Emma Healey's presentation on the ENHANCE Project to the Programme Steering Committee on 26th July 2016, at Keele University.

1. Improving the Care of People with
Long-Term Conditions who have
joint pain, anxiety and/or depression
Emma Healey
(on behalf of the ENHANCE study team)

2. Overview
• Background
• Aim of the ENHANCE pilot trial
• Intervention & training development
• Trial design
• Progress to date
• Feedback from CLAHRC SAG
• Next steps

3. Long Term Conditions (LTCs)
• Majority managed in primary care
• Established systems in place for QOF conditions
• Non-QOF conditions ‘neglected’
• Osteoarthritis (OA) related pain, anxiety and
depression are frequently comorbid with other
LTCs yet are seldom prioritised by patient or
clinician
• Single disease pathology increasingly uncommon
• May result in higher levels of disability, poorer
prognosis and increased health care costs

4. Fred
Diabetes
Asthma
Cataract
High blood
pressure
Depression
Joint Pain

5. Diabetes
Asthma
Cataract
High blood
pressure
Depression
Joint Pain
Worsen prognosis
of LTCs
Opportunities
for intervention
Fred

6. Hypothesis
The health of people with LTCs can be improved by
identifying and initiating treatment of OA related joint
pain and / or anxiety and depression at a LTC review

7. Aim:
To examine the feasibility and acceptability of an
integrated approach to LTC management, tackling the
under-diagnosis and under-management of OA-related
pain and anxiety and/or depression in older adults with
other LTCs in primary care.
The ENHANCE pilot trial

8. Intervention & training
development

9. Stakeholder Engagement
Patient/professional
advisory groups –
identify good practice,
discuss evidence,
training needs, doability
Wider stakeholder
workshops (nurses, GPs,
commissioner, AHPs,
mental health/pain
specialist) to discuss
evidence and co-design
intervention
Nurse focus group –
feedback on the
intervention, integration
into consultation,
identify training needs
Underpinned by theory e.g. Theoretical Domains Framework (TDF)

10. Stakeholder Engagement
Patient/professional
advisory groups –
identify good practice,
discuss evidence,
training needs, doability
Wider stakeholder
workshops (nurses, GPs,
commissioner, AHPs,
mental health/pain
specialist) to discuss
evidence and co-design
intervention
Nurse focus group –
feedback on the
intervention, integration
into consultation,
identify training needs
Underpinned by theory e.g. Theoretical Domains Framework (TDF)

11. The ENHANCE Review
Nurse led
LTC
Review
Initial Management
e.g. Written information,
advice, referrals
Case finding
Joint Pain
Anxiety / Depression
Extra 20
minutes
funded
The
ENHANCE
EMIS
Template

12. Stakeholder Engagement
Patient/professional
advisory groups –
identify good practice,
discuss evidence,
training needs, doability
Wider stakeholder
workshops (nurses, GPs,
commissioner, AHPs,
mental health/pain
specialist) to discuss
evidence and co-design
intervention
Nurse focus group –
feedback on the
intervention, integration
into consultation,
identify training needs
Underpinned by theory e.g. Theoretical Domains Framework (TDF)

13. Training development
TDF Domains identified from Focus Group Strategies to address barriers

14. Training outline
• Practice training
Training sessions (plus mentoring)
– Initial 1hr update session in practice
• GPs, Practice nurse(s), Practice Manager
• Focus on OA, anxiety and depression
– 2 half day sessions in practice
• Delivery of the ENHANCE review and use of the ENHANCE template
• Developed and delivered by study training team
• Dr Andrew Finney, Dr Val Tan, Dr Mark Porcheret, Prof Carolyn Chew-
Graham, Dr Vince Cooper, Simon Wathall, Julie Shufflebotham
• Local IAPT and physiotherapy service training

15. Pilot trial overview
• 4 General Practices
• Patients attending chronic disease reviews
with the practice nurse
−asthma
−COPD
−cardiovascular diseases
−diabetes
• Recruit 300 patients over 6 months
• Stepped wedge design

16. • Stepped wedge design with 4 steps
July 2015
Week
Jan 2016
1 - 6 7-11 12-16 17-21 22-27
Practice Step 1 Step 2 Step 3 Step 4
1
2
3
4
control period
intervention period
in-house training
Study Design

17. Data collection
• Mixed methods approach
• Self-reported patient questionnaires
⁻ Phase 1 (post consultation), Phase 2 (6 weeks) and Phase
3 (6 months)
• Medical record review (MRR)
• Qualitative interviews and audio-recording of the
ENHANCE review

