Clinical trial protocol - Implementing clinical practice guidelines for cancer pain in adults to ensure equitable, cost-effective, evidence-based, person-centred care:A phase III pragmatic stepped wedge cluster randomised controlled trial of guidelines and screening with implementation strategies versus guidelines and screening alone to improve pain in adults with cancer attending outpatients oncology and palliative care centres — ASN Events
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  3. Clinical trial protocol - Implementing clinical practice guidelines for cancer pain in adults to ensure equitable, cost-effective, evidence-based, person-centred care:A phase III pragmatic stepped wedge cluster randomised controlled trial of guidelines and screening with implementation strategies versus guidelines and screening alone to improve pain in adults with cancer attending outpatients oncology and palliative care centres

Clinical trial protocol - Implementing clinical practice guidelines for cancer pain in adults to ensure equitable, cost-effective, evidence-based, person-centred care:A phase III pragmatic stepped wedge cluster randomised controlled trial of guidelines and screening with implementation strategies versus guidelines and screening alone to improve pain in adults with cancer attending outpatients oncology and palliative care centres (#327)

Melanie Lovell 1 , Tim Luckett 2 , Jane Phillips 2 , Meera Agar 3 , Louise Ryan 2 , Lawrence Lam 4 , Nikki McCaffrey 5 , Fran Boyle 6 , John Stubbs 7 , Tim Shaw 6 , David Currow 5 , Annmarie Hosie 2 , Patricia Davidson 8
  1. HammondCare, Greenwich, NSW, Australia
  2. University of Technology, Sydney
  3. Braeside Hospital, Wetherill Park
  4. Hong Kong Institute of Education , Hong Kong
  5. Flinders University, Adelaide
  6. Sydney University, Sydney
  7. Canspeak, Sydney
  8. Faculty of Nursing, Johns Hopkins University, Baltimore

Background

This study aims to evaluate the effectiveness and cost-effectiveness of a suite of cancer pain guideline implementation resources designed to improve pain outcomes for patients attending ambulatory oncology and palliative care.

Methods

This study will use a stepped-wedge cluster randomised controlled trial design. The clusters will be participating ambulatory oncology and palliative care services. Patients will be eligible if they present to a participating service with cancer and pain during the study period. During an initial control phase, services will be equipped with a system for screening patients for pain. During a training phase, ‘clinical champions’ and clinical staff at each centre will be supported to tailor the implementation resources to their centre’s needs. In the intervention phase, services will be given procedures to feed back screening results to medical teams prior to consultation and the following guideline implementation strategies: 1) a patient goal setting tool, pain management plan and diary; 2) QStream health professional education program; and 3) audit and feedback regarding centre performance on key standards of care.

The trial’s primary outcome will be patients’ pain severity one week after presenting with moderate pain, defined as ≥5 on a 0-10 numerical rating scale. Secondary outcomes will include quality of life, carer experience, and cost-effectiveness. Eighty-two patients per centre at 6 sites (N=492) will provide >90% power to detect the main effect. Cost-effectiveness analysis will estimate the incremental cost per extra quality adjusted life year. A qualitative sub-study will investigate aspects of the intervention that have worked well or could be improved from the perspectives of patients, carers and centre staff.

Conclusion

Better management of pain has potential to increase quality of life and caregiver experience. If found effective, the strategies evaluated in this trial will be made freely available on the Cancer Council of Australia Cancer Guideline Wiki.

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