An Evaluation of Amoxicillin/Clavulanate Stability in Aqueous Systems, Including Its Suitability for Outpatient Parenteral Antimicrobial Therapy (OPAT).

Purpose: Amoxicillin/clavulanate antibiotic combination is suitable for treating a range of infections, including some suited for Outpatient Parenteral Antimicrobial Therapy (OPAT). The aim of the study was to evaluate shelf-life values of amoxicillin at clinical concentrations in the presence of clavulanate for use in OPAT. Methods: A stability-indicating HPLC assay was developed and validated. Kinetic studies were performed at 1 mg/mL and 15 mg/mL amoxicillin at 40-60 °C. Studies in elastomeric infusers included the pH lowered from 8.73 to 6.52 for 1 mg/mL; 8.85 to 7.69 for 7.5 mg/mL and 8.68 to 8.40 for 15 mg/mL amoxicillin plus clavulanate and stored at 2.9 °C. Results: Amoxicillin and clavulanate eluted at 5.2 and 3.0 minutes, respectively, with linear concentration relationships. Forced degradation retained base-line separation of each component in the presence of degradation products. Amoxicillin 1 mg/mL had a shelf-life of 4.85 hours at pH 6.53 and 40 °C which on extrapolation to 25 °C was 22.8 h. Clavulanate was 1.38 h at 40 °C and 4.0 h at 25 °C. Amoxicillin 15 mg/mL at pH 8.34 gave a shelf-life of 0.11 h at 40 °C and clavulanate 0.41 h. In elastomeric infusers, amoxicillin 1 mg/mL, with lowering pH from 8.73 to 6.52, improved the shelf-life at 2.9 °C from 72 to >263.8 h and similarly for clavulanate. At 7.5 mg/mL amoxicillin, lowering pH from 8.85 to 7.69 improved the shelf-life from 4.2 to 51.8 h and clavulanate from 4.2 to 48.0 h. At 15 mg/mL amoxicillin, the shelf-life values at pH 8.68 or 8.40 were 3.8 h and 1.6 h and similarly for clavulanate. Conclusion: Amoxicillin and clavulanate showed adequate stability at 2.9 °C for OPAT storage at 1 mg/mL and possibly 7.5 mg/mL, but not 15 mg/mL. Low shelf-life values at 25 °C also limit administration times.

Differences in COVID-19 Outpatient Antiviral Treatment Among Adults Aged ≥65 Years by Age Group - National Patient-Centered Clinical Research Network, United States, April 2022-September 2023.

Adults aged ≥65 years experience the highest risk for COVID-19-related hospitalization and death, with risk increasing with increasing age; outpatient antiviral treatment reduces the risk for these severe outcomes. Despite the proven benefit of COVID-19 antiviral treatment, information on differences in use among older adults with COVID-19 by age group is limited. Nonhospitalized patients aged ≥65 years with COVID-19 during April 2022-September 2023 were identified from the National Patient-Centered Clinical Research Network. Differences in use of antiviral treatment among patients aged 65-74, 75-89, and ≥90 years were assessed. Multivariable logistic regression was used to estimate the association between age and nonreceipt of antiviral treatment. Among 393,390 persons aged ≥65 years, 45.9% received outpatient COVID-19 antivirals, including 48.4%, 43.5%, and 35.2% among those aged 65-75, 76-89, and ≥90 years, respectively. Patients aged 75-89 and ≥90 years had 1.17 (95% CI = 1.15-1.19) and 1.54 (95% CI = 1.49-1.61) times the adjusted odds of being untreated, respectively, compared with those aged 65-74 years. Among 12,543 patients with severe outcomes, 2,648 (21.1%) had received an outpatient COVID-19 antiviral medication, compared with 177,874 (46.7%) of 380,847 patients without severe outcomes. Antiviral use is underutilized among adults ≥65 years; the oldest adults are least likely to receive treatment. To prevent COVID-19-associated morbidity and mortality, increased use of COVID-19 antiviral medications among older adults is needed.

Optimal Pediatric Outpatient Antibiotic Prescribing.

Importance: In the US, 50% of all pediatric outpatient antibiotics prescribed are unnecessary or inappropriate. Less is known about the appropriateness of pediatric outpatient antibiotic prescribing. Objective: To identify the overall percentage of outpatient antibiotic prescriptions that are optimal according to guideline recommendations for first-line antibiotic choice and duration. Design, Setting, and Participants: This cross-sectional study obtained data on any clinical encounter for a patient younger than 20 years with at least 1 outpatient oral antibiotic, intramuscular ceftriaxone, or penicillin prescription filled in the state of Tennessee from January 1 to December 31, 2022, from IQVIA's Longitudinal Prescription Claims and Medical Claims databases. Each clinical encounter was assigned a single diagnosis corresponding to the lowest applicable tier in a 3-tier antibiotic tier system. Antibiotics prescribed for tier 1 (nearly always required) or tier 2 (sometimes required) diagnoses were compared with published national guidelines. Antibiotics prescribed for tier 3 (rarely ever required) diagnoses were considered to be suboptimal for both choice and duration. Main Outcomes and Measures: Primary outcome was the percentage of optimal antibiotic prescriptions consistent with guideline recommendations for first-line antibiotic choice and duration. Secondary outcomes were the associations of optimal prescribing by diagnosis, suboptimal antibiotic choice, and patient- and clinician-level factors (ie, age and Social Vulnerability Index) with optimal antibiotic choice, which were measured by odds ratios (ORs) and 95% CIs calculated using a multivariable logistic regression model. Results: A total of 506 633 antibiotics were prescribed in 488 818 clinical encounters (for 247 843 females [50.7%]; mean [SD] age, 8.36 [5.5] years). Of these antibiotics, 21 055 (4.2%) were for tier 1 diagnoses, 288 044 (56.9%) for tier 2 diagnoses, and 197 660 (39.0%) for tier 3 diagnoses. Additionally, 194 906 antibiotics (38.5%) were optimal for antibiotic choice, 259 786 (51.3%) for duration, and 159 050 (31.4%) for both choice and duration. Acute otitis media (AOM) and pharyngitis were the most common indications, with 85 635 of 127 312 (67.3%) clinical encounters for AOM and 42 969 of 76 865 (55.9%) clinical encounters for pharyngitis being optimal for antibiotic choice. Only 257 of 4472 (5.7%) antibiotics prescribed for community-acquired pneumonia had a 5-day duration. Optimal antibiotic choice was more likely in patients who were younger (OR, 0.98; 95% CI, 0.98-0.98) and were less socially vulnerable (OR, 0.84; 95% CI, 0.82-0.86). Conclusions and Relevance: This cross-sectional study found that less than one-third of antibiotics prescribed to pediatric outpatients in Tennessee were optimal for choice and duration. Four stewardship interventions may be targeted: (1) reduce the number of prescriptions for tier 3 diagnoses, (2) increase optimal prescribing for AOM and pharyngitis, (3) provide clinician education on shorter antibiotic treatment courses for community-acquired pneumonia, and (4) promote optimal antibiotic prescribing in resource-limited settings.

Predictors of medication regimen complexity and its impact on hemoglobin a1c in type 2 diabetes patients: a retrospective analysis in ambulatory care in Makkah City.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a widespread chronic disease that poses a significant management challenge due to the complexity of the associated medication regimens, which can have a considerable impact on patient outcomes. OBJECTIVES: Explore the complexity level of diabetes medications among patients with T2DM and to identify the predictors of medication regimen complexity (MRC) and its correlation with hemoglobin A1C (HbA1c) levels. DESIGN: Retrospective, cross-sectional study. SETTING: An ambulatory care setting of a tertiary hospital in Makkah City, Saudi Arabia. PATIENTS AND METHODS: Patients with T2DM referred to the diabetic clinic were identified and assessed for eligibility. The data were collected from patient electronic medical records between October 2022 and September 2023. The MRC Index was used to evaluate the complexity of the patients' medication regimens. MAIN OUTCOMES MEASURES: MRC index scores and HbA1c levels. SAMPLE SIZE: 353 records of patients with T2DM. RESULTS: The analysis revealed that 61.8% (n=218) of patients had high MRC, with the dosing frequency contributing significantly to their MRC (mean=3.9, SD=1.9). Having polypharmacy and longstanding T2DM were predictors of high MRC (odds ratios=4.9 and 2.6, respectively; P≤.01). Additionally, there was an inverse association between the patients' diabetes-specific MRC index scores and their glycemic control (odds ratios=0.2, P<.001). CONCLUSION: The study findings highlight the importance of considering MRC in managing T2DM. Simplifying medication regimens and optimizing medication management strategies can improve patient outcomes. Further research is needed to explore interventions to reduce MRC and enhance diabetes management in this population. LIMITATIONS: Retrospective study design measuring the MRC at a diabetes-specific level.

Continuity of care and hospitalization frequency for ambulatory care-sensitive conditions after hearing-disability onset: a retrospective cohort study.

We assessed the effect of continuity of care (COC) on the frequency of hospitalization for Ambulatory care-sensitive conditions (ACSCs) to estimate the impact of COC and hearing disability relative to the controls. This retrospective cohort study used claim data of Korean National Health Insurance Service - National Sample Cohort 2.0 DB. We used propensity score matching to determine a control group for the hearing disability group by age, sex, and the Charlson Comorbidity Index. The hearing-impaired group included 720 participants, and the non-disabled control group, consisting of individuals without any form of disability, had 1,423 individuals. We used the frequency of hospitalization for ACSCs during one-year follow-up as the dependent variable for Poisson regression. We measured COC with the Bice-Boxerman Continuity of Care Index (COCI); higher COCI values represent better continuity of care, with COCI values ranging from 0 to 1. Poisson regression showed that disability status modifies the effect of COCI on the incidence of hospitalization. COCI = 1 reduced hospitalizations in people with hearing disabilities (adjusted Incidence Rate Ratio [aIRR]: 0.30, 95% CI: 0.20-0.44) but was not statistically significant for controls. In the COCI = 1 group, the effect of disability was not significant(aIRR: 1.10, 95% CI: 0.83-1.44). Compared to people without disabilities, enhanced COC for people with hearing disabilities was more effective in preventing hospitalizations for ACSCs.

The impact of a web-based prognostic calculator on prognostic confidence in outpatient palliative care.

PURPOSE: Clinicians are often uncertain about their prognostic estimates, which may impede prognostic communication and clinical decision-making. We assessed the impact of a web-based prognostic calculator on physicians' prognostic confidence. METHODS: In this prospective study, palliative care physicians estimated the prognosis of patients with advanced cancer in an outpatient clinic using the temporal, surprise, and probabilistic approaches for 6 m, 3 m, 2 m, 1 m, 2 w, 1 w, and 3 d. They then reviewed information from www.predictsurvival.com , which calculated survival estimates from seven validated prognostic scores, including the Palliative Prognostic Score, Palliative Prognostic Index, and Palliative Performance Status, and again provided their prognostic estimates after calculator use. The primary outcome was prognostic confidence in temporal CPS (0-10 numeric rating scale, 0 = not confident, 10 = most confident). RESULTS: Twenty palliative care physicians estimated prognoses for 217 patients. The mean (standard deviation) prognostic confidence significantly increased from 5.59 (1.68) before to 6.94 (1.39) after calculator use (p < 0.001). A significantly greater proportion of physicians reported feeling confident enough in their prognosis to share it with patients (44% vs. 74%, p < 0.001) and formulate care recommendations (80% vs. 94%, p < 0.001) after calculator use. Prognostic accuracy did not differ significantly before or after calculator use, ranging from 55-100%, 29-98%, and 48-100% for the temporal, surprise, and probabilistic approaches, respectively. CONCLUSION: This web-based prognostic calculator was associated with increased prognostic confidence and willingness to discuss prognosis. Further research is needed to examine how prognostic tools may augment prognostic discussions and clinical decision-making.

From evidence to practice: real-world insights into outpatient management of acute uncomplicated diverticulitis.

