Clinical trial NCT03537638: Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With SLE
Official title: Effectiveness and Cost-effectiveness of a Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Quality of life
Multicomponent intervention
Clinical Practice Guideline
Computerized clinical decision support system
Activity
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-05-25
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of self-perceived activity of the SLE
timeFrame: 18 months
Secondary outcomes:
measure: Change in professional's knowledge about SLE management
timeFrame: 18 months
measure: Change in self-perceived health-related quality of life
timeFrame: 18 months
measure: Change in self-perceived health-related quality of life
timeFrame: 18 months
measure: Patient's perception of their participation in decision making
timeFrame: 18 months
measure: Professional's attitude to partnership with the patient for shared decision making
timeFrame: 18 months
measure: Professionals' adherence to CPG-SLE recommendations
timeFrame: 18 months
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación del Servicio Canario de la Salud
Study officials:
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: María de Mar Trujillo Martin, PhD
role: PRINCIPAL_INVESTIGATOR
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