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A randomized clinical trial of the health evaluation and referral assistant (HERA): research methods.

ABSTRACT: The Health Evaluation and Referral Assistant (HERA) is a web-based program designed to facilitate screening, brief intervention, and referral to treatment (SBIRT) for tobacco, alcohol, and drug abuse. After the patient completes a computerized substance abuse assessment, the HERA produces a summary report with evidence-based recommended clinical actions for the healthcare provider (the Healthcare Provider Report) and a report for the patient (the Patient Feedback Report) that provides education regarding the consequences of use, personally tailored motivational messages, and a tailored substance abuse treatment referral list. For those who provide authorization, the HERA faxes the individual's contact information to a substance abuse treatment provider matched to the individual's substance use severity and personal characteristics, like insurance and location of residence (dynamic referral). This paper summarizes the methods used for a randomized controlled trial to evaluate the HERA's efficacy in leading to increased treatment initiation and reduced substance use. The study was performed in four emergency departments. Individual patients were randomized into one of two conditions: the HERA or assessment only. A total of 4269 patients were screened and 1006 participants enrolled. The sample was comprised of 427 tobacco users, 212 risky alcohol users, and 367 illicit drug users. Forty-two percent used more than one substance class. The enrolled sample was similar to the eligible patient population. The study should enhance understanding of whether computer-facilitated SBIRT can impact process of care variables, such as promoting substance abuse treatment initiation, as well as its effect on subsequent substance abuse and related outcomes.

SUBMITTER: Boudreaux ED

PROVIDER: S-EPMC3979303 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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A randomized clinical trial of the health evaluation and referral assistant (HERA): research methods.

Boudreaux Edwin D ED Abar Beau B Baumann Brigitte M BM Grissom Grant G

Contemporary clinical trials 20130507 2

The Health Evaluation and Referral Assistant (HERA) is a web-based program designed to facilitate screening, brief intervention, and referral to treatment (SBIRT) for tobacco, alcohol, and drug abuse. After the patient completes a computerized substance abuse assessment, the HERA produces a summary report with evidence-based recommended clinical actions for the healthcare provider (the Healthcare Provider Report) and a report for the patient (the Patient Feedback Report) that provides education ...[more]

PMID: 23665335

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Project description:BACKGROUND:Computer technologies hold promise for implementing alcohol screening, brief intervention, and referral to treatment (SBIRT). Questions concerning the most effective and appropriate SBIRT model remain. OBJECTIVE:The aim of this study was to evaluate the impact of a computerized SBIRT system called the Health Evaluation and Referral Assistant (HERA) on risky alcohol use treatment initiation. METHODS:Alcohol users (N=319) presenting to an emergency department (ED) were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment control, and were followed for 3 months. Analyses compared alcohol treatment provider contact, treatment initiation, treatment completion, and alcohol use across condition using univariate comparisons, generalized estimating equations (GEEs), and post hoc chi-square analyses. RESULTS:HERA participants (n=212; control=115; intervention=97) did not differ between conditions on initial contact with an alcohol treatment provider, treatment initiation, treatment completion, or change in risky alcohol use behavior. Subanalyses indicated that HERA participants, who accepted a faxed referral, were more likely to initiate contact with a treatment provider and initiate treatment for risky alcohol use, but were not more likely to continue engaging in treatment, or to complete treatment and change risky alcohol use behavior over the 3-month period following the ED visit. CONCLUSIONS:The HERA promoted initial contact with an alcohol treatment provider and initiation of treatment for those who accepted the faxed referral, but it did not lead to reduced risky alcohol use behavior. Factors which may have limited the HERA's impact include lack of support for the intervention by clinical staff, the low intensity of the brief and stand-alone design of the intervention, and barriers related to patient follow-through, (eg, a lack of transportation or childcare, fees for services, or schedule conflicts). TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): NCT01153373; https://clinicaltrials.gov/ct2/show/NCT01153373 (Archived by WebCite at http://www.webcitation.org/6pHQEpuIF).

Project description:Importance:Tear film breakup time assessment is an integral component of dry eye evaluation. To our knowledge, the comparative discriminative ability of the noninvasive Keratograph (Oculus) vs conventional fluorescein method in detecting dry eye is unknown. Objective:To compare tear film stability measurements obtained with an automated noninvasive corneal topographer vs conventional fluorescein methods and evaluate their respective discriminative ability in detecting dry eye. Design, Setting, and Participants:This investigator-masked randomized crossover trial was conducted at a single-center university clinic between May 26, 2016, and October 3, 2016, and included 74 participants 18 years or older. Participants were recruited into 2 equally sized age, sex, and race/ethnicity-matched groups, with and without symptomatic dry eye (Ocular Surface Disease Index ?13). Interventions:Participants were assigned to receive a noninvasive keratograph evaluation and topical fluorescein instillation in a randomized order. Main Outcomes and Measures:Noninvasive keratograph breakup time (NIKBUT) and fluorescein breakup time (TBUT). Area under the receiver operating characteristic curve, Youden-optimal diagnostic cutoff sensitivity, and specificity of NIKBUT and TBUT in detecting dry eye. Results:Seventy-four participants (74 eyes; 43 women [58.1%]) with a mean (SD) age of 24 (4) years were randomized. Noninvasive keratograph breakup time was significantly longer than TBUT in participants with dry eye (median, 6.3 seconds vs 4.3 seconds [difference, 2.0 seconds]; 95% CI, 1.1-3.4 seconds; P?=?.003), and healthy participants (median, 11.9 seconds vs 5.0 seconds [difference, 6.9 seconds]; 95% CI, 4.7-7.6 seconds; P?<?.001). Fluorescein breakup time measurements were more narrowly distributed in both the dry eye (variance, 188 seconds2 vs 27.9 seconds2; P?<?.001) and control groups (variance, 113 seconds2 vs 13.4 seconds2; P?<?.001). The discriminative ability of NIKBUT in detecting dry eye (area under the receiver operating characteristic curve, 0.68; 95% CI, 0.56-0.81; P?=?.007) was greater than that of TBUT (area under the receiver operating characteristic curve, 0.57; 95% CI, 0.44-0.70; P?=?.31). The optimal diagnostic cutoff for NIKBUT was 9 seconds or less with a sensitivity of 68% (95% CI, 50%-82%), specificity of 70% (95% CI, 53%-84%), positive likelihood ratio of 2.27 (95% CI, 1.32-3.91), and negative likelihood ratio of 0.46 (95% CI, 0.28-0.77). The optimal threshold for TBUT was 5 seconds or less with a sensitivity of 54% (95% CI, 37%-71%), specificity of 68% (95% CI, 50%-82%), positive likelihood ratio of 1.67 (95% CI, 0.96-2.89), and negative likelihood ratio of 0.68 (95% CI, 0.45-1.03). Conclusions and Relevance:Conventional fluorescein tear film breakup time measurements were significantly shorter with narrower distributions, while automated noninvasive keratograph readings displayed superior discriminative ability in detecting dry eye. Trial Registration:anzctr.org.au Identifier: ACTRN12617001428358.

Project description:BackgroundA new dashboard, the 360ºCHILD-profile, was developed to adopt personalized health care within preventive child health care. On this profile, holistic health data are visualized in a single image to provide parents, adolescents, and caregivers direct access to a manageable résumé of a child's medical record. Theoretical ordering, conforming to "International Classification of Functioning, Disability and Health for Children and Youth", guides clinical reasoning toward the biopsychosocial concept of health. It is yet unknown if and how this promising tool functions in practice, and a variety of feasibility questions must be addressed.ObjectiveThis paper describes the design and methods of a feasibility randomized controlled trial (RCT), with the aim of evaluating the RCT's feasibility (recruitment, response, measure completion, and intervention allocation) and 360ºCHILD-profile's feasibility (usability and potential effectiveness).MethodsA pragmatic mixed methods study design was chosen, starting with an RCT to measure feasibility and health literacy in 2 parallel groups (1:1). Qualitative research will then be used to understand and explain quantitative findings and to explore the stakeholders' perspectives on the potential of the 360ºCHILD-profile. Participants will include child health care professionals (n≥30), parents (n≥30), and caregivers (n≥10) of children who experience developmental problems (age 0-16 years). Children will only be able to participate if they are older than 11 years (adolescents, n≥10). The 2 groups included in the study will receive standard care. The experimental group will additionally receive personalized 360ºCHILD-profiles.ResultsAfter an intervention period of 6 months, quantitative outcomes will be measured, analyzed (descriptive feasibility statistics and preliminary between-group differences) and used to purposively sample for semistructured interviews.ConclusionsStudy results will provide knowledge for building theory on the 360ºCHILD-profile and designing future (effect) studies.Trial registrationNetherlands Trial Register NTR6909; https://www.trialregister.nl/trial/6731.International registered report identifier (irrid)DERR1-10.2196/21942.

Project description:ImportanceStudies in high-income countries provide limited evidence from randomized clinical trials on the benefits of teleretinal screening to identify diabetic retinopathy (DR).ObjectiveTo evaluate the effectiveness of teleretinal-screening hospital referral (TR) compared with universal hospital referral (UR) in people with diabetes.Design, setting, and participantsA cluster randomized clinical trial of 8 diabetes clinics within 10 km from Aravind Eye Hospital (AEH), Madurai, India, was conducted. Participants included 801 patients older than 50 years. The study was conducted from May 21, 2014, to February 7, 2015; data analysis was performed from March 12 to June 16, 2015.InterventionsIn the TR cohort, nonmydriatic, 3-field, 45° retinal images were remotely graded by a retinal specialist and patients with DR, probable DR, or ungradable images were referred to AEH for a retinal examination. In the UR cohort, all patients were referred for a retinal examination at AEH.Main outcomes and measuresHospital-diagnosed DR.ResultsOf the 801 participants, 401 were women (50.1%) (mean [SD] age, 60.0 [7.3] years); mean diabetes duration was 8.6 (6.6) years. In the TR cohort, 96 of 398 patients (24.1%) who underwent teleretinal imaging were referred with probable DR (53 [13.3%]) or nongradable images (43 [10.8%]). Hospital attendance at AEH was proportionately higher with TR (54 of 96 referred [56.3%]) compared with UR (150 of 400 referred [37.5%]). The intention-to-treat analysis based on all patients eligible for referral in each arm showed that proportionately more patients with TR (36 of 96 [37.5]%) were diagnosed with DR compared with UR (50 of 400 [12.5%]) (unadjusted risk ratio [RR], 3.00; 95% CI, 2.01-4.48). These results were little changed by inclusion of covariates (RR, 2.72; 95% CI, 1.90-3.91). The RR was lower in the per-protocol analysis based on all patients who adhered to referral (covariate-adjusted RR, 1.75; 95% CI, 1.12-2.74). Diagnoses of DR were predominantly mild or moderate nonproliferative DR (36 in TR and 43 in UR). In the UR arm, there were 4 cases of severe nonproliferative DR and 2 cases of proliferative DR. Age (RR, 0.98; 95% CI, 0.95-0.99), female sex (RR, 0.79; 95% CI, 0.64-0.98), and hypertension diagnosis (RR, 0.81; 95% CI, 0.68-0.95) were factors associated with lower attendance. Those with higher secondary educational level or more were twice as likely to attend (RR, 2.00; 95% CI, 1.32-3.03).Conclusions and relevanceThe proportionate yield of DR cases was higher in the TR arm, confirming the potential benefit, at least in the setting of eye hospitals in India, of a targeted referral approach using teleretinal screening to identify patients with DR.Trial registrationClinicalTrials.gov identifier: NCT02085681.

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A randomized clinical trial of the health evaluation and referral assistant (HERA): research methods.

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A randomized clinical trial of the health evaluation and referral assistant (HERA): research methods.

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