Intensive Cryotherapy in the Emergency Department (ICED): A Randomized Controlled Trial
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ABSTRACT: Introduction
Pain control is an essential component of musculoskeletal injury treatment in the emergency department (ED). We evaluated the most effective type of cryotherapy for analgesia of acute musculoskeletal injury and the impact on opioid utilization. Methods
This was a prospective, randomized, single-blind controlled trial of adult ED patients who presented with acute musculoskeletal pain. Patients were randomized to either intensive targeted cryotherapy (crushed wetted ice in a plastic bag) or agitated chemical cold pack applied to the injury site for 20 minutes. All other diagnostic and therapeutic orders were at the discretion of the treating physician. Visual analog pain scores were measured at the time of cryotherapy application, at 20 minutes (time of cryotherapy removal), and at 60 minutes (40 minutes after removal). Results
We enrolled 38 patients, 17 randomized to intensive targeted cryotherapy and 21 to chemical cold packs, with well-matched demographics. The intensive targeted cryotherapy group achieved significantly greater pain relief at 20 minutes (2.1 [95% confidence interval (CI), 1.3 – 2.9] vs 0.9 [95% CI, 0.3 – 1.5], P < 0.05) and at 60 minutes (2.7 [95% CI, 1.6 – 3.7] vs 1.2 [95% CI, 0.6 – 1.7], P < 0.05), number need to trial (NNT) = 3.2. Opioid administration in the ED was significantly lower in the intensive targeted cryotherapy group (1 [6%] vs 7 [33%], P < 0.05), NNT = 3.6. Those who received a discharge opiate prescription had significantly higher 60-minute pain scores (7.3 ± 2.2 vs 4.1 ± 2.7, P < 0.05). Conclusion
Intensive targeted cryotherapy provided more effective analgesia than chemical cold packs for acute musculoskeletal injuries in the ED and may contribute to lower opioid usage.
SUBMITTER: Leroux E
PROVIDER: S-EPMC7972361 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundEmergency department (ED) visits contribute substantially to health care expenditures. Case management has been proposed as a strategy to address the medical and social needs of complex patients. However, strong research designs to evaluate the effectiveness of such interventions are limited.ObjectivesTo evaluate whether a community-based case management program was associated with reduced ED utilization among complex patients.DesignPatients whose risk exceeded a threshold were randomly assigned to a group offered case management or to the control group. Assignment occurred at five intervals between November 2017 and January 2019. Program effectiveness for all assigned patients was assessed using an intention-to-treat effect. Program effectiveness among those who received treatment was assessed using a local average treatment effect, estimated using instrumental variables. Both estimators were adjusted for baseline characteristics using linear models.ParticipantsAdults over age 18 with at least one health care encounter with Michigan Medicine or St. Joseph Mercy Health System between June 2, 2016, and November 27, 2018.InterventionsIntervention arm participants (n = 486) were offered coordinated case management across medical, mental health, and social service organizations. Control arm participants (n = 409) received usual care.Main measuresThe primary outcome was the number of ED visits in the 6 months following randomization into the study. Secondary outcomes were 6-month counts of inpatient and outpatient visits.Key resultsOf the 486 patients assigned to the intervention, 131 (27%) consented to receive case management. The intention-to-treat effect on ED visits was + 0.14 (95% CI: - 0.27 to + 0.55). The local average treatment effect among those who consented and received case management was + 0.53 (95% CI: - 1.00 to + 2.05). Intention-to-treat and local average treatment effects were not significant for secondary outcomes.ConclusionsThe community case management intervention targeting ED visits was not associated with reduced utilization. Future case management interventions may benefit from additional patient engagement strategies and longer evaluation time periods.Trial registrationClinicaltrials.gov Identifier: NCT03293160.
| S-EPMC8390593 | biostudies-literature
Project description:ObjectivesSignificant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate-risk syncope patients presenting to the ED.MethodsWe performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit.ResultsAfter screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = -25.4, 95% confidence interval = -13.5 to -37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days.ConclusionsAmong ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.
