Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation

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

Key components of external facilitation in an acute stroke quality improvement collaborative in the Veterans Health Administration

“…Other important experiences identified for future external facilitation efforts include establishing rapport and communication with teams, applying process improvement tools, suggesting solutions and empowering teams to identify sources of help, and keeping teams focused and on track. Our data supports the literature that key roles of external facilitation [ 27 ] include fostering support to the field teams through identifying referrals and resources as well as providing guidance [ 23 ] through the planned tasks and application of tools [ 2 ]. With this relationship established, the usage of tools and changing practices could then be improved.…”

Psychiatrists' follow-up of identified metabolic risk: a mixed-method analysis of outcomes and influences on practice

“…The time constraints, focus on psychiatric symptoms, concerns about role diffusion, and beliefs that patients are unable/unwilling to modify lifestyles have all been described as constraining attention to physical health. 7 , 17 – 22 This study, however, extends these findings by contextualising such proximal influences on practice. In combination with the multiple demands on their limited time, psychiatrists' understanding of the health of people with SMI as a product of dynamic interactions between personal characteristics and social conditions beyond their control contributes to ambivalence about their roles and observed clinical inertia.…”

A Hybrid III stepped wedge cluster randomized trial testing an implementation strategy to facilitate the use of an evidence-based practice in VA Homeless Primary Care Treatment Programs

“…1, for this project, Facilitation will be initiated in month 7 of year 1 and run for 12 months at each site. In operationalizing Facilitation, a research team member (JLS) with extensive experience and expertise in applying external facilitation strategies to support adoption of evidence-based practices will serve as EF [2, 19, 37, 38]. A clinical team member from the GLA VA will serve as IF.…”