Proportion Of Eligible Patients Research Articles

Study protocol: type II hybrid effectiveness-implementation study of routine functional status screening in VA primary care

BackgroundMaintaining functional status, defined as the ability to perform daily activities such as bathing, dressing, and preparing meals, is central to older adults’ quality of life, health, and ability to remain independent. Identifying functional impairments – defined as having difficulty or needing help performing these activities – is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into routine patient care has been slow and inconsistent due to the burden posed by current tools. The goal of the Patient-Aligned Care Team (PACT) Functional Status Screening Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve identification and management of functional impairment among older veterans in Veterans Health Administration (VHA) primary care settings.MethodsWe will conduct a hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial at 8 VHA sites using the Practical, Robust Implementation and Sustainability Model (PRISM) to guide implementation and evaluation. During a Pre-Implementation phase, we will engage clinical partners and develop local adaptations to maximize intervention-setting fit. During an Implementation phase, we will launch a standard bundle of implementation strategies (coalition building, champions, technical assistance) and system-level audit and feedback, identify sites with low uptake, and randomize those sites to receive continued standard vs. enhanced strategies (standard strategies plus clinician-level audit and feedback). The primary implementation outcome is reach (proportion of eligible patients at each site who receive screening/assessment) and the primary effectiveness outcome is appropriate management of impairment (proportion of patients with identified impairments who receive related referrals).DiscussionImplementing routine measurement of functional status in primary care has the potential to improve identification and management of functional impairment for older veterans. Improved management includes increasing access to services and supports for veterans and family caregivers, reducing potentially preventable acute care utilization, and allowing veterans to live in the least restrictive setting for as long as possible. Implementation will also provide data to inform the delivery of proactive interventions to prevent and delay development of functional impairment and improve quality of life, health, and independence.Trial registrationRegistered at ClinicalTrials.gov on May 7, 2024, at NCT06404970 (https://clinicaltrials.gov/).Reporting guidelinesStandards for Reporting Implementation Studies (Additional file 1).

The Uptake of the Influenza Vaccine in Patients With Cystic Fibrosis: A Retrospective Study.

Children with cystic fibrosis are more likely to become severely unwell with influenza-associated illness compared to children without chronic lung disease. The provision of accessible influenza vaccinations is essential in the prevention of infection. To describe the prevalence of the influenza vaccine uptake in children with cystic fibrosis from 2016 to 2020 at a single tertiary paediatric hospital site and determine if the COVID pandemic of 2020 and the introduction of telehealth encounters affected the vaccine uptake. A retrospective study of children with cystic fibrosis aged 6 months to 18 years who reside in South Australia was performed using the Women's and Children's Hospital (WCH) Respiratory Department cystic fibrosis database from 2016 to 2020. The Australian Immunisation Register (AIR) was used to determine vaccination status during this period. One hundred and eighty two children with cystic fibrosis were identified, one hundred and seventy two of whom vaccination records were available on the Australian Immunisation Register. Proportion of eligible patients who were vaccinated ranged from 66% to 88% in the years 2016-2019. There was no significant decrease in uptake during the COVID-19 pandemic in 2020 (75%). Despite the introduction of Telehealth reviews in 2020 majority (66%) of patients continued to have exclusive face-to-face appointments, of which 73% received the vaccination. Vaccination coverage of those who received combination of Telehealth and face-to-face was 81%. The high influenza vaccination rate of South Australian children with cystic fibrosis is consistent with rates seen in other tertiary centres globally. This study demonstrated that the pandemic and introduction of Telehealth appointments did not have any impact in the uptake of the influenza vaccination in our South Australian population.

Pragmatic online obesity treatment in primary care: a hybrid randomized clinical trial of implementation strategies

