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BACKGROUND Hydroxyurea therapy is effective in reducing sickle cell disease (SCD)-related complications and is recommended by NHLBI care guidelines. However, hydroxyurea is underutilized, and adherence is suboptimal. We are testing a multi-level mobile health (mHealth) intervention to increase hydroxyurea adherence among patients and prescribing among providers in a multi-center clinical trial. In the first two study sites, participants were exposed to the early phases of the COVID-19 pandemic, which included disruption to their regular SCD care. The contextual changes that occurred as part of the pandemic response can affect implementation of new interventions. OBJECTIVE We aimed at describing the impact of COVID-19 pandemic on implementation of an mHealth behavioral intervention aimed at improving hydroxyurea adherence among patients with SCD. METHODS The first two sites initiated enrollment three months prior to the start of the pandemic (11/2019-3/2020). During implementation, Site A clinics shut down for 2 months and Site B clinics for 9 months. We used the Reach Effectiveness Adoption Implementation and Maintenance 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 Percentage 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 change in PDC, adjusting for baseline PDC, lock down duration, and site. We also conducted semi-structured 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 3/15/2020 (85.9% to 70.3%). The overall mean increase in PDC from baseline to week 12 was 4.5% (p=0.32) and to week 24 was 1.5% (p=0.70). Mean change in PDC was greater at Site A (12 weeks: 20.9%, p=0.0029; 24 weeks: 16.7%, p=0.0139) compared to Site B (12 weeks: -8.2%, p=0.14; 24 weeks: -10.3%, p=0.0151). After adjusting for other predictors, change in PDC was 13.8% greater in those with increased app use after 3/15/20. Interview findings indicated Site B’s closure during COVID-19 had a greater impact on patients, but almost all patients reported InCharge Health helped support more consistent medication use. CONCLUSIONS We found significant impacts of the early clinic lock downs, which reduced implementation of the mHealth intervention. This disruption led to reduced patient adherence to hydroxyurea. However, disruptions to mHealth implementation were lower among participants who experienced shorter clinic lock downs and were associated with higher hydroxyurea adherence. Investigation of added strategies to mitigate effects of care interruptions during major emergencies (e.g., patient coaching, health navigation) may “insulate” the implementation of interventions to increase medication adherence. CLINICALTRIAL ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 INTERNATIONAL REGISTERED REPORT RR2-10.2196/16319

Background: Sickle cell disease (SCD) is a chronic blood disorder, which disproportionately impacts Black individuals. Hydroxyurea therapy prevents SCD-related complications; yet it is underutilized, which contributes to further health inequities. Mobile health (mHealth) apps for patients and providers have the potential to improve hydroxyurea adherence. Our objective was to use the RE-AIM framework to evaluate the impact of the COVID-19 pandemic on implementation and effectiveness of patient and provider hydroxyurea (HU) mHealth apps (InCharge Health app and HU Toolbox app, respectively) in two large academic medical centers. Methods: Patient-level data (n=46) were collected between 11/2019-7/2020. Adherence was measured by calculating Percentage of Days Covered (PDC) from prescription records over 24 weeks before implementing the mHealth apps and during 12 and 24 weeks of implementation. As a response to the COVID-19 pandemic and to reduce virus spread, both sites temporarily suspended non-emergent clinical activities. During implementation, Site A clinics shut down for approximately 2 months (3/2020-5/2020) and Site B clinics for 7 months (3/2020-10/2020). To better understand contextual factors associated with mHealth implementation, we purposively sampled participants according to app use level (high vs low) and conducted semi-structured interviews with adult SCD patients, providers (physicians, nurse practitioners, and physician assistants), administrators, and research staff between 6/2020 and 3/2021. Results: A total of 46 patients participated and contributed to the PDC hydroxyurea adherence data. Mean change in PDC, adjusted for baseline PDC, was greater at Site A than at Site B (12-weeks: difference = 16.59%, p=.01, Figure 1A; 24-weeks: difference = 15.08%, p=.01, Figure 1B). Eleven patients (mean age 26.2 years old, 64% males, 100% Black, 73% HbSS, 45% low app users) and 11 providers (mean age 36.7 years old, 73% females, 36% Black, 54.5% physicians, average 8 years in practice, 36% low app users) completed the semi-structured interviews across the 2 sites. Site B was more affected during the COVID-19 pandemic where patients had difficulty obtaining hydroxyurea and other challenges related to reaching their providers and clinic setting for non-urgent or emergent reasons. In addition, participants with lower baseline hydroxyurea adherence level, as measured by PDC, had a more remarkable improvement in their PDC values at 12 weeks (Figure 1C) and 24 weeks (Figure 1D) Additional qualitative data focused on the implementation process were collected from 3 administrators, and 4 research staff. Among patients, both high and low app users reported the pandemic was a barrier to getting needed care (e.g., difficulty getting to hospital/clinic) and obtaining hydroxyurea; this was particularly a concern among low app users at Site B. Among providers, all but 2 high app users reported the pandemic did not impact app use, but nearly all low users perceived the pandemic to be a barrier to using the provider app because fewer patients came to clinic for maintenance SCD visits during the COVID-19 pandemic. Low users also reported the pandemic would negatively impact continued use of the app. Administrators and research staff also said reduced in-person clinic visits were a barrier to app implementation. Conclusions: mHealth apps are promising tools for improving hydroxyurea adherence among adolescents and adults with SCD. Contextual data show that some patients who experienced challenges accessing healthcare during COVID-19 pandemic have also experienced challenges navigating mHealth implementation. A focus on removing barriers to mobile apps use during care disruptions will likely improve patient and provider mHealth apps implementation, and ultimately, reduce health inequities for this vulnerable population. Our findings suggest that strategies such as including an mHealth facilitator has the potential to help addressing some of these implementation challenges. Note: Sherif Badawy and Lisa DiMartino are co-first authors with equal contribution Figure 1 Figure 1. Disclosures Badawy: Sanofi Genzyme: Consultancy; Bluebird Bio Inc: Consultancy; Vertex Pharmaceuticals Inc: Consultancy. Shah: Alexion: Speakers Bureau; Bluebird Bio: Consultancy; CSL Behring: Consultancy; Emmaus: Consultancy; GBT: Consultancy, Research Funding, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Novartis: Research Funding, Speakers Bureau. Hankins: Bluebird Bio: Consultancy; UpToDate: Consultancy; Vindico Medical Education: Consultancy; Global Blood Therapeutics: Consultancy.

INTRODUCTION: Treatment of vaso-occlusive episodes (VOE) are the most common reason for ED treatment of sickle cell disease (SCD). We 1) compared perceptions of the usability and ability to manage VOE pain between ED nurses and other ED provider types, ED sites, and VOE protocols (individualized versus weight-based), and 2) identified ED nurse and other provider protocol suggestions. METHODS: A secondary analysis of provider survey data collected immediately after caring for a patient enrolled in a randomized control trial comparing weight based vs. individualized opioid dosing for VOE. Research staff asked the ED nurse and other ED providers (nurse practitioners [NPs], physician assistants [PAs], residents and attending physicians) five questions related to the protocol’s ease of use and ability to manage pain. RESULTS: There were 236 surveys completed. Attending physicians (n=15), residents (n=88), PAs (n=21), and NPs (n=1) were more satisfied than nurses (n=111) with the clarity of the analgesic ordering (97.6% vs. 0%, p = 0.0001), and ability to manage the patient’s VOE pain (91% vs. 0%, p = 0.0001). When comparing both protocols with the usual ED strategy in their ED to manage VOE, more nurses than other ED providers perceived the study patients’ pain management protocol as better (100% vs. 35.2%, p = 0.0001).Other ED providers perceived the individualized versus weight-based protocol as better at managing pain than their usual ED strategy (70.3% vs. 59.5%, p = 0.04). CONCLUSION: The individualized protocol was perceived as better in managing VOE than the weight-based ED strategy. While physicians were satisfied with the clarity of the protocols, nurses were not. Improved protocol usability is required for widespread ED implementation.

Introduction: Vaso-occlusive episodes are the most common complication experienced by individuals with sickle cell disease (SCD). Treatment in an emergency department (ED) is often required and significant variability in care exists. In 2014, NHLBI published evidence based recommendations suggesting treatment with either an individualized opioid dosing or standard weight-based protocol; however the supporting evidence grade was Consensus - Panel Expertise. As outlined in the results section, the aim of this project was to compare change in pain scores, patient safety and system utilization variables between patients randomized to an individualized or weight based (standard) dosing protocol for treatment of VOC from arrival to discharge in an ED setting. Methods: A randomized controlled trial was conducted in two EDs (OH and NY). Adults with SCD were eligible for inclusion and recruited during a hospitalization, clinic visit or at the end of an ED visit. Patients were randomized to treatment with an individualized opioid dosing protocol (developed by the SCD physician based on patients' prior opioid use) or standard weight based protocol. Both protocols were supported by the NHLBI recommendations for treatment of VOE (2014) to include repeat dosing. Protocols were made available on the electronic medical record for future ED visits (up to five visits/patient), should they occur. ED physicians were informed of the protocol and ordered analgesics. Research staff was notified when ED visits occurred for enrolled patients and obtained assessments of pain (0-100 cm VAS) every 30 minutes from placement in the ED to one of 3 study endpoints: 1) 6 hours; 2) decision to admit to the hospital; 3) discharge home. The unit of analysis was the ED visit rather than patient. The primary outcome was change in pain score from arrival to study endpoint. Research staff reviewed the medical record 30 days after the ED visit to determine secondary outcomes of hospital admission, re-admission and new ED visits within 72 hours, 7 and 30 days post the index ED visit. The medical record was reviewed for administration of narcan, intubation, or assisted ventilation. A hierarchical linear mixed effects model adjusting for nested patient and site effects were used to test for a difference in the mean pain change scores in the treatment arms. Generalized Linear Models adjusting for nested patient and site effects were performed to evaluate differences in the dichotomized secondary outcomes. Results: 106 patients enrolled in the study with 52 patients (sites: 25 OH, 27 NY) contributing a total of 126 ED visits over 12 months. Among the 52 patients with visits, the median number of ED visits/patient was 2.0, 58% were male, and the median age was 27 years (range: 21 to 60). No patients in either treatment arm required narcan, intubation, or assisted ventilation. Pain change: Mixed effect model adjusted mean ± standard deviation, higher positive score = greater pain reduction; *Fisher's Exact Test result due to low cell frequency. Conclusions: An individualized opioid dosing protocol resulted in a larger reduction in pain scores and lower hospital admission rate among patients with SCD treated for VOE in two EDs when compared to treatment with a weight-based opioid protocol. However, there was a tendency for more frequent ED re-visits within 72 hours, 7 and 30 days among patients in the individualized opioid dosing protocol. A pragmatic RCT with a larger and more heterogeneous sample of patients and ED settings is required to provide definitive evidence to guide treatment of VOE. Table 1. Table 1. Disclosures Tanabe: NHLBI: Research Funding. Bosworth:WestMeadVaco: Research Funding; CVS carematix: Consultancy; Improved Patient Outcomes: Research Funding; Johnson & Johnson: Consultancy, Research Funding; Genentech: Consultancy; sanofi: Honoraria, Research Funding; Pharma Foundation: Research Funding.