Shared Decision-Making Toolkit for Sickle Cell Disease
(EMPOWER-AYA Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nemours Children's Clinic
Disqualifiers: Seizures, Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.
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 data supports the effectiveness of the Shared Decision Making Intervention treatment for sickle cell disease?
Research shows that shared decision-making (SDM) can improve health outcomes for children with sickle cell disease by involving them and their parents in treatment decisions. A study found that using a decision aid for hydroxyurea, a drug for sickle cell anemia, improved knowledge and reduced decisional conflict, suggesting that SDM can help in making informed treatment choices.
12345Is the Shared Decision-Making Toolkit for Sickle Cell Disease safe for humans?
The research articles do not provide specific safety data for the Shared Decision-Making Toolkit itself, but they focus on improving decision-making processes for treatments like hydroxyurea in sickle cell disease. There is no mention of safety concerns related to the decision-making process itself.
13678How does the Shared Decision Making Intervention treatment differ from other treatments for sickle cell disease?
The Shared Decision Making Intervention is unique because it focuses on involving patients and their families in the decision-making process about their treatment options, rather than just prescribing a specific medical treatment. This approach aims to improve health outcomes by ensuring that treatment decisions align with the patient's values and preferences.
123910Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Shared Decision Making Toolkit without VRExperimental Treatment1 Intervention
Group II: Shared Decision Making Toolkit including VRExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nemours Children's Hospital, DelawareWilmington, DE
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Who Is Running the Clinical Trial?
Nemours Children's ClinicLead Sponsor
References
Shared decision-making between paediatric haematologists, children with sickle cell disease and their parents: an exploratory study. [2023]Children with sickle cell disease (SCD) face various healthcare choices to be made during the disease process that may impact their lives. Shared decision-making (SDM) could improve their health outcomes. We assessed if, and to what extent, paediatricians engage children with SCD and/or their parents in the decision-making process. In this observational cross-sectional study, paediatric SCD patients and their parents visiting the outpatient paediatrics clinic of a university hospital participated in a SDM baseline measurement. Two evaluators independently and objectively analysed the level of patient involvement in decision-making from the audio-recordings of the consultations using the OPTION-5 instrument, a 0-20-point scale from which scores are usually expressed as a percentage of ideal SDM. The level of SDM, as perceived by patients, parents and paediatricians, was appreciated using the SDM-Q-9 and SDM-Q-Doc questionnaires, respectively. Scores could range from 0% (no SDM) to 100% (exemplary SDM). Twenty-four consultations in which a decision needed to be made about SCD treatment were audiotaped and analysed; six were from each paediatrician. The group consisted of 17 male and 7 female patients from various cultural backgrounds between 2 and 17 years old, with a mean age of 9.4 years (SD 4.2). Median OPTION-5 scores were 25.0% [IQR] 20.0-40.0%; range 0-55%). Median SDM-Q-9 and SDM-Q-Doc scores were 56.7% (IQR 39.4-88.9%) and 68.9% (IQR 57.8-77.8%), respectively.
Proponent or collaborative: Physician perspectives and approaches to disease modifying therapies in sickle cell disease. [2022]Sickle cell disease (SCD) is an inherited blood disorder that primarily affects African-American and other ethnic minority populations. There are three available disease-modifying therapies for sickle cell disease: hydroxyurea (HU), bone marrow transplantation (BMT), and chronic blood transfusion (CBT). Since these treatments vary in their therapeutic intent, efficacy in preventing progression of the disease, short and long-term adverse effects, costs and patient burden, the decision-making process regarding these therapies is complicated for both the patient and healthcare provider. While previous research has focused on the patient perspective of treatment-related decision making, there is a paucity of research investigating the physician perspective of treatment-related decision making. We conducted a qualitative study with physicians who were experts in the field of SCD. Interviews focused on physician perceptions of patient decisional needs as well as physicians' approach to decision making regarding disease-modifying therapies in SCD. Thirty-six physician interviews were analyzed, with a focus on their perspectives regarding available treatment options and on how they approach decision making with patients. We identified two narrative approaches. The Collaborative approach (CA) was characterized by emphasizing the need to discuss all possible treatment options to ensure that the patient and/or family was equipped to make an informed decision. The Proponent approach (PA) was characterized by strongly advocating a pre-determined treatment plan and providing patients/families with information, with the objective of convincing them to accept the treatment. An interplay of patient-related and disease-related factors, decision type and physician-related factors, as well as institutional frameworks, influenced physician perspectives on treatment options and decision making regarding these therapies. These findings point to the potential value of developing systems to foster patient engagement as a way of facilitating shared decision making.
Development of a Hydroxyurea Decision Aid for Parents of Children With Sickle Cell Anemia. [2020]National evidence-based guidelines recommend offering hydroxyurea to patients with sickle cell anemia 9 months of age and older using shared decision making, but offer no strategies to aid implementation. We developed a hydroxyurea multicomponent decision aid via a needs assessment, clinic observations, and iterative feedback to address parent decision needs and promote a discussion between clinicians and parents. A total of 75 parents and 28 clinicians participated across all phases. The decision aid was rated as useful. Hydroxyurea knowledge improved and decisional conflict decreased supporting the potential for use to facilitate shared decision making in pediatric sickle cell anemia.