Online behavioral weight loss (BWL) in primary care is effective and disseminable. This trial compared two implementation approaches on program uptake, use, and weight loss via a pragmatic hybrid type 2 implementation-effectiveness design to evaluate online BWL implementation (Rx Weight Loss [RxWL]) and effectiveness. This manuscript presents the implementation results. RxWL was implemented across a state-wide network of primary care clinics using lower- and higher-intensity implementation strategies (Basic [base program] and Enhanced [base plus enhanced training and dashboard], respectively) between 2018 and 2022. Nurse care managers (NCMs; N = 23) were recruited and block-randomized to implementation condition. Adult primary care patients (body mass index [BMI] > 25 kg/m2, internet-connected device access) were referred and enrolled by their NCMs. Outcomes were the proportion of eligible patients who enrolled in and completed RxWL by NCM condition, initial weight loss and regain over 12 and 24 months by NCM condition, and clinician acceptability and feasibility. NCMs (N = 12 Enhanced, N = 11 Basic) in Enhanced enrolled more patients (N = 490) than in Basic (N = 164). Although the proportion of patients who completed RxWL and mean weight loss did not differ by condition, different enrollment rates resulted in the Enhanced condition engaging more patients. NCMs rated RxWL as acceptable and feasible with no difference by condition. Findings support connecting primary care patients with technology-based health behavior change programs. Clinical trial registration number: ClinicalTrials.Gov identifier NCT03488212: https://clinicaltrials.gov/ct2/show/NCT03488212. Trial registration: clinicaltrials.gov Identifier: https://clinicaltrials.gov/study/NCT03488212.

Projected Annual Lecanemab Treatment Eligibility in an Irish Regional Specialist Memory Clinic.

The advent of Disease Modifying Therapies (DMTs) for the treatment of Alzheimer's Disease (AD) has the potential to transform the lives of those with early AD. Timely identification of eligible patients is needed to ensure treatments are delivered during a narrow window of therapeutic opportunity. Appropriate clinical service design will hinge on improved understanding of future demands, thus there is a pressing need to investigate patient eligibility in real world clinical cohorts. The primary aim of this study is to assess the eligibility by appropriate use criteria (AUC) for lecanemab therapy in a real-world, undifferentiated clinical patient cohort attending a Regional Specialist Memory Clinic (RSMC), with the secondary aims of determining the proportion of patients with biomarker positive Alzheimer's Disease (AD) who would be eligible for lecanemab therapy by AUC. Clinical trial eligibility criteria were also applied to both groups and discrepancies that exist between eligibility rates explored. A retrospective cohort study of all new patients attending a RSMC from 1st January 2022 to 31st December 2022 was conducted. Data collected included demographic details, outcomes of diagnostic assessments and comorbidities. MRI images, where indicated, were reviewed. Amyloid positivity was defined as either Amyloid and Tau positive (A+T+) or Amyloid positive with a positive P-Tau/Ab42 ratio on cerebrospinal fluid (CSF) testing. Appropriate use criteria (AUC) and clinical trial criteria for lecanemab were applied. Proportion of eligible patients was calculated. Eleven (5.9%) of 188 new patient attenders were eligible (average age 66.7years [SD 8.9], 63.6% female) by AUC, with 26.2% of patients with biomarker positive Alzheimer's Disease eligible for lecanemab therapy. The most common reason for exclusion was a lack of biomarker confirmation of AD pathology followed by cognitive ineligibility (based on defined cognitive testing cut-offs) at the time of referral and/or initial assessment. Only 40.4% of patients had CSF testing for AD biomarkers while almost 20% of the patients with biomarker positive AD were excluded due to lack of a screening MRI in the previous 12months. In this study, the potential eligibility rate by AUC of the entire patient cohort (5.9%) was limited by the small proportion of patients who had CSF testing for AD biomarkers. So while disease-modification with Lecanemab is a welcome therapeutic advance, although only a small proportion of people currently attending specialist services will be eligible. Successful delivery of DMTs will require significant resource allocation and optimisation of referral pathways to facilitate early identification of potentially eligible patients.

Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study)

IntroductionSuicidal ideation (SI) is a common and severe cause of morbidity in adolescents. Patients frequently present to the emergency department (ED) for care, yet there is no acute therapeutic intervention...

Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry.

