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

• Published in: BMC health services research 2019-11, Vol.19 (1), p.783-783, Article 783
• Main Authors: Trujillo-Martín, María M, Ramallo-Fariéa, Yolanda, del Pino-Sedeéo, Tasmania, Rúa-Figueroa, Ãéigo, Trujillo-Martín, Elisa, Vallejo-Torres, Laura, Imaz-Iglesia, Iéaki, Sánchez-de-Madariaga, Ricardo, de Pascual-Medina, Ana M, Serrano-Aguilar, Pedro, García Sagredo, Pilar, Arteaga González, Arantxa, Casas Hernández, Laura, Delgado Sanchez, Monica, Magdalena Armas, Laura, Rodríguez Regalado, Cristina, Hernández Beriain, Jose A, Novoa Medina, Francisco J, Tejera Segura, Beatriz, Troche Duarte, Monica, Erausquin, Celia, Almeida, Cristina, Delgado Frias, Esmeralda, Hernández Hernández, Vanesa, Feraz Amaro, Ivan, Rodriguez Lozano, Beatriz
• Format: Article
• Language: English
• Subjects: Care management; Clinical decision making; Clinical medicine; Clinical practice guideline; Clinical practice guidelines; Communication; Cost analysis; Cost-Benefit Analysis; Cost-effectiveness; Decision making; Decision support aids; Economic aspects; Education; Electronic communication; Electronic records; Health aspects; Health care industry; Health Knowledge, Attitudes, Practice; Health services; Hematology; Hospitals; Hospitals, Public; Humans; Implementation; Informed consent; Intervention; Lupus; Lupus erythematosus; Lupus Erythematosus, Systemic - therapy; Medical care quality; Medical personnel; Medical records; Morbidity; Mortality; Patient-centered care; Patients; Practice guidelines (Medicine); Practice Guidelines as Topic; Professionals; Program Evaluation; Research Design; Rheumatologists - education; Spain; Study Protocol; Systemic lupus erythematosus; Technology; Treatment Outcome
• ISSN: 1472-6963; 1472-6963
• DOI: 10.1186/s12913-019-4589-9

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). 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. 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. ClinicalT