Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      This project proposes to develop, test and evaluate targeted interventions to improve
      clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a
      stepped-wedge design, The investigators will test two innovative interventions utilizing
      mobile health 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 clinical knowledge barriers in prescribing and
      monitoring hydroxyurea use. These two interventions will be tested through the following
      aims:

      Aim 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge
      Barriers to Hydroxyurea Use. Primary hypothesis: The investigators hypothesize that among
      adolescents and adults with SCD, the adherence to hydroxyurea, as measured by percentage of
      days covered (PDC), will increase by at least 20% at 24 weeks after receiving the InCharge
      Health app, compared to their hydroxyurea adherence at baseline.

      Sub-aim 1.a. To examine and assess both patient engagement and behaviors related to use of
      the InCharge Health app, the investigators will evaluate consistent use of the app among
      enrolled patients, patient satisfaction, and continued use of the app beyond the study
      period.

      Sub-Aim 1.b. To examine the clinical influence of the use of the InCharge Health app on PDC,
      patients' clinical outcomes, perceived health literacy, health related quality of life, and
      perceived self-efficacy between baseline and 24 weeks.

      Aim 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors.

      Sub-Aim 2.a. To examine and assess provider engagement and behaviors related to use of the HU
      Toolbox, the investigators will evaluate consistent use of the app among enrolled providers,
      providers' satisfaction, and continued use of the app beyond the study period.

      Sub-Aim 2.b. To assess the combined effects of the patient and provider mHealth interventions
      on hydroxyurea and health care utilization, the investigators will examine if the changes in
      hydroxyurea adherence are enhanced by the use of both provider and patient interventions
      compared to those not exposed to one or both interventions.

      Aim 3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth
      Interventions.
    

Detailed description: 
      The National Heart, Lung, and Blood Institute (NHLBI) created the Sickle Cell Disease
      Implementation Consortium (SCDIC) to apply implementation science methods to identify and
      address barriers to guideline-based care in sickle cell disease (SCD) and promote
      evidence-based treatment for SCD patients between ages 15 to 45 years. The SCDIC conducted a
      systematic literature review and a comprehensive needs assessment among the eight
      participating centers. A major conclusion was that care redesign to support better
      hydroxyurea utilization would likely improve clinical outcomes for patients with SCD.
      Hydroxyurea therapy has been shown to improve patient outcomes and reduce disease
      complications and is endorsed by the NHLBI. SCDIC now proposes to develop, test and evaluate
      targeted interventions to improve clinical provider prescribing of and patient adherence to
      hydroxyurea.

      The overall purpose of this proposed project is to address barriers identified by the needs
      assessment to improve adherence with 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, via a stepped-wedge
      design, 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. These two interventions will be tested through the following aims:

      Aim 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge
      Barriers to Hydroxyurea Use. Primary hypothesis: The investigators hypothesize that among
      adolescents and adults with SCD, the adherence to hydroxyurea, as measured by percentage of
      days covered (PDC), will increase by at least 20% at 24 weeks after receiving the InCharge
      Health app, compared to their hydroxyurea adherence at baseline.

      Sub-aim 1.a. To examine and assess both patient engagement and behaviors related to use of
      the InCharge Health app, the investigators will evaluate consistent use of the app among
      enrolled patients, patient satisfaction, and continued use of the app beyond the study
      period.

      Sub-Aim 1.b. To examine the clinical influence of the use of the InCharge Health app on PDC,
      patients' clinical outcomes, perceived health literacy, health related quality of life, and
      perceived self-efficacy between baseline and 24 weeks.

      Aim 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors. The
      investigators will examine among providers using the HU Toolbox App if there is an increase
      in reported awareness of hydroxyurea benefits and risks, accurate prescribing of hydroxyurea,
      and perceived self-efficacy to correctly administer hydroxyurea therapy between baseline and
      after 9 months of using the HU Toolbox app.

      Sub-Aim 2.a. To examine and assess provider engagement and behaviors related to use of the HU
      Toolbox, the investigators will evaluate consistent use of the app among enrolled providers,
      providers' satisfaction, and continued use of the app beyond the study period.

      Sub-Aim 2.b. To assess the combined effects of the patient and provider mHealth interventions
      on hydroxyurea and health care utilization, the investigators will examine if the changes in
      hydroxyurea adherence are enhanced by the use of both provider and patient interventions
      compared to those not exposed to one or both interventions.

      Aim 3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth
      Interventions. The investigators will evaluate the strategies used by participating sites in
      supporting the implementation of mHealth interventions via a mixed-method evaluation of the
      facilitators and barriers in adopting and implementing the mHealth interventions from
      multiple stakeholder perspectives: patient, provider, and organization.

      Both mHealth interventions will be tested concurrently and because the investigators are
      using a stepped-wedge design, each site will enter the study at different times. Provider
      participants will receive the HU Toolbox intervention for 9 months with a lagged but
      overlapping introduction of the InCharge Health intervention patient participants for 24
      weeks. The implementation evaluation will be guided by RE-AIM to assess the Reach,
      Effectiveness, Adoption, Implementation and Maintenance of the interventions. All sites will
      also complete follow-on needs assessment and medical record abstractions that will provide
      data to evaluate other patient and provider outcomes, barriers and enablers to hydroxyurea
      prescribing, use, and monitoring.

      mHealth technology can be leveraged to support more effective use of hydroxyurea and
      eventually improved SCD clinical outcomes. If the mHealth applications tested in this study
      show preliminary efficacy, both apps could be scaled up within SCDIC centers and expanded to
      other institutions outside the SCDIC.
    

Intervention name(s): InCharge Health mobile application; HU Toolbox mobile application
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The InCharge Health app features include: Daily reminders; Ability to customize content of message and time of day when the message comes; Symptom tracker to monitor daily pain and mood; 7-day streak that tracks daily adherence; Graphing adherence against pain symptoms; Communication feature allowing the patient to connect to the clinic and a "health partner"; Link to discussion forum where communication to other patients can occur; Education bank that provides information about SCD and hydroxyurea. Participants can delay daily push notifications. If hospitalized, participants may stop notifications. A special feature of the app is to set up a "health partner", who may be a person the participant may choose from his/her contact list and who will receive notifications if it had been <4 hours since not documenting the use of hydroxyurea. The "app healthy partner" will be encouraged to message the participant to remind him/her to take the medication.; The HU Toolbox app includes algorithms for hydroxyurea use and is ready for immediate use on Apple and Android operating systems. In addition, it has the NHLBI guidelines adapted for pediatrics (guidelines/recommendations separated by age) and for adults (guidelines/ recommendations separated by organ system, laboratory, or physical exam finding). The HU Toolbox app includes the ability to search guidelines for key words and add notes. Algorithms are also included as PDF documents that can be printed out or emailed. Finally, a contact list of local SCD specialists and important contacts is included, so providers can easily contact SCD experts and expect an answer in 24 hours or less. The HU Toolbox app is easily updated with all data and resources stored on a cloud-based server that can provide instant up-to-date information to those using the app.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: nonrandomized, closed cohort, stepped-wedge cluster trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: implementation science; sickle cell anemia; digital medicine; adherence; hydroxycarbamide; health innovation