Dataset Information

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.

ABSTRACT: BACKGROUND:Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. METHODS AND FINDINGS:In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ? 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. CONCLUSIONS:An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02319525.

SUBMITTER: Singh JA

PROVIDER: S-EPMC6505936 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.

Singh Jasvinder A JA Fraenkel Liana L Green Candace C Alarcón Graciela S GS Barton Jennifer L JL Saag Kenneth G KG Hanrahan Leslie M LM Raymond Sandra C SC Kimberly Robert P RP Leong Amye L AL Reyes Elyse E Street Richard L RL Suarez-Almazor Maria E ME Eakin Guy S GS Marrow Laura L Morgan Charity J CJ Caro Brennda B Sloan Jeffrey A JA Jandali Bochra B Garcia Salvador R SR Grossman Jennifer J Winthrop Kevin L KL Trupin Laura L Dall'Era Maria M Meara Alexa A Rizvi Tara T Chatham W Winn WW Yazdany Jinoos J

PLoS medicine 20190508 5

<h4>Background</h4>Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.<h4>Methods and findings</h4>In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized t ...[more]

PMID: 31067237

Similar Datasets

Project description:Systemic Lupus erythematosus (SLE), also commonly referred to as lupus, is a rare, but sometimes, fatal disease, that primarily affects young women. Lupus nephritis, a common manifestation of lupus, is more common and more devastating in patients of minority race/ethnicity. Patients have negative views of immunosuppressive drugs for lupus nephritis due to a concern about side effects and under-appreciation of its benefit. We designed a study to assess the effectiveness of individualized, computerized patient decision-aid for immunosuppressive drugs for lupus nephritis compared to a standard pamphlet for patient decision-making.Adult women with lupus nephritis, with a current lupus nephritis flare or at risk of a future lupus nephritis flare will be randomized to individualized, computerized patient decision-aid for immunosuppressive drugs vs. standard pamphlet with information about lupus and its treatment including immunosuppressive drugs and outcomes. Patients will complete outcome assessments immediately after the intervention has been administered. Patients will be followed at 3-months with a brief survey, either in person or on the phone, and at 6-months with medical record review for exploratory outcomes. Co-primary outcomes are decisional conflict and informed choice regarding immunosuppressive drugs (combines values, knowledge and choice). Secondary outcomes include: (1) assessment of patient-physician communication by assessing audio-taped physician-patient communication after intervention administration; (2) concordance between patient's desired and actual role in immunosuppressive drugs decision-making using the control preference scale (CPS); and (3) patient perception of physician interaction using the interpersonal process of care- short form (IPC-SF).This is one of the first studies to evaluate the effectiveness of an educational intervention targeting minorities with lupus nephritis. This patient-centered lupus nephritis decision-aid will be available in the public domain in English and Spanish.ClinicalTrials.gov Identifier: NCT02319525 ; registered on November 5, 2014.

Project description:ObjectiveTo provide the details of the study protocol for an observational, case study design, implementation trial.MethodsImplementing the DEcision-Aid for Lupus (IDEAL) study will put into practice a shared decision-making (SDM) strategy, using an individualized, culturally appropriate computerized decision-aid (DA) for lupus patients in 15 geographically diverse clinics in the USA. The overarching frameworks that guide this implementation study are the Consolidated Framework for Implementation Research (CFIR) and Powell's typology of implementation strategies. All 15 clinics will receive standardized capacity-building activities for lupus DA implementation in the clinic, including education, training, technical assistance, re-training, and incorporation of a clinic champion in the core team of each site. In addition, clinics will also choose among clinic-targeted activities to integrate the DA into existing work processes and/or patient-targeted activities to raise awareness and educate patients about the DA. These activities will be chosen to stimulate participant recruitment and retention activities that support the implementation of the DA at their clinic. In study aim 1, using surveys and semi-structured interviews with clinic personnel in 15 lupus clinics, we will assess stakeholder needs and identify clinic and contextual characteristics that inform the implementation strategy component selection and influence implementation effectiveness. Study aim 2 is to implement and assess the effectiveness of the IDEAL (standardized and tailored) strategy in 15 lupus clinics by examining the changes in our primary outcome of penetration, i.e., the proportion of all eligible patients in the clinic that receive the lupus DA, and secondary outcomes include DA appropriateness, acceptability, success, permanence, and feasibility. Study aim 3 is to identify ways to sustain and disseminate our lupus DA via semi-structured debriefing interviews with key clinic personnel and patients.DiscussionThe study will enroll at least 500 patient participants with lupus across all 15 sites and assess the effectiveness in implementing the DA in various clinic settings across the USA.Trial registrationClinicalTrials.gov, NCT03735238 . Protocol version number: 15, date 6/8/2020.

