Shared Decision-Making Toolkit for Sickle Cell Disease

(EMPOWER-AYA Trial)

Overseen By Clinical Research Coordinator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Seizures, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help young people with sickle cell disease (SCD) make better treatment decisions. Participants will use a decision-making toolkit, the Shared Decision Making Intervention, with some experiencing virtual reality and others using traditional materials like print and video. The goal is to determine which method better aids in understanding treatment options. It is suitable for individuals aged 15-25 with SCD, treated at specific Nemours hospitals, who are considering new treatments. The trial aims to assess whether this approach is helpful and easy to use for patients and their caregivers. As an unphased trial, this study provides a unique opportunity to explore innovative decision-making tools that could significantly enhance the treatment experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on decision-making tools rather than medication changes.

What prior data suggests that this shared decision-making intervention is safe for adolescents and young adults with sickle cell disease?

Research shows that shared decision-making (SDM) is a recommended approach in healthcare, facilitating collaborative choices between patients and doctors by discussing treatment options and preferences.

The Shared Decision-Making Toolkit without VR uses tools like printed materials and videos to aid decision-making. Studies have shown it is well-received, with no major safety issues reported. Clinics use it to support conversations about treatments.

The Shared Decision-Making Toolkit with VR is similar but includes virtual reality to enhance the experience. Research suggests that the VR component is safe and makes the process more engaging for both patients and healthcare providers. This version helps overcome barriers to using certain therapies by making information easier to understand.

Overall, both versions of the toolkit are designed to be safe and helpful, aiming to make treatment decisions clearer and more comfortable for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shared Decision Making Toolkit for Sickle Cell Disease because it aims to empower patients by actively involving them in their treatment choices. This toolkit is distinctive because it includes an innovative use of virtual reality (VR) in one of its arms, which could enhance the patient experience by providing a more immersive and engaging way to understand treatment options. Unlike standard treatments that focus primarily on managing symptoms with medications like hydroxyurea or blood transfusions, this approach seeks to improve the overall decision-making process and patient satisfaction. By involving patients more directly in their health care, the toolkit has the potential to lead to more personalized and effective treatment outcomes.

What evidence suggests that this shared decision-making intervention is effective for sickle cell disease?

Research has shown that involving patients in healthcare decisions leads to better outcomes for those with sickle cell disease. This approach, known as shared decision-making, helps patients and caregivers choose the best treatments by actively participating in the decision process. In this trial, participants will join one of two groups: one using a shared decision-making toolkit without VR and the other using the toolkit with VR. Studies have found that a shared decision-making toolkit can lead to better treatment choices and improved care. Adding virtual reality (VR) to the toolkit makes it more engaging and helps patients better understand their condition and treatment options. VR simplifies complex information, making learning easier, especially for teenagers and young adults. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 15-25 with sickle cell disease (SCD), along with their caregivers, who are fluent in English. Participants must be receiving treatment at Nemours or ChristianaCare and considered by their healthcare provider as candidates for new SCD treatments.

Inclusion Criteria

Nemours SCD healthcare providers will also be included.

English language fluency is a requirement for all participants.

I am 15-25 years old with SCD and eligible for new treatments.

Exclusion Criteria

Patients/caregivers who previously participated in usability testing of the intervention will be excluded.

Providers still completing training will be excluded.

I do not have a history of seizures, can complete interviews, and if under 18, have a guardian for consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the shared decision making intervention, including either virtual reality or standard patient education materials

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for acute healthcare utilization and satisfaction with the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Shared Decision Making Intervention

Trial Overview The study tests a shared decision-making toolkit designed to help patients with SCD make informed choices about their treatment. Some will use the toolkit with virtual reality education, while others will have standard materials like print and video.

How Is the Trial Designed?

Group I: Shared Decision Making Toolkit without VR Experimental Treatment 1 Intervention

Group II: Shared Decision Making Toolkit including VR Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Published Research Related to This Trial

Patients with sickle cell disease and their caregivers feel that while healthcare provider education is helpful, it does not fully meet their learning needs, leading them to seek additional information independently.

The study identified that improving quality of life is a primary concern for patients and caregivers when considering treatment options, and they expressed a preference for peer experiences as a source of information, highlighting the potential benefit of a web-based decision aid to support their educational needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational needs of patients and caregivers living with sickle cell disease results in development of web-based patient decision aid. Ross, D., Sinha, C., Bakshi, N., et al.[2021]

A qualitative study involving 20 interviews with caregivers and individuals with sickle cell disease (SCD) revealed that decision-making around opioid use for pain management is complex and requires collaboration among patients, families, and healthcare providers.

The study identified key themes that can enhance shared decision-making strategies in clinical settings, emphasizing the importance of considering personal values, psychological states, and the context of care when discussing opioid therapy for pain management in SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Family Opioid Decision-Making for Pain Management in Sickle Cell Disease: A Qualitative Study. Phillips, S., Schlenz, AM., D'Alton, S., et al.[2023]

A qualitative study involving 36 physician interviews revealed two main approaches to decision-making in sickle cell disease treatments: the Collaborative approach, which emphasizes discussing all treatment options with patients, and the Proponent approach, which advocates for a specific treatment plan to persuade patients.

