4R Care Delivery Program results: Impact of implementation metrics on patient self-management and 4R usefulness.

e19211 Background: We previously proposed a 4R model of teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence plan, including a novel visual feature describing timing and sequence of care. We report final results of a program which tested 4R at 5 safety net and 5 non safety net US centers from 2016 to 2019. Methods: Patients with stage 0-III breast cancer received 4R plans (4R Cohort). We surveyed 4R cohort and a historical control cohort of patients receiving care at same centers pre-4R. We assessed the usefulness of 4R to the 4R cohort and the impact on pSM in 4R cohort compared to historical cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control). 4R significantly increased the composite pSM score and 5 of 7 pSM metrics vs control (Table). The increase was not influenced by patient age, stage or whether treated at safety net site. pSM scores increased in 4R vs control cohort to a similar extent for patients < 65 years old (74% vs 51%, p = .0001) as for patients ≥ 65 years old (78% vs 57%, p = .0002). pSM improved similarly for patients with stage 0 or I breast cancer (77% vs 56%, p = .0001) as for patients with stage II or III breast cancer (72% vs 54%, p = .0001). Safety net patients showed pSM increase (77% vs 51%, p = .0001) similar to non safety net patients (74% vs 58%, p = .0002). Within the 4R cohort, 80% found 4R useful for organizing care and 70% found the novel visual feature useful to manage care timing and sequence. Usefulness was similar for age groups and stages, but higher for safety net than non safety net patients (88% vs 74%, p = .0008). Conclusions: 4R markedly improved patient self-management in early breast cancer across age groups and cancer stages, but further enhancements are needed to benefit as many patients as possible. 4R benefits in safety net setting indicate that 4R may reduce disparities. [Table: see text]

172 Background: Under the NCI ASCO Teams Project, we proposed a 4R Model of teamwork and patient self-management (pSM) (Trosman JOP ’16). 4R (Right Info/Care/Patient/Time) enables patient (pt) and care team to manage complex care continuum with an innovative multimodality 4R Care Project Plan. 4R includes a novel “project” feature – a graphical description of care interdependencies. 4R was previously piloted at 3 Chicago centers (Trosman ASCO ‘18). Methods: In this new study, we improved and tested 4R for impact on pSM at 4 safety net and 3 non safety net centers across the US. 4R Plans were provided to stage 0-III breast cancer pts Jan - Nov’18 (4R cohort). We surveyed the 4R cohort and a historical control cohort of pts who received care at same centers pre-4R, Jan - Dec ’17. Results: Survey response rates: 65%, 105/162 (4R cohort); 44%, 190/432 (control). 4R markedly improved 4 of 5 pSM metrics vs control (Table). Additional analyses showed that safety net pts had a significant increase in 4R vs control cohort in “seldom overwhelmed” (84%, 49/58 vs 64%, 67/104 respectively, p = .007), while non safety net pts had nonsignificant increase. Other metrics improved to a similar extent for safety net vs non safety net pts. Within the 4R cohort, 85% found 4R useful in organizing their care and 73% found 4R’s novel “project” feature useful in understanding care interdependencies. Safety net pts reported similar usefulness of 4R in organizing their care as non safety net pts (88%, 51/58 vs 81%, 38/47, NS) and similar usefulness of the “project’ feature in understanding care interdependencies as non safety net pts (74% vs. 72%, NS). Conclusions: 4R significantly improved patient self-management, but further efforts are needed to expand the benefit to as close to a 100% of pts as feasible. Safety net pts benefited from 4R at similar or higher rates than non safety net pts, indicating that 4R may reduce care disparities. An expansion of 4R across the US continues this work. [Table: see text]

