Implementation of Shared Decision Making in Rheumatoid Arthritis: A Stepped Wedge, Cluster-randomized Trial (RAiSeD)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    2196
  • sponsor
    VA Office of Research and Development
Updated on 21 October 2022
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Summary

Shared decision making is the first overarching principle for the treat to target guidelines for rheumatoid arthritis (RA) and has been proposed as a potential mechanism to reduce health disparities, however there is little evidence to inform effective ways to implement this practice in the care of Veterans with RA. The purpose of this project is to evaluate the effectiveness of a multi-component shared decision making intervention on RA disease activity, adherence to RA medications and patient knowledge of RA. The proposed research will contribute to fundamental knowledge about how to effectively foster shared decision making across varied VA rheumatology clinical settings to improve patient disease outcomes and experience; and support clinicians to engage patients in meaningful ways with the ultimate goal to improve health, reduce disability, and eliminate disparities.

Description

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. 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 to foster SDM in a systematic way across VA exist.

Significance/Impact: Veterans with RA are disproportionately male, have more comorbidities, and higher mortality rates in comparison to the general population. SDM is the first principal of the RA treat to target guidelines. However, significant gaps in knowledge of effective interventions to support SDM exist - particularly in VA. This proposal is responsive to three VA HSR&D priority domains: 1) health care value, 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 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 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 clinically important differences in a standard disease activity index. Hypothesis 2: Veterans will have greater RA knowledge and better adherence after exposure to this intervention. Exploratory Hypothesis: The SDM intervention will have a greater effect in the likelihood of lowering disease activity among racial/ethnic minorities and Veterans with limited health literacy. Aim 2: Evaluate 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 effectiveness of a novel SDM intervention across three sites. Participants: Veterans with RA and rheumatology clinicians; Intervention: multicomponent SDM intervention ; Control: participants at each site during the pre-intervention period; 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 has the potential to speed the translation of SDM research within VA and nationally to improve quality of care for all persons with RA.

Details
Condition Rheumatoid Arthritis
Treatment Patient activation, Clinician communication training, RA Medication summary guide and RA Choice
Clinical Study IdentifierNCT05530694
SponsorVA Office of Research and Development
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion criteria for patient participants (Aims 1 & 2)
Meet administrative data definition of rheumatoid arthritis (see recruitment section)
Receive rheumatology outpatient care at participating clinics and seen at least once in prior 12 months
Age 18 years or older
English speaking
Moderate to high RA disease activity within 6 months prior to enrollment
Inclusion criteria for professional participants (Aims 1-3)
Rheumatology attendings, fellows or advanced practice partners (nurse practitioners or physicians assistants) at the respective clinics
Have seen patients at their respective clinics for at least 12 months prior
Inclusion criteria for non-clinician participants (Aim 3)
Have held a leadership position within their respective institution for minimum of 12 months prior to enrollment
Have worked in the rheumatology clinic setting at their respective institution for minimum of 12 months prior

Exclusion Criteria

Exclusion criteria for patient participants (Aims 1 & 2)
Cognitive impairment
Inability to speak
Exclusion criteria for professional participants (Aims 1-3)
Have seen patients in clinic < 12 months prior to study start
Exclusion criteria for non-clinician participants (Aim 3)
Have held a leadership position within their respective institution for <12 months
Have worked in a clinic setting other than rheumatology
Have worked in a clinic setting <12 months
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