| S-EPMC7483321 | biostudies-literature
Project description:The aim was to evaluate if the addition of video discharge instructions (VDIs) to usual verbal information improved the comprehension of information provided to caregivers of patients who consult for acute gastroenteritis (AGE). We conducted an open-label, parallel, randomized trial, enrolling patients who consulted for AGE at a tertiary hospital. First, caregivers answered a written test concerning AGE characteristics and management. They were randomly allocated to a control group, which received the usual verbal instructions, or to an intervention group, which additionally received VDI. After discharge, caregivers were contacted by telephone and answered the same test, satisfaction questions, and follow-up information. From September 2019 to March 2020, 139 patients were randomized, 118 completed follow-up. The mean score was 3.13 (SD 1.07) over 5 points in the initial test and 3.96 (SD 0.96) in the follow-up test. Patients in the intervention group had a greater improvement (1.17 points, SD 1.11) than those in the control group (0.47 points, SD 0.94, p < 0.001). In the follow-up test, 49.1% in the intervention group and 18.6% in the control group answered all questions correctly (p < 0.001). There were no significant differences in return visits. Caregivers gave high satisfaction scores regardless of the allocation group.Conclusion: Video instructions improve caregivers' understanding of discharge information.Trial registration: [NCT04463355, retrospectively registered July 9, 2020]. What is Known: • Poor comprehension of discharge instructions leads to incorrect treatment after discharge, increased readmissions and a reduction of caregivers' satisfaction. • Video discharge instructions are useful providing concise information independently of the patients' health literacy level or communication skills of the health care provider What is New: • The addition of video discharge instructions to verbal instructions improves caregivers' knowledge about AGE improved with respect to those who only receive verbal instructions • Video instructions do not add extra time to the emergency department visits.
| S-EPMC7541201 | biostudies-literature
Project description:BACKGROUND:Although this has not been fully studied, videos and pictorial brochures might be equivalent methods of delivering HIV/AIDS and HIV testing information to emergency departments (ED) patients. It also is not known how well or for how long such knowledge is retained, if this information should be tailored according to patient health literacy, and if retention of this knowledge impacts future HIV testing behavior. METHODS:We will conduct a multi-site, randomized, controlled, longitudinal trial among 600 English- and 600 Spanish-speaking 18-64-year-old ED patients to investigate these questions. We will stratify our sample within language (English vs. Spanish) by health literacy level (lower vs. higher) and randomly assign patients to receive HIV/AIDS and HIV testing information by video or pictorial brochure. All patients will be tested for HIV in the ED. At 12-months post-enrollment, we will invite participants to be tested again for HIV. As primary aims, we will compare the efficacy of pictorial brochures and videos in improving short-term (in ED) HIV/AIDS and HIV testing knowledge and retaining this knowledge over 12 months. We will determine if and how short-term improvement and longer-term retention of knowledge interacts with information delivery mode (pictorial brochure or video), patient health literacy level (lower or higher), and language (English or Spanish). As secondary aims, using the Information-Motivation-Behavioral Skills (IMB) model as a heuristic framework, we will measure constructs from the IMB model relevant to our study, and assess their impact on HIV re-testing behavior; we will also examine the moderating influences of information delivery mode, language, and health literacy level. In addition, we will explore simplified screening strategies to identify ED patients with lower health literacy as ways to implement a tailored approach to HIV/AIDS and HIV testing information delivery in EDs. DISCUSSION:Study findings will guide ED-based delivery of HIV/AIDS and HIV testing information; that is, whether delivery modes (video or pictorial brochure) should be selected for patients by language and/or health literacy level. The results also will inform EDs when, how, and for whom information needs to be provided for those undergoing testing again for HIV within a one-year period. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02284451 . Posted November 6, 2014.
| S-EPMC6038177 | biostudies-literature
Project description:BACKGROUND:The rapid control of patients presenting to the emergency department (ED) with psychomotor agitation and violent behavior is paramount for the safety of patients and ED staff. The use of intramuscular (IM) ketamine in the pre-hospital and ED settings has demonstrated promising preliminary results to provide rapid and safe behavioral control. A prospective, randomized controlled trial is required to measure the potential superiority of IM ketamine compared to current standard care (IM benzodiazepines plus antipsychotics). METHODS:This will be a parallel, prospective, randomized, controlled trial of 5 mg/kg IM ketamine compared to a combination of 5 mg IM midazolam and 5 mg IM haloperidol. The study will enroll approximately 184 patients, randomized equally to two study arms. There will be one study visit during which study medication will be administered and assessments will be completed. A follow-up safety visit will occur on day 3. The primary objective of this study is to compare IM ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the ED with psychomotor agitation and violent behavior, as measured by the Richmond Agitation-Sedation Scale (RASS). DISCUSSION:We present a novel study to determine whether ketamine is a rapid and safe option, compared to a combination of midazolam and haloperidol for the sedation of patients presenting to the ED with psychomotor agitation and violent behavior. To our knowledge, this study is the first randomized controlled trial to compare ketamine to current standard care for this indication. We have attempted to address numerous logistical issues with the design of this study including a waiver of consent, ensuring adequate blinding of outcome assessors, patient enrolment, and data monitoring. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03375671 . Registered on 18 December 2017.
