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Efficacy of a clinical decision-support system in an HIV practice: a randomized trial.

ABSTRACT: Data to support improved patient outcomes from clinical decision-support systems (CDSSs) are lacking in HIV care.To test the efficacy of a CDSS in improving HIV outcomes in an outpatient clinic.Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00678600)Massachusetts General Hospital HIV Clinic.HIV care providers and their patients.Computer alerts were generated for virologic failure (HIV RNA level >400 copies/mL after a previous HIV RNA level ?400 copies/mL), evidence of suboptimal follow-up, and 11 abnormal laboratory test results. Providers received interactive computer alerts, facilitating appointment rescheduling and repeated laboratory testing, for half of their patients and static alerts for the other half.The primary end point was change in CD4 cell count. Other end points included time to clinical event, 6-month suboptimal follow-up, and severe laboratory toxicity.Thirty-three HIV care providers followed 1011 patients with HIV. In the intervention group, the mean increase in CD4 cell count was greater (0.0053 vs. 0.0032 × 109 cells/L per month; difference, 0.0021 × 109 cells/L per month [95% CI, 0.0001 to 0.004]; P = 0.040) and the rate of 6-month suboptimal follow-up was lower (20.6 vs. 30.1 events per 100 patient-years; P = 0.022) than those in the control group. Median time to next scheduled appointment was shorter in the intervention group than in the control group after a suboptimal follow-up alert (1.71 vs. 3.48 months; P < 0.001) and after a toxicity alert (2.79 vs. >6 months; P = 0.072). More than 90% of providers supported adopting the CDSS as part of standard care.This was a 1-year informatics study conducted at a single hospital subspecialty clinic.A CDSS using interactive provider alerts improved CD4 cell counts and clinic follow-up for patients with HIV. Wider implementation of such systems can provide important clinical benefits.National Institute of Allergy and Infectious Diseases.

SUBMITTER: Robbins GK

PROVIDER: S-EPMC3829692 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Efficacy of a clinical decision-support system in an HIV practice: a randomized trial.

Robbins Gregory K GK Lester William W Johnson Kristin L KL Chang Yuchiao Y Estey Gregory G Surrao Dominic D Zachary Kimon K Lammert Sara M SM Chueh Henry C HC Meigs James B JB Freedberg Kenneth A KA

Annals of internal medicine 20121201 11

<h4>Background</h4>Data to support improved patient outcomes from clinical decision-support systems (CDSSs) are lacking in HIV care.<h4>Objective</h4>To test the efficacy of a CDSS in improving HIV outcomes in an outpatient clinic.<h4>Design</h4>Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00678600)<h4>Setting</h4>Massachusetts General Hospital HIV Clinic.<h4>Participants</h4>HIV care providers and their patients.<h4>Intervention</h4>Computer alerts were generated fo ...[more]

PMID: 23208165

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Project description:BackgroundLoss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings.MethodsWe analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU.ResultsAmong 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio-aOR 0.70 (95% CI 0.65-0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5-25.0) and 30.6% (95% CI 27.9-33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio-aHR 0.85 (95% CI 0.78-0.92)).ConclusionA CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively.