Carotid-related strokes (CRS) are largely unresponsive to intravenous thrombolysis and are often large and disabling. Little is known about contemporary CRS referral pathways and proportion of eligible patients who receive emergency mechanical reperfusion (EMR). Referral pathways, serial imaging, treatment data, and neurologic outcomes were evaluated in consecutive CRS patients presenting over 18 months in catchment area of a major carotid disease referral center with proximal-protected CAS expertise, on-site neurology, and stroke thrombectomy capability (Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD Stent - SAFEGUARD-STROKE Registry; companion to SAFEGUARD-STROKE Study NCT05195658). Of 101 EMR-eligible patients (31% i.v.-thrombolyzed, 39.5% women, age 39-89 years, 94.1% ASPECTS 9-10, 90.1% pre-stroke mRS 0-1), 57 (56.4%) were EMR-referred. Referrals were either endovascular (Comprehensive Stroke Centre, CSC, 21.0%; Stroke Thrombectomy-Capable CAS Centre, STCC, 70.2%) or to vascular surgery (VS, 1.8%), with >1 referral attempt in 7.0% patients (CSC/VS or VS/CSC or CSC/VS/STCC). Baseline clinical and imaging characteristics were not different between EMR-treated and EMR-untreated patients. EMR was delivered to 42.6% eligible patients (emergency carotid surgery 0%; STCC rejections 0%). On multivariable analysis, non-tandem CRS was a predictor of not getting referred for EMR (OR 0.36; 95%CI 0.14-0.93, P=0.03). Ninety-day neurologic status was profoundly better in EMR-treated patients; mRS 0-2 (83.7% vs. 34.5%); mRS 3-5 (11.6% vs. 53.4%), mRS 6 (4.6% vs. 12.1%); P<0.001 for all. EMR-treatment substantially improves CRS neurologic outcomes but only a minority of EMR-eligible patients receive EMR. To increase the likelihood of brain-saving treatment, EMR-eligible stroke referral and management pathways, including those for CSC/VS-rejected patients, should involve stroke thrombectomy-capable centres with endovascular carotid treatment expertise.

Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study

Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.

Abstract 4798: MRI screening for brain metastases (BrM) versus SYMptom-directed brain imaging for patients with triple negative (TN) or HER2+ metastatic breast cancer (MBC): An ad-hoc interim analysis of a randomized phase II pilot study

Abstract Background: Patients with HER2+ or TN MBC are at high risk of developing BrM, but the role of MRI screening for early detection of asymptomatic BrM has not yet been established. Methods: We conducted a multicentre phase II pilot study, which randomized patients with TN or HER2+ MBC to 1 year of BrM screening (contrast enhanced brain MRI at baseline, 4, 8, and 12 months) versus a control arm of symptom directed brain imaging (MRI only if symptoms of BrM develop). The primary goal was to determine the feasibility of a future randomized trial of BrM screening versus symptom-directed imaging in this patient population. Key inclusion criteria were age ≥18; TN MBC diagnosed ≤12 weeks prior to study entry or HER2+ MBC with no restrictions regarding time of diagnosis; no symptoms of BrM or known asymptomatic BrM; ECOG ≥ 1 and no MRI contraindications. Overall (EORTC QLQ BN20) and neurologic-specific (FACT-BR tools) quality-of-life as well as cancer-related anxiety (NCI PRO-CTCAE) were assessed at baseline, 6 and 15 months. Criteria rendering a future trial “not feasible” were defined a-priori as: &amp;lt;30% of eligible patients enroll in the study, &amp;lt;50% complete the study protocol, and/or &amp;gt;50% of patients allocated to the control arm during the 1 year study period are screened for asymptomatic BrM with CT or MRI. Results: Between 2018 and 2023, 44 patients from 3 participating centres enrolled in the study. Thirty-five participants (80%) had HER2+ and 9 (20%) had TN MBC. Of the 22 patients randomized to each of the study arms; 3 patients (8%) in each arm withdrew prior to study completion. Reasons for withdrawal included claustrophobia (n=3) or discontent with their randomised arm (n=3) or follow-up requirements (n=1). Metrics regarding the proportion of eligible patients who enrolled in the study were only collected from the Sunnybrook Odette Cancer Centre site; of 91 patients approached, 38 (42%) enrolled in the study. Within the 12-month study period, the incidence of BrM among patients in the screening arm was n=3 (14%) versus n=4 (18%) in the control arm. To-date among patients in the study arm, 11 (50%) completed the 12-month screening protocol, 5 (23%) remain on study and 6 (27%) did not complete the protocol due to either death or early study withdrawal. Among patients in the control arm, 10 (45%) completed 12-month follow-up, 4 (18%) remain on study and 8 (36%) did not complete follow-up due to either death or early study withdrawal. In total, 13 patients (59%) in the control arm had brain imaging, 4 in the absence of neurological symptoms. Conclusion: A large randomized trial to investigate the utility of MRI-based surveillance for asymptomatic detection of BrM in the proposed patient population is likely feasible, although episodic brain imaging in the control arm was common. Analysis of patient reported outcomes is ongoing. Citation Format: Katarzyna Joanna Jerzak, Megan Shum, Gregory Pond, Orit Freedman, Gursimran Chandhoke, Tatiana Conrad, Priscilla Brastianos, Gregory Stanisz, Arjun Sahgal, Ellen Warner. MRI screening for brain metastases (BrM) versus SYMptom-directed brain imaging for patients with triple negative (TN) or HER2+ metastatic breast cancer (MBC): An ad-hoc interim analysis of a randomized phase II pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4798.

The Adhesive Capsulitis Corticosteroid and Dilation (ACCorD) randomized controlled trial.

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder.

A feasibility study of provider-level implementation strategies to improve access to colorectal cancer screening for patients with schizophrenia: ACCESS2 (N-EQUITY 2104) trial

BackgroundPeople with schizophrenia have a lower colorectal screening rate than the general population. A previous study reported an intervention using case management to encourage colorectal cancer screening for patients with schizophrenia in psychiatric outpatient settings. In this feasibility study, we developed provider-level implementation strategies and evaluated the feasibility of conducting a definitive trial in terms of the penetration of the intervention assessed at the patient level. Additionally, we examined the fidelity of strategies to implement the intervention at the provider level in a routine clinical psychiatric setting.MethodsThis was a multicenter, single-arm feasibility study with medical staff at psychiatric hospitals in Japan. The provider-level implementation strategies developed in this study included three key elements (organizing an implementation team appointed by the facility director, interactive assistance using a clear guide that outlines who in the hospital should do what, and developing accessible educational materials) to overcome major barriers to implementation of the intervention and four additional elements (progress monitoring, joint meetings and information sharing among participating sites, adaptation of encouragement methods to specific contexts, and education of on-site staff), with reference to the elements identified in the Expert Recommendations for Implementing Change (ERIC). The feasibility of the strategies was evaluated by the proportion of patients who were eligible for encouragement (patients with schizophrenia aged 40, 50, or 60) who received encouragement. We set the goal of providing encouragement to at least 40% of eligible patients at each site.ResultsTwo public and four private psychiatric hospitals in Okayama and Shimane prefectures participated in this study. Regarding fidelity, all elements of the strategies were conducted as planned. Following the procedures in the guide, each team prepared and provided encouragement according to their own facility and region. Penetration, defined as the proportion of eligible patients who received encouragement, ranged from 33.3 to 100%; five of the six facilities achieved the target proportion.ConclusionsThe provider-level implementation strategies to implement encouragement were feasible in terms of penetration of the intervention assessed at the patient level. The results support the feasibility of proceeding with a future definitive trial of these strategies.Trial registrationjRCT, jRCT1060220026. Registered on 06/04/2022.

Implementing patient decision aids into general practice clinical decision support systems: Feasibility study in cardiovascular disease prevention.

Patient decision aids (DA) facilitate shared decision making, but implementation remains a challenge. This study tested the feasibility of integrating a cardiovascular disease (CVD) prevention DA into general practice software. We developed a desktop computer application (app) to auto-populate a CVD prevention DA from general practice medical records. 4 practices received monthly practice reports from July-Nov 2021, and 2 practices use the app with limited engagement. CVD risk assessment data and app use were monitored. The proportion of eligible patients with complete CVD risk assessment data ranged from 59 to 94%. Monthly app use ranged from 0 to 285 sessions by 13 individual practice staff including GPs and nurses, with staff using the app an average of 67 sessions during the study period. High users in the 5-month study period continued to use the app for 10months. Low use was attributed to reduced staff capacity during COVID-19 and technical issues. High users sustained interest in the app, but additional strategies are required for low users. The study will inform implementation plans for new guidelines. This study showed it is feasible to integrate patient decision aids with Australian general practice software, despite the challenges of COVID-19 at the time of the study.

Prevalence and Time Trends of Oral Anticoagulant Utilization in Adults with Sickle Cell Disease

Background: Sickle cell disease (SCD) is an inherited red blood cell disorder, caused by a genetic mutation in the β-hemoglobin chain. SCD is associated with chronic activation of coagulation and an increased risk of venous thromboembolism (VTE). Although the American Society of Hematology guidelines recommend indefinite anticoagulation for unprovoked or recurrent provoked VTE, no guidance is given regarding choice of anticoagulant due to a paucity of data. Existing evidence on the use of anticoagulants in patients with SCD has been mostly focused on oral anticoagulants, was limited by small sample sizes, and did not clearly demonstrate the temporal utilization patterns. Real-world evidence on oral anticoagulant use in SCD from large population-based studies is largely lacking. This study examined the prevalence and time trends of oral anticoagulant utilization in patients with SCD in the United States (US). Methods: This retrospective, repeated cross-sectional study analyzed the Cerner Health Facts® database from January 1, 2011, to December 31, 2016, which captures longitudinal electronic medical records (EMR) of patient data from participating facilities in the US. To be included, patients were required to (1) have ≥ 1 inpatient or emergency department encounters with SCD, or 2 outpatient encounters that were 30 days apart in a calendar year from 2012 to 2016, (2) have ≥ 1 prescription records on the encounters with SCD, (3) aged ≥ 18 years at index, and (4) have ≥ 1 encounter with SCD in a year prior to the index. For patients with multiple encounters with SCD in the calendar year, we randomly selected one encounter with SCD and defined it as the index. In this design, a patient contributed only one observation per year but may contribute to multiple years of observations if meeting the selection criterion. The outcome was the use of anticoagulants, defined as any prescription drug encounter for an oral anticoagulant (Vitamin K antagonist [VKA]: warfarin; direct oral anticoagulants [DOACs]: apixaban, rivaroxaban, dabigatran, edoxaban) within a grace period of 7 days discharged from the index. The independent variable was each calendar year measured as dummy variables. Covariates were measured during the 12-month baseline period prior to the index, which included patient demographics, comorbidities and complications of SCD, and facility characteristics. Time trends on the proportions of eligible patients with anticoagulant use against the calendar years of the SCD diagnosis were plotted, and the significance on the crude trend was examined using Cochran-Armitage trend test. In the main analysis, a modified Poisson regression by using generalized estimating equations (GEEs) estimated the adjusted prevalence ratios (APRs) for the trends and covariates associated with any anticoagulant utilization. In subgroup analysis, we estimated the APRs of covariates for the use of DOACs versus VKA. Results: The cohort included 8,824 adult patients with SCD in 182 facilities using automated Cerner EMR system for the years 2012 to 2016. Prescription rates of all oral anticoagulants gradually increased from 2012 to 2014; the rates of VKA prescriptions substantially dropped from 11.1/1000 to 4.1/1000 persons between 2014 and 2016, whereas prescription rates of DOACs increased significantly from 12.0/1000 to 29.1/1000. Prevalence of VTE was stable at approximately 6.2/1000 to 7.5/1000 between 2012 and 2016. Prescription rates of DOACs were lower in patients with (versus without) VTE (6.1/1000 vs 7.3/1000), while a reversed prescription pattern was observed for VKA (VTE [yes vs no]: 4.4/1000 vs 1.8/1000). Controlling for covariates, our main analysis demonstrated that patients with a diagnosis of acute chest syndrome, pulmonary hypertension, and depression were 1.51, 2.30, and 1.57 times more likely to have oral anticoagulant prescription, respectively (all p &amp;lt;0.05). Subgroup analysis showed that having a diagnosis of VTE was associated with a decreased likelihood of DOACs prescription relative to VKA (APR= 0.75, 95%CI: 0.62-0.91). Conclusion: Prescription of oral anticoagulants in adults with SCD has significantly increased from 2012 to 2016 and the increase was dominated by DOACs. The treatment paradox of a lower relative rate of DOACs utilization versus VKA in adults with SCD requires more study to understand the reasons and additional clinical outcomes associated with the utilization patterns.

Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial

BackgroundHome Blood Pressure Monitoring (HBPM) that includes a team with a clinical pharmacist is an evidence-based intervention that improves blood pressure (BP). Yet, strategies for promoting its adoption in primary care are lacking. We developed potentially feasible and sustainable implementation strategies to improve hypertension control and BP equity. MethodsWe assessed barriers and facilitators to HBPM and iteratively adapted implementation strategies through key informative interviews and guidance from a multistakeholder stakeholder team involving investigators, clinicians, and practice administration. ResultsStrategies include: 1) pro-active outreach to patients; 2) provision of BP devices; 3) deployment of automated bidirectional texting to support patients through education messages for patients to transmit their readings to the clinical team; 3) a hypertension visit note template; 4) monthly audit and feedback reports on progress to the team; and 5) training to the patients and teams. We will use a stepped wedge randomized trial to assess RE-AIM outcomes. These are defined as follows Reach: the proportion of eligible patients who agree to participate in the BP texting; Effectiveness: the proportion of eligible patients with their last BP reading <140/90 (six months); Adoption: the proportion of patients invited to the BP texting; Implementation: patients who text their BP reading ≥10 of days per month; and Maintenance: sustained BP control post-intervention (twelve months). We will also examine RE-AIM metrics stratified by race and ethnicity. ConclusionsFindings will inform the impact of strategies for the adoption of team-based HPBM and the impact of the intervention on hypertension control and equity.Registration details: www.ClinicalTrials.gov Identifier: NCT05488795.

Differences in Use of Clinical Decision Support Tools and Implementation of Aspirin, Blood Pressure Control, Cholesterol Management, and Smoking Cessation Quality Metrics in Small Practices by Race and Sex

Practice-level evidence is needed to clarify the value of population-based clinical decision support (CDS) tools in reducing racial and sex disparities in cardiovascular care. To evaluate the association between CDS tools and racial and sex disparities in the aspirin use, blood pressure control, cholesterol management, and smoking cessation (ABCS) care quality metrics among smaller primary care practices. This cross-sectional study used practice-level data from the Agency for Healthcare Research and Quality-funded EvidenceNOW initiative. The national initiative from May 1, 2015, to April 30, 2021, spanned 12 US states and focused on improving cardiovascular preventive care by providing quality improvement support to smaller primary care practices. A total of 576 primary care practices in EvidenceNOW submitted both survey data and electronic health record (EHR)-derived ABCS data stratified by race and sex. Practice-level estimates of disparities between Black and White patients and between male and female patients were calculated as the difference in proportions of eligible patients within each practice meeting ABCS care quality metrics. The association between CDS tools (EHR prompts, standing orders, and clinical registries) and disparities was evaluated by multiply imputed multivariable models for each CDS tool, adjusted for practice rurality, ownership, and size. Across the 576 practices included in the analysis, 219 (38.0%) had patient panels that were more than half White and 327 (56.8%) had panels that were more than half women. The proportion of White compared with Black patients meeting metrics for blood pressure (difference, 5.16% [95% CI, 4.29%-6.02%]; P < .001) and cholesterol management (difference, 1.49% [95% CI, 0.04%-2.93%] P = .04) was higher; the proportion of men meeting metrics for aspirin use (difference, 4.36% [95% CI, 3.34%-5.38%]; P < .001) and cholesterol management (difference, 3.88% [95% CI, 3.14%-4.63%]; P < .001) was higher compared with women. Conversely, the proportion of women meeting practice blood pressure control (difference, -1.80% [95% CI, -2.32% to -1.28%]; P < .001) and smoking cessation counseling (difference, -1.67% [95% CI, -2.38% to -0.95%]; P < .001) metrics was higher compared with men. Use of CDS tools was not associated with differences in race or sex disparities except for the smoking metric. Practices using CDS tools showed a higher proportion of men meeting the smoking counseling metric than women (coefficient, 3.82 [95% CI, 0.95-6.68]; P = .009). The findings of this cross-sectional study suggest that practices using CDS tools had small disparities that were not statistically significant, but CDS tools were not associated with reductions in disparities. More research is needed on effective practice-level interventions to mitigate disparities.

High Frequency of Tertiary Cardiology Referral, Admission or Death of Eligible Patients Following Delay in Recruiting for the Te Kūiti Access to Cardiology Pilot Study

The Te Kūiti Access to Cardiology Pilot Study was designed to assess, in a high Māori proportion general practitioner (GP) population (Te Kūiti) with increased cardiovascular risk, whether a simple local screening protocol followed, if indicated, by more definitive cardiology tests performed locally would identify people for treatment or tertiary referral earlier than a normal care control group. Delay from risk score assessments to study commencement of 2.5 years occurred due to funding and COVID-19. The frequency of tertiary cardiology referral, admission, or death in this intervening period were assessed. Te Kūiti GP patients aged 35–74 with a 5-year cardiovascular disease (CVD) risk score of ≥10% (PREDICT CVD) were eligible for the study. Current cardiology or patients within 2 years were excluded. The delay to start period was between February 2020 and August 2022 (2.5 years). The proportion of eligible patients now excluded (now under or referred to Waikato Hospital cardiology, those deceased/deceased due to cardiovascular cause, and other (moved out of area, under palliative care)) was assessed. Groups were sorted by gender (male/female) and ethnicity (Māori and non-Māori). The Table show summary data of those initially eligible patients who were later excluded. The Māori and non-Māori males and Māori females were referred or died from cardiovascular disease at rates in 2.5 years close to those predicted at 5 years by PREDICT CVD. This high rate of referral/death suggests that these groups may be good targets to attempt interventions to facilitate early diagnosis and implement preventive therapies.TableMāori maleNon-Māori maleMāori femaleNon-Māori femaleTotal number with CVD risk score of ≥10% by January 202016225711954Number excluded by August 2022 “Exclusion group”46 (28.4%)60 (23.3%)25 (21.0%)10 (18.5%)Exclusion criteria: now under cardiology/referral to cardiology made23 (14.2%)37 (14.4%)16 (13.4%)3 (5.5%)Exclusion criteria: deceased10 (6.2%)7 (2.7%)4 (3.4%)1 (1.9%)Deceased due to heart disease3 (1.9%)2 (0.8%)1 (0.8%)0 (0.0)%Total cardiovascular disease exclusions26 (16.1%)39 (15.2%)17 (14.2%)3 (5.5%)Exclusion criteria: other131656Mean CVD risk score of total number17.215.517.215.1Mean CVD risk score of exclusion group17.6316.5418.5213.6 Open table in a new tab

Assessing Strengths, Challenges, and Equity Via Pragmatic Evaluation of a Social Care Program

ObjectiveModels of pragmatic social care program evaluations are needed as many are clinical services programs and are not focused on research, limiting the ability to address key evidence gaps. We describe the use of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to conduct a pragmatic evaluation of a pediatric ambulatory social care program. MethodsOur evaluation was based on automated electronic health record data on clinics, community partners, social care program processes, and social needs screen data linked to patient sociodemographic characteristics from February 2020 to September 2021. Two Reach outcomes were assessed: 1) the proportion of eligible patients that completed social needs screening and 2) the proportion of positive screens that receive social care program follow-up. The Effectiveness outcome was meeting families’ resource need(s). ResultsReach among eligible patients who completed screening was 79.2%. Reach for positive screens receiving social care program referrals demonstrated a higher proportion of referrals among patients with a preferred healthcare language (PHL) of Spanish (45.1%) compared to English (31.2%, P < .001). Effectiveness analyses demonstrated that overall, 75.1% of social care program referrals had all social resource needs met, 17.5% had some needs met, and 7.4% had no needs met. The percent of patients with all resource needs met was higher for patients with PHL of Spanish or Non-English, Non-Spanish (79% for each respectively) compared to English (73%, P = .023). ConclusionsMaximizing automated data collection is likely the most feasible way for social care programs to complete evaluation activities outside of the research context.

54 The Association of Patient Characteristics on Provider Referrals to a Health-system Based Diabetes Prevention Program in the Bronx, NY.

OBJECTIVES/GOALS: The Diabetes Prevention Program (DPP) has been shown to reduce diabetes risk by 58%. Men, particularly men of color, are underrepresented in DPP, while they experience higher diabetes-related morbidity. We examine whether race, ethnicity, and gender disparities in engagement are associated with the risk of referral to DPP in primary care METHODS/STUDY POPULATION: Using electronic health record (EHR) from a large urban health system in the Bronx, NY, with an in-house DPP, we examined patient, visit, referral data for DPP-eligible, adult patients with a primary care visit between July 2015 and December 2017. Eligibility included: hemoglobin A1c between 5.7-6.4%; a body mass index (BMI)≥24 kg/m2 (≥22 if Asian); and having no prior diagnosis of diabetes. A total of 26987 patients were included in this study. We examined patient race, ethnicity, preferred language, visit and prescription history, and health payer, among other characteristics. SPSS was used for univariate and bivariate analyses to examine associations between patient characteristics and referral followed by a logistic regression to examine the multivariate association between predictors and referrals. RESULTS/ANTICIPATED RESULTS: Of all DPP-eligible patients, 49% were Hispanic/Latino, and 39% were non-Hispanic Black. Around one-third (34%) of all eligible patients were men. Among all eligible patients in the sample, only 10% were referred to DPP. There were significant differences in the proportion of eligible patients who were referred versus those who were not referred. Women were referred at more than twice the prevalence of men (8.26% to 2.41%), with Hispanic women being referred most frequently (3.59%), and non-Hispanic white men being referred least frequently (.07%) Ethnicity, race, sex, age, number of provider visits, and number of chronic conditions all impacted healthcare provider referral rates to DPP. The health system’s unique free-of-charge DPP likely influenced the lack of significance of patient health insurance. DISCUSSION/SIGNIFICANCE: Given the implementation of DPP at-scale there is an urgent need to understand the patient and systems-level factors that are associated with referring individuals in the DPP. By detecting characteristics of health systems and patients that warrant special attention, we can improve equitable access to evidence-based diabetes prevention.

Improving Home Caregiver Independence With Central Line Care for Pediatric Cancer Patients.

