Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition.
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ABSTRACT: Background
Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants.Methods
Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months.Discussion
Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities.Trial registration
ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.
SUBMITTER: Skolarus LE
PROVIDER: S-EPMC8611628 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS:Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION:The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION:This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.
| S-EPMC7268693 | biostudies-literature
Project description:ObjectiveEmergency department-initiated buprenorphine (BUP) for opioid use disorder is an evidence-based practice, but limited data exist on BUP initiation practices in real-world settings. We sought to characterize protocols for BUP initiation among a geographically diverse sample of emergency departments (EDs).MethodsIn December 2020, we reviewed prestudy clinical BUP initiation protocols from all EDs participating in CTN0099 Emergency Department-INitiated bupreNOrphine VAlidaTION (ED-INNOVATION). We abstracted information on processes for identification of treatment-eligible patients, BUP administration, and discharge care.ResultsAll participating ED-INNOVATION sites across 22 states submitted protocols; 31 protocols were analyzed. Identification of treatment-eligible patients: Most EDs 22 (71%) relied on clinician judgment to determine appropriateness of BUP treatment with only 7 (23%) requiring decision support tools or diagnosis checklists. Before BUP initiation, 27 (87%) protocols required a documented Clinical Opiate Withdrawal Scale (COWS) score; 4 (13%) required a clinical diagnosis of withdrawal with optional COWS score. Twenty-seven (87%) recommended a minimum COWS score of 8 for ED-initiated BUP. BUP administration: Initial BUP dose ranged from 2-16 mg (mode = 4). For continued withdrawal symptoms, 27 (87%) protocols recommended an interval of 30-60 minutes between first and second BUP dose. Total BUP dose in the ED ranged from 8 to 32 mg. Discharge care: Twenty-eight (90%) protocols recommended a BUP prescription (mode 16 mg daily) at discharge. Naloxone prescription and/or provision was suggested in 23 (74%) protocols.ConclusionsIn this geographically diverse sample of EDs, protocols for ED-initiated BUP differed between sites. Future work should evaluate the association between this variation and patient outcomes.
| S-EPMC8630357 | biostudies-literature
Project description:Emergency departments (ED) are increasingly providing buprenorphine to persons with opioid use disorder. Buprenorphine programs in the ED have strong support from public health leaders and emergency medicine specialty societies and have proven to be clinically effective, cost effective, and feasible. Even so, few ED buprenorphine programs currently exist. Given this imbalance between evidence-based practice and current practice, proven behavior change approaches can be used to guide local efforts to expand ED buprenorphine capacity. In this paper, we use the theory of planned behavior to identify and address the 1) clinician factors, 2) institutional factors, and 3) external factors surrounding ED buprenorphine implementation. By doing so, we seek to provide actionable and pragmatic recommendations to increase ED buprenorphine availability across different practice settings.
| S-EPMC9391022 | biostudies-literature
Project description:Background and aimsIn a recent randomized trial, patients with opioid dependence receiving brief intervention, emergency department (ED)-initiated buprenorphine and ongoing follow-up in primary care with buprenorphine (buprenorphine) were twice as likely to be engaged in addiction treatment compared with referral to community-based treatment (referral) or brief intervention and referral (brief intervention). Our aim was to evaluate the relative cost-effectiveness of these three methods of intervening on opioid dependence in the ED.DesignMeasured health-care use was converted to dollar values. We considered a health-care system perspective and constructed cost-effectiveness acceptability curves that indicate the probability each treatment is cost-effective under different thresholds of willingness-to-pay for outcomes studied.SettingAn urban ED in the United States.ParticipantsOpioid-dependent patients aged 18 years or older.MeasurementsSelf-reported 30-day assessment data were used to construct cost-effectiveness acceptability curves for patient engagement in formal addiction treatment at 30 days and the number of days illicit opioid-free in the past week.FindingsConsidering only health-care system costs, cost-effectiveness acceptability curves indicate that at all positive willingness-to-pay values, ED-initiated buprenorphine treatment was more cost-effective than brief intervention or referral. For example, at a willingness-to-pay threshold of $1000 for 30-day treatment engagement, we are 79% certain ED-initiated buprenorphine is most cost-effective compared with other studied treatments. Similar results were found for days illicit opioid-free in the past week. Results were robust to secondary analyses that included patients with missing cost data, included crime and patient time costs in the numerator, and to changes in unit price estimates.ConclusionIn the United States, emergency department-initiated buprenorphine intervention for patients with opioid dependence provides high value compared with referral to community-based treatment or combined brief intervention and referral.
