Implementation of Shared Decision Making in Rheumatoid Arthritis: A Stepped Wedge, Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 8
- 主要终点
- Disease activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Exclusion criteria for patient participants (Aims 1 & 2):
- •Cognitive impairment
- •Inability to speak
- •Exclusion criteria for professional participants (Aims 1-3):
- •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
研究组 & 干预措施
Control
Usual care
Intervention
Intervention phase
干预措施: Clinician communication training (Behavioral)
Intervention
Intervention phase
干预措施: Patient activation (Behavioral)
Intervention
Intervention phase
干预措施: RA Medication summary guide and RA Choice (Behavioral)
结局指标
主要结局
Disease activity
时间窗: 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.
次要结局
- Change in adherence(measured at baseline, 6 months and 12 months on a subset)
- Change in OPTION-5 (objective measure of shared decision making)(through study completion (up to 4 years), on average 1 time per year)
- SURE questionnaire(through study completion (up to 4 years), on average 3 times per year)
- Change in rheumatoid arthritis knowledge(measured at baseline, 6 months and 12 months on a subset)
- CollaboRATE questionnaire(through study completion (up to 4 years), on average 3 times per year)