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

Study Overview
=================
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.

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

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Behavioral: Multicomponent intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent Intervention<br>Rheumatologist and internist receive a multicomponent intervention | Behavioral: Multicomponent intervention<br>* 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.<br>|
| No Intervention: Control<br>Rheumatologist and internist provide the usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of self-perceived activity of the SLE | Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in professional's knowledge about SLE management | Acquired knowledges assessed by a questionnaire designed ad hoc | 18 months | 
| Change in self-perceived health-related quality of life | Self-perceived health-related quality of life using EQ-5D - 5L questionnaire | 18 months | 
| Change in self-perceived health-related quality of life | Self-perceived health-related quality of life using LupusQol questionnaire | 18 months | 
| Patient's perception of their participation in decision making | Patient's perception of clinician facilitation and decision-making process using the Shared Decision-Making (SDM-Q-9) Questionnaire | 18 months | 
| Professional's attitude to partnership with the patient for shared decision making | Professionals' attitudes towards shared decision making assessed by the Leeds Attitude Towards Concordance II Scale (LATCon II) | 18 months | 
| Professionals' adherence to CPG-SLE recommendations | Degree of professional adherence to recommendations will be determined through data collection from clinical records in terms of percentage of patients with adequate treatment according to SLE-CPG recommendations | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Quality of life, Multicomponent intervention, Clinical Practice Guideline, Computerized clinical decision support system, Activity