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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.
BMJ Open. 2017 Sep 15; 7(9):e015154.BO

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.

Authors+Show Affiliations

Department of Urology, VU University Medical Center, Amsterdam, The Netherlands.Department of Clinical, Neuro- and developmental Psychology, Faculty of Behavioral and Movement Sciences, Amsterdam Public Health research institute, VU University, Amsterdam, The Netherlands. Cancer Centre Amsterdam (CCA), VU University Medical Center, Amsterdam, The Netherlands.Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.Department of Urology, VU University Medical Center, Amsterdam, The Netherlands.Department of Urology, VU University Medical Center, Amsterdam, The Netherlands.Department of Urology, VU University Medical Center, Amsterdam, The Netherlands.Department of Clinical, Neuro- and developmental Psychology, Faculty of Behavioral and Movement Sciences, Amsterdam Public Health research institute, VU University, Amsterdam, The Netherlands. Cancer Centre Amsterdam (CCA), VU University Medical Center, Amsterdam, The Netherlands. Department of Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28918408

Citation

Al-Itejawi, Hoda H M., et al. "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." BMJ Open, vol. 7, no. 9, 2017, pp. e015154.
Al-Itejawi HHM, van Uden-Kraan CF, van de Ven PM, et al. 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. BMJ Open. 2017;7(9):e015154.
Al-Itejawi, H. H. M., van Uden-Kraan, C. F., van de Ven, P. M., Coupé, V. M. H., Vis, A. N., Nieuwenhuijzen, J. A., van Moorselaar, J. A., & Verdonck-de Leeuw, I. M. (2017). 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. BMJ Open, 7(9), e015154. https://doi.org/10.1136/bmjopen-2016-015154
Al-Itejawi HHM, et al. 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. BMJ Open. 2017 Sep 15;7(9):e015154. PubMed PMID: 28918408.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Al-Itejawi,Hoda H M, AU - van Uden-Kraan,Cornelia F, AU - van de Ven,Peter M, AU - Coupé,Veerle M H, AU - Vis,André N, AU - Nieuwenhuijzen,Jakko A, AU - van Moorselaar,Jeroen A, AU - Verdonck-de Leeuw,Irma M, Y1 - 2017/09/15/ PY - 2017/9/18/entrez PY - 2017/9/18/pubmed PY - 2018/5/31/medline KW - Shared decision making KW - decision aid KW - prostate cancer KW - protocol SP - e015154 EP - e015154 JF - BMJ open JO - BMJ Open VL - 7 IS - 9 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/28918408/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_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=28918408 DB - PRIME DP - Unbound Medicine ER -