Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol

Alana Fisher; Louise Sharpe; Daniel Costa; Josephine Anderson; Vijaya Manicavasagar; Ilona Juraskova

doi:10.1016/j.conctc.2018.11.004

Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol

Contemp Clin Trials Commun. 2018 Nov 9:12:137-144. doi: 10.1016/j.conctc.2018.11.004. eCollection 2018 Dec.

Authors

Alana Fisher^{1

2}, Louise Sharpe¹, Daniel Costa³, Josephine Anderson⁴, Vijaya Manicavasagar⁴, Ilona Juraskova^{1

2}

Affiliations

¹ School of Psychology, Brennan MacCallum Building (A18), The University of Sydney, NSW, 2006, Australia.
² Centre for Medical and Evidence-based Decision-making (CeMPED), Level 6, Chris O'Brien Lifehouse (C39Z), The University of Sydney, NSW, 2006, Australia.
³ Sydney Medical School, Edward Ford Building (A27), The University of Sydney, NSW, 2006, Australia.
⁴ The Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW, 2031, Australia.

Abstract

Background/aims: This paper describes the protocol for a feasibility study for a parallel Phase II randomised control trial (RCT) aiming to evaluate a novel decision-aid website (e-DA) to support young adults with bipolar II disorder (BPII), and their families.

Material and methods: The e-DA was developed according to the International Patient Decision-Aid Standards (IPDAS). Participants will be 40 young adults (18-30 years) referred to a specialist outpatient clinical facility, who have a confirmed clinical diagnosis of BPII. Participants will be randomised (1:1) to receive access to the clinic's online factsheets/website with (Intervention) or without (Control) the e-DA. A series of validated and purpose-designed questionnaires will be administered at baseline (T0), immediately post-decision (T1), and 3 months post-decision (T2). Questionnaires assess key decision-making constructs related to decision-making quality, including: decisional conflict, subjective and objective treatment knowledge, values-based informed choice, concordance between preferred/actual decision-making involvement, preparation for decision-making, and decisional regret. Self-report symptom severity and anxiety will ascertain the safety of e-DA use. The focus of analyses will be to assess effect sizes, in order to guide a future RCT.

Discussion: This feasibility study will evaluate a world first, evidence-based online decision-support resource, a DA website, for young adults with BPII and their families who are deciding on treatment options for relapse prevention. Findings will determine the e-DA's feasibility in RCT procedures (i.e., outpatient clinical setting) and provide estimates of effect sizes on outcomes related to improving treatment decision-making and patient outcomes in a sample of potential end-users, compared to usual care.

Trial registration: This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12617000840381.

Keywords: Bipolar II disorder; Decisional conflict; Informed choice; Randomised controlled trial; Treatment decision-aid; Young adults.