| S-EPMC5657503 | biostudies-literature
Project description:Out-of-network emergency department (ED) use, or use that occurs outside the contracted network, may lead to increased care fragmentation and cost. We examined factors associated with out-of-network ED use among Medicaid beneficiaries.Enrollment, claims, and encounter data for adult Medi-Cal health plan members with 1+ ED visits and complete Medicaid eligibility during the study period from 2013 to 2014.We analyzed the data to identify factors associated with out-of-network ED use classified by mode of arrival (ambulance vs. nonambulance).We extracted encounter, ambulance, and ED census data and linked them together based on ED visit date.Of 11,143 ED visits, 6,808 (61.1 percent) were out-of-network. The number of hours the study ED was on ambulance diversion increased the odds of out-of-network visits for the 3,365 (30.2 percent) ED visits arriving by ambulance. For all visit types, assignment to a primary care clinic at the in-network hospital and having had any primary care visit during the study period decreased the odds of out-of-network ED care. Individuals were more likely to go out-of-network for ED care if they lived in neighborhoods containing out-of-network EDs.There are a number of factors related to out-of-network ED use, including the proximity and density of out-of-network EDs, race and ethnicity, a prior history of out-of-network ED use, and individuals' connection to primary care. EDs that serve Medicaid beneficiaries may need to explore alternative sites and modalities of care as alternatives to the ED, and consider their ability to absorb large numbers of out-of-network visits given already limited capacity.
| S-EPMC5682123 | biostudies-other
Project description:There has been a substantial rise in the number of publications and training opportunities on the care and treatment of emergency department (ED) patients with opioid use disorder over the past several years. The American College of Emergency Physicians recently published recommendations for providing buprenorphine to patients with opioid use disorder, but barriers to implementing this clinical practice remain. We describe the models for implementing ED-initiated buprenorphine at 4 diverse urban, academic medical centers across the country as part of a federally funded effort termed "Project ED Health." These 4 sites successfully implemented unique ED-initiated buprenorphine programs as part of a comparison of implementation facilitation to traditional educational dissemination on the uptake of ED-initiated buprenorphine. Each site describes the elements central to the ED process, including screening, treatment initiation, referral, and follow-up, while harnessing organizational characteristics, including ED culture. Finally, we discuss common facilitators to program success, including information technology and electronic medical record integration, hospital-level support, strong connections with outpatient partners, and quality improvement processes.
| S-EPMC9588652 | biostudies-literature
Project description:IntroductionPatients with coronavirus disease 2019 (COVID-19) can develop rapidly progressive respiratory failure. Ventilation strategies during the COVID-19 pandemic seek to minimize patient mortality. In this study we examine associations between the availability of emergency department (ED)-initiated high-flow nasal cannula (HFNC) for patients presenting with COVID-19 respiratory distress and outcomes, including rates of endotracheal intubation (ETT), mortality, and hospital length of stay.MethodsWe performed a retrospective, non-concurrent cohort study of patients with COVID-19 respiratory distress presenting to the ED who required HFNC or ETT in the ED or within 24 hours following ED departure. Comparisons were made between patients presenting before and after the introduction of an ED-HFNC protocol.ResultsUse of HFNC was associated with a reduced rate of ETT in the ED (46.4% vs 26.3%, P <0.001) and decreased the cumulative proportion of patients who required ETT within 24 hours of ED departure (85.7% vs 32.6%, P <0.001) or during their entire hospitalization (89.3% vs 48.4%, P <0.001). Using HFNC was also associated with a trend toward increased survival to hospital discharge; however, this was not statistically significant (50.0% vs 68.4%, P = 0.115). There was no impact on intensive care unit or hospital length of stay. Demographics, comorbidities, and illness severity were similar in both cohorts.ConclusionsThe institution of an ED-HFNC protocol for patients with COVID-19 respiratory distress was associated with reductions in the rate of ETT. Early initiation of HFNC is a promising strategy for avoiding ETT and improving outcomes in patients with COVID-19.
