Monitoring and Management for Metabolic Side Effects of Antipsychotics

Treatment of psychotic disorders consists primarily of antipsychotic medications, which are
associated with metabolic side effects such as overweight/obesity, diabetes, and
dyslipidemia. Expert consensus and evidence-based recommendations have been developed for
assessment and management of these conditions; however, research studies show deficits and
delays in metabolic monitoring for patients prescribed antipsychotics. This purpose of this
study is to test a quality improvement intervention to enhance implementation of
recommendations for assessing and managing metabolic side effects in patients prescribed
antipsychotic medications.

Study Objectives are:

- Objective 1: To test the effect of an Evidence-Based Quality Improvement/Facilitation
(EBQI/F) intervention as an augmentation to a national implementation initiative on
rates of monitoring for metabolic side effects of antipsychotics in sites likely to
encounter greater challenges to implementation.

- Objective 2: To test the effect of the EBQI/F intervention as an augmentation to the
national implementation initiative on management of metabolic side effects of
antipsychotics in sites likely to encounter greater challenges to implementation.

- Objective 3: To assess the direct costs of the EBQI/F intervention, and explore
potential variations in costs of the EBQI/F intervention in sites with lower versus
higher organizational challenges.

Methods This study employs a cluster randomized design with eligible study sites including VA
Medical Centers with 300 patients receiving a new antipsychotic prescription in the first six
months of Fiscal Year 2008. Twelve sites have been recruited and matched according to level
of organizational readiness-to-change. Randomization to intervention or control group was
conducted within each of the six site-pairs. Study participants include VA employees involved
in the monitoring and management of patients treated with antipsychotics at participating
sites. The intervention involves researchers partnering with clinical stakeholders, offering
tailoring in local implementation strategies to address barriers to metabolic side-effect
monitoring and management. External facilitation to support, problem-solve and refine
implementation will be provided for a six-month implementation phase. The effectiveness of
the EBQI/F intervention combined with the ongoing national quality improvement initiative at
six sites (intervention sites) will be compared to six matched comparison sites exposed to
the national quality improvement initiative alone (control sites).

Inclusion Criteria:

- Providers involved in antipsychotic management or management of metabolic side effects
and related conditions

Exclusion Criteria:

- None