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Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE).

ABSTRACT: Domestic violence is a serious problem affecting the health and wellbeing of women globally. Interventions in health care settings have primarily focused on screening and referral, however, women often may not disclose abuse to health practitioners. The internet offers a confidential space in which women can assess the health of their relationships and make a plan for safety and wellbeing for themselves and their children. This randomised controlled trial is testing the effectiveness of a web-based healthy relationship tool and safety decision aid (I-DECIDE). Based broadly on the IRIS trial in the United States, it has been adapted for the Australian context where it is conducted entirely online and uses the Psychosocial Readiness Model as the basis for the intervention.In this two arm, pragmatic randomised controlled trial, women who have experienced abuse or fear of a partner in the previous 6 months will be computer randomised to receive either the I-DECIDE website or a comparator website (basic relationship and safety advice). The intervention includes self-directed reflection exercises on their relationship, danger level, priority setting, and results in an individualised, tailored action plan. Primary self-reported outcomes are: self-efficacy (General Self-Efficacy Scale) immediately after completion, 6 and 12 months post-baseline; and depressive symptoms (Centre for Epidemiologic Studies Depression Scale, Revised, 6 and 12 months post-baseline). Secondary outcomes include mean number of helpful actions for safety and wellbeing, mean level of fear of partner and cost-effectiveness.This fully-automated trial will evaluate a web-based self-information, self-reflection and self-management tool for domestic violence. We hypothesise that the improvement in self-efficacy and mental health will be mediated by increased perceived support and awareness encouraging positive change. If shown to be effective, I-DECIDE could be easily incorporated into the community sector and health care settings, providing an alternative to formal services for women not ready or able to acknowledge abuse and access specialised services.Trial registered on 15(th) December 2014 with the Australian New Zealand Clinical Trials Registry ACTRN12614001306606.

SUBMITTER: Hegarty K

PROVIDER: S-EPMC4522060 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE).

Hegarty Kelsey K Tarzia Laura L Murray Elizabeth E Valpied Jodie J Humphreys Cathy C Taft Angela A Gold Lisa L Glass Nancy N

BMC public health 20150801

<h4>Background</h4>Domestic violence is a serious problem affecting the health and wellbeing of women globally. Interventions in health care settings have primarily focused on screening and referral, however, women often may not disclose abuse to health practitioners. The internet offers a confidential space in which women can assess the health of their relationships and make a plan for safety and wellbeing for themselves and their children. This randomised controlled trial is testing the effect ...[more]

PMID: 26231225

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Project description:BACKGROUND:Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE:The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS:We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS:Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Māori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Māori and 0.76 (95% CI -5.57 to 7.09) for non-Māori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Māori and 1.36 (-3.16 to 5.88) for non-Māori. No study-related adverse events were reported. CONCLUSIONS:The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Māori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).

Project description:BackgroundWeb-based tools developed to facilitate a shared decision-making (SDM) process may facilitate the implementation of lung cancer screening (LCS), an evidence-based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that affect the benefits and potential harms of LCS and thus may value a veteran-centric LCS decision tool (LCSDecTool).ObjectiveThis study aims to conduct usability testing of an LCSDecTool designed for veterans receiving care at a Veteran Affairs medical center.MethodsUsability testing of the LCSDecTool was conducted in a prototype version (phase 1) and a high-fidelity version (phase 2). A total of 18 veterans and 8 clinicians participated in phase 1, and 43 veterans participated in phase 2. Quantitative outcomes from the users included the System Usability Scale (SUS) and the End User Computing Satisfaction (EUCS) in phase 1 and the SUS, EUCS, and Patient Engagement scale in phase 2. Qualitative data were obtained from observations of user sessions and brief interviews. The results of phase 1 informed the modifications of the prototype for the high-fidelity version. Phase 2 usability testing took place in the context of a pilot hybrid type 1 effectiveness-implementation trial.ResultsIn the phase 1 prototype usability testing, the mean SUS score (potential range: 0-100) was 81.90 (SD 9.80), corresponding to an excellent level of usability. The mean EUCS score (potential range: 1-5) was 4.30 (SD 0.71). In the phase 2 high-fidelity usability testing, the mean SUS score was 65.76 (SD 15.23), corresponding to a good level of usability. The mean EUCS score was 3.91 (SD 0.95); and the mean Patient Engagement scale score (potential range 1 [low] to 5 [high]) was 4.62 (SD 0.67). The median time to completion in minutes was 13 (IQR 10-16). A thematic analysis of user statements documented during phase 2 high-fidelity usability testing identified the following themes: a low baseline level of awareness and knowledge about LCS increased after use of the LCSDecTool; users sought more detailed descriptions about the LCS process; the LCSDecTool was generally easy to use, but specific navigation challenges remained; some users noted difficulty understanding medical terms used in the LCSDecTool; and use of the tool evoked veterans' struggles with prior attempts at smoking cessation.ConclusionsOur findings support the development and use of this eHealth technology in the primary care clinical setting as a way to engage veterans, inform them about a new cancer control screening test, and prepare them to participate in an SDM discussion with their provider.

