Clinical Trial Finder

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 18 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. 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): -none. 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

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.

Arms

No Intervention: Control

Usual care

Experimental: Intervention

Intervention phase

Interventions

Behavioral: - Clinician communication training

The clinician training is a generic, skills- and attitude-based approach for clinicians to acknowledge their decision making conversations with patients that 1) there is more than one option, and 2) patient's views matter in deciding what to do next. This tools-free approach can be used on the spot when needed and is termed fostering choice awareness (FCA). The one-hour training consists of 4 parts: 1) a knowledge session on evidence and guidelines on effective conversations and SDM, 2) video-review of behaviors which foster or hinder choice awareness, 3) clinical simulations in which clinicians practice fostering choice awareness behaviors, and 4) a reminder card for use in future clinic visits. Video clips will be of patient-clinician conversations around treatment decision making to prompt and probe clinicians' experiences, improve understanding, and improve practice.

Behavioral: - Patient activation

The patient activation component consists of three questions patients can ask their clinician to help them become more involved: "1. What are my options?; 2. What are the possible benefits and harms of those options?; 3. How likely are each of those benefits and harms to happen to me?" These questions have been used in studies to promote improved communication in a number of conditions including cardiovascular disease, cancer, and women's health.

Behavioral: - RA Medication summary guide and RA Choice

RA Choice presents information on FDA-approved RA treatments in a set of cards, which can be used alone or in combination based on a patient's preference, values, and the clinician's experience. The RA medication summary guide describes options for medication, physical therapy, occupational therapy, and ways to stay healthy with diet and exercise. Tool development followed key principles of creating low literacy materials that featured icons, short phrases written in plain language, and included topics of interest to RA patients faced with a medication decision. For the proposed study, we will include a paper-based version of the tool, or a web-based version available for telephone or VA Video Connect (VVC) visits. The tools will be updated to include new FDA-approved therapies (e.g., JAK inhibitors).