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:BackgroundAn Internet safety decision aid was developed to help abused women understand their risk for repeat and near-lethal intimate partner violence, clarify priorities related to safety, and develop an action plan customized to these priorities.PurposeTo test the effectiveness of a safety decision aid compared with usual safety planning (control) delivered through a secure website, using a multistate RCT design. The paper evaluates the effectiveness of the safety decision aid in reducing decisional conflict after a single use by abused women.DesignRCT referred to as Internet Resource for Intervention and Safety (IRIS).Setting/participantsAbused women who spoke English (n=708) were enrolled in a four-state RCT.InterventionThe intervention was an interactive safety decision aid with personalized safety plan; the control condition was usual safety planning resources. Both were delivered to participants through the secure study website.Main outcome measuresThis paper compares women's decisional conflict about safety: total decisional conflict and the four subscales of this measure (feeling: uninformed, uncertain, unsupported, and unclear about safety priorities) between intervention/control conditions. Data were collected from March 2011 to May 2013 and analyzed from January to March 2014.ResultsImmediately following the first use of the interactive safety decision aid, intervention women had significantly lower total decisional conflict than control women, controlling for baseline value of decisional conflict (p=0.002, effect size=0.12). After controlling for baseline values, the safety decision aid group had significantly greater reduction in feeling uncertain (p=0.006, effect size=0.07) and in feeling unsupported (p=0.008, effect size=0.07) about safety than the usual safety planning group.ConclusionsAbused women randomized to the safety decision aid reported less decisional conflict about their safety in the abusive intimate relationship after one use compared to women randomized to the usual safety planning condition.

Project description:IntroductionTreatment with sirolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been shown to be efficacious in the MRL/lpr and NZB x NZW F1 mouse models of lupus nephritis, indicating a critical role for the mTOR pathway in both models. This type of demonstration of efficacy in animal models is usually a pre-requisite for advancement into clinical development. However, efficacy in an animal model often has not translated to the desired activity in the clinic. Therefore, a more profound understanding of the mechanistic similarities and differences between various animal models and human diseases is highly desirable.MethodsTranscriptional profiling was performed on kidneys from mice with lupus nephritis; from mice who had efficacious drug treatment; and from mice before they developed nephritis. Analysis of variance with false discovery rate adjusted to p < 0.05 and an average fold change of two or more was used to identify transcripts significantly associated with disease and response to therapy. Pathway analyses (using various bioinformatics tools) were carried out to understand the basis for drug efficacy in the mouse model. The relevance in human lupus of the pathways identified in the mouse model was explored using information from several databases derived from the published literature.ResultsWe identified a set of nephritis-associated genes in mouse kidney. Expression of the majority of these returned to asymptomatic levels on sirolimus treatment, confirming the correlation between expression levels and symptoms of nephritis. Network analysis showed that many of these nephritis genes are known to interact with the mTOR pathway. This led us to ask what human diseases are linked to the mTOR pathway. We constructed the mTOR pathway interactome consisting of proteins that interact with members of the mTOR pathway and identified a strong association between mTOR pathway genes and genes reported in the literature as being involved in human lupus.ConclusionsOur findings implicate the mTOR pathway as a critical contributor to human lupus. This broad pathway-based approach to understanding the similarities in, and differences between, animal models and human diseases may have broader utility.

Dataset Information

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.

Publications

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets