Improving the Care of People withLong-Term Conditions who have

joint pain, anxiety and/or depression

Emma Healey

(on behalf of the ENHANCE study team)

Overview

• Background

• Aim of the ENHANCE pilot trial

• Intervention & training development

• Trial design

• Progress to date

• Feedback from CLAHRC SAG

• Next steps

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

Fred

Diabetes

Asthma

Cataract

High blood pressure

Depression

Joint Pain

Diabetes

Asthma

Cataract

High blood pressure

Depression

Joint Pain

Worsen prognosis of LTCs

Opportunities for intervention

Fred

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

Aim:To examine the feasibility and acceptability of anintegrated approach to LTC management, tackling theunder-diagnosis and under-management of OA-relatedpain and anxiety and/or depression in older adults withother LTCs in primary care.

The ENHANCE pilot trial

Intervention & training development

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)

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)

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

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)

Training development

TDF Domains identified from Focus Group Strategies to address barriers

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

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

• Stepped wedge design with 4 steps

July 2015Week

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 periodintervention periodin-house training

Study Design

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

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)

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

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

Next Steps

• Complete data collection

– Patient questionnaires: Phase 3 (6 months)

– Medical record review (MRR)

• Data analysis

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?”

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

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

AcknowledgementsNorth Staffordshire Clinical Partners:

North Staffs / Stoke / South Staffs / Shropshire CCGStaffordshire and Stoke-on-Trent Partnership Trust

ENHANCE Patient and Nurse Advisory GroupsKeele 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

Questionnaire data collection

Measures Description

Data collection timing

Phase 1 Phase 2Phase2

MDCPhase3

Phase 3

MDC

Primary outcome measures

Health outcomeEQ-5D-5L

(EuroQoL Group 1990; Herdman et al 2011)

Secondary outcome measures

Symptoms of depressionPHQ-9(Kroenke et al 2001)

x x

Symptoms of anxietyGAD7(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 reviewGPAQ 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