Stop Cancer PAIN Trial- An Implementation Research Project Funded by the National Breast Cancer Foundation

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2 The Great Gatsby

3 Touching the Void Bridging the chasm between clinical guideline development and local site implementation Professor Melanie Lovell Hospice New Zealand, 2016

4 Stop Cancer PAIN Trial- An Implementation Research Project Funded by the National Breast Cancer Foundation FACULTY OF MEDICINE Lead investigator: Prof Melanie Lovell, Consultant Palliative Care Physician, HammondCare Chief investigators: Prof Jane Phillips, Prof Meera Agar,, Prof Fran Boyle, Prof Patricia Davidson, Dr Tim Luckett, Prof David Currow, Prof Louise Ryan, Dr Nikki McCaffrey, Prof Tim Shaw, Associate investigators: Beverley Noble and John Stubbs (consumers), Prof Ian Olver, Prof Geoff Mitchell. Prof Katy Clark, Prof Stephen Clarke, Prof Martin Stockler, A/Prof Odette Spruyt, Mary-Rose Birch

5 Outline Pain undertreated, big evidence practice gap Development of the intervention Implementation research where, why, Implementation strategies how, who Implementation science what, an example Implementation stories - when

6 The complex problem of pain! What is required to manage pain? Reporting by both patient Health professional assessment & management skills Health systems to support care Patient adherence

7 Key features of complex interventions Number of interacting components Number and difficulty of behaviours required by those delivering or receiving the intervention Number of groups or organisational levels targeted by the intervention Number and variability of outcomes Degree of flexibility or tailoring of the intervention permitted (Non-standardisation/reproducibility; Hawe, JECH 2004) Non-pharmacological and behavioural interventions

8 MRC framework for the development & evaluation of complex interventions Craig et al (2008) Feasibility and Piloting Testing procedures Estimating recruitment and retention Determining sample size Development Identifying the evidence base Identifying or developing theory Modelling process and outcomes Evaluation Assessing effectiveness Understanding change process Assessing cost effectiveness Implementation Dissemination Surveillance and monitoring Long-term follow-up

9 Work by the team to date Adapted international guidelines and developed clinical pathway (Cancer Council Australia Cancer Guidelines Wiki) National survey of current practice (N=527) (Luckett, 2012; Lovell, 2014, Phillips, 2014) Two systematic literature reviews (Luckett, 2013; Marie, 2013) Clinical process mapping at single SPC unit to develop methods for identifying local barriers Quasi-experimental evaluation of health professional education for cancer pain assessment (Phillips, 2014) Pilot of clinical pathway/guidelines and implementation strategies in Specialist Palliative Care unit and oncology.

10 Cancer_pain_management

11 Model of Translational Research

12 Implementation research Why? Caretrack Runciman MJA 2012 The adult Australians in this sample received appropriate care at 57% (95% CI, 54% 60%) of eligible health care encounters. Compliance with indicators of appropriate care at condition level ranged from 13% (95% CI, 1% 43%) for alcohol dependence to 90% (95% CI, 85% 93%) for coronary artery disease. For health care providers with more than 300 eligible encounters each, overall compliance ranged from 32% to 86%.

13 Overview of the Clinical Care Standard development process (ACQSHC) Clinical Care Area/Clinical Issue Requires Sources of Evidence (guidelines, standards, data, reports, policies) Quality Statements Quality Measures National Indicators Distilled Into Produc e Clinical Care Standard Development Year 1 Inform Implementation Strategies Identify Clinical and Patient Decision Support Tools Develo p CCS Development Year 1-2

14 Audit Results Victorian Government Pain Clinical Indicators Audit tool. INDICATORS Ind1 = Use of validated pain scale screening Ind2a = Assessment of pain at first presentation Ind2b = Documented pain treatment / management plan Ind2c = Evidence pain plan discussed with patient Ind3 = Regular pain assessment Ind4a = Bowel regime plan Ind5 = Routine opioids for break through cancer pain (BT) Ind6 = Scheduled medication at regular intervals The audit tool found to be feasible to use as part of complex system intervention for improving cancer pain management. A pain assessment chart improved compliance

