BACKGROUND/RATIONALE:
Second-generation antipsychotics (SGAs) are prescribed to over 80% of veterans with psychotic disorders. Unfortunately, treatment with many SGAs is associated with metabolic side effects such as obesity, diabetes, and hyperlipidemia. Recommendations for monitoring and management of these effects are contained in VA clinical practice guidelines for psychoses, obesity, diabetes, and dyslipidemia. However, research has found low rates of metabolic monitoring and significant delays in management of metabolic abnormalities among patients treated with antipsychotics. In 2008, VA Mental Health Services developed a national implementation strategy, which involved education (including a 2010 national meeting) and a technical support center to increase rates of metabolic side effect monitoring and appropriate management of these effects. The proposed study tested an implementation intervention to enhance uptake of evidence-based tools and strategies to improve monitoring and management of metabolic side effects of antipsychotics, within the context of the national implementation effort.

OBJECTIVE(S):
Objective 1: To test the effect of an Evidence-Based Quality Improvement / Facilitation (EBQI/F) intervention as an augmentation to the national implementation strategy on monitoring of metabolic side effects of antipsychotics.
Objective 2: To test the effect of the EBQI/F intervention as an augmentation to the national implementation strategy on management of metabolic side effects of antipsychotics.
Objective 3: To assess the direct costs of the EBQI/F intervention, and to explore variations in costs of the EBQI/F intervention in sites with low- versus high- organizational readiness-to-change.

METHODS:
The study employed a cluster-randomized design to test the EBQI/F intervention combined with the national implementation strategy, compared to the national implementation strategy alone. The study was conducted at 12 facilities that were systematically selected based on performance on relevant clinical indicators. Sites were matched on a measure of organizational stress and randomized to intervention or control conditions. The intervention included a site visit, during which EBQI methods were used to facilitate the development of an implementation plan by site personnel; ongoing external facilitation by a study team member; and access to effective quality improvement tools and strategies, e.g., a VistA computer routine that produced weekly reports of patients due for monitoring or management actions.

Rates of monitoring for weight, glucose/hemoglobin A1c, and LDL within 30 days of a new antipsychotic prescription (baseline) and 31-120 days later (follow-up) were determined using CDW data. CPRS record review was performed to assess management of weight gain, hyperglycemia/elevated hemoglobin A1c, and elevated LDL. Descriptive analyses were conducted and repeated measures regression analyses were performed to examine intervention effects on performance of guideline-recommended metabolic monitoring and management during pre-implementation, implementation, and post-implementation study periods, controlling for sociodemographic variables. Formative evaluation methods were also used to support development of local implementation strategies, document and evaluate the process and success of the EBQI/F intervention, identify barriers/facilitators, and identify potential refinements to the intervention for future implementation efforts.

FINDINGS/RESULTS:
Qualitative analysis of developmental formative evaluation interviews with providers (N = 91) identified numerous barriers to following metabolic monitoring and management recommendations, including inadequate staffing, insufficient provider time, missing equipment, lab issues, lack of provider knowledge, issues with relevant clinical reminders, inter-provider communication, missed appointments, patient preferences, and lack of patient education.

A total of 16,476 patients were identified throughout the study periods as having a new antipsychotic prescription requiring metabolic monitoring. Monitoring rates were low overall. Interestingly, monitoring rates at all sites tended to decline throughout the study. However, at intervention sites, rates of baseline monitoring for the three metabolic parameters decreased less from pre-implementation to implementation periods than did monitoring for the comparable parameters at control sites. The intervention x time interaction terms were significant both for baseline weight monitoring (OR = 1.19, 95% CI 1.02-1.38) and follow-up weight monitoring (OR = 1.20, 95% CI 1.03-1.39). Intervention x time interactions were not significant for monitoring rates of glucose/hemoglobin A1c or LDL. Over 1,000 medical records of patients who developed new metabolic side effects were reviewed. Rates of management actions were modest (e.g., only 32.9% of patients with elevated glucose had management action(s) within 30 days). There were no substantial differences between intervention and control groups with regard to change over time, except for glucose management, which increased from 28.6% to 48.6% at intervention sites, but only from 32.3% to 40.5% at control sites.

Implementation-focused and summative formative evaluation found that uptake of quality improvement tools was limited, in part due to insufficient staff time, staff turnover, and competing demands to complete other initiatives. Costs of implementation efforts were similar to those reported in previous studies, and mainly consisted of external facilitators' time.

