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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03537638
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Servicio Canario de Salud

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Multicomponent intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Multicomponent Intervention
Rheumatologist and internist receive a multicomponent intervention
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.

No Intervention: Control
Rheumatologist and internist provide the usual care

Primary Outcome Measures :
  1. Change of self-perceived activity of the SLE [ Time Frame: 18 months ]
    Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire

Secondary Outcome Measures :
  1. Change in knowledge [ Time Frame: 18 months ]
    Acquired knowledges assessed by a questionnaire designed ad hoc

  2. Change in self-perceived health-related quality of life EQ-5D - 5L [ Time Frame: 18 months ]
    Self-perceived health-related quality of life using EQ-5D - 5L questionnaire

  3. Change in patient's perception about clinician facilitation and decisiom-making process [ Time Frame: 18 moths ]
    Patient's perception of clinician facilitation and decision-making process using the Shared Decision-Making (SDM-Q-9) Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03537638

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Contact: María de Mar Trujillo Martin, PhD +34 922 684019 ext 209
Contact: Yolanda Ramallo Fariña +34 922 684019

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Servicio de Evaluación del Servicio Canario de la Salud Recruiting
Santa Cruz de Tenerife, Spain, 38004
Contact: María del Mar Trujillo Martín, PhD    +34 922 684019 ext 209   
Principal Investigator: María del Mar Trujillo Martín, PhD         
Sub-Investigator: Yolanda Ramallo Fariña         
Sub-Investigator: Laura Vallejo Torres, PhD         
Sub-Investigator: Pilar García Sagredo         
Sub-Investigator: Iñaki Imaz Iglesia, PhD         
Sub-Investigator: Roberto Martín Fernández         
Sub-Investigator: Iñigo Rúa-Figueroa Fernández de Larrinoa, MD, PhD         
Sub-Investigator: Ana María Pascual         
Sub-Investigator: Elisa Trujillo Martín, MD, PhD         
Sub-Investigator: Jose Angel Hernández Beriain, MD, PhD         
Sub-Investigator: Laura Casas Hernández, MD, PhD         
Sponsors and Collaborators
Servicio Canario de Salud
Instituto de Salud Carlos III
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Principal Investigator: María de Mar Trujillo Martin, PhD Servicio de Evaluación del Servicio Canario de la Salud

Panzarasa S, et al.Technical Solutions for Integrating Clinical Practice Guidelines with Electronic Patient Records. Volume 5943 of LNAI. Springer-Verlag 2010;141 -154

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Responsible Party: Servicio Canario de Salud Identifier: NCT03537638     History of Changes
Other Study ID Numbers: PI15/01377
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servicio Canario de Salud:
Quality of life
Multicomponent intervention
Clinical Practice Guideline
Computerized clinical decision support system
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases