NCT03537638

Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With SLE

Effectiveness and Cost-effectiveness of a Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With Systemic Lupus Erythematosus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Servicio Canario de Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BEHAVIORAL	Multicomponent intervention	Intervention to rheumatologist and internist responsible for the care of patients with SLE. Implementation multicomponent intervention consisting of: educational component, a computerized clinical decision support system developed from the clinical practice guide - SLE and automated feedback integrated into the electronic medical record system.

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-10-19
• Completion: 2020-12-31
• First posted: 2018-05-25
• Last updated: 2021-09-22

Locations

1 site across 1 country: Spain