Does Arthritis Self-management Help? A Randomised Controlled Trial of an Arthritis Self-Management Programme in Primary Care

The Trial Grant Holders: Marta Buszewicz, Greta Rait, Mark Griffin University College London Andy Haines London School of Hygiene & Tropical Medicine Julie Barlow University of Coventry Project Manager: Angela Atkinson UCL Health Economists: Jeni Beecham, Anita Patel Centre for the Economics of Mental Health Intervention provided by Arthritis Care RCT funded by the MRC

Grant Holders:

Marta Buszewicz, Greta Rait, Mark Griffin University College London

Andy Haines London School of Hygiene & Tropical Medicine Julie Barlow University of Coventry

Project Manager: Angela Atkinson UCL

Health Economists: Jeni Beecham, Anita Patel

Centre for the Economics of Mental Health

Intervention provided by Arthritis Care

RCT funded by the MRC

Contents of Presentation Background to the DASH trial Study design Working with the voluntary sector Results Discussion points

Background to the DASH trial

Study design

Working with the voluntary sector

Results

Discussion points

Background Osteoarthritis is a common & chronic condition, causing: Pain & functional disability Anxiety & depression Lowered quality of life It is associated with high direct (medical) & indirect (social & community costs Estimated total cost of £ 5.5 billion in 1999-2000 Perception that ‘medical’ treatments do not address many problems patients have

Osteoarthritis is a common & chronic condition, causing:

Pain & functional disability

Anxiety & depression

Lowered quality of life

It is associated with high direct (medical) & indirect (social & community costs

Estimated total cost of £ 5.5 billion in 1999-2000

Perception that ‘medical’ treatments do not address many problems patients have

Previous results from studies examining arthritis self- management programmes in the USA & UK Improvements in anxiety & depression, exercise taken, sense of control over arthritis & better communication with doctors (reduced pain in some studies) Sustained use of self-management techniques Decrease in visits to doctors (in some studies) Results so far with volunteer patients only Recent systematic reviews raise some queries about methodology and effect sizes

Improvements in anxiety & depression, exercise taken, sense of control over arthritis & better communication with doctors (reduced pain in some studies)

Sustained use of self-management techniques

Decrease in visits to doctors (in some studies)

Results so far with volunteer patients only

Recent systematic reviews raise some queries about methodology and effect sizes

Arthritis Self-Management Programmes (ASMPs) Developed in the USA – started pragmatically, but theoretical basis in Bandura’s self-efficacy theory People with arthritis are a resource – have innate problem solving skills Effective self-management techniques are taught by trained volunteers who have arthritis Key component is building on small experiences of mastery with peers

Developed in the USA – started pragmatically, but theoretical basis in Bandura’s self-efficacy theory

People with arthritis are a resource – have innate problem solving skills

Effective self-management techniques are taught by trained volunteers who have arthritis

Key component is building on small experiences of mastery with peers

“ Challenging Arthritis” (ASMP delivered by Arthritis Care) Six, weekly, structured group sessions Education about condition & its management Help individual to develop individual behavioural and cognitive strategies Aim to improve communication with family & health professionals Quality assured

Six, weekly, structured group sessions

Education about condition & its management

Help individual to develop individual behavioural and cognitive strategies

Aim to improve communication with family & health professionals

Quality assured

‘ Expert Patients’ Initiative UK government initiative to address living with chronic diseases – first introduced in 2002 Expert Patients’ Programme Generic self-management programmes Based on Lorig’s US self management programmes Funded initially by the government via PCTs National roll-out before pilot evaluations complete No clear evidence of cost-effectiveness Recent RCT results very similar to ours for ASMP

UK government initiative to address living with chronic diseases – first introduced in 2002

Expert Patients’ Programme

Generic self-management programmes

Based on Lorig’s US self management programmes

Funded initially by the government via PCTs

National roll-out before pilot evaluations complete

No clear evidence of cost-effectiveness

Recent RCT results very similar to ours for ASMP

Study Objectives To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis: participation in ‘Challenging Arthritis’ groups improves quality of life (1o outcome) participation affects pain, function, control over symptoms, anxiety or depression (2o outcomes) the intervention is cost-effective (also a qualitative arm led by team in Coventry)

