A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making

Puma Sundaresan; Brittany Ager; Sandra Turner; Dan Costa; Andrew Kneebone; Maria Pearse; Henry Woo; Stephanie Tesson; Ilona Juraskova; Phyllis Butow

doi:10.1016/j.radonc.2017.08.013

A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making

Radiother Oncol. 2017 Oct;125(1):124-129. doi: 10.1016/j.radonc.2017.08.013. Epub 2017 Aug 23.

Authors

Affiliations

¹ Sydney Medical School, University of Sydney, Australia; Radiation Oncology Network, Westmead Hospital, NSW, Australia. Electronic address: psun8480@sydney.edu.au.
² Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Australia.
³ Sydney Medical School, University of Sydney, Australia; Radiation Oncology Network, Westmead Hospital, NSW, Australia.
⁴ Sydney Medical School, University of Sydney, Australia; Pain Management Research Institute, Royal North Shore Hospital, Australia.
⁵ Sydney Medical School, University of Sydney, Australia; Northern Sydney Cancer Centre, Australia.
⁶ Department of Radiation Oncology, Auckland City Hospital, New Zealand.
⁷ Sydney Medical School, University of Sydney, Australia.
⁸ Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Australia; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Australia.

PMID: 28844330
DOI: 10.1016/j.radonc.2017.08.013

Abstract

Background and purpose: Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment.

Materials and methods: Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT.

Results: 129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT.

Conclusions: This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation.

Keywords: Clinical trials; Decision Aid; Informed consent; Patient decision-making; Trial recruitment.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Aged
Decision Making
Decision Support Techniques*
Humans
Informed Consent
Male
Middle Aged
Patient Participation
Prostatic Neoplasms / radiotherapy*
Randomized Controlled Trials as Topic / methods
Surveys and Questionnaires