Defining the Role of Social Vulnerability in Treatment and Survival in Localized Colon Cancer: A Retrospective Cohort Study.

OBJECTIVE: To determine whether variations in Social Vulnerability Index (SVI) are associated with disparities in colon cancer surgery and mortality. SUMMARY BACKGROUND DATA: Colon cancer mortality is influenced by health care access, which is affected by individual and community-level factors. Prior studies have not used the SVI to compare surgical access and survival in localized colon cancer patients. Further, it is unclear if those above 65 years are more vulnerable to variations in SVI. METHODS: We queried the Texas and California Cancer Registries from 2004-2017 to identify patients with localized colonic adenocarcinoma and categorized patients into <65 and ≥65 years. Our outcomes were survival and access to surgical intervention. The independent variable was census tract social vulnerability index, with higher scores indicating more social vulnerability. We used multivariable logistic regression and Cox proportional hazards for analysis. RESULTS: We included 73,923 patients with a mean age of 68.6 years (SD 13.0), mean SVI of 47.2 (SD 27.6), and 51.1% male. After adjustment, increasing SVI was associated with reduced odds of undergoing surgery (OR 0.996; 95% CI 0.995-0.997; P < 0.0001 and increased mortality (HR 1.002; 95% CI 1.001-1.002; P < 0.0001). Patients < 65 years were more sensitive to variation in SVI. CONCLUSIONS: Increased social vulnerability was associated with reduced odds of receiving surgery for early-stage colon cancer as well as increased mortality. These findings amplify the need for policy changes at the local, state, and federal level to address community-level vulnerability to improve access to surgical care and reduce mortality.

Effect of Hospital Cancer Designation on use of Multimodal Therapy and Survival of Metastatic Colorectal Cancer: A State-Wide Analysis.

BACKGROUND: Stage IV colorectal cancer (CRC) often requires multidisciplinary approach. However, multimodal treatment options (receipt of > 1 type of treatment) may not be uniformly delivered across health systems. We characterized the association between center-level cancer center designation and receipt of multimodal treatment and survival. METHODS: The Texas Cancer Registry was used to identify patients diagnosed with stage IV CRC from 2004-2017. We identified those who received care at either: a National Cancer Institute-designated (NCI-D), an American College of Surgeons-Commission on Cancer-designated (ACS-D), or an undesignated facility. We used multivariable logistic regression and Cox regression for analysis to assess receipt of one or more treatment modality and 5-year overall survival. RESULTS: Of 19,355 patients with stage IV CRC, 2955 (15%) received care at an NCI-D facility and 5871 (30%) received multimodal therapy. Both NCI-D (odds ratio [OR] 1.64; 95% confidence interval [CI] 1.49-1.81) and ACS-D (OR 1.37; 95% CI 1.27-1.48) were associated with increased likelihood of multimodal therapy compared with undesignated centers. NCI-D also was associated with significantly improved survival (hazard ratio [HR] 0.74; 95% CI 0.70-0.78), although ACS-D was associated with a modest improvement in survival (HR 0.95; 95% CI 0.92-0.99). Receipt of multimodal therapy was strongly associated with improved survival (HR 0.61; 95% CI 0.59-0.63). CONCLUSIONS: In patients with stage IV CRC, treatment at ACS-D and NCI-D facilities was associated with increased use of multimodality therapy and improved survival. However, only a small proportion of patients have access to these specialized centers, highlighting a need for expanded access to multimodal therapies at other centers.

Are care experiences associated with survival among cancer patients? An analysis of the SEER-CAHPS data resource.

