Hydroxyurea is an efficacious treatment for sickle cell disease (SCD), but adoption is low among individuals with SCD. The objective of this study was to examine barriers to patients’ adherence to hydroxyurea use regimens by using the intentional and unintentional medication nonadherence framework. We interviewed individuals with SCD age 15 to 49.9 years who were participants in the Sickle Cell Disease Implementation Consortium (SCDIC) Needs Assessment. The intentional and unintentional medication nonadherence framework explains barriers to using hydroxyurea and adds granularity to the understanding of medication adherence barriers unique to the SCD population. In total, 90 semi-structured interviews were completed across 5 of the 8 SCDIC sites. Among interviewed participants, 57.8% (n = 52) were currently taking hydroxyurea, 28.9% (n = 26) were former hydroxyurea users at the time of the interview, and 13.3% (n = 12) had never used hydroxyurea but were familiar with the medication. Using a constructivist grounded theory approach, we discovered important themes that contributed to nonadherence to hydroxyurea, which were categorized under unintentional (eg, Forgetfulness, External Influencers) and intentional (Negative Perceptions of Hydroxyurea, Aversion to Taking Any Medications) nonadherence types. Participants more frequently endorsed adherence barriers that fell into the unintentional nonadherence type (70%) vs intentional nonadherence type (30%). Results from this study will help SCD health care providers understand patient choices and decisions as being either unintentional or intentional, guide tailored clinical discussions regarding hydroxyurea therapy, and develop specific, more nuanced interventions to address nonadherence factors.

Background Sickle cell disease (SCD) is an inherited blood disorder causing acute complications and chronic progressive end organ damage. SCD is associated with significant morbidity, early mortality, impaired health-related quality of life, and increased acute health care utilization. Hydroxyurea is a US Food and Drug Administration–approved medication that reduces disease complications, acute health care utilization, and costs. However, adherence to hydroxyurea is suboptimal. Mobile health (mHealth) interventions have the potential to improve hydroxyurea adherence, but few examples exist that are specific to the SCD population. Objective This study aimed to design a mHealth intervention for individuals with SCD to improve adherence to hydroxyurea, using a user-centered design that was informed by specific barriers to hydroxyurea adherence and utilization in this population. Methods This study consisted of 4 phases. In phase 1, individuals with SCD and health care providers participated in an optimization digital workshop. In phase 2, patients completed surveys pertaining to their interest in mHealth use, barriers and facilitators to hydroxyurea use, and health literacy. Phases 3 and 4 involved semistructured interviews and focus groups, respectively, and used the Health Belief Model (HBM) as the framework to investigate drivers of poor hydroxyurea adherence and to inform the development of an app prototype. In addition, in phase 4, we have incorporated the patients’ feedback on the preliminary app prototype and its features. Results Barriers to hydroxyurea adherence were consistent with the literature and included forgetfulness and several specific thoughts and emotions associated with hydroxyurea use (eg, fear of side effects, depression, stigma, and hopelessness). In addition, more than half of the participants reported potentially low health literacy. Preferred patient app features included 7 key components, namely (1) medication reminders and tracker, (2) disease education, (3) communication, (4) personalization, (5) motivation, (6) support during pain episodes, and (7) social support. Utilizing a user-centered design approach, data obtained from patients and providers were translated into features within the app, mapping to components of the HBM and the specific drivers of hydroxyurea adherence and matching the literacy level of the population, resulting in the development of a novel mobile app called InCharge Health. Conclusions The InCharge Health app is an mHealth intervention developed with substantial input from users and by mapping the HBM as the framework that guided the choice for its components. InCharge Health is a customized product for the SCD population aimed at optimizing medication adherence, with the end goal of improving quality of life and health outcomes among patients with SCD. The efficacy and implementation of the InCharge Health app as an mHealth intervention to promote hydroxyurea adherence will be tested in a future stepped-wedge multicenter trial for adolescents and adults with SCD.

