Monitoring and Management for Metabolic Side Effects of Antipsychotics (AMMP)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01875861
First received: June 5, 2013
Last updated: November 13, 2013
Last verified: November 2013

June 5, 2013
November 13, 2013
January 2011
December 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record.
Same as current
Complete list of historical versions of study NCT01875861 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record.
  • 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 ] [ Designated as safety issue: No ]
    For each monthly observation: The proportion of patients at each site with elevated BMI or weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.
Same as current
Not Provided
Not Provided
 
Monitoring and Management for Metabolic Side Effects of Antipsychotics
Monitoring and Management for Metabolic Effects of Antipsychotics

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Mental Health
  • Psychotic Disorders
Other: 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 Name: EBQI/F
  • Experimental: Intervention
    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.
    Intervention: Other: Evidence-Based Quality Improvement Plus Facilitation
  • No Intervention: Comparison
    "Usual care," in the context of the MIAMI Project.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- None

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01875861
SDP 08-375
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard R. Owen, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Department of Veterans Affairs
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP