Symptom Monitoring Research Articles

An electronic patient-reported outcome symptom monitor: the Chinese experience with rapid development of a ready-to-go symptom monitor

An electronic patient-reported outcome symptom monitor: the Chinese experience with rapid development of a ready-to-go symptom monitor

A novel nurse-led, multidisciplinary, and guideline-directed disease intensive management program improves long-term survival of pulmonary hypertension patients

Abstract Background Although the overall survival of pulmonary hypertension (PH) patients improved in the current era, better management strategy for PH patients still needs further exploration. Here, we proposed a novel nurse-led, multidisciplinary, and guideline-directed disease intensive management program and hypothesized this strategy would improve the overall survival of PH patients. Methods Patients were prospectively enrolled and divided into the intensive management group (IDM) and the conventional disease care (CDC) group voluntarily. Intensive management was nurse-led and delivered by multidisciplinary teams, including patient education, symptoms monitoring, and patient adherence improvement with careful outpatient or inpatient assessment every 3 months and medicine prescription whenever needed. Patients with conventional care were treated by primary cardiologists’ consultants and telephone follow-ups every year. Results Overall, 413 PH patients were finally included. Both total survival (p<0.001) and event-free survival (p=0.008) of the IDM group were significantly higher than the CDC group. After adjustment of age and sex, intensive management was also an independent protective predictor for both primary [all-cause mortality, HR 0.378, 95% CI (0.214-0.668), p<0.001] and composite endpoints [all-cause mortality and re-hospitalization, HR 0.648, 95% CI (0.454-0.927), p=0.017]. In subgroup analysis, IDM was beneficial in prolonging the overall survival of patients in high-risk situations (HR 0.283, 95% CI 0.125-0.641, p=0.002) and with advanced RV dysfunction (HR 0.250, 95% CI 0.123-0.510, p<0.001). Conclusion Nurse-led, multidisciplinary, and guideline-directed disease intensive management program represented an ideal method to strengthen the overall and event-free survival of PH patients, especially for those in advanced stages of PH.Novel management program

Association between self-care behaviour and multiple frailty domains in older patients with heart failure

Abstract Background/Introduction Heart failure (HF) self-care is important for the effective management of HF, reducing clinical events such as all-cause mortality and hospitalizations. HF self-care behaviours encompass comply with a regimen involving medication, diet, and exercise, symptom monitoring, and seeking assistance when symptoms occur. Frailty, prevalent among older patients with HF, involves physical, social, and cognitive domains. Identified factors influencing self-care behaviours in patients with HF include age, social support, and knowledge of the condition. Despite research on the association between self-care behaviours and frailty, there is a notable gap in studies that explore the relationship between self-care behaviour and multiple domains of frailty, particularly with adjustments for clinical characteristics. Purpose The aim of this study was to assess the association between self-care behaviour and multiple domains of frailty in older patients with HF. Methods The study included 182 patients with HF who were aged 65 years or older. Self-care behaviour was assessed 5 months after their discharge using the European Heart Failure Self-Care Behaviour Scale (EHFScBS), a self-report questionnaire. Frailty was assessed using the revised Japanese version of the Cardiovascular Health Study criteria (J-CHS) for physical frailty, and using Makizako’s five items for social frailty, and using Mini-Cog for cognitive decline. We used multiple regression analysis to assess the association between self-care score and multiple frailty domains and the number of frailty domains. The adjusted model was constructed based on age, gender, body mass index, New York Heart Association Classification, left ventricular ejection fraction, log-transformed B-type natriuretic peptide, estimated glomerular filtration rate and history of HF. In addition, we used multiple regression analysis to assess the association between the EHFScBS subitems score complying with regimen, asking for help, and adapting activities and multiple frailty domains and the number of frailty domains. Results According to the results of a multiple regression analysis, poor self-care behaviour was significantly associated with physical and social frailty and the number of frailty domains (all p < 0.05), even after adjusting for clinical characteristics. Poor complying with regimen was also significantly associated with physical and social frailty and the number of frailty domains (all p < 0.05). Poor asking for help was significantly associated with social frailty and the number of frailty domains (all p < 0.05). Conclusion The study indicates that poor self-care behaviour is linked to physical and social frailty, in addition to the cumulative number of frailty domains in older patients with HF, even when clinical characteristics are taken into consideration. This underscores the importance of factoring in the frailty status when guiding patients with HF in disease management.

An Agent-Based "Virtual Clinical Trial" for the Analysis and Evaluation of COPD Patients Cohorts Behavior

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to symptoms such as shortness of breath, coughing, and chest tightness. Treatment typically involves lifestyle adjustments, medication, and pulmonary rehabilitation to improve lung function and quality of life. This study presents a model examining COPD patient behavior within cohort-based strategies, focusing on how environmental factors impact vital signs across the entire cohort. We developed a comprehensive virtual clinical trial model that encompasses study protocol design, participant recruitment, virtual data collection, outcome analysis, and conclusions. This includes remote symptom monitoring, virtual healthcare consultations, treatment adherence assessments, and research data collection. Additionally, we explore the influence of external variables such as environmental conditions, comorbidities, and lifestyle factors on chronic disease symptoms and disease stability. We used an Agent-Based Model(ABM) to incorporate these factors to assess COPD progression and treatment efficacy. Individual agents represent COPD patients, each characterized by attributes such as age, smoking history, lung function, comorbidities, and treatment plans.

Posttraumatic Stress Disorder and Substance Use Disorder Screening, Assessment, and Treatment.

We review prevalence, etiology, impact on treatment, and best practices for treatment of posttraumatic stress disorder (PTSD) in a substance use disorder (SUD) treatment setting. Recommendations are given related to screening, assessment, and symptom monitoring. PTSD and SUDs are highly comorbid. This comorbidity is associated with higher acuity, more difficulty completing treatment, and worse prognosis. Integrated treatment is recommended, and trauma-focused psychotherapies combined with pharmacotherapy show particular promise. PTSD is highly prevalent in substance using samples, negatively impacting treatment course and worsening prognosis. This comorbidity has been explained by a variety of models, with self-medication having garnered the most support. Trauma-focused psychotherapies combined with pharmacotherapy demonstrate the most efficacy and are recommended when treating co-occurring SUDs and PTSD. Specifically, prolonged exposure (PE), concurrent treatment of PTSD and SUDs using PE (COPE), and cognitive processing therapy (CPT) have been seen as promising trauma-focused treatments. Investigations into ways to best augment therapy are also underway, both through treatment format and neuromodulation. Several recommendations are given.

Drug-induced myocarditis: a real-world pharmacovigilance study using the FDA adverse event reporting system database

ABSTRACT Background Myocarditis is a rare but potentially life-threatening inflammation of the heart muscle that can be caused by various drugs. This study aimed to comprehensively evaluate the risk of drug-induced myocarditis using data from the FDA Adverse Event Reporting System (FAERS) database. Methods We queried the FAERS database for reports of myocarditis from Q1 2004 to Q4 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were calculated to detect disproportionality signals for drugs associated with myocarditis. Results A total of 8,212 myocarditis-related reports were identified in the FAERS database. The most frequently reported drugs were clozapine (N = 1269), followed by nivolumab (N = 621), pembrolizumab (N = 358), mesalazine (252), and olanzapine (N = 191). Disproportionality analysis revealed strong signals for the top 50 drugs, including mesalazine (ROR 48.01, 95% CI 42.29-54.49), cemiplimab (ROR 38.84, 95% CI 26.71-56.47), clozapine (ROR 35.21, 95% CI 33.13-37.39), nivolumab (ROR 23.21, 95% CI 21.38-25.2), atezolizumab (ROR 20.75, 95% CI 17.91-24.05) and pembrolizumab (ROR 19.90, 95% CI 17.89-22.13). Conclusions Our findings suggest a potential risk of drug-induced myocarditis associated with various medications. Close monitoring for signs and symptoms of myocarditis is crucial, especially in patients with risk factors or those receiving these drugs. Further investigations are warranted to establish causality and identify risk factors.

Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial

BackgroundPremenopausal women with early stage, high risk hormone receptor positive breast cancer are at risk of early discontinuation of adjuvant endocrine therapy (ET), primarily because of toxicity, which can increase the risk of disease recurrence and death. We hypothesize that identification of bothersome symptoms between clinic visits, and automated notification of clinicians about symptoms, will result in improved persistence with ET. MethodsPre- and perimenopausal women planning to receive adjuvant treatment with tamoxifen or an aromatase inhibitor plus ovarian function suppression or ablation for treatment of breast cancer are eligible. A total of 540 participants will be enrolled and randomized 1:1 to patient education with or without Active Symptom Monitoring (ASM). The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email, or telephone weekly for 24 weeks, then every 4 weeks for 48 weeks. All participants will complete a battery of questionnaires every 12 weeks to examine symptoms, beliefs about medicine, self-efficacy, and ET adherence. Optional blood draws will be collected at baseline and after 12, 48, and 72 weeks of therapy to examine estradiol and ET concentrations. The primary endpoint is time to nonpersistence with initially prescribed ET within the first 72 weeks, evaluated using Kaplan-Meier plots and multivariable Cox regression. ConclusionWe expect early identification and management of ET-related toxicities to improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for premenopausal women at high risk of breast cancer recurrence.Clinicaltrials.govNCT05568472

Digital health apps : How to achieve the successful integration into healthcare

Digital health applications (apps) have been available on prescription since 2019 and offer a multitude of functions in health monitoring, symptom recognition, follow-up monitoring and patient care. The Digital Care Act from 2023 strives for a comprehensive integration of apps into medical care. The utilization of artificial intelligence (AI) in health apps promises an earlier diagnosis, sensitive symptom monitoring, optimization of courses of treatment, more effective doctor-patient communication and saving of resources. The integration of health apps and AI can enable a stronger personalized high-value care.

Enhancing palliative care for advanced cancer patients: evaluating implementation and impact of a virtual nurse-led symptom monitoring and telehealth initiative

BackgroundAs a result of the COVID-19 pandemic, we implemented a novel nurse-led symptom monitoring and virtual telehealth program for patients with advanced cancer on palliative care.AimsTo evaluate the reach, effectiveness, adoption, implementation, maintenance and acceptability of our program.MethodsThis was a prospective study carried out in a cohort of patients with advanced cancer over the period of 3rd June 2020 to 22nd October 2021. Demographic characteristics, cancer diagnosis, and functional status of patients were collected upon recruitment. Patients were asked to complete a patient-reported outcome measure (the Integrated Palliative Care Outcome Scale, IPOS) prior to the first palliative care consult and subsequently every week for the duration of their participation in the program (12 weeks). The IPOS measures the severity of physical symptoms, emotional concerns, information, and financial needs. Participants’ utilization of healthcare services by participants 3 months before, during and 3 months after the telemedicine program was reviewed. At the end of the program, a client satisfaction questionnaire (CSQ-4) to survey participants’ experience with the telehealth program and their willingness to pay for this program was administered.ResultsReach: The recruitment to adoption ratio of the program was 0.71. Acceptability:: Participants expressed satisfactory experience. Effectiveness: We noted that the severity of patients’ symptoms and number of emergency department visits decreased over time with nurse support. Adoption: we received referrals from 23 oncologists, yielding an adoption rate of 70%. Implementation: Of the 99 patients recruited for the program, 88.9% of them managed to complete their initial video consults as planned. 16% of them failed to complete the program due to factors such as patient demising. Maintenance: The declining rate of IPOS completion throughout the study period (98.9% at week 1 to 60.8% at week 12) demonstrated the difficulties in sustaining regular administration of self-reported patient outcome measures.ConclusionThe telemedicine program was effective and acceptable. We noted challenges in sustaining the administration of patient reported outcome measures over time. Further studies on how we can improve the sustainability of symptom monitoring in a telehealth program for patients with advanced illnesses, under palliative care, should be conducted.

Provision of digital health interventions for young people with ADHD in primary care: findings from a survey and scoping review

BackgroundPeople with attention-deficit hyperactivity disorder (ADHD) are at risk of negative health outcomes, with risks reduced through evidence-based treatments. Therefore, ensuring continued access to treatment for young people with ADHD, especially as they transition from child to adult services, is a priority. Currently many young people with ADHD are unable to access adequate care, with negative consequences for patients and their communities. Preliminary evidence suggests digital health interventions (DHIs) may act as an effective adjunct to usual care, helping overcome barriers to access, and improving outcomes by increasing understanding of ADHD as a long-term condition. The aim of this mixed methods study is to explore the healthcare information preferences of people with lived experience of ADHD in the primary care context and considers these in the light of the emerging body of literature on DHIs for ADHD. To explore this, a descriptive summary of cross-sectional survey responses was compared and discussed in the context of DHIs identified in a scoping review.ResultsDigital apps, followed by support groups, were deemed the most useful information resource types by survey respondents, but were the least currently used/provided. Over 40% participants indicated a preference for signposting to all resource types by their general practitioner (GP), suggesting that GPs are credible sources for ADHD healthcare information. The scoping review identified nine studies of DHI for ADHD, consisting of games, symptom monitoring, psychoeducation, and medication reminders, with limited evidence of effectiveness/implementation.ConclusionsPeople with ADHD state a preference for digital apps as an adjunct to usual care. However, these are currently the least provided information resource in primary care, indicating a key area for future development. The limited evidence base on DHIs for ADHD suggests combining digital apps and support networks, and utilising multimodal delivery methods may also enhance the delivery of healthcare information.

Digital assessments for children and adolescents with ADHD: a scoping review.

In spite of rapid advances in evidence-based treatments for attention deficit hyperactivity disorder (ADHD), community access to rigorous gold-standard diagnostic assessments has lagged far behind due to barriers such as the costs and limited availability of comprehensive diagnostic evaluations. Digital assessment of attention and behavior has the potential to lead to scalable approaches that could be used to screen large numbers of children and/or increase access to high-quality, scalable diagnostic evaluations, especially if designed using user-centered participatory and ability-based frameworks. Current research on assessment has begun to take a user-centered approach by actively involving participants to ensure the development of assessments that meet the needs of users (e.g., clinicians, teachers, patients). The objective of this mapping review was to identify and categorize digital mental health assessments designed to aid in the initial diagnosis of ADHD as well as ongoing monitoring of symptoms following diagnosis. Results suggested that the assessment tools currently described in the literature target both cognition and motor behaviors. These assessments were conducted using a variety of technological platforms, including telemedicine, wearables/sensors, the web, virtual reality, serious games, robots, and computer applications/software. Although it is evident that there is growing interest in the design of digital assessment tools, research involving tools with the potential for widespread deployment is still in the early stages of development. As these and other tools are developed and evaluated, it is critical that researchers engage patients and key stakeholders early in the design process.

Somatic and mental symptoms associated with dysglycaemia, diabetes-related complications and mental conditions in people with diabetes: Assessments in daily life using continuous glucose monitoring and ecological momentary assessment.

To analyse the potential drivers (glucose level, complications, diabetes type, gender, age and mental health) of diabetes symptoms using continuous glucose monitoring (CGM) and ecological momentary assessment. Participants used a smartphone application to rate 25 diabetes symptoms in their daily lives over 8 days. These symptoms were grouped into four blocks so that each symptom was rated six times on 2 days (noon, afternoon and evening). The symptom ratings were associated with the glucose levels for the previous 2 hours, measured with CGM. Linear mixed-effects models were used, allowing for nested random effects and the conduct of N = 1 analysis of individual associations. In total, 192 individuals with type 1 diabetes and 179 with type 2 diabetes completed 6380 app check-ins. Four symptoms showed a significant negative association with glucose values, indicating higher ratings at lower glucose (speech difficulties, P = .003; coordination problems, P = .00005; confusion, P = .049; and food cravings, P = .0003). Four symptoms showed a significant positive association with glucose values, indicating higher scores at higher glucose (thirst, P = .0001; urination, P = .0003; taste disturbances, P = .021; and itching, P = .0120). There were also significant positive associations between microangiopathy and eight symptoms. Elevated depression and diabetes distress were associated with higher symptom scores. N = 1 analysis showed highly idiosyncratic associations between symptom reports and glucose levels. The N = 1 analysis facilitated the creation of personalized symptom profiles related to glucose levels with consideration of factors such as complications, gender, body mass index, depression and diabetes distress. This approach can enhance precision monitoring for diabetes symptoms in precision medicine.

8242 A Case of Ayme Gripp Syndrome

Abstract Disclosure: P. Jaisinghani: Consulting Fee; Self; Novo Nordisk. J. Pappas: None. We present a 35 year old female with cataracts, generalized seizures and oligodontia, referred to us for hair loss and elevated TSH. For over 10 years, patient had a diffuse hair loss which progressed to a focal patch of hair loss in the setting of prior use of keppra and seborrheic dermatitis. Patient has regular menses, and no symptoms of hyper/hypothyroidism or family history of thyroid disease. Patient established care with dermatology and scalp biopsy noted early androgenetic alopecia. Physical exam was notable for short stature, height 4'11, 98 lbs, BMI 19.8 kg/m², progeric appearance, facial hyperpigmented spot, hair thinning, palpable thyroid R>L. Laboratory evaluation included TSH 6.150 (0.450 - 4.500 uIU/mL), DHEAS 263 (84.8 - 378.0 ug/dL), total testosterone 15 (10 - 55 ng/dL), FSH 6.6 (Follicular phase 3.5 - 12.5 mIU/mL), LH 7.6 (Follicular phase 2.4 - 12.5 mIU/mL), estradiol 83 (Follicular phase 12.5 - 166.0 pg/mL). Thyroid US demonstrated smaller than average size left lobe measuring 2.93 cm x 0.84 cm x 1.36cm vs right lobe measured 4.34 cm x 0.90 cm x 1.62. Labs noted TSH 5.690 (0.450 - 4.500 uIU/mL), establishing subclinical hypothyroidism and negative thyroid antibodies. Clinical genetics evaluation included trio exome sequencing which revealed a de novo pathogenic variant p.(Ser54Leu) (TCG>TTG): c.161 C>T in exon 1 of the MAF gene (NM_005360.4) which establishes the diagnosis of a Ayme- Gripp syndrome (AGS). AGS is characterized by a triad of cataract, sensorineural hearing loss, and characteristic facial features in combination with neurodevelopmental abnormalities. 21 affected individuals from 19 families have been reported with AGS. Clinical features in our case characteristic of AGS included short stature, brachycephaly, midface hypoplasia, long philtrum and premature hair loss. Hypothyroidism was identified in childhood in 3/15 identified individuals who responded to thyroid hormone replacement therapy. For this patient, we will monitor thyroid function tests every 3-6 months and monitor for symptoms of hypothyroidism. Patient has been referred to cardiology and nephrology, and will continue to follow with genetics and dermatology. Our case further establishes the association of hypothyroidism with AGS. Our case demonstrates the value of expanding the differential of endocrinopathies to rare genetic conditions which are currently identifiable by clinically available genomic tests. Presentation: 6/1/2024

Self-Monitoring Practices and Use of Self-Monitoring Technologies by People with Rheumatic and Musculoskeletal Diseases: An International Survey Study

Background/Objectives: Digital health applications (DHAs) promise to improve disease self-management, but adherence remains suboptimal. We aimed to explore self-monitoring practices of rheumatic and musculoskeletal diseases (RMD) patients. A web-survey was conducted over 7 months including RMD patients to study their self-monitoring practices and the potential of DHAs. Methods: Health, sociodemographic, and technology adherence indicators were retrieved for comparison. Regression analyses and unsupervised profiling were performed to investigate multiple patient profiles. Results: From 228 responses gathered, most reported willingness to use DHAs to monitor their condition (78% agreement), although the majority rarely/never tracked symptoms (64%), often due to stable condition or no perceived value (62%). Of those tracking regularly, 52% used non-digital means. Participants with regular self-monitoring practices were more open to use a self-monitoring app (OR = 0.8 [0.6, 0.9]; p = 0.008) and be embedded in multidisciplinary care (OR = 1.4 [1.1, 1.6]; p < 0.001), but showed worse health status (g = 0.4; p = 0.006). Cluster analyses revealed three distinct groups of reasons for not tracking regularly (χ2 = 174.4; p < 0.001), two characterised by perceived low disease activity. Conclusions: Effective use of DHAs remains limited and non-digital means prevail in symptom monitoring. Findings suggest that better patient engagement strategies and passive monitoring should be adopted in early development stages of DHAs for better long-term disease self-care.

Association between food insecurity and healthcare utilization among patients at a breast oncology center.

143 Background: A breast cancer (BC) diagnosis often creates or exacerbates financial stress. As a result, many patients with BC struggle with a lack of consistent access to nutritious food due to limited resources, a condition termed “food insecurity” (FI). We investigated the association between FI and healthcare utilization among breast oncology patients at our urban academic medical center. Methods: Screening for health-related social needs (HRSN) was conducted primarily through the electronic patient portal, at appointment registration for a breast oncology clinic visit. The 8-item HRSN survey included 2 questions on access to food resources and 1 question quantifying emergency department (ED) visits over the past year. Any level of food hardship or concern constituted a positive FI screen. We conducted a retrospective analysis among patients evaluated between 11/2/22 and 4/20/24. Clinical and demographic data were obtained from the electronic health record (EHR). We evaluated the association between FI and health care utilization measures (ED visits, inpatient admissions) with a Pearson's Chi-squared test and univariate logistic regression. Results: A total of 2820 patients were screened for HRSN and provided responses to at least 1 FI question, of which 19.7% (555) reported some level of FI. Food-insecure patients self-reported significantly higher rates of ED visits in the past 12 months compared to food-secure patients: 43.2% vs 22.6% reported at least 1 ED visit, respectively (p<0.001), and 25.0% vs 8.45% reported multiple ED visits, respectively (p<0.001). Overall, FI was associated with 2.5 times the odds of self-reporting at least 1 ED visit (univariate OR 2.47, p<0.001). Similarly, on review of EHR data, 33.3% of food-insecure patients had at least 1 ED visit (vs 20.0% of food-secure patients, p<0.001), and 6.13% had 3 or more ED visits (vs 2.83%, p<0.001) during the study period. On univariate analysis, food-insecure patients had double the odds of having at least 1 ED visit documented in the EHR (univariate OR 2.00, p<0.001). We examined reasons for ED presentations among 186 food-insecure patients with ED visits during the study period, and found that 23.8% had at least 1 cancer-related complaint (oncological treatment-related (16.8%) and/or BC symptom-related (8.6%)). The incidence of inpatient admissions during the study period was similar among food-insecure vs food-secure patients (19.8% vs 18.4%, p=0.467). Conclusions: In this analysis of FI and health care delivery measures, ED utilization was significantly higher among food-insecure patients. A quarter of food-insecure patients who presented to the ED had oncological complaints. FI may be a marker of unmet healthcare needs in patient with cancer, and targeted interventions focused on symptom monitoring and management are warranted to optimize healthcare utilization.

Patient and provider perceptions of the benefits and limitations of implementing ePRO-driven remote symptom monitoring into real-world cancer care settings.

325 Background: Remote symptom monitoring (RSM) utilizes electronic patient-reported outcomes (ePROs) to facilitate the monitoring and management of treatment-related symptoms outside of traditional healthcare appointment settings. Research suggests benefits surrounding the implementation of RSM; however, there is a literature gap regarding patient and provider perceptions of its implemented use. Methods: This qualitative study included patients and providers from the University of Alabama at Birmingham (UAB) and the Mitchell Cancer Institute (MCI) in Mobile, Alabama, who participated in semi-structured interviews aimed at gaining insight into the experiences of and perceptions surrounding RSM utilization. Interviews occurred over the phone, via digital videoconference, or in person, and were transcribed and inductively coded using NVivo software alongside a constant comparative method to establish a grounded coding schema. Results: Forty patients (20 UAB; 20 MCI) and 30 oncology providers (16 UAB; 14 MCI) identified 25 benefits across 3 overarching themes. Patients and providers found RSM Facilitated Proactive Management enabling early symptom identification and intervention, which helped to reduce symptom burden. Both groups also noticed RSM Improved Therapeutic Alliance, by fostering the relationship between the patient and their care team and enhancing the patient’s sense of safety and security through continued and sincere communication. Patients and providers also discussed how RSM Promoted Self-Efficacy and Management among Patients by allowing patients to feel involved and in control of their care, while giving them an inclination to be active members in their care. Providers felt that more active patient involvement in care contributed to a more accurate and thorough reporting of symptoms. Patients and providers also noted drawbacks regarding RSM, including lack of need in cases of no or mild symptoms. Conclusions: Patients and providers recognized the impact RSM had on patient care during cancer treatment. However, given some of the perceived limitations, patient and provider evaluations should continue to ensure successful implementation in future clinical trials. Clinical trial information: NCT04809740 .

Advances in diagnosis and subtyping of Gaucher disease & assessment and monitoring of neurological symptoms

Advances in diagnosis and subtyping of Gaucher disease & assessment and monitoring of neurological symptoms

Development and implementation of an equitable and efficient navigation program to address supportive care needs in patients with cancer.

58 Background: Despite evidence backing the use of navigation along the cancer care trajectory, existing programs struggle to deliver services efficiently and equitably. To bridge this gap, we developed and implemented a patient-centric, data-driven navigation program that leverages a risk-stratification approach to prioritize and address unmet needs. Methods: Our program was developed with key principles to address inefficiencies in existing navigation systems. First, we embedded the program within our institution’s Epic environment, using data-driven risk calculators, dashboards, flowsheets, and templates to support the navigation curriculum. Second, the program structure aligned with the patient’s journey from initial consult through treatment, focusing on early identification of unmet needs, centralized resourcing, and remote symptom monitoring for high-risk patients. Third, we unified the workflows of navigators, intake personnel, triage nurses, and providers, fostering system-wide collaboration. Results: The program has been successfully implemented in patients with new consults in gastrointestinal, breast, and hematologic oncology. To date, 2,080 patients have had an initial assessment leading to a Navigation Assessment Score (NAS) that predicts longitudinal burden of unmet needs and directs subsequent resourcing. 226 referrals have been generated to: cancer rehabilitation (76), nutrition (60), psychosocial oncology (48), tobacco cessation (39), and palliative care (3). Remote symptom monitoring was piloted in 34 gastrointestinal oncology patients meeting the calculated highest decile risk for unplanned acute care event use. Proportions of patients with a NAS score (N=2,080): 69.3% White, 17.7% Black, 3% Latinx, 1.8% Asian, 0.9% American Indian; referrals (N=226): 61.2% White, 23.0% Black, 4.9% Latinx, 1.1% Asian, 0.5% American Indian; remote symptom monitoring (N=34): 79.4% White, 11.8% Black, 5.9% American Indian. Except for Latinx patients, these distributions align with the patient population in gastrointestinal, breast, and hematologic oncology (N=4,267; 68.0% White, 22.5% Black, 6.4% Latinx, 1.9% Asian, 0.9% American Indian). Conclusions: Development and implementation of our program is feasible, and the approach has potential to mitigate disparities in cancer service delivery and outcomes. Ongoing efforts include exploring accessibility among Latinx patients and developing the business case for sustainability and scaling.

Understanding health literacy's moderating role in remote monitoring for adjuvant endocrine therapy: Findings from a randomized clinical trial.

