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

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.

Grant Number: 5I01HX003260-04
NIH Institute/Center: VA
Principal Investigator: Jennifer Barton