Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial

María M Trujillo-Martín, Yolanda Ramallo-Fariña, Tasmania Del Pino-Sedeño, Íñigo Rúa-Figueroa, Elisa Trujillo-Martín, Laura Vallejo-Torres, Iñaki Imaz-Iglesia, Ricardo Sánchez-de-Madariaga, Ana M de Pascual-Medina, Pedro Serrano-Aguilar, SLE-CPG-Implementation Group, Pilar García Sagredo, Arantxa Arteaga González, Laura Casas Hernández, Monica Delgado Sanchez, Laura Magdalena Armas, Cristina Rodríguez Regalado, Jose A Hernández Beriain, Francisco J Novoa Medina, Beatriz Tejera Segura, Monica Troche Duarte, Celia Erausquin, Cristina Almeida, Esmeralda Delgado Frias, Vanesa Hernández Hernández, Ivan Feraz Amaro, Beatriz Rodriguez Lozano, María M Trujillo-Martín, Yolanda Ramallo-Fariña, Tasmania Del Pino-Sedeño, Íñigo Rúa-Figueroa, Elisa Trujillo-Martín, Laura Vallejo-Torres, Iñaki Imaz-Iglesia, Ricardo Sánchez-de-Madariaga, Ana M de Pascual-Medina, Pedro Serrano-Aguilar, SLE-CPG-Implementation Group, Pilar García Sagredo, Arantxa Arteaga González, Laura Casas Hernández, Monica Delgado Sanchez, Laura Magdalena Armas, Cristina Rodríguez Regalado, Jose A Hernández Beriain, Francisco J Novoa Medina, Beatriz Tejera Segura, Monica Troche Duarte, Celia Erausquin, Cristina Almeida, Esmeralda Delgado Frias, Vanesa Hernández Hernández, Ivan Feraz Amaro, Beatriz Rodriguez Lozano

Abstract

Background: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE).

Methods: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned.

Discussion: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting.

Trial registration: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Keywords: Care management; Clinical practice guideline; Cost-effectiveness; Decision support aids; Electronic communication; Implementation; Knowledge transfer; Multicomponent intervention; Secondary care; Systemic lupus erythematosus.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of study procedures. EDS: electronic decision support

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Source: PubMed

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