224 Background: Under the “NCI ASCO Teams” Project, we proposed a 4R Model of teamwork and patient self-management (pSM) (Trosman JOP ’16). 4R is Right Info / Care / Patient / Time. It enables patient (pt) and care team to manage interdependent care along the care continuum with an innovative multimodality personalized 4R Care Project Plan. We piloted 4R at 3 centers (academic, community, safety net) and assessed its impact on pSM. Methods: 4R Plans were administered to breast cancer pts stage 0-III Sep ’16 – Aug ’17 (4R cohort). We surveyed the 4R cohort and a comparable historical cohort of pts who received care pre-4R, Jun ’15 – May ’16 (control). We used simple frequencies and Fisher’s exact test in analyses. Results: Survey response rates: 68%, 185/271 (4R cohort); 47%, 241/410 (control). 75% of 4R respondents reported 4R Plans very useful / useful in overall understanding and organizing their care; 68% found 4R’s novel “project” component, very useful / useful in managing timing & sequencing of interdependent care. Care complexity impacted 4R usefulness: 67% of pts who received > 6 care services found 4R very useful / useful vs. 47% of pts who received < = 6 services, p = .01. Pts with lower care complexity suggested how to make 4R more useful to them, eg focus on endocrine therapy. Table compares pSM metrics in the 4R and control cohort. Care complexity was a significant factor of feeling overwhelmed for pts in the control cohort (51% of pts receiving > 6 care services felt overwhelmed vs. 31% of pts receiving < = 6 services, p = .02), but not a significant factor for pts in the 4R cohort (30% vs. 28%, p = .9). Conclusions: The 4R model significantly improved pt self-management in early breast cancer and reduced the impact of care complexity on pts, but provider factors of pSM need improvement. A 4R pilot at additional 12 cancer centers across the U.S. is in progress.[Table: see text]

Perioperative venous thromboembolism (VTE) is a significant cause of morbidity and mortality after gynecologic cancer surgery. Here we report a quality improvement intervention to increase perioperative VTE chemoprophylaxis compliance. All operations performed by a gynecologic oncologist at a tertiary urban university medical center admitted to the hospital for at least one midnight were included. Using a pre/post design with a washout period, we sought to increase perioperative VTE chemoprophylaxis compliance from 22% in the historical control (HC) cohort to 90% in the quality improvement (QI) cohort. The perioperative VTE chemoprophylaxis process was standardized by addressing four domains: preoperative VTE chemoprophylaxis, surgical time-out, postoperative VTE chemoprophylaxis, and intervention education and compliance tracking. Pearson's chi-square test was used to compare HC vs QI cohort compliance. There were 130 surgical cases in the HC cohort and 131 in the QI cohort. Forty-two percent underwent laparotomy, and 57% had cancer at the time of operation. VTE chemoprophylaxis compliance improved from 22% in the HC cohort to 82% in the QI cohort (p < 0.001). Preoperative VTE chemoprophylaxis compliance improved from 76% in the HC cohort to 94% in the QI cohort (p < 0.001), and postoperative VTE chemoprophylaxis compliance improved from 27% to 87% (p < 0.001). Thirty-day postoperative VTE occurred in three patients (2%) in the HC cohort and none in the QI cohort (p = 0.08). A low-cost and low-technology QI initiative intervention improved perioperative compliance with VTE chemoprophylaxis.

This study sought to investigate specific contact force (CF) parameters to guide cavotricuspid isthmus (CTI) ablation and compare the outcome with a historical control cohort. Patients (30) undergoing CTI ablation were enrolled prospectively in the Study cohort and compared with a retrospective Control cohort of 30 patients. Ablation in the Study cohort was performed using CF parameters >10 g and <40 g and a Force Time Integral (FTI) of 800 ± 10 g. The Control cohort underwent traditionally guided CTI ablation. Traditional parameters (electrogram and impedance change) were assessed in both cohorts. All ablations regardless of achieving targets were included in data analysis. Bidirectional CTI block was achieved in all of the Study and 27 of the Control cohort. Atrial flutter recurred in 3 (10%) patients (follow-up 564 ± 212 days) in the study cohort and in 3 (10%) patients (follow-up 804 ± 540 days) in the Control cohort. There were no major complications in either cohort. Traditional parameters correlated poorly with CF parameters. In the Study cohort, flutter recurrence was associated with significantly lower FTI and ablation duration, but was not associated with total average CF. CTI ablation can be safely performed using CF parameters guiding ablation, with similar long-term results to a historical ablation control group. Potentially CF parameters may provide adjunctive information to enable a more efficient CTI ablation. Further research is required to confirm this.

Context: Interferon beta is widely prescribed to treat multiple sclerosis (MS); however, its relationship with disability progression has yet to be established. Objective: To investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS. Design, Setting, and Patients: Retrospective cohort study based on prospectively collected data (1985-2008) from British Columbia, Canada. Patients with relapsing-remitting MS treated with interferon beta (n = 868) were compared with untreated contemporary (n = 829) and historical (n = 959) cohorts. Main Outcome Measures: The main outcome measure was time from interferon beta treatment eligibility (baseline) to a confirmed and sustained score of 6 (requiring a cane to walk 100 m; confirmed at >150 days with no measurable improvement) on the Expanded Disability Status Scale (EDSS) (range, 0-10, with higher scores indicating higher disability). A multivariable Cox regression model with interferon beta treatment included as a time-varying covariate was used to assess the hazard of disease progression associated with interferon beta treatment. Analyses also included propensity score adjustment to address confounding by indication. Results: The median active follow-up times (first to last EDSS measurement) were as follows: for the interferon beta–treated cohort, 5.1 years (interquartile range [IQR], 3.0-7.0 years); for the contemporary control cohort, 4.0 years (IQR, 2.1-6.4 years); and for the historical control cohort, 10.8 years (IQR, 6.3-14.7 years). The observed outcome rates for reaching a sustained EDSS score of 6 were 10.8%, 5.3%, and 23.1% in the 3 cohorts, respectively. After adjustment for potential baseline confounders (sex, age, disease duration, and EDSS score), exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort (hazard ratio, 1.30; 95% CI, 0.92-1.83; P = .14) or the historical control cohort (hazard ratio, 0.77; 95% CI, 0.58-1.02; P = .07) were considered. Further adjustment for comorbidities and socioeconomic status, where possible, did not change interpretations, and propensity score adjustment did not substantially change the results. Conclusion: Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.

Interferon beta is widely prescribed to treat multiple sclerosis (MS); however, its relationship with disability progression has yet to be established. To investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS. Retrospective cohort study based on prospectively collected data (1985-2008) from British Columbia, Canada. Patients with relapsing-remitting MS treated with interferon beta (n = 868) were compared with untreated contemporary (n = 829) and historical (n = 959) cohorts. The main outcome measure was time from interferon beta treatment eligibility (baseline) to a confirmed and sustained score of 6 (requiring a cane to walk 100 m; confirmed at >150 days with no measurable improvement) on the Expanded Disability Status Scale (EDSS) (range, 0-10, with higher scores indicating higher disability). A multivariable Cox regression model with interferon beta treatment included as a time-varying covariate was used to assess the hazard of disease progression associated with interferon beta treatment. Analyses also included propensity score adjustment to address confounding by indication. The median active follow-up times (first to last EDSS measurement) were as follows: for the interferon beta-treated cohort, 5.1 years (interquartile range [IQR], 3.0-7.0 years); for the contemporary control cohort, 4.0 years (IQR, 2.1-6.4 years); and for the historical control cohort, 10.8 years (IQR, 6.3-14.7 years). The observed outcome rates for reaching a sustained EDSS score of 6 were 10.8%, 5.3%, and 23.1% in the 3 cohorts, respectively. After adjustment for potential baseline confounders (sex, age, disease duration, and EDSS score), exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort (hazard ratio, 1.30; 95% CI, 0.92-1.83; P = .14) or the historical control cohort (hazard ratio, 0.77; 95% CI, 0.58-1.02; P = .07) were considered. Further adjustment for comorbidities and socioeconomic status, where possible, did not change interpretations, and propensity score adjustment did not substantially change the results. Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.

