Monitoring and Management for Metabolic Side Effects of Antipsychotics

Psychotic Disorders Clinical Trial

— AMMP  

Official title:

Monitoring and Management for Metabolic Effects of Antipsychotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875861
• Other study ID #: SDP 08-375
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: April 2017

Study information

• Verified date: February 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	North Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)	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 monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Secondary	Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight	For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.	Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases