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Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial
  1. Hoda H M Al-Itejawi1,
  2. Cornelia F van Uden-Kraan2,3,
  3. Peter M van de Ven4,
  4. Veerle M H Coupé4,
  5. André N Vis1,
  6. Jakko A Nieuwenhuijzen1,
  7. Jeroen A van Moorselaar1,
  8. Irma M Verdonck-de Leeuw2,3,5
  1. 1 Department of Urology, VU University Medical Center, Amsterdam, The Netherlands
  2. 2 Department of Clinical, Neuro- and developmental Psychology, Faculty of Behavioral and Movement Sciences, Amsterdam Public Health research institute, VU University, Amsterdam, The Netherlands
  3. 3 Cancer Centre Amsterdam (CCA), VU University Medical Center, Amsterdam, The Netherlands
  4. 4 Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
  5. 5 Department of Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands
  1. Correspondence to Professor dr Irma M Verdonck-de Leeuw; im.verdonck{at}vumc.nl

Abstract

Introduction Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care.

Methods/analysis A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.

The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient’s quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner’s treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.

Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation.

Ethics and dissemination This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals.

Trial registration Nederlands Trial Register NTR TC5177, registration date: May 28th 2015.Pre-results.

  • Shared decision making
  • decision aid
  • protocol
  • prostate cancer

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors HHMA, CFvU-K, PMvdV, VMHC, ANV, JAN, JAvM and IMV-dL contributed to the design of the study. HHMA is conducting this study in fulfilment of a PhD and will be responsible for data collection, analysis and interpretation. The present manuscript was drafted by HHMA, CFvU-K, PMvdV, VMHC, ANV, JAN, JAvM and IMV-dL. All authors revised this manuscript critically. All authors have read and approved the final manuscript.

  • Funding This research project is funded by the CZ Innovation Fund (grant 2013–00070) and co-funded by an unrestricted educational grant from Astellas Pharmaceuticals (grant PAS-596). These funding sources had no involvement in data collection, analysis, the preparation of this manuscript or the decision to submit the article for publication.

  • Competing interests None declared.

  • Ethics approval The Medical Ethics Committee of VU University MedicalCenter (Amsterdam, The Netherlands) has confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to this stepped-wedge trial.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data will be available in a machine-readable database, fully anonymised in order to guarantee security and anonymity to the participants. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. The (intellectual) property rights with regard to the generated data will rest at the VU University Medical Center, Amsterdam, The Netherlands. Interested parties can request a non-exclusive licence for research and educational purposes. The non-exclusive licence may only be requested after the completion of the thesis to be written reserving the generated data.

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