15 Barriers to cancer pain management resulting in evidence-practice gap and under-treated pain Service level Poor care coordination Clinician level Lack of knowledge / expertise Lack of time / perception pain management is not part of role Patient level Reluctance to report pain Disproportionate fear of opioid addiction and tolerance (Oldenmenger, 2009; Jacobsen, 2009; Luckett 2013)

16 Identifying evidence-based strategies to enhance guideline uptake

17 Behavior change wheel, Michie 2011

18 Stop Cancer PAIN strategies to improve pain care Screening Rationale Research shows that clinicians are not good at identifying pain and other symptoms Patients may be reluctant to raise pain for various reasons (e.g. don t want to bother doctor, think pain is inevitable with cancer or a sign of progression) Good evidence that screening of pain and other symptoms can improve processes of care (e.g. referral) and outcomes (reduced symptoms) Time efficient (Etkind, 2014; Kotronoulas, 2014; Luckett, 2009)

19 Stop Cancer PAIN strategies to improve pain care Audit and feedback Proven to be effective in making care more evidence-based by a Cochrane review (Ivers, 2012) Proven to improve concordance with cancer pain guidelines (Dulko, 2010) Stop PAIN audit tool focuses on 8 standards of care emphasised by all international guidelines (Dy, 2008) 19

20 Stop Cancer PAIN Audit Tool

21 Stop Cancer PAIN Audit Tool

22 Stop Cancer PAIN strategies to improve pain care Qstream Clinician Education Qstream has been proven to improve concordance with guidelines in RCTs (e.g. Kerfoot, 2009) based education and assessment module based on learning theory Multiple choice questions based on cancer pain clinical case scenarios Iterative and brief (2 minutes per scenario) can fit in around daily duties Stop PAIN module tests understanding of recommendations in the Australian Guidelines for Cancer Pain Management in Adults 22

23 Qstream Clinician Education

24 Stop Cancer PAIN strategies to improve pain care High level evidence that patient education improves pain (better than some analgesics!) Crucial elements likely to include not only information to improve understanding and assist self-management but also feeling of empowerment/control/self-efficacy (Marie, 2013) Managing cancer pain booklet includes goal setting, management plan and pain diary to help patients and clinicians better understand triggers and individual needs and priorities. Also serves as patient-held record to improve coordination between oncology and other services (e.g. GP). 24

25 Patient self-management tool Stop PAIN - provision of Managing cancer pain selfmanagement and Cancer Council NSW Overcoming cancer pain booklets + oneoff brief training on how to use them to be reviewed at every consultation

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27 Stop Cancer PAIN Trial- A Translational Research Project Funded by the National Breast Cancer Foundation FACULTY OF MEDICINE Lead investigator: Prof Melanie Lovell, Consultant Palliative Care Physician, HammondCare Chief investigators: Prof Jane Phillips, Prof Meera Agar,, Prof Fran Boyle, Prof Patricia Davidson, Dr Tim Luckett, Prof David Currow, Prof Louise Ryan, Dr Nikki McCaffrey, Prof Tim Shaw, Associate investigators: Beverley Noble and John Stubbs (consumers), Prof Ian Olver, Prof Geoff Mitchell. Prof Katy Clark, Prof Stephen Clarke, Prof Martin Stockler, A/Prof Odette Spruyt, Mary-Rose Birch

28 Aim To evaluate the effectiveness and cost-effectiveness of a suite of strategies designed to implement Australian clinical practice guidelines to improve pain outcomes in adult outpatients with cancer in metropolitan, regional and rural oncology and palliative care settings.

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30 Stop Cancer PAIN Trial - Ethics approval from SWSLHD HREC - Registered on ANZCTR - Included in Cancer Institute NSW Clinical Trials Portfolio - First example of a T3 (implementation) trial

31 Sites and participants Sites - 8 outpatient oncology and palliative care units - Diverse in size, services, location (including rural, remote) Participants patients at each site with cancer and moderate pain - Family carers - Health professionals and front-of-house administrative staff

32 Trial design: Stepped-wedge cluster RCT Centres Arms 1 Control Training and intervention 2 Control Training and intervention 3 Control Training and intervention 4 Control Training and intervention 5 Control Training and intervention 6 Control Training and intervention 7 Control Training and intervention 8 Control Training and intervention