Project description:BackgroundIn cancers with a chronic phase, patients and family caregivers face difficult decisions such as whether to start a novel therapy, whether to enroll in a clinical trial, and when to stop treatment. These decisions are complex, require an understanding of uncertainty, and necessitate the consideration of patients' informed preferences. For some cancers, such as medullary thyroid carcinoma, these decisions may also involve significant out-of-pocket costs and effects on family members. Providers have expressed a need for web-based interventions that can be delivered between consultations to provide education and prepare patients and families to discuss these decisions. To ensure that these tools are effective, usable, and understandable, studies are needed to identify patients', families', and providers' decision-making needs and optimal design strategies for a web-based patient decision aid.ObjectiveFollowing the international guidelines for the development of a web-based patient decision aid, the objectives of this study are to engage potential users to guide development; review the existing literature and available tools; assess users' decision-making experiences, needs, and design recommendations; and identify shared decision-making approaches to address each need.MethodsThis study used the decisional needs assessment approach, which included creating a stakeholder advisory panel, mapping decision pathways, conducting an environmental scan of existing materials, and administering a decisional needs assessment questionnaire. Thematic analyses identified current decision-making pathways, unmet decision-making needs, and decision support strategies for meeting each need.ResultsThe stakeholders reported wide heterogeneity in decision timing and pathways. Relevant existing materials included 2 systematic reviews, 9 additional papers, and multiple educational websites, but none of these met the criteria for a patient decision aid. Patients and family members (n=54) emphasized the need for plain language (46/54, 85%), shared decision making (45/54, 83%), and help with family discussions (39/54, 72%). Additional needs included information about uncertainty, lived experience, and costs. Providers (n=10) reported needing interventions that address misinformation (9/10, 90%), foster realistic expectations (9/10, 90%), and address mistrust in clinical trials (5/10, 50%). Additional needs included provider tools that support shared decision making. Both groups recommended designing a web-based patient decision aid that can be tailored to (64/64, 100%) and delivered on a hospital website (53/64, 83%), focuses on quality of life (45/64, 70%), and provides step-by-step guidance (43/64, 67%). The study team identified best practices to meet each need, which are presented in the proposed decision support design guide.ConclusionsPatients, families, and providers report multifaceted decision support needs during the chronic phase of cancer. Web-based patient decision aids that provide tailored support over time and explicitly address uncertainty, quality of life, realistic expectations, and effects on families are needed.

Project description:BackgroundDecisions of whether to disclose mental health conditions are extremely personal and require the consideration of multiple factors associated with the disclosure process (eg, weighing the risks and benefits). Decision aid tools help people make these complex decisions. Such an aid needs to be confidential, easily accessible, and easy to use with the potential to access the tool on multiple occasions. Web programs are well suited to meet these requirements and, if properly developed, can provide feasible, accessible, affordable, and effective workplace interventions.ObjectiveThis study aims to gain insights from potential end users, in this case both employees and organizations, into what type of components including language, style, and content would avoid potential stigma and ensure that elements of clear value for users would be built into a web-based decision aid tool that aims to assist employees in making decisions about the disclosure of their mental health condition at work.MethodsA participatory design approach was used to allow developers, researchers, experts, and end users to collaborate in co-designing the tool. During the user research phase of the development of the web-based tool, a participatory design workshop approach was selected as a part of a larger study of focus groups. Australian employees and managers in rural, suburban, and urban locations participated in an exploratory qualitative study involving participatory workshops designed to elicit their perspectives and preferences for a decision aid tool.ResultsA total of 2 workshops were conducted with 13 participants. The majority were from a transport company (9/13, 69%), male (8/13, 62%), and employed full time (11/13, 85%). Six employees had previous experience disclosing their own mental health condition, and 7 were in a supervisory role and had previously been disclosed to. In any co-design development, there are certain trade-offs that need to be made between the views of experts, developers, end users, and the available budget. In this specific instance of a very delicate, personal decision, the end users provided valuable design insights into key areas such as language, and they were very antipathetic to a key feature, the avatar, which was thought to be desirable by experts and developers. Findings including aspects of the tool where all stakeholders were in agreement, aspects where some stakeholders disagreed and adaptations were implemented, where disagreements could not be implemented because of financial constraints, and misalignment between stakeholders and how to decide on a balance were shared.ConclusionsThe co-design with a lived experience approach is useful for contributing much to the design, language, and features. The key in this study was balancing the needs of the workers and the potential impact for the managers and organizations, while ensuring legislation and regulation requirements were upheld.

Dataset Information

Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE).

Publications

Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE).

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