BACKGROUND: Diverticulitis is experiencing a significant increase in prevalence and its widespread in-hospital management results in a high burden on healthcare systems worldwide. This study compared inpatient and outpatient approach of acute non-complicated diverticulitis using a non-selected population in a real-world setting. METHODS: This observational retrospective study included all consecutive patients from two Portuguese institutions diagnosed between January 2017 and December 2021 with non-complicated diverticulitis according to the modified Hinchey Classification. The primary endpoints were to identify criteria for inpatient treatment and compare the outcomes on the basis of the treatment regimen. The secondary endpoints were to determine the predictive factors for clinical outcomes, focusing on treatment failure, pain recurrence, and the need for elective surgery following the initial episode. RESULTS: A total of 688 patients were included in this study, 437 treated as outpatients and 251 hospitalized. Inpatient management was significantly associated with higher preadmission American society of anesthesiologists (ASA) score (p = 0.004), fever (p = 0.030), leukocytosis (p < 0.001), and elevated C-reactive protein (CRP) (p < 0.001). No significant association was found between failure of conservative treatment and patient's age, ASA score, baseline CRP, presence of systemic inflammatory response syndrome (SIRS), and inpatient or outpatient treatment regimen. Pain recurrence was significantly associated with higher CRP levels (p = 0.049), inpatient treatment regime (p = 0.009) and post index episode mesalazine prescription (p = 0.006). Moreover, the need for elective surgery was significantly associated with the presence of previous episodes (p = 0.004) and pain recurrence (p < 0.001). CONCLUSIONS: The majority of patients with uncomplicated diverticulitis of the left colon experience successful conservative approach and can be safely managed in an ambulatory setting. Neither treatment failure, recurrence of pain, or need for posterior elective surgery are associated with outpatient treatment regimen.

A descriptive study of first time outpatient public psychiatric care after 65 years.

BACKGROUND: Mental health in the older adults represents a public health issue, especially depression and suicide, and even more in the Brittany French region. Community Mental Health Centers (CMHC) are the front-line French psychiatric healthcare organizations, but the number, characteristics and trajectories of the older adults consulting there for the first time are unknown. METHOD: An exhaustive cross-sectional study from medical records about first-time consultants in any CMHC of the Guillaume Régnier Hospital Center in 2019, and quantifying and describing the 65 and over ones according to socio-demographic, clinical, geographic and trajectory criteria. RESULTS: This population represents 9.7% of all first consulting in CMHCs. We can note that 70.5% are female, 46.8% are living alone and 31.2% are widowed. These 3 rates are higher than in the general population. The main diagnosis we found is mood disorder (35.1%). Organic mental disorders are scarce (8.2%). Most people are referred by a general practitioner (53.4%) or a specialist/hospital center (23.7%). The main referral at the end is to CMHC care (73.6%). Only 20.0% had a referral to non-psychiatric health professionals (GP, coordination support teams, geriatrics, other professionals). Significant differences in the referral at the end exist between 65 and 74, who are more referred to CMHC professionals, and 75 and over, who are more frequently referred to non-psychiatric health professionals. Significant discrepancies about who referred are found according to community area-type. CONCLUSION: These results align with the literature about known health-related characteristics and the importance of depression in the older people. They question the link with non-psychiatric professionals, and the need to structure a homogeneous care organization in psychiatric care for the older adults with trained professionals, especially for the 75 and over.

Impact of the Coronavirus Disease 2019 Pandemic on Outpatient Visits for Diabetic Retinopathy in Japan: A Retrospective Cohort Study.

