comparison evaluated the long-term effects of the intervention @ 12 months </li></ul><ul><ul><li>Analysis of co-variance (ANCOVA) accounting for baseline score with multiple imputation </li></ul></ul><ul><li>Further Analyses   </li></ul><ul><ul><li>‘ Per protocol imputation’ – accounting for compliance with intervention (>= 4 sessions) </li></ul></ul><ul><ul><li>Analysis of data on those with ‘complete’ data only </li></ul></ul>
    18. 18. Results - recruitment
    19. 19. Results – baseline characteristics   Intervention   n=406 Control   n=406 Age (yrs) Mean (S.D.)   68.4 (8.2 ) 68.7 (8.6) Gender Female   255 (62.8%) 255 (62.8%) Owner Occupier 323 (82.6%) 302 (78.6%) Ethnicity White   388 (99.5%) 382 (99.2%) Age left school < 16 years 249 (63.8%) 259 (67.6%) Higher education   107 (27.6%) 102 (26.7%)
    20. 20. Results – Challenging Arthritis course attendance <ul><ul><li>219 people in the intervention group (56 %) attended >= 4 intervention sessions </li></ul></ul><ul><ul><li>29% did not attend any of the sessions </li></ul></ul>
    21. 21. OUTCOMES Adjusted difference in means & (95% C.I.) at 4 months Adjusted difference in means & (95% C.I.) at 12 months SF 36 MENTAL HEALTH Intention to Treat (ITT) Per protocol analysis   0.11 (-1.18,1.40) 0.82 (-0.94,2.57)   1.35 (-0.03, 2.74) 1.56 (- 0.28, 3.39) SF 36 PHYSICAL HEALTH Intention to Treat (ITT) Per protocol analysis   0.22 (-1.5, 1.94) - 0.37 (-2.02,1.28)   0.33 (- 1.31, 1.98) 0.24 (- 1.63, 2.11) WOMAC PAIN Intention to Treat (ITT) Per protocol analysis   - 0.15 (- 0.57,0.28) - 0.30 (- 0.79,0.19)   - 0.33 (- 0.78, 0.13) - 0.47 (- 1.05, 0.10) WOMAC STIFFNESS Intention to Treat (ITT) Per protocol analysis   - 0.05 (-0.28,0.17) - 0.12 (- 0.36,0.11)   - 0.17 (- 0.43, 0.09) - 0.13 (- 0.40, 0.14) WOMAC FUNCTION Intention to Treat (ITT) Per protocol analysis   - 1.22 (- 2.59, 0.16) - 0.80 (- 2.24, 0.63)   - 1.17 (- 2.84, 0.50) - 0.95 (- 2.63, 0.74) HADS ANXIETY Intention to Treat (ITT) Per protocol analysis   - 0.36 (- 0.76,0.05) - 0.68 (- 1.15,- 0.20) *   - 0.62 (-1.08,- 0.16) * - 0.72 (-1.24,- 0.21) * HADS DEPRESSION Intention to Treat (ITT) Per protocol analysis   - 0.40 (- 0.76,- 0.03) * - 0.57 (- 0.96,- 0.18) *   - 0.41 (- 0.82, 0.01) - 0.33 (- 0.76, 0.10) ASE - PAIN Intention to Treat (ITT) Per protocol analysis   1.63 (0.83, 2.43) * 2.55 (1.56, 3.56) *   0.98 (0.07, 1.89) * 1.43 (0.37, 2.48) * ASE - OTHER Intention to Treat (ITT) Per protocol analysis   1.83 (0.74, 2.92) * 2.81 (1.74, 3.87) *   1.58 (0.25, 2.90) * 1.54 (0.48, 2.60) *
    22. 22. Outcome plots - positive difference in means favours treatment SF 36 Mental Health SF 36 Physical Health
    23. 23. Outcome plots continued ASE Pain ASE Other
    24. 24. Outcome plots - negative difference in means favours treatment HADS Anxiety HADS Depression
    25. 25. Outcome plots continued WOMAC Pain WOMAC Stiffness WOMAC Physical Functioning
    26. 26. 12 Month Results - Summary <ul><li>Small non significant change in SF-36 mental health scale </li></ul><ul><li>Significant differences occurred in: </li></ul><ul><ul><li>Reduced anxiety </li></ul></ul><ul><ul><li>Improved self efficacy – pain and ‘other’ </li></ul></ul><ul><li>No significant change in: </li></ul><ul><ul><li>Function, pain, stiffness, depression (after 4 months) </li></ul></ul><ul><ul><li>GP/nurse attendance & costs of medication </li></ul></ul><ul><ul><li>Number of ‘clinically’ anxious participants </li></ul></ul><ul><ul><li>No significant differences in other health & social care costs </li></ul></ul>
    27. 27. Economic Evaluation <ul><li>No significant differences between groups at 12 months in: </li></ul><ul><ul><li>Costs to statutory services (health & social care) </li></ul></ul><ul><ul><li>Costs to patient, family, friends </li></ul></ul><ul><ul><li>Indirect costs – time off work (patient / carer) </li></ul></ul><ul><ul><li>Total costs – including & excluding ASMP cost </li></ul></ul><ul><li>Cost effectiveness Acceptability Curves (CEACs) </li></ul><ul><ul><li>Small advantages on SF-36 translated into low </li></ul></ul><ul><ul><li>incremental cost-effectiveness ratios & high probabilities </li></ul></ul><ul><ul><li>of cost effectiveness for societal costs, but not health / </li></ul></ul><ul><ul><li>social care costs </li></ul></ul><ul><ul><li>Cost-effectiveness conclusions based on QALYs </li></ul></ul><ul><ul><li>incremental cost / QALY exceed range suggested by NICE </li></ul></ul>
    28. 28. Summary / Discussion (1) <ul><ul><li>Does arthritis self-management work? </li></ul></ul><ul><ul><li>Statistically significant, but small changes in anxiety and ASE at 12 months (and mental health SF 36 on straight imputation) </li></ul></ul><ul><ul><li>Trend in all outcomes favouring the intervention </li></ul></ul><ul><ul><li>What do these mean (a) clinically (b) for patients </li></ul></ul><ul><ul><li>Qualitative work suggests </li></ul></ul><ul><ul><li>? patients recruited from primary care less severely unwell & several interviewed already self-manage </li></ul></ul>
    29. 29. Summary / Discussion (2) <ul><li>How does the intervention work? </li></ul><ul><ul><li>How might the intervention impact on anxiety and self-efficacy in terms of a complex intervention </li></ul></ul><ul><ul><li>Is it a mental health intervention? </li></ul></ul><ul><ul><li>Are there a sub-group likely to do particularly well </li></ul></ul><ul><li>Economic Evaluation </li></ul><ul><ul><li>Should this be supplied on the NHS as it stands ? </li></ul></ul><ul><li>Policy </li></ul><ul><ul><li>What does this mean for the Expert Patient Initiative advocating self-management courses for a range of chronic diseases and funded by PCTs? </li></ul></ul>

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