Implementation of shared decision making in rheumatoid arthritis: A stepped wedge, cluster-randomized trial

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Background: Rheumatoid arthritis (RA) impacts quality of life causing disability in up to 1% of the population and 2% of those 60 and older. Men with RA have twice the risk of death as the general population, in part due to higher disease activity. Despite advances in treatment options and strategies, disparities in outcomes by race/ethnicity persist. Treatment decisions after failure with first-line methotrexate are complex, involve trade- offs in terms of harm, and require individualized decisions. In shared decision making (SDM), patients and clinicians work together to identify how to best address the patient’s situation. SDM has been proposed as a way to reduce disparities, but uptake is suboptimal and no effective tools or trainings to foster SDM in a systematic, uniform way across VA exist. Significance/Impact: Veterans with RA are disproportionately male, have greater number of comorbidities, and higher mortality. SDM is the first principal of the RA treat to target guidelines but significant gaps in knowledge of effective interventions to support SDM exist – particularly in VA. This proposal to test the effectiveness of a novel, multicomponent SDM intervention is responsive to three VA HSR&D priority domains: 1) health care value (SDM is associated with reducing overuse), 2) quality of health care, and 3) health equity. Innovation: Treatment studies in RA have focused primarily on white women, while men, who represent the VA RA population, have poorer outcomes. Targeting this large subgroup to evaluate the impact of an SDM intervention on disease outcomes and adherence is novel. Use of a novel approach combining clinician training and a decision aid to recognize the unique needs of Veterans with RA is innovative. Specific Aims: Aim 1: Evaluate the effectiveness of a multi-component SDM intervention (clinician training, patient activation, RA Choice decision aid) in a stepped-wedge, cluster-randomized controlled trial on improvement in disease activity, RA knowledge, and adherence. Hypothesis 1: During SDM intervention phases, Veterans will have lower disease activity compared to during control periods and will be more likely to experience a minimally clinically important difference in a standard disease activity index. Hypothesis 2: Veterans will have higher RA knowledge and better adherence after being exposed to the intervention. Exploratory Hypothesis: The SDM intervention will have greater effect in likelihood of lowering disease activity among racial/ethnic minorities and Veterans with limited health literacy. Aim 2: Evaluate the effectiveness of a multi-component intervention to facilitate SDM. Hypothesis: An SDM intervention for Veterans with RA will result in higher uptake of SDM in enrolled clinics during the intervention phase, relative to control phase. Aim 3: Conduct a qualitative evaluation of the SDM intervention and local implementation to inform future dissemination. Methodology: A stepped-wedge, cluster-randomized controlled trial design will be used to evaluate the effectiveness of a novel SDM intervention across three sites. Participants: Veterans with RA and rheumatology clinicians; Intervention: multicomponent SDM intervention (clinician training, patient activation prompts, decision aid); Control: participants at each site during the pre-intervention period will serve as controls; Outcomes: RA disease activity; patient-reported measures of adherence, knowledge, SDM, and an objective measure of SDM. Time: pre-intervention, intervention, and post-intervention phases for each step, measures collected over 42 months. Implementation/Next Steps: The proposed effectiveness study led by an experienced, transdisciplinary team of SDM and VA health services researchers has the potential to speed the translation of SDM research within VA and beyond, through collaboration with operational partners in VISN 20 and VA subspecialists nationally to improve quality of care for all persons with RA.