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Breathlessness Intervention Service (BIS)

Using fast-track trial methodology to evaluate a breathlessness intervention service for patients with advanced disease Morag Farquhar Macmillan Post-Doctoral Research Fellow GPPCRU University of Cambridge IPH Showcase 14 th February 2011. Breathlessness Intervention Service (BIS).

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Breathlessness Intervention Service (BIS)

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  1. Using fast-track trial methodology to evaluate a breathlessness intervention service for patients with advanced disease Morag Farquhar Macmillan Post-Doctoral Research Fellow GPPCRU University of Cambridge IPH Showcase 14th February 2011

  2. Breathlessness Intervention Service (BIS) • aims to help people live with breathlessness in advanced disease • any diagnosis (cancer or non-cancer) • works jointly with patients & carers • advises referrers • multi-disciplinary hospital-based service functioning in the community • ‘toolkit’ of pharmacological and non-pharmacological interventions • complex intervention (MRC framework) – Phase III RCT

  3. RCTs in palliative care • Randomised Controlled Trials (RCTs): • ‘gold standard’ for evaluating services • intervention & control group > compare outcomes • RCTs in palliative care problematic: • recruitment - patients (& referrers) reluctant to randomisation to non-intervention arm • attrition – deterioration / death • non-RCT: • before-after study (observational study) • but are any identified changes due to the intervention?

  4. Fast-track methodology • fast-track RCT: • ‘fast-track’ group (intervention immediately) • ‘control’ group (intervention after waiting list) • also called: • ‘delayed intervention trial’ • ‘deferred intervention trial’ • ‘waiting list trial’ or ‘wait list trial’ • fast-track RCT: • strength of an RCT, but appears acceptable to palliative care patients & referrers [Farquhar M, Higginson IJ, Booth S. Fast-Track Trials in Palliative Care: An Alternative Randomized Controlled Trial Design.Jnl Pall Med 2009;12(3):213]

  5. BIS Phase III fast-track RCT • fast-track single-blind pragmatic RCT of BIS versus standard care • mixed methods RCT (qualitative & quantitative data) • multiple perspectives: patients, carers, referrers, providers • economic evaluation • design informed by Phase II pilot RCT [Farquhar M, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliative Care 2009; 8:9] • different disease trajectories: BIS service model varies by disease group (interventions & timing)…

  6. Phase III: BIS service model • patients with non-malignant conditions (e.g. COPD, heart failure): • 3 visits • 3 phone calls • over 4 week period • patients with malignancies (any cancer): • 1 visit (ideally with primary care) • 2 phone calls • over 2 week period • two sub-protocols (two RCTs in one…)

  7. Eligible patients (n=158) Agreed to recruitment visit n=98 Withdrawn (significant deterioration between agreeing to recruitment visit and visit) / died (n=11) Baseline interview t1 (n=87) WEEK 1 2 3 4 5 6 7 8 9 10 Fast track group Waiting list group Starts to receive BIS (n=44) Receives standard care (n=43) Mid-intervention interview t2 (n=41) Mid-waiting interview t2 (n=38) Taken off study n=0 (died) End of intervention interview t3 (n=41) End of waiting interview t3 (n=38) Waiting list group starts to receive BIS Referrer interview Mid-intervention interview t4 (n=37) End of intervention interview t5 (n=37) Follow up interview t5 (n=36) Referrer interview = intervention BIS Phase III: non-malignant conditions sub-protocol n=87 patients 4 week intervention n= 24/33 referrers (73% RR)

  8. Eligible patients (n=?) Agreed to recruitment visit n=? Withdrawn (significant deterioration between agreeing to recruitment visit and visit) (n=?) Baseline interview t1 (n=?) WEEK 1 2 3 4 5 6 Fast track group Waiting list group Starts to receive BIS (n=?) Receives standard care (n=?) Taken off study n=? (died) End of intervention interview t3 (n=?) End of waiting interview t3( n=?) Waiting list group starts to receive BIS (n=?) Follow up interview t5 (n=?) Referrer interview End of intervention interview t5 (n=?) Referrer interview = intervention BIS Phase III: malignant conditions sub-protocol n=26 / 60 patients 2 week intervention

  9. Phase III fast-track RCT: other data • as well as patients’ & carers’ and outcomes within RCT… • views of (qualitative interviews – process & outcome): • referrers • providers • intervention data (fidelity): • BIS records • audio-recordings

  10. BIS evaluation key collaborators: Dr Morag Farquhar (University of Cambridge) Prof Irene Higginson (KCL) Prof Chris Todd (University of Manchester) Dr Toby Prevost (University of Cambridge & KCL) Prof Paul McCrone (KCL) Dr Sara Booth (CUHNFT) RA: Barbara Brafman-Kennedy (CUHNFT) Funders: NIHR Research for Patient Benefit (BBK) Macmillan Cancer Support (MF) This presentation presents independent research commissioned by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) programme (Grant Reference Number PB-PG-0107-11134). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department.

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