45 Background: Despite the efficacy of oral adjuvant endocrine therapy (AET) for improving survival among women with hormone receptor-positive early-stage breast cancer, adherence rates remain low. Our THRIVE study (NCT03592771) investigated the effectiveness of a mobile health remote monitoring app with and without tailored educational messages on AET adherence among women with breast cancer and found no statistically significant treatment effects on 1-year AET adherence overall. Health literacy contributes to patients’ understanding of their treatment plans. We conducted a post hoc analysis of the THRIVE study to examine if health literacy moderates the effectiveness of this intervention. Methods: This non-blinded randomized controlled trial included women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across three states. Participants used a pillbox to electronically monitor AET adherence for 1 year and completed surveys at enrollment. Consented participants were randomized into (1) “App”, receiving access to the study adherence and symptom monitoring app for 6 months, with increasing/severe symptoms and missed doses reported in the app triggering follow-ups from the oncology team; (2) “App+Feedback”, receiving additional weekly text messages about managing symptoms, adherence, and communication for 6 months; or (3) “Enhanced Usual Care (EUC).” The primary outcome was 1-year AET adherence captured with the pillbox (≥80% Proportion of Days Covered [PDC] vs. < 80%). The enrollment survey captured participant’s sociodemographic characteristics, including race and ethnicity, education, household income, and health literacy. We used a linear probability model to measure the interaction between the study arm and health literacy on AET adherence. Results: Among 304 women randomized (104 EUC, 98 App, and 102 App+Feedback), the 12-month follow-up retention rate was 88% (n = 266) and 19.4% reported low health literacy at enrollment. Low health literacy was more prevalent among Black (29.4%) vs. White (13.4%) participants (p < 0.001), those with incomes below the federal poverty level (34.4% vs. 17.2% of those with higher incomes, p = 0.02), and those with only a high school degree or lower education (31.7%) vs. with those with some college or higher education (16.4%, p < 0.01). In the low health literacy group, 80.0% of App+Feedback were AET adherent vs. 42.1% of EUC, a 37.9 percentage point (ppt) difference (95% CI: 4.1 to 71.7, p = 0.03); in higher literacy group adherence, 47.1% of App+Feedback vs. 59.0% of EUC were adherent, a -11.8 ppt difference (95% CI: -27.9 to 4.3, p = 0.15). Conclusions: A remote monitoring app with tailored educational text messages led to higher 1-year AET adherence among participants with low health literacy, but not for those with high health literacy. Clinical trial information: NCT03592771 .

Impact of real-world remote symptom monitoring program on hospitalizations and ICU admissions.

377 Background: Previous randomized controlled trials have demonstrated benefits to patients from remote symptom monitoring (RSM) with electronic patient-reported outcomes (ePROs) including healthcare utilization. However, less is known about the impact of RSM in diverse, real-world populations. Methods: This cross-sectional analysis from a hybrid, type 2 implementation-effectiveness trial evaluated the impact of RSM on healthcare utilization amongst patients with cancer receiving chemotherapy, immunotherapy, monoclonal antibody, or targeted therapy at two academiccancer centers in the Southeastern United States. Modified Poisson regression models with robust standard error and 95% confidence interval (CI) was used to calculate the relative risk (RR) of any hospital or ICU utilization between patients receiving RSM and controls for 3 and 6 months after index date. Models were controlled for age at index, race, sex, cancer type, cancer stage, insurance, prior treatment, comorbidities, RUCA, and follow-up during COVID-19 pandemic. Additional logistic regression models were used to estimate odds ratios (OR) for subset analysis stratified by race (Black or African American, Other, or White), rurality using Rural-Urban Commuting Area Codes, and neighborhood disadvantage using Area Deprivation Index (ADI). Results: From 5/2021-2/2024, 1215 patients were enrolled in RSM; 27% were Black, 16% lived in a rural area, and 25% lived in an area with high neighborhood disadvantage. The populations receiving RSM were similar to the control population (n = 4559); 26% were Black, 22% lived in a rural area, and 28% lived in area with high neighborhood disadvantage. The unadjusted relative risk of hospitalization for patients receiving RSM and control patients were 0.70 (95% CI, 0.63-0.70) and 0.77 (95% CI, 0.71-0.85), respectively. In adjusted analyses, hospitalizations were lower amongst patients receiving RSM compared to control patients with a RR of 0.82 (95% CI 0.73-0.92). Similar patterns were observed for ICU admissions (RR 0.59; 95% CI,0.40-0.88). Analysis by patient subgroup was similar to the overall analysis. A lower odd of hospitalizations and ICU admissions at 6 months was observed across all subset analyses: Black vs. White patients (OR 0.80; OR 0.48); rural vs. urban patients (OR 0.78; OR 0.68); and patients living in areas of high vs. lower neighborhood disadvantage (OR 0.59; OR 0.33). Conclusions: The use of RSM amongst patients receiving treatment for cancer is associated with reductions in hospitalizations and ICU admissions in real-world, diverse settings. Further work to expand this intervention nationally is needed. Clinical trial information: NCT04809740 .