Effectiveness and Cost-effectiveness of a Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Change of self-perceived activity of the SLE
研究概览
简要总结
Principal objective: To produce scientific knowledge on the effectiveness and cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a Clinical Practice Guideline (CPG) for Systemic Lupus Erythematosus (SLE), formed by an educative intervention, an computerized clinical decision support system (SADC), complemented by an automated feedback built into the electronic clinical record.
Secondary objectives will be previously developed: 1) the analysis of medical practice variations along the care of SLE patients in the Canary Islands Health Service (SCS); 2) the best available scientific evidence to support the optimal development of the SADC; 3) the context and the barriers to innovation implementation in the SCS; and 4) the development of the contents for the implementation strategy, including the SADC and the automated feedback.
Methods for the main objective: The main objective will be assessed under an open, multicentric and randomized (by clusters) clinical trial, in the SCS. The multicomponent intervention will be compared to the usual procedures for CPG dissemination. The main measure will be the self-perceived activity of SLE rated by the SLAQ scale. Self-perceived health related quality of life (HRQoL) data will be obtained by means of the questionnaire EQ-5D-5L , to estimate a cost-effectiveness ratio.
Methods for secondary objectives: The rest of the objectives will be developed by a mix of quantitative and qualitative research methods to allow adapting the design, development and execution of the intervention to the characteristics of the context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients:
- •Adults (older than 18 years) diagnosed with SLE of any seriousness and situation (active, remission or clinically quiescent and serologically active), who agree to participate and sign informed consent.
- •Health professionals:
- •Physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible SLE.
排除标准
- •Patients:
- •SLE limited to the skin, advanced chronic kidney disease (dialysis or renal transplant); Mental illnesses and / or sensory or cognitive deficits; or participating in extension or follow-up studies of another RCT (possible change in follow-up guidelines). Participants in observational studies may be included as they do not change usual practice.
研究组 & 干预措施
Multicomponent Intervention
Rheumatologist and internist receive a multicomponent intervention
干预措施: Multicomponent intervention (Behavioral)
Control
Rheumatologist and internist provide the usual care
结局指标
主要结局
Change of self-perceived activity of the SLE
时间窗: 18 months
Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire
次要结局
- Change in self-perceived health-related quality of life(18 months)
- Change in professional's knowledge about SLE management(18 months)
- Patient's perception of their participation in decision making(18 months)
- Professional's attitude to partnership with the patient for shared decision making(18 months)
- Professionals' adherence to CPG-SLE recommendations(18 months)