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Project description:BackgroundAcute upper respiratory tract infections are a common cause of emergency department (ED) visits and often result in unnecessary antibiotic treatment.MethodsWe conducted a randomized clinical trial to evaluate the impact of a rapid, multipathogen respiratory panel (RP) test vs usual care (control). Patients were eligible if they were ≥12 months old, had symptoms of upper respiratory infection or influenza-like illness, and were not on antibiotics. The primary outcome was antibiotic prescription; secondary outcomes included antiviral prescription, disposition, and length of stay (ClinicalTrials.gov# NCT02957136).ResultsOf 191 patients enrolled, 93 (49%) received RP testing; 98 (51%) received usual care. Fifty-three (57%) RP and 7 (7%) control patients had a virus detected and reported during the ED visit (P = .0001). Twenty (22%) RP patients and 33 (34%) usual care patients received antibiotics during the ED visit (-12%; 95% confidence interval, -25% to 0.4%; P = .06/0.08); 9 RP patients received antibiotics despite having a virus detected. The magnitude of antibiotic reduction was greater in children (-19%) vs adults (-9%, post hoc analysis). There was no difference in antiviral use, length of stay, or disposition.ConclusionsRapid RP testing was associated with a trend toward decreased antibiotic use, suggesting a potential benefit from more rapid viral tests in the ED. Future studies should determine if specific groups are more likely to benefit from testing and evaluate the relative cost and effectiveness of broad testing, focused testing, and a combined diagnostic and antimicrobial stewardship approach.
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Project description:BackgroundBurnout is a significant concern among health care professionals, particularly those working in the emergency department (ED). Given the negative personal and professional consequences that burnout can have on all health care professionals, multidisciplinary solutions are needed to address burnout. Our objective was to evaluate the feasibility and potential impact of resilience training delivered through a smartphone application on burnout among health care professionals working at a tertiary-care pediatric ED.MethodsWe conducted a single-center pilot randomized controlled study enrolling multidisciplinary health care professionals working in our ED. Participants assigned to the intervention group received self-driven access to a smartphone application that provided a structured resilience curriculum for a period of 3 months. The participants completed psychometric assessments both prior to and following the invention period. Changes in psychometric measures of the intervention group were then compared with a waitlist-control group.ResultsFollowing the intervention period, a total of 20 participants were included in the final analysis. The change in participant scores on psychometric measures prior to and following the intervention period was calculated. A statistically significant mean decrease in burnout measure (emotional exhaustion subscale of Maslach-Burnout Inventory mean score -5.88, p < .001) and increase in mindfulness measure (Mindful Attention Awareness Scale mean score 0.51, p < .001) was observed among the intervention group participants.Conclusions/application to practiceOur study suggests that a resilience training program delivered using a smartphone application can be an effective intervention in reducing burnout and increasing mindfulness skills. Our study also demonstrated the potential feasibility of a randomized controlled study of burnout within a multidisciplinary group of health care professionals.
| S-EPMC10080362 | biostudies-literature
Project description:BackgroundUncontrolled or undiagnosed hypertension (HTN) is estimated to be as high as 46% in emergency departments (EDs). Uncontrolled HTN contributes significantly to cardiovascular morbidity and disproportionately affects communities of color. EDs serve high risk populations with uncontrolled conditions that are often missed by other clinical settings and effective interventions for uncontrolled HTN in the ED are critically needed. The ED is well situated to decrease the disparities in HTN control by providing a streamlined intervention to high risk populations that may use the ED as their primary care.MethodsTargeting of UnControlled Hypertension in the Emergency Department (TOUCHED), is a two-arm single site randomized controlled trial of 770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit. The primary outcome is differences in mean systolic blood pressure (SBP) at 6-months post enrollment. Secondary outcomes include differences in mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP at 6-months. Additionally, improvement in cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge will also be assessed as part of this study.ConclusionsThe TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.Trial registrationclinicaltrials.gov Identifier: NCT03749499.
