Monitoring and Management for Metabolic Side Effects of Antipsychotics
NCT ID: NCT01875861
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2011-01-31
2017-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Evidence-Based Quality Improvement plus external facilitation to promote uptake of quality improvement tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, tools, and improvement strategies relevant to metabolic monitoring and management.
Evidence-Based Quality Improvement Plus Facilitation
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.
Comparison
"Usual care," in the context of the MIAMI Project.
No interventions assigned to this group
Interventions
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Evidence-Based Quality Improvement Plus Facilitation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Richard R. Owen, MD
Role: PRINCIPAL_INVESTIGATOR
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Locations
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Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, United States
Countries
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References
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Helfrich CD, Blevins D, Smith JL, Kelly PA, Hogan TP, Hagedorn H, Dubbert PM, Sales AE. Predicting implementation from organizational readiness for change: a study protocol. Implement Sci. 2011 Jul 22;6:76. doi: 10.1186/1748-5908-6-76.
Owen RR, Drummond KL, Viverito KM, Marchant K, Pope SK, Smith JL, Landes RD. Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation. Implement Sci. 2013 Oct 8;8:120. doi: 10.1186/1748-5908-8-120.
Fortney JC, Owen RR. Increasing treatment engagement for persons with serious mental illness using personal health records. Am J Psychiatry. 2014 Mar;171(3):259-61. doi: 10.1176/appi.ajp.2013.13121701. No abstract available.
Other Identifiers
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SDP 08-375
Identifier Type: -
Identifier Source: org_study_id
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