PURPOSE: Cancer patients' care experiences encompass the range of interactions with the health care system and are an important indicator of care quality, which may influence survival outcomes. This study evaluates relationships between care experiences and survival using a large, nationally representative sample of cancer patients. METHODS: We used linked SEER (Surveillance Epidemiology and End Results)-CAHPS (Consumer Assessment of Healthcare Providers and Systems) data to identify people diagnosed 8/2006-12/2013, focusing on 10 solid tumor cancer sites with the highest mortality rates among those > 65. CAHPS measures included 5 global ratings and 3 composite scores. We used survey-weighted Cox proportional hazard models comparing survival time for those who had lower (0-8) vs higher ratings (9-10) and lower (0-89) vs higher (90-100) composite scores, adjusting for case-mix and additional covariates. RESULTS: We identified 2,263 eligible people; 26% died by 5-year post-survey completion or end of follow-up (12/31/2017). We found lower Prescription Drug Plan (PDP) ratings were significantly associated with lower mortality (adjusted HR = 0.67, p = 0.03). Lower Getting Needed Care scores were also significantly associated with lower mortality (adjusted HR = 0.79, p = 0.04). For other care experience measures, general health status, cancer stage, and comorbidities were more predictive of survival (p < .05). CONCLUSIONS: Except for PDP and Getting Needed Care, survival was similar for those with worse versus better care experiences. Patients with poorer cancer prognoses may perceive better services from their drug plan and more responsive care from clinical providers compared to those with better prognoses. Further research is needed examining processes underlying perceptions of care experiences and survival.

The influence of formal and informal policies and practices on health care innovation implementation: A mixed-methods analysis.

BACKGROUND: The implementation science literature has contributed important insights regarding the influence of formal policies and practices on health care innovation implementation, whereas informal implementation policies and practices have garnered little attention. The broader literature suggests that informal implementation policies and practices could also influence innovation use. PURPOSE: We used the Organizational Theory of Innovation Implementation to further understand the role of formal and informal implementation policies and practices as determinants of implementation effectiveness. We examined their role within the context of initiatives to increase palliative care consultation in inpatient oncology. METHODS: We used a case study design in two organizational settings within one academic medical center: medical and gynecologic oncology. We completed semistructured interviews with medical (n = 12) and gynecologic (n = 10) oncology clinicians using questions based on organizational theory. Quantitative data assessed implementation effectiveness, defined as aggregated palliative care consult rates within oncology services from 2010 to 2016. Four palliative care clinicians were interviewed to gain additional implementation context insights. RESULTS: Medical oncology employed multiple formal policies and practices including training and clinician prompting to support palliative care consultation and a top-down approach, yet most clinicians were unaware of the policies and practices, contributing to a weak implementation climate. In contrast, gynecologic oncology employed one formal policy (written guideline of criteria for initiating a consult) but also relied on informal policies and practices, such as spontaneous feedback and communication; they adopted a bottom-up approach, contributing to broader clinician awareness and strong implementation climate. Both services exhibited variable, increasing consult rates over time. PRACTICE IMPLICATIONS: Informal policies and practices may compensate or substitute for formal policies and practices under certain conditions (e.g., smaller health care organizations). Further research is needed to investigate the role of formal and informal policies and practices in shaping a strong and sustainable implementation climate and subsequent effective innovation implementation.

Meausures of organizational characteristics associated with adoption and/or implementation of innovations: A systematic review.

BACKGROUND: This paper identifies and describes measures of constructs relevant to the adoption or implementation of innovations (i.e., new policies, programs or practices) at the organizational-level. This work is intended to advance the field of dissemination and implementation research by aiding scientists in the identification of existing measures and highlighting methodological issues that require additional attention. METHODS: We searched for published studies (1973-2013) in 11 bibliographic databases for quantitative, empirical studies that presented outcome data related to adoption and/or implementation of an innovation. Included studies had to assess latent constructs related to the "inner setting" of the organization, as defined by the Consolidated Framework for Implementation Research. RESULTS: Of the 76 studies included, most (86%) were cross sectional and nearly half (49%) were conducted in health care settings. Nearly half (46%) involved implementation of evidence-based or "best practice" strategies; roughly a quarter (26%) examined use of new technologies. Primary outcomes most often assessed were innovation implementation (57%) and adoption (34%); while 4% of included studies assessed both outcomes. There was wide variability in conceptual and operational definitions of organizational constructs. The two most frequently assessed constructs included "organizational climate" and "readiness for implementation." More than half (55%) of the studies did not articulate an organizational theory or conceptual framework guiding the inquiry; about a third (34%) referenced Diffusion of Innovations theory. Overall, only 46% of articles reported psychometric properties of measures assessing latent organizational characteristics. Of these, 94% (33/35) described reliability and 71% (25/35) reported on validity. CONCLUSIONS: The lack of clarity associated with construct definitions, inconsistent use of theory, absence of standardized reporting criteria for implementation research, and the fact that few measures have demonstrated reliability or validity were among the limitations highlighted in our review. Given these findings, we recommend that increased attention be devoted toward the development or refinement of measures using common psychometric standards. In addition, there is a need for measure development and testing across diverse settings, among diverse population samples, and for a variety of types of innovations.

The Relationship Between Cancer Survivors' Socioeconomic Status and Reports of Follow-up Care Discussions with Providers.

Socioeconomically disadvantaged cancer survivors are less likely to have adequate follow-up care. In this study, we examined whether socioeconomically disadvantaged survivors are at risk for not having follow-up care discussions with providers, a critical determinant of access to follow-up care and desirable health outcomes. Using the 2011 Medical Expenditure Panel Survey and Experiences with Cancer Survivorship Supplement, we used a binary logit model with sample weights to examine associations between 1320 cancer survivors' socioeconomic status (SES) and reports of follow-up care discussions with providers, controlling for clinical and demographic characteristics. The multivariable model indicated survivors with incomes ≤200 % Federal Poverty Level (FPL) had a lower probability of reporting a follow-up care discussion than survivors with incomes >400 % FPL (p < 0.05). Survivors with less than high school education had a lower probability of reporting a discussion than survivors who had a college education or greater (p < 0.05). However, even after controlling for income, survivors with financial hardship had a greater probability of reporting a discussion than survivors with no financial hardship (p < 0.05). Insurance status was not a significant predictor of reporting a discussion (p > 0.05). Socioeconomically disadvantaged cancer survivors are at risk for not having follow-up care discussions with providers, particularly those who report lower income and education. The development of educational interventions targeting provider communication with socioeconomically disadvantaged cancer survivors, and survivors' understanding of the benefits of follow-up care discussions, may promote access to these services. Future research assessing mechanisms underlying relationships between survivors' SES indicators and reports of follow-up care discussions with providers is also warranted.

Perceptions of Cancer Clinical Research Among African American Men in North Carolina.

ACKNOWLEDGEMENTS: The authors are grateful to the men and women who participated in our Focus Groups and shared with us their very personal cancer experience. Their insight is valuable, and will inform and improve cancer care for future generations. The authors thank the Greensboro area Community Research Advocates - especially April Durr, Elvira Mebane, Marie McAdoo, Kathy Norcott, and Cindy Taylor - who assisted in the conduct of the study, including interpretation of results. They also thank Gratia Wright of First Research Group for her expertise in moderating and executing all of the focus groups, and Lindsey Haynes-Maslow for her assistance in responding to reviewer comments. The study was funded as a part of the Carolina Community Network program, funded by a grant from the National Cancer Institute (U01-CA114629). This study was reviewed and approved by the Institutional Review Board (IRB) at the University of North Carolina at Chapel Hill. OBJECTIVE: The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing state-of-the-art care to the broader community, where most cancer care is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden. DESIGN: This study applied community-based participatory research (CBPR) methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina. RESULTS: Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research: signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this misunderstanding as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment. CONCLUSION: Findings indicate the importance of clinical trial education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trial information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in improving patient-physician communication through culturally competent terminology and trial referral systems.

Implementation of Health IT for Cancer Screening in US Primary Care: Scoping Review.

BACKGROUND: A substantial percentage of the US population is not up to date on guideline-recommended cancer screenings. Identifying interventions that effectively improve screening rates would enhance the delivery of such screening. Interventions involving health IT (HIT) show promise, but much remains unknown about how HIT is optimized to support cancer screening in primary care. OBJECTIVE: This scoping review aims to identify (1) HIT-based interventions that effectively support guideline concordance in breast, cervical, and colorectal cancer screening provision and follow-up in the primary care setting and (2) barriers or facilitators to the implementation of effective HIT in this setting. METHODS: Following scoping review guidelines, we searched MEDLINE, CINAHL Plus, Web of Science, and IEEE Xplore databases for US-based studies from 2015 to 2021 that featured HIT targeting breast, colorectal, and cervical cancer screening in primary care. Studies were dual screened using a review criteria checklist. Data extraction was guided by the following implementation science frameworks: the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework; the Expert Recommendations for Implementing Change taxonomy; and implementation strategy reporting domains. It was also guided by the Integrated Technology Implementation Model that incorporates theories of both implementation science and technology adoption. Reporting was guided by PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). RESULTS: A total of 101 studies met the inclusion criteria. Most studies (85/101, 84.2%) involved electronic health record-based HIT interventions. The most common HIT function was clinical decision support, primarily used for panel management or at the point of care. Most studies related to HIT targeting colorectal cancer screening (83/101, 82.2%), followed by studies related to breast cancer screening (28/101, 27.7%), and cervical cancer screening (19/101, 18.8%). Improvements in cancer screening were associated with HIT-based interventions in most studies (36/54, 67% of colorectal cancer-relevant studies; 9/14, 64% of breast cancer-relevant studies; and 7/10, 70% of cervical cancer-relevant studies). Most studies (79/101, 78.2%) reported on the reach of certain interventions, while 17.8% (18/101) of the included studies reported on the adoption or maintenance. Reported barriers and facilitators to HIT adoption primarily related to inner context factors of primary care settings (eg, staffing and organizational policies that support or hinder HIT adoption). Implementation strategies for HIT adoption were reported in 23.8% (24/101) of the included studies. CONCLUSIONS: There are substantial evidence gaps regarding the effectiveness of HIT-based interventions, especially those targeting guideline-concordant breast and colorectal cancer screening in primary care. Even less is known about how to enhance the adoption of technologies that have been proven effective in supporting breast, colorectal, or cervical cancer screening. Research is needed to ensure that the potential benefits of effective HIT-based interventions equitably reach diverse primary care populations.

Creation of an Inflammatory Bowel Disease Referral Pathway for Identifying Patients Who Would Benefit From Inflammatory Bowel Disease Specialist Consultation.

BACKGROUND: Recommendations regarding signs and symptoms that should prompt referral of patients with inflammatory bowel disease (IBD) to an IBD specialist for a consultation could serve to improve the quality of care for these patients. Our aim was to develop a consult care pathway consisting of clinical features related to IBD that should prompt appropriate consultation. METHODS: A scoping literature review was performed to identify clinical features that should prompt consultation with an IBD specialist. A panel of 11 experts was convened over 4 meetings to develop a consult care pathway using the RAND/UCLA Appropriateness Method. Items identified via scoping review were ranked and were divided into major and minor criteria. Additionally, a literature and panel review was conducted assessing potential barriers and facilitators to implementing the consult care pathway. RESULTS: Of 43 features assessed, 13 were included in the care pathway as major criteria and 15 were included as minor criteria. Experts agreed that stratification into major criteria and minor criteria was appropriate and that 1 major or 2 or more minor criteria should be required to consider consultation. The greatest barrier to implementation was considered to be organizational resource allocation, while endorsements by national gastroenterology and general medicine societies were considered to be the strongest facilitator. CONCLUSIONS: This novel referral care pathway identifies key criteria that could be used to triage patients with IBD who would benefit from IBD specialist consultation. Future research will be required to validate these findings and assess the impact of implementing this pathway in routine IBD-related care.

This study aimed to develop a care pathway consisting of clinical features that should prompt inflammatory bowel disease expert consultation. A scoping literature review was performed to identify attributes, and an expert panel finalized the structure and components of the pathway.

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.

BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

Systematic symptom management in the IMPACT Consortium: rationale and design for 3 effectiveness-implementation trials.

