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BACKGROUND: serious illness conversations (SIC), particularly for persons living with cognitive impairment (PLCI), inconsistently happen in primary care. Pragmatic, scalable strategies are needed to promote SIC for PLCI. DESIGN: Pragmatic, prospective single-arm pilot study that occurred between July 1, 2021 and May 30, 2022 across seven primary care practices in North Carolina. PARTICIPANTS: Community-dwelling patients aged 65 and older with known or probable mild cognitive impairment or dementia (with decision-making capacity) and their care partners (if available). INTERVENTION: SIC telehealth intervention (TeleVoice) via video or telephone to assist PLCI in discussing their current goals, values, and future medical preferences, while facilitating documentation within the EHR. MAIN OUTCOMES: Main feasibility outcomes included reach/enrollment, intervention completion, and adoption rates at the clinic and provider level. Primary effectiveness outcomes included SIC documentation and quality within the EHR and usage of advance care planning billing (ACP) codes. RESULTS: Of the 163 eligible PLCI approached, 107 (66%) enrolled (mean age 83.7 years, 68.2% female, 16.8% Black, 22% living in a geographic area of high socioeconomic disadvantage) and 81 (76%) completed the SIC telehealth intervention; 45 care partners agreed to participate (mean age 71.5 years, 80% female). Adoption at clinic level was 50%, while 75% of providers within these clinics participated. Among PLCI that completed the intervention, SIC documentation and usage of ACP billing codes was 100% and 96%, respectively, with 96% (n = 78) having high-quality SIC documentation. No significant differences were observed between telephone and video visits. CONCLUSION: These findings provide preliminary evidence to support the feasibility of conducting SICs through telehealth to specifically meet the needs of community-dwelling PLCI. Further investigation of the sustainability of the intervention and its long-term impact on patient and caregiver outcomes is needed.
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PURPOSE: Healthy cancer survivorship involves patients' active engagement with preventative health behaviors and follow-up care. While clinicians and patients have typically held dual responsibility for activating these behaviors, transitioning some clinician effort to technology and health coaches may enhance guideline implementation. This paper reports on the acceptability of the Shared Healthcare Actions & Reflections Electronic systems in survivorship (SHARE-S) program, an entirely virtual multicomponent intervention incorporating e-referrals, remotely-delivered health coaching, and automated text messages to enhance patient self-management and promote healthy survivorship. METHODS: SHARE-S was evaluated in single group hybrid implementation-effectiveness pilot study. Patients were e-referred from the clinical team to health coaches for three health self-management coaching calls and received text messages to enhance coaching. Semi-structured qualitative interviews were conducted with 21 patient participants, 2 referring clinicians, and 2 health coaches to determine intervention acceptability (attitudes, appropriateness, suitability, convenience, and perceived effectiveness) and to identify important elements of the program and potential mechanisms of action to guide future implementation. RESULTS: SHARE-S was described as impactful and convenient. The nondirective, patient-centered health coaching and mindfulness exercises were deemed most acceptable; text messages were less acceptable. Stakeholders suggested increased flexibility in format, frequency, timing, and length of participation, and additional tailored educational materials. Patients reported tangible health behavior changes, improved mood, and increased accountability and self-efficacy. CONCLUSIONS: SHARE-S is overall an acceptable and potentially effective intervention that may enhance survivors' self-management and well-being. Alterations to tailored content, timing, and dose should be tested to determine impact on acceptability and outcomes.
Subject(s)
Cancer Survivors , Mentoring , Qualitative Research , Humans , Female , Male , Middle Aged , Cancer Survivors/psychology , Mentoring/methods , Aged , Pilot Projects , Survivorship , Adult , Neoplasms/therapy , Neoplasms/psychology , Self-Management/methods , Text Messaging , Patient Acceptance of Health Care/psychology , Health Behavior , TelemedicineABSTRACT
BACKGROUND: Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients. METHODS: An unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients' all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients). DISCUSSION: Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers. TRIAL REGISTRATION: Clinicaltrials.gov NCT05828823. Registered on 25 April 2023.
Subject(s)
Multicenter Studies as Topic , Renal Dialysis , Humans , Treatment Outcome , Time Factors , Comparative Effectiveness Research , Randomized Controlled Trials as Topic , Equivalence Trials as Topic , United States , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/diagnosisABSTRACT
BACKGROUND: Numerous prior opinion papers, administrative electronic health record data studies, and cross-sectional surveys of telehealth during the pandemic have been published, but none have combined assessments of video visit success monitoring with longitudinal assessments of perceived challenges to the rapid adoption of video visits during the pandemic. OBJECTIVE: This study aims to quantify (1) the use of video visits (compared with in-person and telephone visits) over time during the pandemic, (2) video visit successful connection rates, and (3) changes in perceived video visit challenges. METHODS: A web-based survey was developed for the dual purpose of monitoring and improving video visit implementation in our health care system during the COVID-19 pandemic. The survey included questions regarding rates of in-person, telephone, and video visits for clinician-patient encounters; the rate of successful connection for video visits; and perceived challenges to video visits (eg, software, hardware, bandwidth, and technology literacy). The survey was distributed via email to physicians, advanced practice professionals, and clinicians in May 2020. The survey was repeated in March 2021. Differences between the 2020 and 2021 responses were adjusted for within-respondent correlation across surveys and tested using generalized estimating equations. RESULTS: A total of 1126 surveys were completed (511 surveys in 2020 and 615 surveys in 2021). In 2020, only 21.7% (73/336) of clinicians reported no difficulty connecting with patients during video visits and 28.6% (93/325) of clinicians reported no difficulty in 2021. The distribution of the percentage of successfully connected video visits ("Over the past two weeks of scheduled visits, what percentage did you successfully connect with patients by video?") was not significantly different between 2020 and 2021 (P=.74). Challenges in conducting video visits persisted over time. Poor connectivity was the most common challenge reported by clinicians. This response increased over time, with 30.5% (156/511) selecting it as a challenge in 2020 and 37.1% (228/615) in 2021 (P=.01). Patients not having access to their electronic health record portals was also a commonly reported challenge (109/511, 21.3% in 2020 and 137/615, 22.3% in 2021, P=.73). CONCLUSIONS: During the pandemic, our health care delivery system rapidly adopted synchronous patient-clinician communication using video visits. As experience with video visits increased, the reported failure rate did not significantly decline, and clinicians continued to report challenges related to general network connectivity and patient access to technology.
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COVID-19 , Communications Media , Humans , COVID-19/epidemiology , Pandemics , Cross-Sectional Studies , CommunicationSubject(s)
Child Health Services , Smoking Cessation , Child , Female , Pregnancy , Humans , Pregnant Women , Smoking/epidemiology , Tobacco SmokingABSTRACT
INTRODUCTION: Initial cancer survivorship care planning efforts focused on information sharing demonstrated limited impact on patient health outcomes. We designed the Shared Healthcare Actions & Reflections Electronic Systems in survivorship (SHARE-S) program to enhance survivorship guideline implementation by transitioning some effort from clinicians to technology and patients through supporting health self-management (e.g., healthy lifestyles). METHODS: We conducted a single-group hybrid implementation-effectiveness pilot study. SHARE-S incorporated three strategies: (1) e-referral from the clinical team for patient engagement, (2) three health self-management coach calls, and (3) text messages to enhance coaching. Our primary implementation measure was the proportion of patients e-referred who enrolled (target >30%). Secondary implementation measures assessed patient engagement. We also measured effectiveness by describing changes in patient health outcomes. RESULTS: Of the 118 cancer survivor patients e-referred, 40 engaged in SHARE-S (proportion enrolled = 34%). Participants had a mean age of 57.4 years (SD = 15.7), 73% were female, 23% were Black/African American, and 5 (12.5%) were from a rural location. Patient-level adherence to coach calls was >90%. Changes from baseline to follow-up showed at least a small effect (Cohen's d = 0.2) for improvements in: mindful attention, alcohol use, physical activity, fruit and vegetable intake, days of mindfulness practice, depressive symptoms, ability to participate in social roles and activities, cancer-specific quality of life, benefits of having cancer, and positive feelings. CONCLUSION: The SHARE-S program successfully engaged cancer survivor patients. Once enrolled, patients showed promising improvements in health outcomes. Supporting patient self-management is an important component of optimizing delivery of cancer survivorship care.
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Neoplasms , Survivorship , Humans , Female , Middle Aged , Male , Pilot Projects , Quality of Life , Neoplasms/therapy , Patient ParticipationABSTRACT
Many head acceleration events (HAEs) observed in youth football emanate from a practice environment. This study aimed to evaluate HAEs in youth football practice drills using a mouthpiece-based sensor, differentiating between inertial and direct HAEs. Head acceleration data were collected from athletes participating on 2 youth football teams (ages 11-13 y) using an instrumented mouthpiece-based sensor during all practice sessions in a single season. Video was recorded and analyzed to verify and assign HAEs to specific practice drill characteristics, including drill intensity, drill classification, and drill type. HAEs were quantified in terms of HAEs per athlete per minute and peak linear and rotational acceleration and rotational velocity. Mixed-effects models were used to evaluate the differences in kinematics, and generalized linear models were used to assess differences in HAE frequency between drill categories. A total of 3237 HAEs were verified and evaluated from 29 football athletes enrolled in this study. Head kinematics varied significantly between drill categorizations. HAEs collected at higher intensities resulted in significantly greater kinematics than lower-intensity drills. The results of this study add to the growing body of evidence informing evidence-based strategies to reduce head impact exposure and concussion risk in youth football practices.
Subject(s)
Brain Concussion , Football , Humans , Adolescent , Head , AccelerationABSTRACT
BACKGROUND: Clinical decision support (CDS) tools in electronic health records (EHRs) are often used as core strategies to support quality improvement programs in the clinical setting. Monitoring the impact (intended and unintended) of these tools is crucial for program evaluation and adaptation. Existing approaches for monitoring typically rely on health care providers' self-reports or direct observation of clinical workflows, which require substantial data collection efforts and are prone to reporting bias. OBJECTIVE: This study aims to develop a novel monitoring method leveraging EHR activity data and demonstrate its use in monitoring the CDS tools implemented by a tobacco cessation program sponsored by the National Cancer Institute's Cancer Center Cessation Initiative (C3I). METHODS: We developed EHR-based metrics to monitor the implementation of two CDS tools: (1) a screening alert reminding clinic staff to complete the smoking assessment and (2) a support alert prompting health care providers to discuss support and treatment options, including referral to a cessation clinic. Using EHR activity data, we measured the completion (encounter-level alert completion rate) and burden (the number of times an alert was fired before completion and time spent handling the alert) of the CDS tools. We report metrics tracked for 12 months post implementation, comparing 7 cancer clinics (2 clinics implemented the screening alert and 5 implemented both alerts) within a C3I center, and identify areas to improve alert design and adoption. RESULTS: The screening alert fired in 5121 encounters during the 12 months post implementation. The encounter-level alert completion rate (clinic staff acknowledged completion of screening in EHR: 0.55; clinic staff completed EHR documentation of screening results: 0.32) remained stable over time but varied considerably across clinics. The support alert fired in 1074 encounters during the 12 months. Providers acted upon (ie, not postponed) the support alert in 87.3% (n=938) of encounters, identified a patient ready to quit in 12% (n=129) of encounters, and ordered a referral to the cessation clinic in 2% (n=22) of encounters. With respect to alert burden, on average, both alerts fired over 2 times (screening alert: 2.7; support alert: 2.1) before completion; time spent postponing the screening alert was similar to completing (52 vs 53 seconds) the alert, and time spent postponing the support alert was more than completing (67 vs 50 seconds) the alert per encounter. These findings inform four areas where the alert design and use can be improved: (1) improving alert adoption and completion through local adaptation, (2) improving support alert efficacy by additional strategies including training in provider-patient communication, (3) improving the accuracy of tracking for alert completion, and (4) balancing alert efficacy with the burden. CONCLUSIONS: EHR activity metrics were able to monitor the success and burden of tobacco cessation alerts, allowing for a more nuanced understanding of potential trade-offs associated with alert implementation. These metrics can be used to guide implementation adaptation and are scalable across diverse settings.
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BACKGROUND: One-half of all people who undergo lung cancer screening (LCS) currently use tobacco. However, few published studies have explored how to implement effective tobacco use treatment optimally during the LCS encounter. RESEARCH QUESTION: Was the Optimizing Lung Screening intervention (OaSiS) effective at reducing tobacco use among patients undergoing LCS in community-based radiology facilities? STUDY DESIGN AND METHODS: The OaSiS study (National Cancer Institute [NCI] Protocol No.: WF-20817CD) is an effectiveness-implementation hybrid type II cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest National Cancer Institute Community Oncology Research Program research base. We randomly assigned 26 radiology facilities in 20 states to the intervention or usual care group. Staff at intervention facilities implemented a variety of strategies targeting the clinic and care team. Eligible patient participants were aged 55 to 77 years undergoing LCS and currently using tobacco. Of 1,094 who completed a baseline survey (523 intervention group, 471 control group) immediately before the LCS appointment, 956 completed the 6-month follow-up (86% retention rate). Fifty-four percent of those who reported not using tobacco at 6 months completed biochemical verification via mailed cotinine assay. Generalized estimating equation marginal models were used in an intention-to-treat analysis to predict 7-day tobacco use abstinence. RESULTS: The average self-reported abstinence among participants varied considerably across facilities (0%-27%). Despite a significant increase in average cessation rate over time (0% at baseline to approximately 13% at 6 months; P < .0001), tobacco use did not differ by trial group at 14 days (OR, 0.96; 95% CI, 0.46-1.99; P = .90), 3 months (OR, 1.17; 95% CI, 0.69-1.99; P = .56), or 6 months (OR, 0.97; 95% CI, 0.65-1.43; P = .87). INTERPRETATION: The OaSiS trial participants showed a significant reduction in tobacco use over time, but no difference by trial arm was found. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03291587; URL: www. CLINICALTRIALS: gov.
Subject(s)
Lung Neoplasms , Smoking Cessation , Tobacco Use Cessation , Humans , Smoking Cessation/methods , Early Detection of Cancer , Lung Neoplasms/diagnosis , LungABSTRACT
Purpose: Costs of Papanicolaou (Pap) tests and mammograms are a primary barrier for women aged 18-39 seeking screening and diagnostic services. Race/ethnicity and rural/border resident status compound their risks for delayed diagnosis, possibly resulting in higher mortality. Methods: We analyzed cross-sectional data from young adult (YA) women (aged 18-39) from a cancer education and patient navigation (PN) program in rural and border Texas from 2012 to 2016. Descriptive statistics, Chi-square tests, and logistic regressions summarized sociodemographic variables and receipt of PN, Pap tests, and mammograms. Results: The sample consisted of 1181 women aged 31.8 years (standard deviation 5.5) on average. A total of 795 (67.3%) received PN, 494 (41.8%) received a Pap test, and 121 (10.3%) received a mammogram. The YA women attending the program due to cost (odds ratio [OR]: 7.24; confidence interval [CI]: 4.74-11.05) and reporting 1 (OR: 3.84; CI: 2.40-6.14) or 2+ barriers (OR: 6.00; CI: 3.61-9.99) had higher odds of being navigated than those not concerned about cost and not identifying a barrier. The YA women attending due to cost (OR: 2.22, CI: 1.61-3.05) and receiving navigation (OR: 1.92; CI: 1.29-2.84) had higher odds of receiving a Pap test than their counterparts. The majority receiving a mammogram were worried about cost (85.1%); 40.5% had a family history of breast cancer, and a doctor or nurse recommended a mammogram for 15.7%. Conclusion: Detection of cervical and breast cancer in YA women residing in rural and border Texas may be improved with PN to assist with financial barriers to care and service coordination.
Subject(s)
Breast Neoplasms , Papanicolaou Test , Female , Young Adult , Humans , Texas , Vaginal Smears , Cross-Sectional Studies , Breast Neoplasms/diagnosisABSTRACT
Background: Patient portals can be an innovative and efficient way to engage patients in advance care planning (ACP). However, comprehension and judgment in older adults with cognitive impairment presents several barriers and challenges to engaging in new technology. Our objective was to develop an ACP portal-based tool (ACPVoice) for community-dwelling persons living with cognitive impairment (PLCI) by engaging end-users in the design process. Methods: Two rounds of cognitive interviews were conducted to identify and resolve cognitive issues related to comprehension, judgment, response, and to assess content validity. Purposive sampling was used with the goal of enrolling 15 different participants (five with mild cognitive impairment and five dyads (those with mild dementia and their care partner) in each round to assess respondents' understanding of questions related to advance care planning to be administered via the patient portal. Results: Twenty PLCI (mean age 78.4, 10 females [50%]) and ten care partners (mean age 60.9, 9 females [90%]) completed cognitive interviews between May 2021 and October 2021. The mean Mini-Mental State Examination score for PLCI was 25.6 (SD 2.6). Unclear wording and undefined vague and/or unfamiliar terms were the major issues identified. Revisions to item wording, response options, and instructions were made to improve question comprehension and response as well as navigational ease. Conclusion: Minor changes to the wording, format, and response options substantially improved respondents' ability to interpret the item content of the ACPVoice tool. Dissemination and implementation of the ACPVoice tool could help to engage community-dwelling PLCI in ACP discussions.
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Advance Care Planning , Cognitive Dysfunction , Dementia , Female , Humans , Aged , Independent Living , Cognitive Dysfunction/therapy , Dementia/psychologyABSTRACT
The National Cancer Institute's Implementation Science Centers in Cancer Control (ISC3) Network represents a large-scale initiative to create an infrastructure to support and enable the efficient, effective, and equitable translation of approaches and evidence-based treatments to reduce cancer risk and improve outcomes. This Cancer MoonshotSM-funded ISC3 Network consists of 7 P50 Centers that support and advance the rapid development, testing, and refinement of innovative approaches to implement a range of evidence-based cancer control interventions. The Centers were designed to have research-practice partnerships at their core and to create the opportunity for a series of pilot studies that could explore new and sometimes risky ideas and embed in their infrastructure a 2-way engagement and collaboration essential to stimulating lasting change. ISC3 also seeks to enhance capacity of researchers, practitioners, and communities to apply implementation science approaches, methods, and measures. The Organizing Framework that guides the work of ISC3 highlights a collective set of 3 core areas of collaboration within and among Centers, including to 1) assess and incorporate dynamic, multilevel context; 2) develop and conduct rapid and responsive pilot and methods studies; and 3) build capacity for knowledge development and exchange. Core operating principles that undergird the Framework include open collaboration, consideration of the dynamic context, and engagement of multiple implementation partners to advance pragmatic methods and health equity and facilitate leadership and capacity building across implementation science and cancer control.
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Implementation Science , Neoplasms , United States , Humans , National Cancer Institute (U.S.) , Delivery of Health Care , Neoplasms/therapy , Capacity Building/methodsABSTRACT
Understanding characteristics of head acceleration events (HAEs) in youth football is vital in developing strategies to improve athlete safety. This study aimed to characterize HAEs in youth football using an instrumented mouthpiece. Youth football athletes (ages 11-13) participating on two teams were enrolled in this study for one season. Each athlete was instrumented with a mouthpiece-based sensor throughout the season. HAEs were verified on film to ensure that mouthpiece-based sensors triggered during contact. The number of HAEs, peak resultant linear and rotational accelerations, and peak resultant rotational velocity were quantified. Mixed effects models were used to evaluate differences in mean kinematic metrics among all HAEs for session type, athlete position, and contact surface. A total of 5,292 HAEs were collected and evaluated from 30 athletes. The median (95th percentile) peak resultant linear acceleration, rotational acceleration, and rotational velocity was 9.5 g (27.0 g), 666.4 rad s-2 (1863.3 rad s-2), and 8.5 rad s-1 (17.4 rad s-1), respectively. Athletes experienced six (22) HAEs per athlete per session (i.e., practice, game). Competition had a significantly higher mean number of HAEs per athlete per session and mean peak rotational acceleration. Peak resultant rotational kinematics varied significantly among athlete positions. Direct head impacts had higher mean kinematics compared to indirect HAEs, from body collisions. The results of this study demonstrate that session type, athlete position, and contact surface (i.e., direct, indirect) may influence HAE exposure in youth football.
Subject(s)
Brain Concussion , Football , Soccer , Adolescent , Humans , Child , Head Protective Devices , Acceleration , Athletes , Biomechanical Phenomena , HeadABSTRACT
Based on the findings from the National Lung Screening Trial, the U.S. Preventive Services Task Force recommends annual low dose computed tomography (LDCT) lung cancer screening (LCS) among high-risk adults. Approximately 54% of individuals seeking LCS report current cigarette smoking. Effective smoking cessation interventions, offered at the time of LCS, enhances the health benefits of screening that are attributable to reductions in lung cancer overall and tobacco-related mortality. Considering these data, the Centers for Medicare & Medicaid Services' (CMS) 2015 decision to cover LCS with LDCT required that radiology imaging facilities make tobacco cessation interventions available for people who smoke. In February 2022, CMS reversed their 2015 coverage requirement for delivering tobacco use treatment at the time of LDCT; CMS retained the requirement for counseling during the shared decision-making visit prior to the exam. The policy change does not diminish the importance of offering high-quality tobacco cessation services in conjunction with routine LDCT for LCS. However, LCS programs face a range of barriers to implementing tobacco use treatment in their settings. As a result, implementation has lagged. Closing the "evidence to practice" gap is the focus of implementation science, a field that offers a set of rigorous methods and a systematic approach to identifying and overcoming contextual barriers to implementing evidence-based guidelines in a range of clinical settings. In this paper, we describe how implementation science frameworks and methods can be used to help guide LCS programs in their efforts to integrate tobacco use treatment and discuss policy changes needed to further facilitate the delivery of TUT as an essential component of the LCS process.
Lung cancer is the leading cause of cancer death in the United States. There is strong evidence, from a large number of international studies, that lung cancer screening for people who meet specific criteria, can reduce lung cancer-related deaths. Based on these findings, the Centers for Medicare and Medicaid decided to provide insurance coverage for lung cancer screening for eligible patients. This includes people aged 5080 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Over 50% of people who seek lung cancer screening report current cigarette smoking. Studies show that offering these smokers support to quit at the time of screening can further increase survival rates by reducing both deaths from lung cancer and other tobacco-related diseases. Unfortunately, lung cancer screening programs do not consistently provide effective treatments to help smokers quit. This is a missed opportunity to engage smokers in quitting when the health risk of tobacco use is most salient, and therefore smokers may be more willing to engage in tobacco use treatment. This paper provides detailed guidance on how programs can implement high quality tobacco use treatment services in conjunction with lung cancer screening.
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Lung Neoplasms , Smoking Cessation , Aged , Humans , United States , Early Detection of Cancer/methods , Lung Neoplasms/diagnosis , Implementation Science , Smoking Cessation/methods , Medicare , Tobacco Use/prevention & control , PolicyABSTRACT
Introduction: The National Cancer Institute Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight clinical trials testing smoking cessation interventions delivered with lung cancer screening (LCS). This investigation compared pooled participant baseline demographic and smoking characteristics of seven SCALE trials to LCS-eligible smokers in three U.S. nationally representative surveys. Methods: Baseline variables (age, sex, race, ethnicity, education, income, cigarettes per day, and time to the first cigarette) from 3614 smokers enrolled in SCALE trials as of September 2020 were compared with pooled data from the Tobacco Use Supplement-Current Population Survey (2018-2019), National Health Interview Survey (2017-2018), and Population Assessment of Tobacco and Health (wave 4, 2016-2017) using the U.S. Preventive Services Task Force 2013 (N = 4803) and 2021 (N = 8604) LCS eligibility criteria. Results: SCALE participants have similar average age as the U.S. LCS-eligible smokers using the 2013 criteria but are 2.8 years older using the 2021 criteria (p < 0.001). SCALE has a lower proportion of men, a higher proportion of Blacks, and slightly higher education and income levels than national surveys (p < 0.001). SCALE participants smoke an average of 17.9 cigarettes per day (SD 9.2) compared with 22.4 (SD 9.3) using the 2013 criteria and 19.6 (SD 9.7) using the 2021 criteria (p < 0.001). The distribution of time to the first cigarette differs between SCALE and the national surveys (p < 0.001), but both indicate high levels of nicotine dependence. Conclusions: SCALE participants smoke slightly less than the LCS-eligible smokers in the general population, perhaps related to socioeconomic status or race. Other demographic variables reveal small but statistically significant differences, likely of limited clinical relevance with respect to tobacco treatment outcomes. SCALE trial results should be applicable to LCS-eligible smokers from the U.S. population.
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BACKGROUND: Informed decision aids provide information in the context of the patient's values and improve informed decision making (IDM). To overcome barriers that interfere with IDM, our team developed an innovative iPad-based application (aka "app") to help patients make informed decisions about colorectal cancer screening. The app assesses patients' eligibility for screening, educates them about their options, and empowers them to request a test via the interactive decision aid. OBJECTIVE: The aim of the study is to explore how informed decision aids can be implemented successfully in primary care clinics, including the facilitators and barriers to implementation; strategies for minimizing barriers; adequacy of draft training materials; and any additional support or training desired by clinics. DESIGN: This work deals with a multicenter qualitative study in rural and urban settings. PARTICIPANTS: A total of 48 individuals participated including primary care practice managers, clinicians, nurses, and front desk staff. APPROACH: Focus groups and semi-structured interviews, with data analysis were guided by thematic analysis. KEY RESULTS: Salient emergent themes were time, workflow, patient age, literacy, and electronic health record (EHR) integration. Saving time was important to most participants. Patient flow was a concern for all clinic staff, and they expressed that any slowdown due to patients using the iPad module or perceived additional work to clinic staff would make staff less motivated to use the program. Participants voiced concern about older patients being unwilling or unable to utilize the iPad and patients with low literacy ability being able to read or comprehend the information. CONCLUSION: Integrating new IDM apps into the current clinic workflow with minimal disruptions would increase the probability of long-term adoption and ultimate sustainability. NIH TRIAL REGISTRY NUMBER: R01CA218416-A1.
Subject(s)
Decision Making , Mass Screening , Focus Groups , Humans , Primary Health Care , Qualitative ResearchABSTRACT
Background Food insecurity (FI) has been associated with an increased atherosclerotic cardiovascular disease (ASCVD) risk; however, the pathways by which FI leads to worse cardiovascular health are unknown. We tested the hypothesis that FI is associated with ASCVD risk through nutritional/anthropometric (eg, worse diet quality and increased weight), psychological/mental health (eg, increased depressive symptoms and risk of substance abuse), and access to care pathways. Methods and Results We conducted a cross-sectional study of adults (aged 40-79 years) using the 2007 to 2016 National Health and Nutrition Examination Survey. Our primary exposure was household FI, and our outcome was 10-year ASCVD risk categorized as low (<5%), borderline (≥5% -<7.5%), intermediate (≥7.5%-<20%), and high risk (≥20%). We used structural equation modeling to evaluate the pathways and multiple mediation analysis to determine direct and indirect effects. Of the 12 429 participants, 2231 (18.0%) reported living in a food-insecure household; 5326 (42.9%) had a low ASCVD risk score, 1402 (11.3%) borderline, 3606 (29.0%) intermediate, and 2095 (16.9%) had a high-risk score. In structural models, we found significant path coefficients between FI and the nutrition/anthropometric (ß, 0.130; SE, 0.027; P<0.001), psychological/mental health (ß, 0.612; SE, 0.043; P<0.001), and access to care (ß, 0.110; SE, 0.036; P=0.002) pathways. We did not find a significant direct effect of FI on ASCVD risk, and the nutrition, psychological, and access to care pathways accounted for 31.6%, 43.9%, and 15.8% of the association, respectively. Conclusions We found that the association between FI and ASCVD risk category was mediated through the nutrition/anthropometric, psychological/mental health, and access to care pathways. Interventions that address all 3 pathways may be needed to mitigate the negative impact of FI on cardiovascular disease.
Subject(s)
Atherosclerosis , Cardiovascular Diseases , Adult , Aged , Atherosclerosis/diagnosis , Atherosclerosis/epidemiology , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cross-Sectional Studies , Food Insecurity , Food Supply , Humans , Middle Aged , Nutrition Surveys , Risk FactorsABSTRACT
Importance: Advance care planning (ACP), especially among vulnerable older adults, remains underused in primary care. Additionally, many ACP initiatives fail to integrate directly into the electronic health record (EHR), resulting in infrequent and disorganized documentation. Objective: To determine whether a nurse navigator-led ACP pathway combined with a health care professional-facing EHR interface improves the occurrence of ACP discussions and their documentation within the EHR. Design, Setting, and Participants: This was a randomized effectiveness trial using the Zelen design, in which patients are randomized prior to informed consent, with only those randomized to the intervention subsequently approached to provide informed consent. Randomization began November 1, 2018, and follow-up concluded November 1, 2019. The study population included patients 65 years or older with multimorbidity combined with either cognitive or physical impairments, and/or frailty, assessed from 8 primary care practices in North Carolina. Interventions: Participants were randomized to either a nurse navigator-led ACP pathway (n = 379) or usual care (n = 380). Main Outcomes and Measures: The primary outcome was documentation of a new ACP discussion within the EHR. Secondary outcomes included the usage of ACP billing codes, designation of a surrogate decision maker, and ACP legal form documentation. Exploratory outcomes included incident health care use. Results: Among 759 randomized patients (mean age 77.7 years, 455 women [59.9%]), the nurse navigator-led ACP pathway resulted in a higher rate of ACP documentation (42.2% vs 3.7%, P < .001) as compared with usual care. The ACP billing codes were used more frequently for patients randomized to the nurse navigator-led ACP pathway (25.3% vs 1.3%, P < .001). Patients randomized to the nurse navigator-led ACP pathway more frequently designated a surrogate decision maker (64% vs 35%, P < .001) and completed ACP legal forms (24.3% vs 10.0%, P < .001). During follow-up, the incidence of emergency department visits and inpatient hospitalizations was similar between the randomized groups (hazard ratio, 1.17; 95% CI, 0.92-1.50). Conclusions and Relevance: A nurse navigator-led ACP pathway integrated with a health care professional-facing EHR interface increased the frequency of ACP discussions and their documentation. Additional research will be required to evaluate whether increased EHR documentation leads to improvements in goal-concordant care. Trial Registration: ClinicalTrials.gov Identifier: NCT03609658.
Subject(s)
Accountable Care Organizations , Advance Care Planning , Patient Navigation , Aged , Aged, 80 and over , Electronic Health Records , Female , Humans , Male , Patient Care Team , Vulnerable PopulationsABSTRACT
BACKGROUND: Guidelines recommend offering cessation interventions to smokers eligible for lung cancer screening, but there is little data comparing specific cessation approaches in this setting. We compared the benefits and costs of different smoking cessation interventions to help screening programs select specific cessation approaches. METHODS: We conducted a societal-perspective cost-effectiveness analysis using a Cancer Intervention and Surveillance Modeling Network model simulating individuals born in 1960 over their lifetimes. Model inputs were derived from Medicare, national cancer registries, published studies, and micro-costing of cessation interventions. We modeled annual lung cancer screening following 2014 US Preventive Services Task Force guidelines plus cessation interventions offered to current smokers at first screen, including pharmacotherapy only or pharmacotherapy with electronic and/or web-based, telephone, individual, or group counseling. Outcomes included lung cancer cases and deaths, life-years saved, quality-adjusted life-years (QALYs) saved, costs, and incremental cost-effectiveness ratios. RESULTS: Compared with screening alone, all cessation interventions decreased cases of and deaths from lung cancer. Compared incrementally, efficient cessation strategies included pharmacotherapy with either web-based cessation ($555 per QALY), telephone counseling ($7562 per QALY), or individual counseling ($35 531 per QALY). Cessation interventions continued to have costs per QALY well below accepted willingness to pay thresholds even with the lowest intervention effects and was more cost-effective in cohorts with higher smoking prevalence. CONCLUSION: All smoking cessation interventions delivered with lung cancer screening are likely to provide benefits at reasonable costs. Because the differences between approaches were small, the choice of intervention should be guided by practical concerns such as staff training and availability.