Abstract
BackgroundTreatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Evidence-based clinical practice guidelines recommend timely assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring and management for these patients. This protocol article describes the project ‘Monitoring and Management for Metabolic Side Effects of Antipsychotics,’ which is testing an approach to implement recommendations for these practices.Methods/DesignThis project employs a cluster randomized clinical trial design to test effectiveness of an evidence-based quality improvement plus facilitation intervention. Eligible study sites were VA Medical Centers with ≥300 patients started on a new antipsychotic prescription in a six-month period. A total of 12 sites, matched in pairs based on scores on an organizational practice survey, were then randomized within pairs to intervention or control conditions.Study participants include VA employees involved in metabolic monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders to facilitate tailoring of local implementation strategies to address barriers to metabolic side-effect monitoring and management. The intervention includes a Design Phase (initial site visit and subsequent development of a local implementation plan); Implementation Phase (guided by an experienced external facilitator); and a Sustainability Phase. Evaluation includes developmental, implementation-focused, progress-focused and interpretative formative evaluation components, as well as summative evaluation. Evaluation methods include surveys, qualitative data collection from provider participants, and quantitative data analysis of data for all patients prescribed a new antipsychotic medication at a study site who are due for monitoring or management of metabolic side effects during the study phases. Changes in rates of recommended monitoring and management actions at intervention and control sites will be compared using time series analyses.DiscussionImproving monitoring for metabolic side effects of antipsychotics, as well as promoting timely evidence-based management when these effects emerge, will lead to improved patient safety and long-term outcomes. This article discusses key strengths and challenges of the study.Trial registrationNCT01875861
Highlights
Treatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia
This study employs a cluster randomized clinical trial design, with matched pairs of Veterans Affairs (VA) facilities defined as the clusters, to test the effectiveness of an evidence-based QI (EBQI) plus facilitation (EBQI/F) intervention combined with the ongoing national quality improvement initiative (MIAMI Project) at six sites compared to six matched comparison sites exposed to the national quality improvement initiative alone
The extent to which metabolic monitoring and management recommendations are followed will be examined at the intervention sites over three six-month intervals: the Pre-implementation Phase, defined as the six-month period prior to the initial EBQI site visit at the intervention sites; the Implementation Phase, which includes active external facilitation (EBQI/F); and the Sustainability Phase, during which the research team continues to evaluate the extent of metabolic monitoring and management, but external facilitation is not provided
Summary
Treatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Evidence-based clinical practice guidelines recommend timely assessment and management of these conditions; research studies show deficits and delays in metabolic monitoring and management for these patients This protocol article describes the project ‘Monitoring and Management for Metabolic Side Effects of Antipsychotics,’ which is testing an approach to implement recommendations for these practices. Failure to properly monitor and manage these side effects can lead to increased risk of mortality due to diabetic ketoacidosis [8] and cardiovascular disease [9] In addition to these treatment-emergent adverse effects, patients with SMIs such as schizophrenia already have a greater prevalence of obesity (42%) [10,11] and diabetes (13%) [12] than the general population
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