The study highlights the complexity of treatment decisions for sickle cell disease, influenced by patient, disease, and physician factors, suggesting a need for systems that enhance patient engagement and shared decision-making in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proponent or collaborative: Physician perspectives and approaches to disease modifying therapies in sickle cell disease. Bakshi, N., Sinha, CB., Ross, D., et al.[2022]

The study assessed the level of shared decision making (SDM) in discussions about hematopoietic stem cell transplantation (HSCT) among 26 patients with sickle cell disease (SCD) and thalassemia, finding a moderate SDM score of 43%.

While patients were informed about treatment options, the process primarily involved one-way communication, indicating a need for improvement in actively engaging patients in discussions about their preferences and treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making for hematopoietic stem cell transplantation in pediatric, adolescent, and young adult patients with a hemoglobinopathy-Shared or not? Mekelenkamp, H., Smiers, F., Camp, N., et al.[2022]

A survey of 63 primary care providers in North Carolina revealed that 64% care for 1 to 10 patients with sickle cell disease, but only 39% regularly communicate with SCD specialists, indicating a gap in co-management practices.

Providers showed low awareness and usage of the SCD Toolbox, which is designed to aid in SCD management, and expressed a preference for accessing the toolbox in various formats such as a website, mobile app, or paper.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and Use of the Sickle Cell Disease Toolbox by Primary Care Providers in North Carolina. Ibemere, SO., Tanabe, P., Bonnabeau, E., et al.[2021]

A series of workshops and educational sessions were organized to empower sickle cell disease (SCD) patients in Europe, allowing them to influence research priorities and enhance their involvement in the scientific community.

These initiatives have improved patient experience and empowerment, benefiting not only patients and caregivers but also health professionals, highlighting the importance of patient-centered approaches in medical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sickle cell disease: embedding patient participation into an international conference can transform the role of lived experience. Pellegrini, M., Chakravorty, S., Del Mar Manu Pereira, M., et al.[2023]

A multicomponent decision aid for hydroxyurea was developed to help parents and clinicians discuss treatment options for children with sickle cell anemia, involving input from 75 parents and 28 clinicians.

The use of this decision aid improved parents' knowledge about hydroxyurea and reduced their decisional conflict, indicating it could effectively support shared decision-making in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Hydroxyurea Decision Aid for Parents of Children With Sickle Cell Anemia. Crosby, LE., Walton, A., Shook, LM., et al.[2020]

In a study of 24 consultations involving children with sickle cell disease, the objective measurement of shared decision-making (SDM) was low, with a median score of only 25%, indicating significant room for improvement in involving patients and their families in treatment decisions.

While subjective perceptions of SDM were fair, there is a notable gap between paediatricians' confidence in their ability to engage families and the actual experience of children and parents, highlighting the need for better training and interventions to enhance SDM practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making between paediatric haematologists, children with sickle cell disease and their parents: an exploratory study. Wijngaarde, R., Koning, M., Fijnvandraat, K., et al.[2023]

Shared decision-making (SDM) is crucial in pediatric care, as it involves collaboration between patients, families, and healthcare providers to make informed health decisions, yet it remains underutilized despite evidence of its benefits.

Insights from a pediatric patient, a parent, and a pediatrician highlight the positive impacts of SDM on care outcomes and emphasize the need for practical recommendations to enhance its adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is sharing really caring? Viewpoints on shared decision-making in paediatrics. Jordan, Z., Tremblay, C., Lipstein, E., et al.[2021]

Patients with sickle cell disease (SCD) consider multiple factors, including lifestyle and health status, when deciding whether to take hydroxyurea (HU), highlighting the complexity of treatment decisions.

Effective communication from healthcare providers, particularly through shared decision-making, significantly influences patients' willingness to engage with HU treatment; those who felt unheard were more likely to disengage from their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Patient-Physician Communication on the Use of Hydroxyurea in Adult Patients with Sickle Cell Disease. Jabour, SM., Beachy, S., Coburn, S., et al.[2020]

Citations

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An Immersive Virtual Reality Curriculum for Pediatric ... An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision Making for Hydroxyurea in Sickle Cell Anemia. Francis J Real ...

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Engaging Caregivers and Providers of Children With Sickle ... Engaging parents of children with sickle cell disease and their providers in shared decision making for hydroxyurea (ENGAGE HU) conceptual model. H-SDM: ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124033524

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Design and Refinement of CyberCell TM , a Virtual Reality ... This study supports the use of VR to provide engaging and interactive education to AYAs with SCD about their condition and treatment options. We ...

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An Immersive Virtual Reality Curriculum for Pediatric ... A HU shared decision-making (H-SDM) toolkit was developed to facilitate such discussions (NCT03442114). It includes: 1) decision aids to support ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S000649711861331X

An Immersive Virtual Reality Curriculum for Pediatric ... A HU shared decision-making (H-SDM) toolkit was developed to facilitate such discussions (NCT03442114). It includes: 1) decision aids to support ...

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Development of a Shared Decision-Making Toolkit for ... The toolkit targets multi-level barriers to use of disease-modifying therapies by providing technology-enhanced tools for: 1) AYAs and ...