| S-EPMC8328178 | biostudies-literature
Project description:ImportanceEmergency department (ED)-initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused.ObjectiveTo evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy.Design, setting, and participantsThis multisite hybrid type 3 effectiveness-implementation nonrandomized trial compared grand rounds with IF, with pre-post 12-month baseline and IF evaluation periods, at 4 academic EDs. The study was conducted from April 1, 2017, to November 30, 2020. Participants were ED and community clinicians treating patients with OUD and observational cohorts of ED patients with untreated OUD. Data were analyzed from July 16, 2021, to July 14, 2022.ExposureA 60-minute in-person grand rounds was compared with IF, a multicomponent facilitation strategy that engaged local champions, developed protocols, and provided learning collaboratives and performance feedback.Main outcomes and measuresThe primary outcomes were the rate of patients in the observational cohorts who received ED-initiated buprenorphine with referral for OUD treatment (primary implementation outcome) and the rate of patients engaged in OUD treatment at 30 days after enrollment (effectiveness outcome). Additional implementation outcomes included the numbers of ED clinicians with an X-waiver to prescribe buprenorphine and ED visits with buprenorphine administered or prescribed and naloxone dispensed or prescribed.ResultsA total of 394 patients were enrolled during the baseline evaluation period and 362 patients were enrolled during the IF evaluation period across all sites, for a total of 756 patients (540 [71.4%] male; mean [SD] age, 39.3 [11.7] years), with 223 Black patients (29.5%) and 394 White patients (52.1%). The cohort included 420 patients (55.6%) who were unemployed, and 431 patients (57.0%) reported unstable housing. Two patients (0.5%) received ED-initiated buprenorphine during the baseline period, compared with 53 patients (14.6%) during the IF evaluation period (P < .001). Forty patients (10.2%) were engaged with OUD treatment during the baseline period, compared with 59 patients (16.3%) during the IF evaluation period (P = .01). Patients in the IF evaluation period who received ED-initiated buprenorphine were more likely to be in treatment at 30 days (19 of 53 patients [35.8%]) than those who did not 40 of 309 patients (12.9%; P < .001). Additionally, there were increases in the numbers of ED clinicians with an X-waiver (from 11 to 196 clinicians) and ED visits with provision of buprenorphine (from 259 to 1256 visits) and naloxone (from 535 to 1091 visits).Conclusions and relevanceIn this multicenter effectiveness-implementation nonrandomized trial, rates of ED-initiated buprenorphine and engagement in OUD treatment were higher in the IF period, especially among patients who received ED-initiated buprenorphine.Trial registrationClinicalTrials.gov Identifier: NCT03023930.
| S-EPMC10077107 | biostudies-literature
Project description:ImportanceThe delivery of palliative care is not standard of care within most emergency departments (EDs).ObjectiveTo compare quality of life, depression, health care utilization, and survival in ED patients with advanced cancer randomized to ED-initiated palliative care consultation vs care as usual.Design, setting, and participantsA single-blind, randomized clinical trial of ED-initiated palliative care consultation for patients with advanced cancer vs usual care took place from June 2011 to April 2014 at an urban, academic ED at a quaternary care referral center. Adult patients with advanced cancer who were able to pass a cognitive screen, had never been seen by palliative care, spoke English or Spanish, and presented to the ED met eligibility criteria; 136 of 298 eligible patients were approached and enrolled in the ED and randomized via balanced block randomization.InterventionsIntervention participants received a comprehensive palliative care consultation by the inpatient team, including an assessment of symptoms, spiritual and/or social needs, and goals of care.Main outcomes and measuresThe primary outcome was quality of life as measured by the change in Functional Assessment of Cancer Therapy-General Measure (FACT-G) score at 12 weeks. Secondary outcomes included major depressive disorder as measured by the Patient Health Questionnaire-9, health care utilization at 180 days, and survival at 1 year.ResultsA total of 136 participants were enrolled, and 69 allocated to palliative care (mean [SD], 55.1 [13.1] years) and 67 were randomized to usual care (mean [SD], 57.8 [14.7] years). Quality of life, as measured by a change in FACT-G score from enrollment to 12 weeks, was significantly higher in patients randomized to the intervention group, who demonstrated a mean (SD) increase of 5.91 (16.65) points compared with 1.08 (16.00) in controls (P = .03 using the nonparametric Wilcoxon test). Median estimates of survival were longer in the intervention group than the control group: 289 (95% CI, 128-453) days vs 132 (95% CI, 80-302) days, although this did not reach statistical significance (P = .20). There were no statistically significant differences in depression, admission to the intensive care unit, and discharge to hospice.Conclusions and relevanceEmergency department-initiated palliative care consultation in advanced cancer improves quality of life in patients with advanced cancer and does not seem to shorten survival; the impact on health care utilization and depression is less clear and warrants further study.Trial registrationclinicaltrials.gov Identifier: NCT01358110.
| S-EPMC9252442 | biostudies-literature
Project description:ImportanceTreatment of opioid use disorder (OUD) with buprenorphine decreases opioid use and prevents morbidity and mortality. Emergency departments (EDs) are an important setting for buprenorphine initiation for patients with untreated OUD; however, readiness varies among ED clinicians.ObjectiveTo characterize barriers and facilitators of readiness to initiate buprenorphine for the treatment of OUD in the ED and identify opportunities to promote readiness across multiple clinician types.Design, setting, and participantsUsing data collected from April 1, 2018, to January 11, 2019, this mixed-methods formative evaluation grounded in the Promoting Action on Research Implementation in Health Services framework included 4 geographically diverse academic EDs. Attending physicians (n = 113), residents (n = 107), and advanced practice clinicians (APCs) (n = 48) completed surveys electronically distributed to all ED clinicians (n = 396). A subset of participants (n = 74) also participated in 1 of 11 focus group discussions. Data were analyzed from June 1, 2018, to February 22, 2020.Main outcomes and measuresClinician readiness to initiate buprenorphine and provide referral for ongoing treatment for patients with OUD treated in the ED was assessed using a visual analog scale. Responders (268 of 396 [67.7%]) were dichotomized as less ready (scores 0-6) or most ready (scores 7-10). An ED-adapted Organizational Readiness to Change Assessment (ORCA) and 11 focus groups were used to assess ratings and perspectives on evidence and context-related factors to promote ED-initiated buprenorphine with referral for ongoing treatment, respectively.ResultsAmong the 268 survey respondents (153 of 260 were men [58.8%], with a mean [SD] of 7.1 [9.8] years since completing formal training), 56 (20.9%) indicated readiness to initiate buprenorphine for ED patients with OUD. Nine of 258 (3.5%) reported Drug Addiction Treatment Act of 2000 training completion. Compared with those who were less ready, clinicians who were most ready to initiate buprenorphine had higher mean scores across all ORCA Evidence subscales (3.50 [95% CI, 3.35-3.65] to 4.33 [95% CI, 4.13-4.53] vs 3.11 [95% CI, 3.03-3.20] to 3.60 [95% CI, 3.49-3.70]; P < .001) and on the Slack Resources of the ORCA Context subscales (3.32 [95% CI, 3.08-3.55] vs 3.0 [95% CI, 2.87-3.12]; P = .02). Barriers to ED-initiated buprenorphine included lack of training and experience in treating OUD with buprenorphine, concerns about ability to link to ongoing care, and competing needs and priorities for ED time and resources. Facilitators to ED-initiated buprenorphine included receiving education and training, development of local departmental protocols, and receiving feedback on patient experiences and gaps in quality of care.Conclusions and relevanceOnly a few ED clinicians had a high level of readiness to initiate buprenorphine; however, many expressed a willingness to learn with sufficient supports. Efforts to promote adoption of ED-initiated buprenorphine will require clinician and system-level changes.
| S-EPMC7215257 | biostudies-literature