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Title: 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
Authors: Trujillo-Martín, María M.
Ramallo-Fariña, Yolanda
Del Pino-Sedeño, Tasmania
Trujillo-Martín, María M.
Ramallo-Fariña, Yolanda
Del Pino-Sedeño, Tasmania
Imaz-Iglesia, Iñaki
Sánchez-De-Madariaga, Ricardo
Serrano-Aguilar, Pedro
Trujillo-Martín, María M.
Ramallo-Fariña, Yolanda
Serrano-Aguilar, Pedro
Trujillo-Martín, María M.
Ramallo-Fariña, Yolanda
Serrano-Aguilar, Pedro
Rúa-Figueroa, Íñigo
Erausquin, Celia
Almeida, Cristina
Trujillo-Martín, Elisa
Frias, Esmeralda Delgado
Hernández, Vanesa Hernández
Amaro, Ivan Feraz
Lozano, Beatriz Rodriguez
Vallejo-Torres, Laura 
Imaz-Iglesia, Iñaki
Sánchez-De-Madariaga, Ricardo
Sagredo, Pilar García
De Pascual-Medina, Ana M.
Serrano-Aguilar, Pedro
González, Arantxa Arteaga
Hernández, Laura Casas
Sanchez, Monica Delgado
Armas, Laura Magdalena
Regalado, Cristina Rodríguez
Beriain, Jose A.Hernández
Medina, Francisco J.Novoa
Segura, Beatriz Tejera
Duarte, Monica Troche
UNESCO Clasification: 32 Ciencias médicas
Keywords: Care Management
Clinical Practice Guideline
Decision Support Aids
Electronic Communication, et al
Issue Date: 2019
Journal: BMC Health Services Research 
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.
ISSN: 1472-6963
DOI: 10.1186/s12913-019-4589-9
Source: BMC Health Services Research [1472-6963], v. 19 (1)
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