18. Success criteria
• Engage GP practices to participate and stay in the trial through
follow-up (4 practices)
• Deliver the training to at least two practice nurses per practice
• Recruit (at least 50% of those invited) and retain (75% of
those that consent) sufficient patients to the research
evaluation
• Satisfaction of patients who received the ‘ENHANCE’ LTC
review should be at least as acceptable as that of those who
received usual care (by comparing mean scores on the GPAQ)
• Recruitment and follow-up rates should be similar in both
arms of the study (a difference in recruitment or follow-up
rate of up to 10% to represent an acceptable level of
deviation)

19. Progress to date
• Nurse training programme developed and delivered
• Training delivered to local IAPT and physiotherapy
services
• Recruitment complete
• 6 month follow-up data collection ongoing
• Interviews complete:
– 8 nurses and 1 GP
– 20 patients
• 24 consultation recordings

20. Recruitment and Follow up
• 319 recruited, 207 are control and 112 are
intervention
• Baseline packs returned 67%; Consent to
follow up 88%
• 6 week follow up 93%; 36 (5%) MDCs sent out
• 6 month follow up 88%; 31 MDCs (6%) sent
out

21. Next Steps
• Complete data collection
– Patient questionnaires: Phase 3 (6 months)
– Medical record review (MRR)
• Data analysis

22. Less integrated: Explicit
departure from usual
consultation
Nurse: “Because you’ve signed
that bloody form and we're
doing this then”.
112 ENHANCE reviews. 24 audio recorded
Integrated: New questions
and discussion integrated into
patient centred discourse
Nurse: “I know you're getting
breathless walking into school
but it does help your joints
doesn’t it, keeping walking?”
Not integrated: Opportunities to
respond to patient cues missed.
Patient: “I don’t get out of breath, you
know the worst part is my knees..
Nurse: “Just so you know your
predicted flow, what we’d expect, you
are actually blowing higher”
Less integrated: content structured according
to computer template
Patient: “ I feel very lonely now, to be fair,
compared to when I was working”
Nurse: “Yeah I can understand that, but we’ll
come back to that aspect you’ve touched on if
that’s OK? Would you say you cough at the
moment?”

23. Main trial design
• Stepped wedge vs cluster
• Pragmatic vs efficacy
• Value of disease/condition focus
• Intervention components for LTC care
• Participant recruitment: selection bias
• Primary outcome measure

24. Funder
• NIHR Health Services and Delivery Research
(HS&DR) – aim spring 2017
• Feedback
– Within scope, relevant and links to previous call
– Demonstrate “immediate practice utility”
– Focus on generalizability
– Link to and build upon HS&DR portfolio
– Detail development work and pilot trial
– Knowledge transfer and mobilisation is a priority
– Include cost effectiveness
– Include service and workforce outcomes

25. Acknowledgements
North Staffordshire Clinical Partners:
North Staffs / Stoke / South Staffs / Shropshire CCG
Staffordshire and Stoke-on-Trent Partnership Trust
ENHANCE Patient and Nurse Advisory Groups
Keele Research Users’ Group
Keele CLAHRC Team:
Professor Christian Mallen, Dr Clare Jinks, Dr Emma Healey, Professor
Carolyn Chew-Graham, Dr Mark Porcheret, Dr Val Tan, Dr Vince
Cooper, Sarah Lawton, Simon Wathall, Dr Andrew Finney, Elaine
Nicholls, Dr Irena Zwierska, Professor Krysia Dziedzic, Dr Jenny Liddle,
Dr Martyn Lewis, Julie Shufflebotham, Jo Jordan, Professor Elaine Hay

26. Questionnaire data collection
Measures Description
Data collection timing
Phase 1 Phase 2
Phase2
MDC
Phase3
Phase 3
MDC
Primary outcome measures
Health outcome
EQ-5D-5L
(EuroQoL Group 1990; Herdman et al 2011)
    
Secondary outcome measures
Symptoms of depression
PHQ-9
(Kroenke et al 2001)
  x  x
Symptoms of anxiety
GAD7
(Spitzer et al 2006)
  x  x
Pain Intensity Numerical Rating Scale 0-10 (NRS)   x  x
Bothersomeness Single question: 1-5 point scale – duration of pain   x  x
Pain interference Single question: 1-5 point scale   x  x
Health perceptions
Single question on general health:
1 – 5 point scale
    
Satisfaction of LTC review
GPAQ Nurse Assessment
(Mead et al 2008)
 x x x x
Content of LTC consultation Questions regarding topics covered by the practice nurse  x x x x
Health economic measures
Health Care Utilisation Health Care Utilisation Questions x x x  x
Work performance Time off work x  x  x
Demographics
Demographics Gender, date of birth     
Socio-economic status Recent paid job title   x  x
Employment Current work situation   x  x
Health literacy
Brief Questions to Identify Patients with Inadequate Health
Literacy
(Chew et al 2004)
 x x x x
MDC = Minimum data collection, Phase 1 = post consultation, Phase 2 = 6 weeks, Phase 3 = 6 months