Monitoring and Management for Metabolic Side Effects of Antipsychotics

NCT01875861 | Completed Results

• 1 other identifier: SDP 08-375
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health; Psychotic Disorders

Keywords

Antipsychotic Agents; Metabolic Syndrome; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)

  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.

  Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases

Secondary Outcomes (2)

• Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)

  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 5% Gain in Body Weight

  Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Evidence-Based Quality Improvement Plus Facilitation

Comparison

NO INTERVENTION

"Usual care," in the context of the MIAMI Project.

Interventions

Evidence-Based Quality Improvement Plus Facilitation OTHER

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.

Also known as: EBQI/F

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (3)

• 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.

  PMID: 21777479 BACKGROUND

• 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.

  PMID: 24103648 BACKGROUND

• 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.

  PMID: 24585327 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Psychotic Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

This study was planned in conjunction with a national effort to improve metabolic monitoring and management for Veterans prescribed antipsychotic medications. However, this study's implementation activities started after the national effort ended..

Results Point of Contact

• Title: Dr. Richard Owen
• Organization: Central Arkansas Veterans Healthcare System

Richard.Owen2@va.gov

(501) 257-1710

Study Officials

• Richard R. Owen, MD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 12, 2013
• Study Start: January 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2017
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)