Purpose: Long-term ramifications of the coronavirus disease 2019 pandemic on various care-seeking characteristics of patients with diabetic retinopathy remain unclear. This study aimed to identify risk factors for dropout from regular fundus examinations (RFEs) in patients with diabetic retinopathy in Japan. Methods: We extracted demographic and health checkup data (April 2018 to March 2021) from the JMDC database. Patients with diabetes identified using diagnosis-related and medication codes were included. The dropout and continuation groups included patients who discontinued and continued to undergo RFEs during the coronavirus disease 2019 pandemic, respectively. Results: The number of RFEs was significantly lower during the mild lockdown period (April and May 2020) than during the prepandemic period. Of the 14,845 patients with diabetes, 2333 (15.7%) dropped out of RFEs during the pandemic, whereas before the pandemic, of the 11,536 patients with diabetes, 1666 (14.4%) dropped out of RFEs (P = 0.004). Factors associated with dropout in the multivariate logistic regression analysis included younger age, male sex, high triglyceride levels, high γ-glutamyl transpeptidase levels, smoking habit, alcohol consumption, weight gain of more than 10 kg since the age of 20 years, and certain stages of lifestyle improvement. Factors associated with continuation included low body mass index and high glycosylated hemoglobin levels. Conclusions: Our findings can assist in identifying patients with diabetes at risk of dropout. Translational Relevance: These results have implications for public health and identifying patients with diabetes at risk of dropout. Education and tailored monitoring regimens could be pivotal role in fostering adherence.

Enhancing rural healthcare through internet-based remote collaborative outpatient services: A comprehensive evaluation in Changzhi, Shanxi Province.

BACKGROUND: The advancement of digital technology, particularly telemedicine, has become crucial in improving healthcare access in rural areas. By integrating cloud computing and mHealth technologies, Internet-based Collaborative Outpatient Clinics offer a promising solution to overcome the limitations of traditional healthcare delivery in underserved communities. METHODS: A trial was conducted in 4 counties of Changzhi City in Shanxi Province, China. The system extended to 495 rural communities and served over 5000 rural residents. Deep learning algorithms were employed to analyze medical data patterns to increase the accuracy of diagnoses and the quality of personalized treatment recommendations. RESULTS: After the implementation of the system, there was a significant improvement in the satisfaction levels of rural residents regarding medical services; the accuracy of medical consultations increased by 30%, and the convenience of medical access improved by 50%. There was also a notable enhancement in overall health management. Satisfaction rates among healthcare professionals and rural inhabitants were over 90% and 85%, respectively, indicating that the system has had a significant positive impact on the quality of health-care services. CONCLUSION: The study confirms the feasibility of implementing telemedicine services in rural areas and offers evidence and an operational framework for promoting innovative healthcare models on a large scale.

[Perceptions and experiences of users who received outpatient COVID-19 care in Santiago, Chile]. / Percepciones y experiencias de usuarios que recibieron cuidados ambulatorios de COVID-19 en Santiago de Chile.

AIM: To explore the perceptions and experiences of COVID-19 patients who received outpatient treatment in public health services in the Metropolitan Region of Chile. METHODS: An exploratory rapid qualitative study was conducted. Individual, telephonic and semi-structured interviews were conducted with patients who received a COVID-19 diagnosis confirmed by a PCR test and who had outpatient treatment for the disease. A thematic analysis was performed. RESULTS: Nine interviews were conducted (six female and three male participants). The main emerging themes were: life before COVID-19, living with the disease at home, recovery process, and Ineffective sanitary measures. Most of the participants highlighted the lack of information about their health and the uncertainty about COVID-19 as the cause of fear for their wellbeing. They also felt guilty for putting at risk others due to their COVID-19-positive status. CONCLUSION: The experiences of patients show the need to strengthen communication and information strategies for patients who receive outpatient care during the pandemic. This is key to reducing misinformation, fear and uncertainty about the progression of the disease and the potential recovery. Consequently, this could impact clinical outcomes and patient satisfaction.

Healthcare outcomes and dispositions in persons with obesity within emergency departments in Ontario, Canada: A cross-sectional analysis of the National Ambulatory Care Reporting System (NACRS), 2018-2022.

