title: Preparing for a randomized controlled trial: strategies to optimize the design of an individualized cardiovascular surgical patient education intervention.
abstract: Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.
authors.affiliation: Daphne Cockwell, School of Nursing, Ryerson University, Toronto, ON, Canada M5B 2K3. Electronic address: sfrederi@ryerson.ca.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Fredericks
authors.affiliation: University of Toronto, University Health Network, Toronto General Hospital, Toronto, ON, Canada M5G 2C4. Electronic address: terry.yau@uhn.on.ca.
authors.forename: Terrence M
authors.initials: TM
authors.lastname: Yau
mesh_terms: D002318:Cardiovascular Diseases / Q000451:nursing* / Q000601:surgery; D006801:Humans; D010353:Patient Education as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design
keywords: Complex interventions; Multiple component interventions; Patient education; Randomized controlled trials; Standardizing interventions