Project description:RationaleClinical decision support (CDS) tools leveraging electronic health records (EHRs) have been an approach for addressing challenges in asthma care but remain under-studied through clinical trials.ObjectivesTo assess the effectiveness and efficiency of Asthma-Guidance and Prediction System (A-GPS), an Artificial Intelligence (AI)-assisted CDS tool, in optimizing asthma management through a randomized clinical trial (RCT).MethodsThis was a single-center pragmatic RCT with a stratified randomization design conducted for one year in the primary care pediatric practice of the Mayo Clinic, MN. Children (<18 years) diagnosed with asthma receiving care at the study site were enrolled along with their 42 primary care providers. Study subjects were stratified into three strata (based on asthma severity, asthma care status, and asthma diagnosis) and were blinded to the assigned groups.MeasurementsIntervention was a quarterly A-GPS report to clinicians including relevant clinical information for asthma management from EHRs and machine learning-based prediction for risk of asthma exacerbation (AE). Primary endpoint was the occurrence of AE within 1 year and secondary outcomes included time required for clinicians to review EHRs for asthma management.Main resultsOut of 555 participants invited to the study, 184 consented for the study and were randomized (90 in intervention and 94 in control group). Median age of 184 participants was 8.5 years. While the proportion of children with AE in both groups decreased from the baseline (P = 0.042), there was no difference in AE frequency between the two groups (12% for the intervention group vs. 15% for the control group, Odds Ratio: 0.82; 95%CI 0.374-1.96; P = 0.626) during the study period. For the secondary end points, A-GPS intervention, however, significantly reduced time for reviewing EHRs for asthma management of each participant (median: 3.5 min, IQR: 2-5), compared to usual care without A-GPS (median: 11.3 min, IQR: 6.3-15); p<0.001). Mean health care costs with 95%CI of children during the trial (compared to before the trial) in the intervention group were lower than those in the control group (-$1,036 [-$2177, $44] for the intervention group vs. +$80 [-$841, $1000] for the control group), though there was no significant difference (p = 0.12). Among those who experienced the first AE during the study period (n = 25), those in the intervention group had timelier follow up by the clinical care team compared to those in the control group but no significant difference was found (HR = 1.93; 95% CI: 0.82-1.45, P = 0.10). There was no difference in the proportion of duration when patients had well-controlled asthma during the study period between the intervention and the control groups.ConclusionsWhile A-GPS-based intervention showed similar reduction in AE events to usual care, it might reduce clinicians' burden for EHRs review resulting in efficient asthma management. A larger RCT is needed for further studying the findings.Trial registrationClinicalTrials.gov Identifier: NCT02865967.

Project description:BackgroundOpioid prescribing for chronic pain is common and controversial, but recommended clinical practices are followed inconsistently in many clinical settings. Strategies for increasing adherence to clinical practice guideline recommendations are needed to increase effectiveness and reduce negative consequences of opioid prescribing in chronic pain patients.MethodsHere we describe the process and outcomes of a project to operationalize the 2003 VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Non-Cancer Pain into a computerized decision support system (DSS) to encourage good opioid prescribing practices during primary care visits. We based the DSS on the existing ATHENA-DSS. We used an iterative process of design, testing, and revision of the DSS by a diverse team including guideline authors, medical informatics experts, clinical content experts, and end-users to convert the written clinical practice guideline into a computable algorithm to generate patient-specific recommendations for care based upon existing information in the electronic medical record (EMR), and a set of clinical tools.ResultsThe iterative revision process identified numerous and varied problems with the initially designed system despite diverse expert participation in the design process. The process of operationalizing the guideline identified areas in which the guideline was vague, left decisions to clinical judgment, or required clarification of detail to insure safe clinical implementation. The revisions led to workable solutions to problems, defined the limits of the DSS and its utility in clinical practice, improved integration into clinical workflow, and improved the clarity and accuracy of system recommendations and tools.ConclusionsUse of this iterative process led to development of a multifunctional DSS that met the approval of the clinical practice guideline authors, content experts, and clinicians involved in testing. The process and experiences described provide a model for development of other DSSs that translate written guidelines into actionable, real-time clinical recommendations.

Project description:Importance:Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. Objective:To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. Design, Setting, and Participants:Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018. Interventions:Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations. Main Outcomes and Measures:The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality. Results:In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods. Conclusions and Relevance:An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes. Trial Registration:ClinicalTrials.gov identifier: NCT02577198.

Project description:Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website.Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions.Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group's (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate.Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention.This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research.

Dataset Information

Efficacy of a clinical decision-support system in an HIV practice: a randomized trial.

Publications

Efficacy of a clinical decision-support system in an HIV practice: a randomized trial.

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