The Role of Patient-Physician Communication on the Use of Hydroxyurea in Adult Patients with Sickle Cell Disease. [2020]This qualitative study analyzed the perspective of patients living with sickle cell disease (SCD) on their process of deciding whether to take hydroxyurea (HU), and the role of physician communication in patients' decision-making process.
Patient and Family Opioid Decision-Making for Pain Management in Sickle Cell Disease: A Qualitative Study. [2023]Pain is a significant symptom experienced frequently by individuals with sickle cell disease (SCD). Pain management includes strategies such as oral rehydration, non-pharmacological therapies (eg, massage, relaxation), and oral analgesics and opioids. Shared decision-making around pain management is emphasized repeatedly in recent guidelines; however, research is sparse regarding factors to be considered in shared decision-making approaches including the perceived risks and benefits of opioids. This qualitative descriptive study was conducted to explore perspectives of decision-making for opioid medications in SCD. We conducted 20 in-depth interviews with caregivers of children with SCD and individuals with SCD to elucidate the decision-making processes around home use of opioid therapy for pain management at a single center. Themes were identified in the domains of the Decision Problem (Alternatives and Choices; Outcomes and Consequences; Complexity), the Context (Multilevel Stressors and Supports; Information; Patient-Provider Interactions), and the Patient (Decision-Making Approaches; Developmental Status; Personal and Life Values; Psychological State). Key findings indicated opioid management for pain in SCD is important yet complex and requires collaboration among patients, families, and providers. Elements of patient and caregiver decision-making identified in this study may be applied to shared decision-making strategies in the clinical setting and future study. PERSPECTIVE: This study illustrates the factors involved in decision-making around home opioid use for pain management in children and young adults with SCD. These findings can be applied to determining shared decision-making approaches around pain management between providers and patients, in accordance with recent SCD pain management guidelines.
Educational needs of patients and caregivers living with sickle cell disease results in development of web-based patient decision aid. [2021]We performed an assessment to understand perceived decisional needs among those living with sickle cell disease. Additionally, we desired understanding of their preferred methods and quality of learning and sought guidance in development of a web-based patient decision aid.
Awareness and Use of the Sickle Cell Disease Toolbox by Primary Care Providers in North Carolina. [2021]Sickle cell disease (SCD) is a complex chronic blood disorder characterized by severe disease complications ideally managed by both hematologists and primary care providers (PCP's). PCP's report knowledge gaps and discomfort with SCD management. Our team developed and a decision support tool for SCD management (SCD Toolbox) based on the National Heart, Lung, and Blood Institute's SCD guidelines. We surveyed PCPs in North Carolina (NC) prior to formal dissemination to determine current co-management practices, assess toolbox acceptability, use, format preferences, and understand which algorithms would be most helpful.
Sickle cell disease: embedding patient participation into an international conference can transform the role of lived experience. [2023]Sickle cell disease (SCD) is an inherited chronic life-threatening disorder with increasing prevalence in Europe. People living with SCD in Europe mainly belong to vulnerable minorities, have a lower level of health education and suffer from isolation compared to those living with other chronic conditions. As a result, SCD patients are much less likely to partner in the design of research related to their condition and are limited in their ability to influence the research agenda. Aiming to increase the influence of patient voice in the development of SCD-related research, we set out to develop patient centered actions in the frame of International Scientific Conferences in collaboration with the ERN-EuroBloodNet, Oxford Blood Group, Annual Sickle Cell Disease and Thalassaemia Conference (ASCAT), the European Hematology Association and the British Society of Hematology.
Is sharing really caring? Viewpoints on shared decision-making in paediatrics. [2021]Shared decision-making (SDM), the cornerstone of family-centred care and the gold standard in health decision-making, occurs when the patient, family members and the health-care team members partner to make health decisions about the child. This partnership involves an exchange of medical information and information about patient/family preferences and values. Together, the health-care team, parent and patient deliberate to determine the best course of action for the child. Despite high-quality evidence supporting its positive impact on outcomes, SDM has not been widely adopted in paediatric clinical practice. Greater understanding of the impact of SDM on all members of the decision triad (parent, patient and health-care provider) may increase the likelihood of SDM adoption. Therefore, we present the viewpoints of a paediatric patient, parent and paediatrician about the use of SDM. A youth living with a rare chronic disease discusses the impacts of being involved and excluded from health decisions. A mother of a son living with a rare nephrotic condition discusses working with a health-care team who are committed and skilled in SDM and the positive impacts SDM has had for her son's care. A general paediatrician with research expertise in SDM discusses the individual and system level challenges and rewards of using SDM in her clinical practice. Based on the viewpoints presented, we offer pragmatic recommendations for using SDM in paediatric clinical practice.
Decision making for hematopoietic stem cell transplantation in pediatric, adolescent, and young adult patients with a hemoglobinopathy-Shared or not? [2022]Hematopoietic stem cell transplantation (HSCT) offers an established curative option for sickle cell disease (SCD) and thalassemia patients but is associated with significant risks. Decision making is a complex process and shared decision making (SDM) could be a fitting approach in case of such preference-sensitive decisions. This study investigated what level of SDM is used in conversations with hemoglobinopathy patients and/or their caregivers considering HSCT as a curative treatment option.