Funded by: Instituto de Salud Carlos III (FIS PI15/01377)

Granted Amount: €45,980.00

Duration: 3 years (2016-2018)

Principal Investigator: María del Mar Trujillo Martín

Collaborating Researchers: Íñigo Rua-Figueroa Fernández de Larrinoa, Elisa Trujillo Martín, José Angel Hernández Beriain, Laura Casas Hernández, Yolanda Ramallo Fariña, Tasmania del Pino Sedeño, Ana María de Pascual y Medina, Laura Vallejo Torres, Ricardo Sánchez de Madariaga, Iñaki Imaz Iglesia

Objectives: Evaluate the effectiveness and cost-effectiveness of a multicomponent knowledge transfer strategy for implementing a clinical practice guideline (CPG) for systemic lupus erythematosus (SLE). Secondary objectives to be achieved beforehand include: analyzing potential variations in clinical practice among professionals caring for people with SLE and their correspondence with scientific knowledge; systematically reviewing the scientific knowledge on Clinical Decision Support Systems (CDSS) integrated into electronic health records to optimize the development of the SLE-CDSS; analyzing the context and potential barriers and facilitators that could influence the implementation and adherence to the SLE-CDSS. Based on the results of these three objectives, the development of various components of the implementation strategy will be addressed.

Methodology:

• Design: Open-label, multicenter, cluster-randomized trial (hospital).
• Setting: 4 reference hospitals from the Canary Islands Health Service.
• Population: Patients with SLE and rheumatologists and internists responsible for their care.
• Sample: 418 patients and 20 professionals (5 per hospital).
• Randomization: By hospital (2 hospitals assigned to the experimental group and 2 to the control group).
• Intervention for the Experimental Group: (educational component for professionals, SLE-CDSS integrated into the electronic health record based on the clinical practice guideline for SLE from the SNS Guidelines Program, and feedback integrated into the electronic health record).
• Primary Outcome: Self-perceived SLE activity (SLAQ scale) and adherence to the SLE-CDSS recommendations.
• Secondary Variables: Health-related quality of life (EQ-5D-5L); patient perception of their involvement in decision-making (SDM-Q-9); adherence to SLE-CDSS recommendations; resource utilization.
• Analysis: Generalized linear model for primary and secondary variables, adjusted for patient severity and adherence to SLE-CDSS recommendations. All analyses will be conducted on an intention-to-treat basis. A structural equation modeling (EQS program) will be applied to test a model of causal relationships between sociodemographic and clinical patient characteristics, intervention, process variables, patient self-efficacy in managing their health, and health outcomes.

Contact Person: María del Mar Trujillo Martín (mar.trujillomartin@sescs.es)