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: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Mental Health
Psychotic Disorders
Other: Evidence-Based Quality Improvement Plus Facilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Monitoring and Management for Metabolic Effects of Antipsychotics

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Comparison
"Usual care," in the context of the MIAMI Project.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875861

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Investigators
Principal Investigator: Richard R. Owen, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01875861     History of Changes
Other Study ID Numbers: SDP 08-375
Study First Received: June 5, 2013
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Antipsychotic Agents
Metabolic Syndrome
Quality Improvement

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 19, 2014