Cancer and its treatment produce deleterious symptoms across the phases of care. Poorly controlled symptoms negatively affect quality of life and result in increased health-care needs and hospitalization. The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium was created to develop 3 large-scale, systematic symptom management systems, deployed through electronic health record platforms, and to test them in pragmatic, randomized, hybrid effectiveness and implementation trials. Here, we describe the IMPACT Consortium's conceptual framework, its organizational components, and plans for evaluation. The study designs and lessons learned are highlighted in the context of disruptions related to the COVID-19 pandemic.

A multilevel mHealth intervention boosts adherence to hydroxyurea in individuals with sickle cell disease.

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSß0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials.

BACKGROUND: The Institute of Medicine (IOM) has recommended that each person with cancer should have access to clinical trials, which have been associated with improving care quality and disparities. With no effective enrollment monitoring system, patterns of trial enrollment remain unclear. PURPOSE: We developed a population-based, statewide system designed to facilitate monitoring of cancer trial enrollment and targeting of future interventions to improve it. METHODS: Person-level cancer incidence data from the North Carolina Central Cancer Registry (NCCCR), person-level treatment trial accrual data from the National Cancer Institute (NCI), and county-level Area Resource Files (ARF) measures for 12 years, 1996-2007, were studied. Deidentified person-level data necessitated county-level analysis. Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for each race, gender, year, and county combination. Multivariable analysis examined factors associated with trial accrual. Sensitivity analyses examined spurious fluctuations and temporal discordance of incidence and enrollment. RESULTS: The NCI treatment trial enrollment rate was 2.39% for whites and 2.20% for minorities from 1996 to 2007, and 2.88% and 2.47%, respectively, from 2005 to 2007. Numerous counties had no minority enrollment. The 2005-2007 enrollment rates for white and minority females was 4.04% and 3.59%, respectively, and for white and minority males was 1.74% and 1.36%, respectively. Counties with a medical school or NCI Community Clinical Oncology Program (CCOP)-affiliated practice had higher trial enrollment. LIMITATIONS: We examined NCI trial accrual only - industry-sponsored and investigator-initiated trials were excluded; however, studies comprise the majority of all clinical trial participants. Delays in data availability may hinder the immediacy of population-based analyses. CONCLUSIONS: Model stability and consistency suggest that this system is effective for population-based enrollment surveillance. For North Carolina, it suggests a worsening disparity in minority trial enrollment, though our analyses elucidate targets for intervention. Regional enrollment variation suggests the importance of access to clinical research networks and infrastructure. Substantial gender differences merit further examination.

Identification of Uncontrolled Symptoms in Cancer Patients Using Natural Language Processing.

CONTEXT: For patients with cancer, uncontrolled pain and other symptoms are the leading cause of unplanned hospitalizations. Early access to specialty palliative care (PC) is effective to reduce symptom burden, but more efficient approaches are needed for rapid identification and referral. Information on symptom burden largely exists in free-text notes, limiting its utility as a trigger for best practice alerts or automated referrals. OBJECTIVES: To evaluate whether natural language processing (NLP) can be used to identify uncontrolled symptoms (pain, dyspnea, or nausea/vomiting) in the electronic health record (EHR) among hospitalized cancer patients with advanced disease. METHODS: The dataset included 1,644 hospitalization encounters for cancer patients admitted from 1/2017 -6/2019. We randomly sampled 296 encounters, which included 15,580 clinical notes. We manually reviewed the notes and recorded symptom severity. The primary endpoint was an indicator for whether a symptom was labeled as "controlled" (none, mild, not reported) or as "uncontrolled" (moderate or severe). We randomly split the data into training and test sets and used the Random Forest algorithm to evaluate final model performance. RESULTS: Our models predicted presence of an uncontrolled symptom with the following performance: pain with 61% accuracy, 69% sensitivity, and 46% specificity (F1: 69.5); nausea/vomiting with 68% accuracy, 21% sensitivity, and 90% specificity (F1: 29.4); and dyspnea with 80% accuracy, 22% sensitivity, and 88% specificity (F1: 21.1). CONCLUSION: This study demonstrated initial feasibility of using NLP to identify hospitalized cancer patients with uncontrolled symptoms. Further model development is needed before these algorithms could be implemented to trigger early access to PC.