To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis:

participation in ‘Challenging Arthritis’ groups improves quality of life (1o outcome)

participation affects pain, function, control over symptoms, anxiety or depression (2o outcomes)

the intervention is cost-effective

(also a qualitative arm led by team in Coventry)

Study Design Randomised controlled trial Intervention: Challenging Arthritis course + education booklet Comparison: Education booklet only Sample size 1000 patients aimed for from power calculation Recruited from the MRC GP Research Framework & other primary care research networks Selection of practices Availability of ‘Challenging Arthritis’ nationally

Randomised controlled trial

Intervention: Challenging Arthritis course + education booklet

Comparison: Education booklet only

Sample size

1000 patients aimed for from power calculation

Recruited from the MRC GP Research Framework & other primary care research networks

Selection of practices

Availability of ‘Challenging Arthritis’ nationally

Inclusion & Exclusion Criteria Age 50 years or above GP diagnosis of osteo-arthritis of knees and / or hips Problems for 1 year+ Significant pain & disability in past month Too immobile to attend course Knee / hip pain under investigation Referral for OA surgery Neurological signs Inability to complete questionnaires

Age 50 years or above

GP diagnosis of osteo-arthritis of knees and / or hips

Problems for 1 year+

Significant pain & disability in past month

Too immobile to attend course

Knee / hip pain under investigation

Referral for OA surgery

Neurological signs

Inability to complete questionnaires

Outcomes to be Measured Measured at baseline, 4 & 12 months 1 0 Quality of Life (SF 36) 2 0 Pain, Functional Disability (WOMAC) Control over Symptoms (arthritis self-efficacy) Anxiety and Depression (HADS) Cost-effectiveness (CSRI) Health Status (Euroquol)

Measured at baseline, 4 & 12 months

1 0 Quality of Life (SF 36)

2 0

Pain, Functional Disability (WOMAC)

Control over Symptoms (arthritis self-efficacy)

Anxiety and Depression (HADS)

Cost-effectiveness (CSRI)

Health Status (Euroquol)

Patient Identification & Recruitment Nurse computer searches Read code diagnoses Repeat prescriptions for NSAIDs & analgesics GP identification Patients seen in surgery over 4-6 week period Letter sent to potential participants inviting for : Research nurse interview Eligibility checked, consent & baseline questionnaires Followed by contact with Project Manager Telephone randomisation and course information sent

Nurse computer searches

Read code diagnoses

Repeat prescriptions for NSAIDs & analgesics

GP identification

Patients seen in surgery over 4-6 week period

Letter sent to potential participants inviting for :

Research nurse interview

Eligibility checked, consent & baseline questionnaires

Followed by contact with Project Manager

Telephone randomisation and course information sent

Qualitative methodology Sample of the intervention group interviewed Baseline, 4 & 12 months Purposively sampled for age, gender, ASE score Initially 30 patients – complete interviews on 17 Aims: To examine patients’ perceptions and attitudes towards the ‘Challenging Arthritis’ intervention To explore how they felt about being referred to an ASMP via their general practice

Sample of the intervention group interviewed

Baseline, 4 & 12 months

Purposively sampled for age, gender, ASE score

Initially 30 patients – complete interviews on 17

Aims:

To examine patients’ perceptions and attitudes towards the ‘Challenging Arthritis’ intervention

To explore how they felt about being referred to an ASMP via their general practice

Collaboration with the Voluntary Sector DASH was the first MRC trial working with the voluntary sector Arthritis Care is a national voluntary organisation supporting people with arthritis – activities include - Support, education and campaigning Delivery of ‘Challenging Arthritis’ & other courses

DASH was the first MRC trial working with the voluntary sector

Arthritis Care is a national voluntary organisation supporting people with arthritis – activities include -

Support, education and campaigning

Delivery of ‘Challenging Arthritis’ & other courses

Arthritis Care Structure of organisation Initially centralised & hierarchical Paid management & unpaid volunteers Funding for Challenging Arthritis courses Aim to be self-funding, including ‘central costs’ Contracts traditionally set up with HAs and other organisations Aim to add to evidence in support of CA courses

Structure of organisation

Initially centralised & hierarchical

Paid management & unpaid volunteers

Funding for Challenging Arthritis courses

Aim to be self-funding, including ‘central costs’