Aim To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. Methods We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: 1) Define design requirements; 2) Prototype and Refine; and 3) Evaluate. Results Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool (CHICAGO Action Plan after ED discharge, CAPE) over current tools. Conclusions Engaging end-users in contextual inquiry resulted in CAPE, a new stakeholder-balanced discharge tool, which is being tested in a multi-center comparative effectiveness trial.

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Background Individuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes. Objective This study will implement an electronic health record–embedded individualized pain plan with provider and patient access in the emergency departments of 8 US academic centers to improve pain treatment for adult patients with sickle cell disease. This study will assess the overall effects of electronic health record–embedded individualized pain plans on improving patient and provider outcomes associated with pain treatment in the emergency department setting and explore barriers and facilitators to the implementation process. Methods A preimplementation and postimplementation study is being conducted by all 8 sites that are members of the National Heart, Lung, and Blood Institute–funded Sickle Cell Disease Implementation Consortium. Adults with sickle cell disease aged 18 to 45 years who had a visit to a participating emergency department for vaso-occlusive episodes within 90 days prior to enrollment will be eligible for inclusion. Patients will be enrolled in the clinic or remotely. The target analytical sample size of this study is 160 patient participants (20 per site) who have had an emergency department visit for vaso-occlusive episode treatment at participating emergency departments during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The electronic health record–embedded individualized pain plans will be written by the patient’s sickle cell disease provider, and sites will work with the local informatics team to identify the best method to build the electronic health record–embedded individualized pain plan with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Technology Acceptance Model 2 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an emergency department vaso-occlusive episode visit, and selected qualitative interviews within 2 weeks of an emergency department visit will be performed to assess the primary outcome, patient-perceived quality of emergency department pain treatment, and additional implementation and intervention outcomes. Electronic health record data will be used to analyze individualized pain plan adherence and additional secondary outcomes, such as hospital admission and readmission rates. Results The study is currently enrolling study participants. The active implementation period is 18 months. Conclusions This study proposes a structured, framework-informed approach to implement electronic health record–embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record–embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers. Trial Registration ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528. International Registered Report Identifier (IRRID) DERR1-10.2196/24818

BACKGROUND Individuals living with sickle cell disease (SCD) often require aggressive treatment of pain associated with vaso-occlusive episodes (VOEs) in the emergency department (ED). Frequently pain relief is poor. The 2014 National Heart, Lung, and Blood Institute (NHLBI) evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of VOEs. This study will implement an Electronic Health Record (EHR)–embedded individualized pain plan (E-IPP) with provider and patient access in the EDs of eight US academic centers to improve pain treatment for adult patients with SCD. OBJECTIVE This study will assess the overall effects of E-IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting and explore barriers and facilitators to the implementation process. METHODS A pre-post implementation study is being conducted by all eight sites that are members of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). Adults with SCD aged 18–45 who had an ED visit within 90 days prior to enrollment will be eligible for inclusion. Patients are enrolled in-clinic or remotely. This study’s target analytical sample size is 160 patient participants, 20 for each site, who have had an ED visit for VOE treatment at participating EDs during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The E-IPPs will be written by the patient’s SCD provider, and sites will work with the local informatics team to identify the best method to build the E-IPP with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an ED VOE visit, and selected qualitative interviews within two weeks of an ED visit will be performed to assess the primary outcome, patient perceived quality of ED pain treatment, and additional implementation and intervention outcomes. EHR data will be used to analyze ED provider E-IPP adherence and additional secondary outcomes, such as hospital admission and re-admission rates. RESULTS The study is currently enrolling study participants. The active implementation period is 18 months. CONCLUSIONS This study proposes a structured, framework-informed approach to implement an E-IPP with both patient and provider access in routine ED practice. The results of the study will inform the implementation of E-IPPs at a larger scale outside of SCDIC centers. CLINICALTRIAL ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528

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