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      Clinical Decision Support System for Guidelines-Based Treatment of Gonococcal Infections, Screening for HIV, and Prescription of Pre-Exposure Prophylaxis: Design and Implementation Study

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          Abstract

          Background

          The syndemic nature of gonococcal infections and HIV provides an opportunity to develop a synergistic intervention tool that could address the need for adequate treatment for gonorrhea, screen for HIV infections, and offer pre-exposure prophylaxis (PrEP) for persons who meet the criteria. By leveraging information available on electronic health records, a clinical decision support (CDS) system tool could fulfill this need and improve adherence to Centers for Disease Control and Prevention (CDC) treatment and screening guidelines for gonorrhea, HIV, and PrEP.

          Objective

          The goal of this study was to translate portions of CDC treatment guidelines for gonorrhea and relevant portions of HIV screening and prescribing PrEP that stem from a diagnosis of gonorrhea as an electronic health record–based CDS intervention. We also assessed whether this CDS solution worked in real-world clinic.

          Methods

          We developed 4 tools for this CDS intervention: a form for capturing sexual history information (SmartForm), rule-based alerts (best practice advisory), an enhanced sexually transmitted infection (STI) order set (SmartSet), and a documentation template (SmartText). A mixed methods pre-post design was used to measure the feasibility, use, and usability of the CDS solution. The study period was 12 weeks with a baseline patient sample of 12 weeks immediately prior to the intervention period for comparison. While the entire clinic had access to the CDS solution, we focused on a subset of clinicians who frequently engage in the screening and treatment of STIs within the clinical site under the name “X-Clinic.” We measured the use of the CDS solution within the population of patients who had either a confirmed gonococcal infection or an STI-related chief complaint. We conducted 4 midpoint surveys and 3 key informant interviews to quantify perception and impact of the CDS solution and solicit suggestions for potential future enhancements. The findings from qualitative data were determined using a combination of explorative and comparative analysis. Statistical analysis was conducted to compare the differences between patient populations in the baseline and intervention periods.

          Results

          Within the X-Clinic, the CDS alerted clinicians (as a best practice advisory) in one-tenth (348/3451, 10.08%) of clinical encounters. These 348 encounters represented 300 patients; SmartForms were opened for half of these patients (157/300, 52.33%) and was completed for most for them (147/300, 89.81%). STI test orders (SmartSet) were initiated by clinical providers in half of those patients (162/300, 54%). HIV screening was performed during about half of those patient encounters (191/348, 54.89%).

          Conclusions

          We successfully built and implemented multiple CDC treatment and screening guidelines into a single cohesive CDS solution. The CDS solution was integrated into the clinical workflow and had a high rate of use.

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          Most cited references53

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          Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

          Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
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            Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

            New England Journal of Medicine, 367(5), 399-410
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              Effect of clinical decision-support systems: a systematic review.

              Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. Agency for Healthcare Research and Quality.
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                Author and article information

                Contributors
                Journal
                JMIR Form Res
                JMIR Form Res
                JFR
                JMIR Formative Research
                JMIR Publications (Toronto, Canada )
                2561-326X
                2024
                15 April 2024
                : 8
                : e53000
                Affiliations
                [1 ] Division of STD Prevention Centers for Disease Control and Prevention Atlanta, GA United States
                [2 ] Public Health Informatics Institute Decatur, GA United States
                [3 ] OCHIN Portland, OR United States
                [4 ] Oregon Health & Sciences University Portland, OR United States
                [5 ] Codman Square Health Center Boston, MA United States
                [6 ] Division of HIV Prevention Centers for Disease Control and Prevention Atlanta, GA United States
                Author notes
                Corresponding Author: Saugat Karki skarki@ 123456cdc.gov
                Author information
                https://orcid.org/0000-0003-2161-678X
                https://orcid.org/0009-0006-3871-7463
                https://orcid.org/0000-0003-1066-1796
                https://orcid.org/0000-0003-4208-8808
                https://orcid.org/0009-0005-8958-9097
                https://orcid.org/0000-0003-1316-5309
                https://orcid.org/0000-0003-0962-8454
                https://orcid.org/0009-0008-7460-9835
                https://orcid.org/0000-0001-9785-4069
                https://orcid.org/0009-0005-0901-0082
                https://orcid.org/0009-0008-1469-373X
                https://orcid.org/0000-0001-6396-2379
                https://orcid.org/0000-0003-3401-2598
                https://orcid.org/0000-0003-1401-2072
                Article
                v8i1e53000
                10.2196/53000
                11058559
                38621237
                ea55fa9c-42e6-4432-af03-04d804fca306
                ©Saugat Karki, Sarah Shaw, Michael Lieberman, Alejandro Pérez, Jonathan Pincus, Priya Jakhmola, Amrita Tailor, Oyinkansola Bukky Ogunrinde, Danielle Sill, Shane Morgan, Miguel Alvarez, Jonathan Todd, Dawn Smith, Ninad Mishra. Originally published in JMIR Formative Research (https://formative.jmir.org), 15.04.2024.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.

                History
                : 22 September 2023
                : 15 December 2023
                : 2 February 2024
                : 21 February 2024
                Categories
                Original Paper
                Original Paper

                clinical decision support systems,cds,gonorrhea,pre-exposure prophylaxis,prep,hiv,sexually transmitted infections,electronic health records,guideline adherence

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