Decision Aid for Therapeutic Options In Sickle Cell Disease
Condition: Sickle Cell Disease; Sickle Cell Anemia; Hemoglobin SS; Hemoglobin SC; Hemoglobin Beta Thalassemia
MeSH terms: Anemia, Sickle Cell; Thalassemia; beta-Thalassemia; Hemoglobin SC Disease
Study type: Interventional

Summary: 
      Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations
      affecting 100,000 individuals in the US, largely of minority origin and associated with
      substantial morbidity, premature mortality, individual suffering, healthcare costs and loss
      of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion
      and curative bone marrow transplantation are offered to patients based on physician
      preference and current practice informed by clinical trials. Decision aids are tools that
      could help translate evidence from these sources into practice by helping clinicians involve
      patients in making deliberate choices based on accessible information about the options
      available and their outcomes and to help them make decisions based on their values and
      preferences.

      The overarching goal of this project is to implement a web based decision aid individualized
      to patient characteristics to help patients with SCD achieve more accurate perception of
      risks and benefits of treatment options and make decisions in congruence with their values
      and preferences. Investigators will use a randomized controlled trial of the effectiveness of
      a web-based decision aid to give patients accurate information about risks and benefits of
      therapies that enable patients to make decisions based on their individual values and
      preferences.
    

Detailed description: 
      Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations
      affecting 100,000 individuals in the US, largely of minority origin and associated with
      substantial morbidity, premature mortality, individual suffering, healthcare costs and loss
      of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion
      and curative bone marrow transplantation are offered to patients based on physician
      preference and current practice informed by clinical trials. Decision aids are tools that
      could help translate evidence from these sources into practice by helping clinicians involve
      patients in making deliberate choices based on accessible information about the options
      available and their outcomes and to help them make decisions based on their values and
      preferences.

      There are minimal data about patient-related barriers to and attitudes towards, the use of
      curative therapies in SCD. Thus significant gaps remain in the understanding of patient
      perspectives, in the provision of accurate information about risks and benefits of therapies
      and of incorporating patients' values and preferences in offering treatment options. There is
      a need for research that helps to understand patient values and preferences and determines
      how to help patients make informed treatment decision in congruence with their values and
      preferences.

      The overarching goal of this project is to implement a web based decision aid individualized
      to patient characteristics to help patients with SCD achieve more accurate perception of
      risks and benefits of treatment options and make decisions in congruence with their values
      and preferences. Investigators will use a randomized controlled trial of the effectiveness of
      a web-based decision aid to give patients accurate information about risks and benefits of
      therapies that enable patients to make decisions based on their individual values and
      preferences.

      Investigators hypothesize that a web based decision aid individualized to patient
      characteristics can improve knowledge and help patients with SCD achieve more accurate
      perception of risks and benefits of treatment options and is associated with lower decisional
      conflict than standard care.

      The aims of the study are to estimate the effectiveness of the decision aid tailored to
      individual patient characteristics on patient knowledge, patient involvement in
      decision-making and decision-making quality, when compared with usual care.
    

Intervention name(s): Decision Aid Tool; Standard Practice
Intervention type(s): Other; Other
Intervention description(s): The tool is a web based decision aid that provides information about the risks and benefits associated with sickle cell disease therapies. Participants will be provided a unique access ID and password to access the information.; Standard of care teaching and discussion regarding treatment options given by patient's healthcare provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Hydroxyurea; Bone marrow transplant; Chronic blood transfusion; Treatment options for sickle cell disease; Decision making