Study Protocols

Care Redesign (MESH)

The purpose of this project is to improve adherence to hydroxyurea therapy. Multiple approaches for improving adherence with pharmaceutical regimens have been studied and demonstrate a need to address barriers that both providers and patients face. This project aims to test two innovative interventions utilizing mobile health (mHealth), to address both patients’ and providers’ needs: 1) an mHealth application for patients (InCharge Health app) that includes multi-component features to address the memory, motivation, and knowledge barriers to hydroxyurea use, and 2) an mHealth toolbox application for providers (HU Toolbox app) that addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea use.

Emergency Department (ALIGN) Protocol

The overall purpose of this study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients’ SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we provide access to the IPP for both adult patients with SCD and their ED providers. The multisite study has a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP is available for all adult ED providers to use as their routine practice, and patients at affiliated local clinics are invited to participate and enroll in the study.  

Needs Assessment

A needs assessment is a systematic process for determining and addressing needs, or "gaps" between the current conditions and desired conditions or "wants". Each center will be responsible for conducting a needs-based community assessment of barriers to care for SCD patients. Centers may elect to assess stakeholders such as patients, providers, clinical staff, and/or community members in determining the needs of their respective communities. Data collection methods for needs assessment vary and may include both quantitative methods, such as structured surveys and qualitative methods, such as focus groups or key informant interviews. There may be some common data elements that are standardized across centers while other measures may be utilized in a specific center or centers.


The Registry is developed in Phase I and continues through Phase II with the goal of enrolling 2400 patients (300 per center) between the ages of 15 and 45 years to conduct comparative studies related to guidelines and recommendations and to address evidence-based management of SCD. The Registry leverages the availability of CDEs in sickle cell disease developed under the PhenX Project and PROMIS to collect standard clinical measures, laboratory values, lifestyle factors, medical history, treatment, healthcare utilization, and patient reported outcomes associated with pain, co-morbidities, quality of life, physical functioning, mental health and barriers to care. Longitudinal data is collected on study subjects throughout study period. The Registry is a resource for identifying gaps in research, conducting data queries and analyses that lead to development and implementation of research studies, and dissemination of research findings from the Registry data.


The overall goal of this project is to define an unaffiliated sickle cell patient, identify strategies to find unaffiliated sickle cell patients, and determine why sickle cell patients may become disconnected from care. Multiple approaches were use to address these problems. First, the project conducted a Delphi consensus survey of sickle cell specialists to define what it means to be a sickle cell specialist and an unaffiliated sickle cell patient. Then, the project conducted two quantitative surveys, one for providers and one for patients, to learn why sickle cell patients may become disconnected from care and learn more about potential strategies to connect patients to care. In addition, sites developed methods to identify unaffiliated patients in their respective areas. Sites then conducted interviews with unaffiliated sickle cell patients to learn detailed reasons as to why patients become disconnected from care.