| S-EPMC8272286 | biostudies-literature
Project description:We compare rates of rapid HIV testing, test offer, and acceptance in an urban emergency department (ED) when conducted by dedicated HIV counselors versus current members of the ED staff.The Universal Screening for HIV Infection in the Emergency Room [USHER] trial is a prospective randomized controlled trial that implemented an HIV screening program in the ED of an urban tertiary medical center. ED patients were screened and consented for trial enrollment by an USHER research assistant. Eligible subjects were randomized to rapid HIV testing (oral OraQuick) offered by a dedicated counselor (counselor arm) or by an ED provider (provider arm). In the counselor arm, counselors-without other clinical responsibilities-assumed nearly all testing-related activities (consent, counseling, delivery of test results). In the provider arm, trained ED emergency service assistants (nursing assistants) consented and tested the participant in the context of other ED-related responsibilities. In this arm, ED house officers, physician assistants, or attending physicians provided HIV test results to trial participants. Outcome measures were rates of HIV testing and test offer among individuals consenting for study participation. Among individuals offered the test, test acceptance was also measured.From February 2007 through July 2008, 8,187 eligible patients were approached in the ED, and 4,855 (59%) consented and were randomized to trial participation. The mean age was 37 years, 65% were women, and 42% were white. The overall testing rate favored the counselor arm (57% versus 27%; P<.001); 80% (1,959/2,446) of subjects in the counselor arm were offered an HIV test compared with 36% (861/2,409) in the provider arm (P<.001). HIV test acceptance was slightly higher in the provider arm (counselor arm 71% versus provider arm 75%; P = .025).Routine rapid HIV testing in the ED was accomplished more frequently by dedicated HIV counselors than by ED staff in the course of routine clinical work. Without dedicated staff, HIV testing in this setting may not be truly routine.
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Project description:Patients who use an emergency department (ED) for acute migraine headaches have higher migraine disability scores, lower socioeconomic status, and are unlikely to have used a migraine-specific medication prior to presentation to the ED. The objective was to determine if a comprehensive migraine intervention, delivered just prior to ED discharge, could improve migraine impact scores 1?month after the ED visit.? This was a randomized controlled trial of a comprehensive migraine intervention versus typical care among patients who presented to an ED for management of acute migraine. At the time of discharge, for patients randomized to comprehensive care, the research team reinforced their diagnosis, shared a migraine education presentation from the National Library of Medicine, provided them with six tablets of sumatriptan 100?mg and 14 tablets of naproxen 500?mg, and if they wished, provided them with an expedited free appointment to the institution's headache clinic. Patients randomized to typical care received the care their attending emergency physicians (EPs) felt was appropriate. The primary outcome was a between-group comparison of the Headache Impact Test (HIT-6) score, a validated headache assessment instrument, 1?month after ED discharge. Secondary outcomes included an assessment of satisfaction with headache care and use of migraine-specific medication within that 1-month period.? Over a 19-month period, 50 migraine patients were enrolled. One-month follow-up was successfully obtained in 92% of patients. Baseline characteristics were comparable. One-month HIT-6 scores in the two groups were nearly identical (59 vs. 56, 95% confidence interval [CI] for difference of 3?=?-5 to 11), as was dissatisfaction with overall headache care (17% vs. 18%, 95% CI for difference of 1%?=?-22% to 24%). Patients randomized to the comprehensive intervention were more likely to be using triptans or migraine-specific therapy (43% vs. 0%, 95% CI for difference of 43%?=?20 to 63%) 1?month later.A comprehensive migraine intervention, when compared to typical care, did not improve HIT-6 scores (a validated measure of the effect of migraine on one's daily life) 1?month after ED discharge. Future work is needed to define a migraine intervention that is practical and useful in an ED, where many underserved patients, of necessity, present for care.
| S-EPMC3473153 | biostudies-literature