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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537638
• Other study ID #: PI15/01377
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Servicio Canario de Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 31, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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.

Locations

Country	Name	City	State
Spain	Servicio de Evaluación del Servicio Canario de la Salud	Santa Cruz de Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Servicio Canario de Salud	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014 Apr 17;9:46. doi: 10.1186/1748-5908-9-46. — View Citation

Kastner M, Bhattacharyya O, Hayden L, Makarski J, Estey E, Durocher L, Chatterjee A, Perrier L, Graham ID, Straus SE, Zwarenstein M, Brouwers M. Guideline uptake is influenced by six implementability domains for creating and communicating guidelines: a realist review. J Clin Epidemiol. 2015 May;68(5):498-509. doi: 10.1016/j.jclinepi.2014.12.013. Epub 2015 Jan 10. Review. — View Citation

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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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Politi MC, Wolin KY, Légaré F. Implementing clinical practice guidelines about health promotion and disease prevention through shared decision making. J Gen Intern Med. 2013 Jun;28(6):838-44. doi: 10.1007/s11606-012-2321-0. Epub 2013 Jan 10. Review. — View Citation

Ramallo-Fariña Y, García-Pérez L, Castilla-Rodríguez I, Perestelo-Pérez L, Wägner AM, de Pablos-Velasco P, Domínguez AC, Cortés MB, Vallejo-Torres L, Ramírez ME, Martín PP, García-Puente I, Salinero-Fort MÁ, Serrano-Aguilar PG; INDICA team. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial. Implement Sci. 2015 Apr 9;10:47. doi: 10.1186/s13012-015-0233-1. — View Citation

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Serrano-Aguilar P, Kovacs FM, Cabrera-Hernández JM, Ramos-Goñi JM, García-Pérez L. Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: a cross-sectional study. BMC Musculoskelet Disord. 2011 Dec 21;12:287. doi: 10.1186/1471-2474-12-287. — View Citation

Serrano-Aguilar P, Trujillo-Martin Mdel M, Pérez de la Rosa A, Cuellar-Pompa L, Saavedra-Medina H, Linertova R, Perestelo-Perez L, Perez-Ramos J, Rivero-Santana A; Spanish SLE CPG Development Group. Patient participation in a Clinical Guideline Development for Systemic Lupus Erythematosus. Patient Educ Couns. 2015 Sep;98(9):1156-63. doi: 10.1016/j.pec.2015.05.022. Epub 2015 Jun 11. Review. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in professional's knowledge about SLE management	Acquired knowledges assessed by a questionnaire designed ad hoc	18 months
Secondary	Change in self-perceived health-related quality of life	Self-perceived health-related quality of life using EQ-5D - 5L questionnaire	18 months
Secondary	Change in self-perceived health-related quality of life	Self-perceived health-related quality of life using LupusQol questionnaire	18 months
Secondary	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
Secondary	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
Secondary	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