Contracts traditionally set up with HAs and other organisations

Aim to add to evidence in support of CA courses

Analysis Plan Participants analysed in randomisation group originally assigned to (ITT), with imputation of missing data Primary comparison evaluated the long-term effects of the intervention @ 12 months Analysis of co-variance (ANCOVA) accounting for baseline score with multiple imputation Further Analyses ‘ Per protocol imputation’ – accounting for compliance with intervention (>= 4 sessions) Analysis of data on those with ‘complete’ data only

Participants analysed in randomisation group originally assigned to (ITT), with imputation of missing data

Primary comparison evaluated the long-term effects of the intervention @ 12 months

Analysis of co-variance (ANCOVA) accounting for baseline score with multiple imputation

Further Analyses

‘ Per protocol imputation’ – accounting for compliance with intervention (>= 4 sessions)

Analysis of data on those with ‘complete’ data only

Results - recruitment

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%)

Results – Challenging Arthritis course attendance 219 people in the intervention group (56 %) attended >= 4 intervention sessions 29% did not attend any of the sessions

219 people in the intervention group (56 %) attended >= 4 intervention sessions

29% did not attend any of the sessions

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) *

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 Small non significant change in SF-36 mental health scale Significant differences occurred in: Reduced anxiety Improved self efficacy – pain and ‘other’ No significant change in: Function, pain, stiffness, depression (after 4 months) GP/nurse attendance & costs of medication Number of ‘clinically’ anxious participants No significant differences in other health & social care costs

Small non significant change in SF-36 mental health scale

Significant differences occurred in:

Reduced anxiety

Improved self efficacy – pain and ‘other’

No significant change in:

Function, pain, stiffness, depression (after 4 months)

GP/nurse attendance & costs of medication

Number of ‘clinically’ anxious participants

No significant differences in other health & social care costs

Economic Evaluation No significant differences between groups at 12 months in: Costs to statutory services (health & social care) Costs to patient, family, friends Indirect costs – time off work (patient / carer) Total costs – including & excluding ASMP cost Cost effectiveness Acceptability Curves (CEACs) Small advantages on SF-36 translated into low incremental cost-effectiveness ratios & high probabilities of cost effectiveness for societal costs, but not health / social care costs Cost-effectiveness conclusions based on QALYs incremental cost / QALY exceed range suggested by NICE

No significant differences between groups at 12 months in:

Costs to statutory services (health & social care)

Costs to patient, family, friends

Indirect costs – time off work (patient / carer)

Total costs – including & excluding ASMP cost

Cost effectiveness Acceptability Curves (CEACs)

Small advantages on SF-36 translated into low

incremental cost-effectiveness ratios & high probabilities

of cost effectiveness for societal costs, but not health /

social care costs

Cost-effectiveness conclusions based on QALYs

incremental cost / QALY exceed range suggested by NICE

Summary / Discussion (1) Does arthritis self-management work? Statistically significant, but small changes in anxiety and ASE at 12 months (and mental health SF 36 on straight imputation) Trend in all outcomes favouring the intervention What do these mean (a) clinically (b) for patients Qualitative work suggests ? patients recruited from primary care less severely unwell & several interviewed already self-manage

Does arthritis self-management work?

Statistically significant, but small changes in anxiety and ASE at 12 months (and mental health SF 36 on straight imputation)

Trend in all outcomes favouring the intervention

What do these mean (a) clinically (b) for patients

Qualitative work suggests

? patients recruited from primary care less severely unwell & several interviewed already self-manage

Summary / Discussion (2) How does the intervention work? How might the intervention impact on anxiety and self-efficacy in terms of a complex intervention Is it a mental health intervention? Are there a sub-group likely to do particularly well Economic Evaluation Should this be supplied on the NHS as it stands ? Policy What does this mean for the Expert Patient Initiative advocating self-management courses for a range of chronic diseases and funded by PCTs?

How does the intervention work?

How might the intervention impact on anxiety and self-efficacy in terms of a complex intervention

Is it a mental health intervention?

Are there a sub-group likely to do particularly well

Economic Evaluation

Should this be supplied on the NHS as it stands ?

Policy

What does this mean for the Expert Patient Initiative advocating self-management courses for a range of chronic diseases and funded by PCTs?