33 Participants: Oncology and Palliative Care outpatients with cancer over 18, worst pain NRS 5 for primary outcome, 2 for secondary outcomes Intervention: Symptom screening system, Australian cancer pain clinical pathway plus Qstream education, audit and feedback and patient-held resources, supportd by implementation manual and clinical champions Control: Symptom screening system, Australian cancer pain clinical pathway Outcome: Primary Probability of 30% reduction in worst pain NRS Secondary Mean worst and average pain, quality of life, patient empowerment, caregiver experience, cost-effectiveness

34 Expected benefits - Cost-effective improvements in cancer pain outcomes for patients and carers - Improved health professional knowledge of cancer pain assessment and management - Improved efficiency in clinical processes for cancer pain care - Increased unit capacity to undertake future quality improvement projects

35 Study flow

36 Intervention arm Training Phase Clinical champions identified and trained to support implementation strategies Clinicians attend brief workshop on guidelines and implementation strategies

37 Clinical change champions Selection of clinical change champions will be conducted in partnership with each centre. Champions can be of any discipline and role provided they meet the criteria summarised in Box 1. Box 1. Features of organisational change champions identified by Shaw et al (2012) Has authority to cultivate an environment for ongoing practice improvement/organisation learning Has a clear vision for the larger organisation and effectively communicates how the project-based innovation fits into that vision Ongoing role Actively and enthusiastically promotes both the specific project as well as ongoing practice improvement Mobilizes resources (internal/external) for ongoing practice improvement Navigates the socio-political environment for ongoing practice improvement Provides leadership for ongoing practice improvement

38 Focus groups at the beginning and end of the project - Interactive group interviews with patients and staff - Aims to explore clinicians and patients views, perceptions, attitudes, and recommendations regarding pain care - Informed consent will be sought from all clinical staff, patients minutes duration - Times, venue and composition decided in consultation with unit

39 Stop Cancer PAIN is a pragmatic trial of a complex intervention - Intervention can be tailored to suit local conditions - Measures process as well as outcomes to inform further refinement and adaptation - Contamination would be a nice problem to have! - Support can be provided by the research team as required

40 Implementation stories Fourth site about to commence

41 Gaps/issues in pain care identified at priority setting session at one site Patient-related barriers Patients don t want to tell us they have pain because they think it means progression and they will be taken off chemo [Patient thinks/says] pain is normal, why would I take drugs [Patient s also think to] save it [pain medication] to the end for when I really need it Coordination/communication/roles and responsibilities The [currently used] assessment [template] doesn t reflect how patients are in the community. [There is] a gap in pain management whose responsibility is this [which discipline] Staff are too busy maintaining patients other needs so pain is not addressed It s hard to know who is responsible for their pain in between [clinic visits every days] and what their pain is like in the gaps It s [also] hard to get them to see a doctor, they would say what can a doctor do? Hard for GP to step in and manage patient pain only formal clinic visits generate a letter to [the] GP [so they may not be aware of issues at other visits]

42 Patient Perspective Pain management, especially non-pharmacological, educational or self-management strategies, is not the primary focus of the oncologist Patients did not expect their oncologist to dedicate time and attention to pain management, and several reported not communicating about their pain during the consultation. There was no other clinician within the centre whose role was dedicated to pain assessment and management. Patients relied more upon on their GP, other specialists, family, and previously or recently learnt strategies to manage their pain.

43 Patient Perspective Ease of access and person-centredness of a regional cancer centre While some participants reported the need to travel to metropolitan areas for investigation and treatment and consequent diagnostic delays, most were highly appreciative of a comprehensive cancer centre being so accessible and welcoming: Patient: I am so happy to be here getting treatment - I'd have hated to have been in the city. Interviewer What's the difference between country and city? Patient: Availability of parking to get to places. The ease of actually getting somewhere Not the overcrowding of consulting rooms and the staff - from my angle - I see them not under the pressure. They devote their time to you and in a very pleasant and lovely way.

44 Conclusion How are we going to improve Lynn s pain? Excellence!

45 Thank you!

46 The Great Gatsby

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