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

Implementation Science

Reid D Landes²  Jeffrey L Smith⁴  Sandra K Pope¹  Kathy Marchant³  Kristen M Viverito¹  Karen L Drummond¹  Richard R Owen¹ 

[1] Department of Psychiatry, University of Arkansas for Medical Sciences College of Medicine, 4301 West Markham, Little Rock, AR, USA;Department of Biostatistics, University of Arkansas for Medical Sciences College of Medicine, 4301 West Markham, Little Rock, AR, USA;VA Center for Mental Healthcare & Outcomes Research, Central Arkansas Veterans Healthcare System, 2200 Fort Roots Dr., North Little Rock, AR, USA;VA Mental Health Quality Enhancement Research Initiative (MH QUERI), Central Arkansas Veterans Healthcare System, 2200 Fort Roots Dr., North Little Rock, AR, USA

关键词: Mental health;    Veterans;    Antipsychotic side effects;    Metabolic management;    Metabolic monitoring;    Metabolic side effects;    External facilitation;    Evidence-based quality improvement;   

Others  :  811044
DOI  :  10.1186/1748-5908-8-120

 received in 2013-05-01, accepted in 2013-10-03,  发布年份 2013

【 摘 要 】

Background

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; 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/Design

This 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.

Discussion

Improving 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 registration

NCT01875861

【 授权许可】

   
2013 Owen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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