Chronic hypoparathyroidism (HypoPT) is associated with impaired renal function.1 This study evaluated change in estimated glomerular filtration rate (eGFR) over a 5-yr period in adult patients (pts) with chronic HypoPT treated with or without recombinant human parathyroid hormone (1–84), rhPTH(1–84). The rhPTH(1–84)-treated pt cohort was derived from NCT01297309 (RACE) and NCT01199614 (HEXT) clinical trials. A historical control pt cohort with HypoPT who did not receive rhPTH(1–84) or rhPTH(1–34) were from the large national US Explorys electronic medical record database (Jan 2007−Aug 2019) using criteria similar to the trial enrollment criteria. The index date was the day after treatment initiation for the rhPTH(1–84) cohort and the day after the first calcitriol prescription for the control. The analysis included pts with eGFR ≥60 mL/min/1.73 m2 at the closest eGFR measurement during the 6 months before index date, ≥2 eGFR measurements ≥3 months apart during the 5 yrs on or after the index date and ≥1 eGFR measurement at 5 yrs (±6 months). For pts from RACE, baseline and study visit data after rhPTH(1–84) initiation were collected from the antecedent trials. Changes in eGFR were assessed in linear mixed and multivariable models (adjusted for age/sex/race, baseline eGFR value, history of hypercalciuria/hypertension/type 2 diabetes (T2D)/acute HypoPT manifestations/cardiovascular condition). There were 72 pts in the rhPTH(1–84) cohort and 174 in the control cohort. Before the index date, pts in the rhPTH(1–84) cohort, compared with the control, were younger (mean±SD, 47.5±11.0 vs 53.9±15.5 yrs; P&amp;lt;0.01), and a lower proportion had acute manifestations of HypoPT (22.2% vs 69.0%; P&amp;lt;0.001) and T2D (2.8% vs 17.8%; P&amp;lt;0.001). Over the 5-yr period, the difference in the rate of eGFR change between the 2 cohorts was 1.45 mL/min/1.73 m2 per yr and 1.33 mL/min/1.73m2 per yr, in the unadjusted and adjusted linear mixed models respectively (both P&amp;lt;0.001); eGFR remained higher in the rhPTH(1–84) cohort at all times. Over 5 yrs, eGFR was relatively stable in the rhPTH(1–84) cohort, but eGFR declined in the control at a rate of −1.58 mL/min/1.73 m2 per yr (unadjusted model, P&amp;lt;0.001), and by −1.57 mL/min/1.73 m2 per yr (adjusted model, P&amp;lt;0.001). By yr 5, pts in the rhPTH(1–84) and control cohort were predicted to have eGFR changes from baseline of +1.51 mL/min/1.73 m2 and −10.48 mL/min/1.73 m2, respectively. Data interpretation is limited by the differing pt management (ie, predefined trial protocols and clinical practice for the control). In pts with chronic HypoPT, the annual rate of eGFR decline over a 5-yr period was significantly lower in pts treated with rhPTH(1–84) compared with controls not treated with rhPTH(1–84). These results support the Chen et al1 analysis of data from the same trials and a regional US health record database. 1. Chen KS, et al. JCEM 2020;105(10)dgaa490

Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study

531 Background: The OncotypeDx genomic assay has been widely used to predict recurrence in those with early-stage ER positive breast cancer to determine whether adjuvant chemotherapy is beneficial. Receiving OncotypeDx results in a timely manner prior to medical oncology appointment is critical to inform adjuvant therapy decisions. In this quality improvement project, we implemented a care delivery optimization for patients with breast cancer receiving OncotypeDx assays in an integrated healthcare system. The optimization was conducted as part of implementing the 4R Oncology model (Right Info / Right Care / Right Patient / Right Time), a novel care model that aims to optimize patient-centric care planning, team-based delivery and patient self-management. Herein, we assess the impact of implementing this model on improving OncotypeDx turnaround time. Methods: We examined two patient groups with newly diagnosed early-stage ER positive breast cancer who attended a multidisciplinary clinic and underwent surgery at a single medical center. The historical control (HC) group received care pre-4R implementation, from January 2019 through June 2020, while the 4R Intervention group received care from July 2020 to December 2021. The OncotypeDx-related care optimization was a team effort of 5 medical specialties that involved establishing an OncotypeDx reflex testing practice, updating workflows, working with a testing company to streamline the process and implementing a method to align result timing with scheduling medical oncology appointments. Bivariate analyses were used to compare the HC and 4R groups on demographic characteristics and OncotypeDx turnaround time. Results: Within the 4R group (N = 208), 72 (34.6%) patients received OncotypeDx and 89 (32.5%) patients from the HC cohort (N = 274) received OncotypeDx. The groups were balanced by median age at time of multidisciplinary clinic visit (HC: 59 years vs 4R: 60 years), female gender (HC: 99.6% vs 4R: 99.5%), race, combined race and ethnicity, language spoken, Charlson Comorbidity Index and tumor characteristics. The average turnaround time from surgery date to delivery of OncotypeDx results was significantly reduced in the 4R cohort (19.4 days) compared to that of the HC cohort (23.1 days), a difference of 3.8 days, p = 0.004. The availability of OncotypeDx results by the first medical oncology visit after surgery increased from 40% in the HC cohort to 69% in the 4R cohort, p = 0.0003, helping optimize the transition to adjuvant therapy for the appropriate population. Conclusions: The implementation of the 4R Oncology model within an integrated healthcare system significantly reduced turnaround time for patients with breast cancer awaiting OncotypeDx results, improving patient-centric care and enabling informed discussions at medical oncology visits. The 4R Oncology model is an effective method to optimize delivery of time-sensitive care.

Allogeneic Hematopoietic Stem Cell Transplantation From Haploidentical Donor After Reduced Intensity Conditioning Regimen Allows Promising Disease Control In Patients With Hematological Diseases

553 Background: Bone loss is common in patients with breast cancer and can impact treatment decisions related to endocrine therapy. Hence, bone density assessment prior to starting endocrine therapy is highly important, especially because endocrine therapy is the first line adjuvant treatment for patients with ER+ breast cancer. Implementing timely bone density assessment is challenging, particularly in the early care trajectory when there are many tests and procedures taking place. We conducted a care delivery optimization in a large health system to implement bone density testing and referral for bone health consultation prior to endocrine therapy. The optimization was conducted as part of implementing the 4R Oncology model (Right Info, Right Care, Right Patient, at the Right Time), a novel approach to improving patient-facing care planning, team-based delivery and patient self-management. Here we describe the impact of this intervention. Methods: A cohort of 278 women with breast cancer who were in the 4R intervention (the 4R cohort) was compared to a historical control cohort of 201 women who received care pre-4R. Demographic, bone health history, and oncologic care data were abstracted from chart review and clinical databases. The prevalence of bone loss and timing of bone density consultation request was compared between the 4R and historical control cohorts. Results: The age, race/ethnicity and rate of ER+ cancer were similar between cohorts. Patients in the 4R cohort were significantly more likely to have received a consultation for bone density screening prior to the start of endocrine therapy (see Table). They were also more likely to receive a bone density test result during their care (Table). These findings remained significant when data were restricted to those ≥ 50 years (as a proxy for postmenopausal status) and those with ER-positive breast cancer. The rates of osteopenia and osteoporosis were similar between the cohorts: control 47%, 24%; 4R cohort: 46%, 23% respectively (data not shown). Conclusions: Care optimization using the 4R Oncology Model was associated with a significant improvement in the timing of bone density testing before initiation of endocrine therapy. The 4R Oncology Model can lead to more informed decision making in adjuvant endocrine therapy for patients with breast cancer. Additional optimizations to improve the rates of bone density tests and referrals will be beneficial.[Table: see text]

Effectiveness of near-infrared spectroscopy-guided continuous chest compression resuscitation without rhythm check in patients with out-of-hospital cardiac arrest: The prospective multicenter TripleCPR 16 study

The role of extended coagulation screening in adult cranial neurosurgery

The Benefits Conferred by Radial Access for Cardiac Catheterization Are Offset by a Paradoxical Increase in the Rate of Vascular Access Site Complications With Femoral Access: The Campeau Radial Paradox.