Home caregivers (eg parents) of pediatric patients with cancer with external central lines (CL) must carefully maintain this device to prevent complications. No guidelines exist to support caregiver skill development, assess CL competency, follow-up after initial CL teaching, and support progress over time. We aimed to achieve >90% caregiver independence with CL care within 1 year through a family-centered quality improvement intervention. Drivers to achieve CL care independence were identified using surveys and interviews of patient or caregivers, a multidisciplinary team with patient or family representatives, and piloting clinic return demonstrations (teach-backs). A family-centered CL care skill-learning curriculum, with a postdischarge teach-back program, was implemented using plan-do-study-act cycles. Patients or caregivers participated until independent with CL flushing. Changes included: language iterations to maximize patient or caregiver engagement, developing standardized tools for home use and for teaching and evaluating caregiver proficiency on the basis of number of nurse prompts required during the teach-back, earlier inpatient training, and clinic redesign to incorporate teach-backs into routine visits. The proportion of eligible patients whose caregiver had achieved independence in CL flushing was the outcome measure. Teach-back program participation was a process measure. Statistical process control charts tracked change over time. After 6 months of quality improvement intervention, >90% of eligible patients had a caregiver achieve independence with CL care. This was sustained for 30 months postintervention. Eighty-eight percent of patients (n = 181) had a caregiver participate in the teach-back program. A family-centered hands-on teach-back program can lead to caregiver independence in CL care.

A multicenter, randomized feasibility analysis comparing restrictive fluids to standard therapy for people with sepsis in the emergency department (REFACED)

Aim: Sepsis presents a problem for fluid management, and clinical consensus exists about intravenous (IV) volume requirements. When adult patients with sepsis who were not in shock presented to the emergency room, our goal was to assess if a 24-hour strategy restricting IV fluid was possible (ED). Methods: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomised, open-label, feasibility study in which sepsis patients who are not in shock are randomly assigned to receive either conventional therapy or 24 hours of restrictive, crystal IV fluid delivery. Fluid boluses were only allowed in the IV fluid restriction group when certain conditions for hypoperfusion were met. The treating team determined the standard of care. Total IV crystalloid fluid volumes were the main result 24 hours after randomization. Total fluid volumes, feasibility tests, and patient-centered outcomes were also considered secondary outcomes. Results: In the initial analysis, we included 123 patients (61 patients under restrictive care and 62 patients under normal treatment). The proportion of eligible patients who met all inclusion criteria and no exclusion criteria was 32% (95% confidence interval [CI] 28%-37%). At 24hrs, the restriction versus standard care groups had mean (± SD) IV crystalloid fluid amounts of 562 (1076) ml and 1370 (1438) ml, respectively (mean difference -801 ml, 95% CI - 1257 to - 345 ml, p = 0.001). In the fluid-restrictive group, 21 (34%) of the patients experienced protocol violations. Adverse events, the need for mechanical breathing or vasopressors, acute renal failure, length of stay, or mortality did not differ across groups. Conclusions: In comparison to normal care, a regimen restricting IV crystalloid fluids in ED patients with sepsis resulted in lower 24-hour fluid amounts. It is possible that a future experiment may focus on patient-centered outcomes.

Is information on social rights accessible to cancer patients?

Brazilian legislation provides for rights for cancer patients in order to assist with their treatment and mitigate the expenses they face during their illness. This study aimed to calculate the proportion of individuals undergoing cancer treatment at a Brazilian Unified National Health System (SUS) referral center who reported being aware of 15 specific legal rights, according to the population subgroup eligible to request each right. All adult cancer patients starting treatment at the Juiz de Fora Women's Association for Preventing and Fighting Cancer Hospital (ASCOMCER), Minas Gerais State, from March to July 2022, were interviewed (n = 62). About 60% of these patients had incomplete primary education or were illiterate, around 75% lived in households with a per capita income below one minimum wage, and 91.9% received treatment from the SUS. For nine of the 15 selected rights, the proportion of eligible patients was higher than 10%, ranging from 17.7% for "Withdrawal from the Severance Pay Fund (FGTS)" to 100% for "priority in the processing of procedures". However, the only one of these rights known to at least 50% of eligible patients was "sickness benefit" (70.6%). The respective proportions were below 5% in three rights, including "exemption from property tax", "exemption from income tax on retirement, pension, and retirement", and "priority in the processing of cases". Cancer patients need to have their comprehensive care strengthened. Therefore, it is crucial to enhance the availability of information regarding the benefits cancer patients may receive from a democratic state that respects the rule of law.