Impact of the COVID-19 Pandemic on the Implementation of Mobile Health to Improve the Uptake of Hydroxyurea in Patients With Sickle Cell Disease: Mixed Methods Study.

BACKGROUND: Hydroxyurea therapy is effective for reducing complications related to sickle cell disease (SCD) and is recommended by National Health Lung and Blood Institute care guidelines. However, hydroxyurea is underutilized, and adherence is suboptimal. We wanted to test a multilevel mobile health (mHealth) intervention to increase hydroxyurea adherence among patients and improve prescribing among providers in a multicenter clinical trial. In the first 2 study sites, participants were exposed to the early phases of the COVID-19 pandemic, which included disruption to their regular SCD care. OBJECTIVE: We aimed to describe the impact of the COVID-19 pandemic on the implementation of an mHealth behavioral intervention for improving hydroxyurea adherence among patients with SCD. METHODS: The first 2 sites initiated enrollment 3 months prior to the start of the pandemic (November 2019 to March 2020). During implementation, site A clinics shut down for 2 months and site B clinics shut down for 9 months. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to evaluate the implementation and effectiveness of the intervention. mHealth implementation was assessed based on patients' daily app use. Adherence to hydroxyurea was calculated as the proportion of days covered (PDC) from prescription records over the first 12 and 24 weeks after implementation. A linear model examined the relationship between app usage and PDC change, adjusting for baseline PDC, lockdown duration, and site. We conducted semistructured interviews with patients, health care providers, administrators, and research staff to identify factors associated with mHealth implementation and effectiveness. We used a mixed methods approach to investigate the convergence of qualitative and quantitative findings. RESULTS: The percentage of patients accessing the app decreased after March 15, 2020 from 86% (n=55) to 70% (n=45). The overall mean PDC increase from baseline to week 12 was 4.5% (P=.32) and to week 24 was 1.5% (P=.70). The mean PDC change was greater at site A (12 weeks: 20.9%; P=.003; 24 weeks: 16.7%; P=.01) than site B (12 weeks: -8.2%; P=.14; 24 weeks: -10.3%; P=.02). After adjustment, PDC change was 13.8% greater in those with increased app use after March 15, 2020. Interview findings indicated that site B's closure during COVID-19 had a greater impact, but almost all patients reported that the InCharge Health app helped support more consistent medication use. CONCLUSIONS: We found significant impacts of the early clinic lockdowns, which reduced implementation of the mHealth intervention and led to reduced patient adherence to hydroxyurea. However, disruptions were lower among participants who experienced shorter clinic lockdowns and were associated with higher hydroxyurea adherence. Investigation of added strategies to mitigate the effects of care interruptions during major emergencies (eg, patient coaching and health navigation) may "insulate" the implementation of interventions to increase medication adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16319.

Identifying barriers to evidence-based care for sickle cell disease: results from the Sickle Cell Disease Implementation Consortium cross-sectional survey of healthcare providers in the USA.

OBJECTIVES: Sickle cell disease (SCD) leads to chronic and acute complications that require specialised care to manage symptoms and optimise clinical results. The National Heart Lung and Blood Institute (NHLBI) evidence-based guidelines assist providers in caring for individuals with SCD, but adoption of these guidelines by providers has not been optimal. The objective of this study was to identify barriers to treating individuals with SCD. METHODS: The SCD Implementation Consortium aimed to investigate the perception and level of comfort of providers regarding evidence-based care by surveying providers in the regions of six clinical centres across the USA, focusing on non-emergency care from the providers' perspective. RESULTS: Respondents included 105 providers delivering clinical care for individuals with SCD. Areas of practice were most frequently paediatrics (24%) or haematology/SCD specialist (24%). The majority (77%) reported that they were comfortable managing acute pain episodes while 63% expressed comfort with managing chronic pain. Haematologists and SCD specialists showed higher comfort levels prescribing opioids (100% vs 67%, p=0.004) and managing care with hydroxyurea (90% vs 51%, p=0.005) compared with non-haematology providers. Approximately 33% of providers were unaware of the 2014 NHLBI guidelines. Nearly 63% of providers felt patients' medical needs were addressed while only 22% felt their mental health needs were met. CONCLUSIONS: A substantial number of providers did not know about NHLBI's SCD care guidelines. Barriers to providing care for patients with SCD were influenced by providers' specialty, training and practice setting. Increasing provider knowledge could improve hydroxyurea utilisation, pain management and mental health support.

Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study.

BACKGROUND: Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. OBJECTIVE: This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. METHODS: We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. RESULTS: The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. CONCLUSIONS: If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16319.

External validity of the cardiovascular health study: a comparison with the Medicare population.

BACKGROUND: The Cardiovascular Health Study (CHS), a population-based prospective cohort study, has been used to identify major risk factors associated with cardiovascular disease and stroke in the elderly. OBJECTIVE: To assess the external validity of the CHS. RESEARCH DESIGN: Comparison of the CHS cohort to a national cohort of Medicare beneficiaries and to Medicare beneficiaries residing in the CHS geographic regions. SUBJECTS: CHS participants and a 5% sample of Medicare beneficiaries. MEASURES: Demographic and administrative characteristics, comorbid conditions, resource use, and mortality. RESULTS: Compared with both Medicare cohorts, the CHS cohort was older and included more men and African American participants. CHS participants were more likely to be enrolled in Medicare managed care than beneficiaries in the national Medicare cohort. Compared with the Medicare cohorts, mortality in the CHS was more than 40% lower at 1 year, approximately 25% lower at 5 years, and approximately 15% lower at 10 years. There were minimal differences in comorbid conditions and health care resource use. CONCLUSION: The CHS cohort is comparable with the Medicare population, particularly with regard to comorbid conditions and resource use, but had lower mortality. The difference in mortality may reflect the CHS recruitment strategy or volunteer bias. These findings suggest it may not be appropriate to project absolute rates of disease and outcomes based on CHS data to the entire Medicare population. However, there is no reason to expect that the relative risks associated with physiologic processes identified by CHS data would differ for nonparticipants.

The impact of two triggered palliative care consultation approaches on consult implementation in oncology.

INTRODUCTION: Studies show palliative care delivered concurrently with cancer treatment improves outcomes, yet palliative care integration with inpatient oncology is underused. A promising approach to improve integration is a triggered palliative care consultation (TPCC). This study evaluated the impact of two TPCC approaches on consistency and quality of consult implementation, operationalized as uptake and timeliness, on solid tumor medical and gynecologic oncology services at an academic hospital. METHODS: The study timeframe was 2010-2016. TPCC in gynecologic oncology began in 2014 and was supported by a single strategy (written guideline); TPCC in medical oncology began in 2015 and was supported by multiple strategies (e.g. training, chart review). Palliative care consult information was chart abstracted and linked to hospital encounter data. We compared the effect of a single strategy vs. usual care, and multiple strategies vs. a single strategy on implementation. Difference-in-differences modified Poisson regression models evaluated whether implementation differed after TPCC; we estimated adjusted relative risk (aRR), controlling for patient demographic and clinical characteristics. RESULTS: Overall, 8.8% of medical oncology and 11.0% of gynecologic oncology inpatient encounters involved palliative care consultation. In regression analyses, TPCC supported by a single strategy in gynecologic oncology was associated with greater uptake vs. usual care (aRR: 1.45, p < .05), and TPCC supported by multiple strategies in medical oncology was associated with greater uptake vs. a single strategy (aRR: 2.34, p < .001). CONCLUSION: Across two inpatient oncology services, TPCC supported by multiple strategies had the greatest impact on uptake. How strategies affect sustained use of palliative care consults remains to be investigated.