Rheumatoid Arthritis Shared Decision Making
- Conditions
- Rheumatoid Arthritis
- Interventions
- Behavioral: Clinician communication trainingBehavioral: Patient activationBehavioral: RA Medication summary guide and RA Choice
- Registration Number
- NCT05530694
- Lead Sponsor
- VA Office of Research and Development
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 792
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention Clinician communication training Intervention phase Intervention RA Medication summary guide and RA Choice Intervention phase Intervention Patient activation Intervention phase
- Primary Outcome Measures
Name Time Method Disease activity through study completion (up to 4 years), on average 3 times per year RA disease activity will be measured using composite score: the Clinical Disease Activity Index (range 0-76) or CDAI. This is a composite score of clinician assessed swollen and tender joints counts, clinician global assessment and patient global assessment of disease activity. Higher score is indicative of higher disease activity.
- Secondary Outcome Measures
Name Time Method Change in adherence measured at baseline, 6 months and 12 months on a subset Patient-reported RA medication adherence will be assessed using a validated single-item measure: "How many times do you think you may have missed taking your pills in the last week?". A response of 1 or greater is considered nonadherent. Among participants taking a biologic therapy (self-injection or infusion), adherence will be measured asking, "How many times do you think you have missed your RA injection or infusion in the past month?" Adherence will be dichotomized into either poor or adequate adherence, with poor adherence defined as missing 1 RA pills over the past week or 1 RA injections in the past month.
Change in OPTION-5 (objective measure of shared decision making) through study completion (up to 4 years), on average 1 time per year OPTION-5 is a measure of direct observation (audio-taped recordings) of shared decision making. The measure contains 5 items scored from 0 (absence of shared decision making) to 4 (optimal performance). A trained external observer will score the clinician on the extent to which they involve the patient in decision making, scores are summed and scaled to fall between 0-100 for ease of interpretation. Higher scores indicate greater uptake of shared decision making.
SURE questionnaire through study completion (up to 4 years), on average 3 times per year SURE is a brief, validated patient-reported 4-item measure to assess patient uncertainty about treatment choice including uncertainty about benefits and risks, what matters most to the patient, support in making the choice, and feeling sure about the best choice. Patients rate each item true or false and scores can range from 0-4. A score below 4 is indicates decisional conflict and a score of 3 or less is considered clinically relevant decisional conflict.
Change in rheumatoid arthritis knowledge measured at baseline, 6 months and 12 months on a subset Patient general knowledge of RA and RA medications will be measured using a 8-item self-reported survey. This measure is designed to capture rudimentary knowledge of RA and RA medications. A score of 7 out of 8 correct answers is considered adequate RA knowledge. One or more missed dose per week is considered poor adherence.
CollaboRATE questionnaire through study completion (up to 4 years), on average 3 times per year CollaboRATE is a brief, validated patient-reported 3-item measure to assess the process of shared decision making. Each item represents a dimension of shared decision making (explanation or the health issue, elicitation of patient preferences, and Integration of patient preferences). The questions are each rated on a 10-point anchored scale from 1 (no effort was made) to 10 (every effort was made). Higher scores indicate a better shared decision making experience.
Trial Locations
- Locations (4)
Wilmington VA Medical Center, Wilmington, DE
🇺🇸Wilmington, Delaware, United States
San Francisco VA Medical Center, San Francisco, CA
🇺🇸San Francisco, California, United States
VA Portland Health Care System, Portland, OR
🇺🇸Portland, Oregon, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
🇺🇸Philadelphia, Pennsylvania, United States