Overview

This trial is active, not recruiting.

Conditions mental health, psychotic disorders
Treatment evidence-based quality improvement plus facilitation
Sponsor VA Office of Research and Development
Start date January 2011
End date March 2016
Trial size 103 participants
Trial identifier NCT01875861, SDP 08-375

Summary

The purpose of this study is to test an approach for implementing guideline recommendations for assessing and managing metabolic side effects (including weight gain, diabetes, elevated lipids) in patients prescribed antipsychotic medications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.
evidence-based quality improvement plus facilitation EBQI/F
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.
(No Intervention)
"Usual care," in the context of the MIAMI Project.

Primary Outcomes

Measure
Change in site-level rates of weight monitoring at baseline (within 30 days of a new antipsychotic prescription)
time frame: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases

Secondary Outcomes

Measure
Change in site-level rates of weight monitoring at follow-up (from 31-120 days after a new antipsychotic prescription)
time frame: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Change in site-level rates of management for obesity or weight gain within 30 days after a recording of BMI of 30 or greater, or 5% gain in body weight
time frame: Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Providers involved in antipsychotic management or management of metabolic side effects and related conditions Exclusion Criteria: - None

Additional Information

Official title Monitoring and Management for Metabolic Effects of Antipsychotics
Principal investigator Richard R. Owen, MD
Description 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 FY08. 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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.