IMPACT:
This project addressed an important patient safety concern for Veterans taking antipsychotic medications, specifically the need for timely monitoring and management of metabolic side effects of antipsychotics. The EBQI intervention only affected weight monitoring, at baseline and follow-up, but these effects were smaller than expected, and not clinically significant. There are several contextual and study-related factors that could help explain study results. Study sites were systematically selected and many had substantial organizational stress, and thus, would be expected to have substantial difficulty mounting a quality improvement intervention in addition to addressing other performance measures, directives, and organizational issues. The levels of organizational stress were evident in our interactions with sites, with turnover of mental health and facility leadership and some changes in key EBQI team members. In such organizationally-stressed sites, 6 months of external facilitation may be insufficient to effect clinically significant change in metabolic monitoring and management. In contrast, other research has shown positive outcomes from more intensive external plus internal facilitation strategies (applied over longer durations) in implementing complex clinical innovations in sites that have previously been unsuccessful.

This study was planned in conjunction with a national effort (see above) to improve metabolic monitoring and management for Veterans prescribed antipsychotic medications. However, this study's implementation activities started after the end of the national effort. A broader implication for future improvement efforts, including implementation research, is that projects should be closely aligned, not only with evidence-based recommendations and mental health leaders' clinical priorities, but also with specific regional or national initiatives.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Fortney JC, Owen RR. Increasing treatment engagement for persons with serious mental illness using personal health records. The American journal of psychiatry. 2014 Mar 1; 171(3):259-61. [view]
2. 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. Implementation science : IS. 2013 Oct 8; 8(1):120. [view]
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. Implementation science : IS. 2011 Jul 22; 6(1):76. [view]

Center Products

1. Hecht MI, Hanks D, Owen RR. Short Video-06: Mental Health and Antipsychotic monitoring. 2016 Jul 1. 6 (6). Available from: http://www.hsrd.research.va.gov/news/video/default.cfm. [view]

VA Cyberseminars

1. Smith JL. Formative Evaluation in Implementation Research: An Overview. [Cyberseminar]. 2013 Jul 15. [view]
2. Owen RR. Improving prescribing for psychiatric illnesses. QUERI Prescribing Practices. [Cyberseminar]. 2014 Oct 14. [view]
3. Owen RR, Niv N. Improving the Health of Veterans Who Receive Antipsychotic Medications: Successful Strategies Shown to Help Implement Routine Monitoring for Metabolic Side Effects. [Cyberseminar]. 2010 Jun 23. [view]

Conference Presentations

1. Drummond KL, Viverito KM, Marchant-Miros K, Smith JL, Owen RR. Barriers to recommended monitoring and management of metabolic side effects of antipsychotic medications in 12 VA Medical Centers. Poster session presented at: National Institute of Mental Health Mental Health Services Research Annual Conference; 2014 Apr 24; Bethesda, MD. [view]
2. Smith JL, Owen RR, Blevins D, Young AS, Niv N, Cohen A, Hudson TJ, Reist C, Marder SR. Clinical-Research Partnerships to Improve Antipsychotic Side Effect Monitoring and Management. Poster session presented at: VA HSR&D Field-Based Quality Improvement in Parallel Circuits Meeting on VA System Redesign, Operational Systems Engineering, and Implementation Research; 2010 Jul 14; Indianapolis, IN. [view]
3. Smith JL, Owen RR, Blevins D, Young AS, Niv N, Cohen A, Hudson TJ, Reist C, Marder SR. Clinical-Research Partnerships to Improve Antipsychotic Side-Effect Monitoring and Management. Poster session presented at: VA “One Team toward One Dream” National Quality, Patient Safety and Systems Redesign Conference; 2010 Jun 22; San Francisco, CA. [view]
4. Henry SR, Zickmund S, Hagedorn H, Conners E, Mittman B, Smith JL. Developing a Plan to Reduce Health Disparities within a Large, Integrated Healthcare System: Planning to Improve Care for Patients in Hard to Reach Locations, The Veterans Health Administration's, Quality Enhancement Research Initiative's (QUERI), Inter-QUERI Equity Workgroup (I-QEW). Paper presented at: National Medical Association Annual Convention and Scientific Assembly; 2010 Aug 1; Orlando, FL. [view]
5. Owen RR, Li C, Viverito KM, Smith JL, Austen MA, Marchant KE, Brace CD, Drummond KL. Effectiveness of an Implementation Strategy to Improve Metabolic Side Effect Monitoring for Patients Prescribed Antipsychotics. Paper presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 8; Philadelphia, PA. [view]
6. Owen RR, Kilbourne A, Young A, Marder S. Improving General Medical Care for Veterans with Mental Illness. Paper presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 19; National Harbor, MD. [view]
7. Hall CG, Smith JL, Benedict S, Brooks J. Nothing about Them, without Them: Techniques for Including Clinicians in Implementation Research. Paper presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 19; National Harbor, MD. [view]

DRA: Mental, Cognitive and Behavioral Disorders, Diabetes and Other Endocrine Disorders
DRE: Treatment - Observational, Prevention, Prognosis
Keywords: Adverse events, Pharmaceuticals, Schizophrenia
MeSH Terms: none