Clozapine is the most effective antipsychotic for the management of treatment-resistant schizophrenia , however, it continues to be under prescribed . Adverse-effects of Clozapine, are one of the contributing factors leading to its low prescription rate , due the significant morbidity and mortality related to Clozapine. In order to monitor and prevent these complications, evidence based practice guidelines recommend dietary modifications, stool softeners and scheduled absolute neutrophil counts (ANC) . In this study, we explore the effectiveness of how a Clozapine provider order sets (CPOS) in an Electronic Medical Records (EMR) system, improves compliance to evidence based practice guidelines; to ensure prevention of Clozapine adverse drug events, and thus, possibility increasing Clozapine use.
We utilized a multistep approach to explore the effectiveness of Clozapine order-sets. First, a Clozapine CPOS, which included: ordering ANC, stool softeners, and a high fiber diet, was implemented in Richmond University Medical Center’s (RUMC) EMR Software (Meditech) (Figure 1). Second, training was provided to prescribing physicians in the psychiatric department.
A retrospective study was conducted to quantitatively analyze Clozapine EMR data over an 18-month period (June 2017–December 2018).
A total of 112 records were retrieved. Twenty-three did not meet study criteria and were excluded. The no order set group was n = 50, with a mean age of 44.4 years; (44% female and 56% male). The order set group was n = 39, with a mean age of 41.2 years (61.5% female and 38.5% male) (Table 1).
|Pre-intervention group||Post-intervention group||Total|
|Female (%)||22 (44%)||24 (61.5%)||46 (51.7%)|
|Male||28 (56%)||15 (38.5%)||43 (48.3%)|
We compared compliance of “order set” vs. “no order set” groups using logistic regression to determine the benefits of CPOS in our patient population. Adverse drug events was measured by the incidence of gastrointestinal hypo-motility , defined by the Constipation Assessment Scale (CAS). Criteria for data analysis included patients in the psychiatric department and who received >1 dose of Clozapine.
CPOS are effective in ensuring compliance with safe prescribing guidelines [95% CI 0.098–0.526, p = .0001].
Adverse drug events were reduced by 35.41% [95% CI 0.104–0.599; p = .005]. In the pre-intervention group, 52% of the patients experienced constipation while on the unit. Compared to only 15% in the post-intervention group (Figure 2).
After the CPOS intervention, the compliance of ordering: stool softeners increased from 32% to 91% (p < .0001); high fiber diet increased from 46%to 68% (p < .0001). The percentage of ordering weekly ANCs at the time of the first Clozapine order increased from 18% to 98% (p < .001).
Despite significant differences found when comparing the two groups, the current sample size remains small. Primarily, due to the implementation of the order set occurring less than a year ago. Future plans include conducting a similar study over a larger time period (+/–2 years from the intervention onset 2016–2020), about a 4-year span. In addition, future plans have been made to implement the CPOS order set throughout all departments at RUMC. Overall, including multiple departments, over a larger time period, will provide a larger sample size.
Compliance of the using the CPOS also varied. The highest occurrence of non-compliance happened in the first few months of new residency training (July–September). Efforts will be made to train incoming residents on the order-set during orientation and by email instructions; providing not only initial training of the PGY-1 class but retraining for senior classes (PGY 2–4) and attending prescribers.
Clozapine CPOS improve compliance with safe prescription guidelines, patient outcome and subsequently have the prospect to increase Clozapine prescription rates. More awareness of CPOS availability and expansion on the use of Clozapine CPOS in different departments at RUMC should be encouraged. Further studies are required to explore effective implementation of medication order sets, in the context of a larger process of patient care practice standards.