INTRODUCTION: The experience of persons with obesity (PwO) in the Canadian healthcare setting has not been widely studied. The objective of this study was to assess care in PwO in emergency departments in Ontario, Canada. METHODS: This secondary analysis made use of 2018-2022 Canadian Institute for Health Information's National Ambulatory Care Reporting System. The sample consisted of 4547 individuals with an obesity diagnosis, and 4547 controls who were matched for sex, age, and main diagnosis. Ordinal logistic and multiple linear regression analyses were used to assess triage scores, wait times, and length of stay. RESULTS: PwO had 4.8 minutes longer wait time for a physician initial assessment (p<0.01), 3.56 hours longer length of stay in the emergency department (p<0.0001), and 55% greater odds (OR = 1.55, 95% CI: 1.43-1.68) of having a less urgent triage score compared to controls matched for main diagnosis. When further matched for triage score, PwO experienced over three hours longer length of stay for triage level 2 (emergent, p<0.01), five hours longer for triage level 3 (urgent, p<0.01), and nearly two hours longer for triage level 4 (less urgent, p<0.05) cases. CONCLUSION: PwO were rated as less urgent and experienced longer wait times and length of stay, compared to controls matched by sex, age, and main diagnosis. Additional research is needed to confirm the consistency of these findings in other provinces/territories, and to examine clinical outcomes, and the underlying reasons for differences.

Clinical Outcomes of a Nurse-Delivered, Technology-Enabled HIV Outpatient Model.

We evaluated Klick, a nurse-led, digitally enabled model of HIV outpatient care, launched in 2020. Klick's smartphone app offers online booking, remote nurse-led consultations, and results. An audit of Klick nurse-led consultations was conducted against BHIVA monitoring guidelines, and nurses were interviewed about their experience. Of 40 Klick patients audited, 4 of 5 BHIVA standards were met: 100% had documented co-medications, smoking history, blood pressure, and viral load data, and 89% received a cardiovascular risk calculation (Targets 97%-90%-90%-90%-90%). Compared to national BHIVA audit findings, Klick performed better across 22 of 24 comparable measures. Nurses safely managed a cohort comprising some complexity (eg, co-morbidities, polypharmacy); no cases were escalated off the pathway, and all were virologically suppressed. Using a digitally supported model, nurses effectively provided safe care to HIV-positive patients with predominantly stable health, enabling consultants to focus on more complex caseloads. Care was comprehensive and person-centered and obtained better outcomes compared to previous national audits.

[Management of acute pain in an outpatient setting]. / Prise en charge de la douleur aiguë en ambulatoire.

The management of acute pain focuses on a multimodal approach integrating both pharmacological and non-pharmacological treatments. In recent years, caution towards opioids has increased, with several studies showing that they are not necessarily more effective than non opioid analgesics for pain relief for musculoskeletal pain, which is the most common painful symptom in outpatient settings, and have the disadvantages of more side effects and a risk of dependence. Adjuvant and non-pharmacological treatments (e.g. manual medicine, acupuncture, hypnosis) are gaining importance to reduce therapeutic escalation and improve pain management. This approach which can be more personalized, aims to minimize risks while ensuring effective relief of acute pain.

La prise en charge de la douleur aiguë se centre autour d'une approche multimodale intégrant des traitements pharmaco­logiques et non pharmacologiques. Ces dernières années, la prudence envers les opiacés s'est accrue, plusieurs études montrant qu'ils ne sont pas forcément plus efficaces que les non-opiacés face à la douleur musculosquelettique notamment, qui est le symptôme douloureux le plus fréquent en ambulatoire, et ont l'inconvénient d'apporter davantage d'effets indésirables et un risque de dépendance. Les traitements adjuvants et non phar­macologiques (comme la médecine manuelle, l'acupuncture, l'hypnose) gagnent en importance pour réduire l'escalade thérapeutique et améliorer la gestion de la douleur. Cette approche personnalisée vise à minimiser les risques tout en assurant un soulagement efficace de la douleur aiguë.

Standardizing Chemotherapy Education to Improve Patient Satisfaction at an Ambulatory Oncology Center.

This quality improvement project implemented a standardized chemotherapy class for newly diagnosed patients receiving oncology care at an urban ambulatory oncology center. Results showed high scores on patient satisfaction qu.

Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design.

BACKGROUND: Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle's effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. METHODS: This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. DISCUSSION: This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov as "Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE)." Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .