Results Summary
What was the research about?
In sickle cell disease, or SCD, red blood cells change shape and block blood flow, causing pain and damage to the body. Hydroxyurea is a medicine that helps keep red blood cells healthy and reduces pain and damage from SCD. But some people may have side effects or other problems when taking this medicine.
National guidelines recommend using shared decision making, or SDM, to discuss treatment with hydroxyurea. SDM helps patients and clinicians, like doctors and nurses, make decisions about treatment together.
In this study, the research team compared two ways to support SDM use:
- SDM program. Clinics received training in communication and SDM. Parents received four decision aids. Decision aids help people choose between two or more healthcare options based on what is most important to them. The decision aids were two small booklets about the medicine, an information card, and a video. In the video, other parents talk about how they made their choice about the medicine.
- Clinician guide. Clinics received current guidelines and a pocket guide for offering hydroxyurea to parents of children with SCD. The guidelines recommended using SDM.
The research team compared parents’ uncertainty about making choices about using hydroxyurea between the two groups.
What were the results?
After three months, the two groups didn’t differ in:
- How uncertain parents were about making a choice about using hydroxyurea
- How satisfied parents felt about their decision
- The level of SDM parents had with their child’s clinician
- How parents felt about their child’s health care or health and well-being
In both groups, parents had less uncertainty about their decision.
Compared with the SDM group, parents in the clinician guide group:
- Had more problems talking about their child’s SCD pain with clinicians
- Were more likely to be offered hydroxyurea (81 percent versus 59 percent)
- Were more likely to receive hydroxyurea (48 percent versus 40 percent)
Who was in the study?
The study included 146 parents of children ages 0–5 with SCD. Children received care from eight SCD clinics across the United States. Among parents, 89 percent were Black, 1 percent were White, 1 percent were Asian, 6 percent were more than one race, and 2 percent were another race. The average age was 30, and 93 percent were women.
What did the research team do?
The research team assigned clinics to receive the clinician guide for at least six months; the clinics then started the SDM program. Parents completed surveys when making a decision about hydroxyurea and again three months later.
Patients, caregivers, clinicians, and community-based organizations helped design the study.
What were the limits of the study?
The research team had trouble recruiting parents, which led to delays in the study. The COVID-19 pandemic caused more recruitment challenges. As a result, the team couldn’t assign clinics by chance to the two groups as planned.
Future research could assign clinics by chance to the two ways to help parents make decisions about hydroxyurea.
How can people use the results?
Clinics can use results when considering ways to support SDM about treatments for SCD.
Professional Abstract
Objective
To compare the effectiveness of a shared decision making support intervention versus clinician receipt of a prescribing guide in reducing parent-reported decisional uncertainty for treating sickle cell disease (SCD) with hydroxyurea
Study Design
Design Element | Description |
---|---|
Design | Quasi-experimental study |
Population | 146 parents of children ages 0–5 with SCD |
Interventions/ Comparators |
|
Outcomes | Primary: parent-reported decisional uncertainty about hydroxyurea for treating SCD, level of shared decision making with clinician Secondary: clinician offer and prescription for hydroxyurea, parent knowledge of hydroxyurea, parent report of satisfaction with decision making, child’s health-related quality of life, child’s neurocognitive functioning, child’s healthcare utilization |
Timeframe | 3-month follow-up for primary outcomes |
This quasi-experimental study compared the effectiveness of a shared decision making support intervention versus clinician receipt of a prescribing guide in reducing parent-reported decisional uncertainty about treating SCD with hydroxyurea. Researchers compared two ways to help patients make decisions:
- Shared decision making intervention. Clinics received training in communication and shared decision making and used four decision aids to help parents with their decision about hydroxyurea. Parents received decision aids in a pre-visit brochure, an in-visit issue card, an after-visit booklet, and in video narratives of parents telling their story about how they made their decision about hydroxyurea.
- Clinician prescribing guide. Clinics received a guide for offering hydroxyurea to patients and used the American Society of Hematology pocket guide as a reference.
Clinics received the clinician guide for at least six months; then they received the shared decision making intervention.
The study included 146 parents of children ages 0–5 with SCD who were receiving care from eight SCD clinics in the South, Northeast, and Midwest regions of the United States. Among parents, 89% were Black, 2% were White, 1% were Asian, 6% were more than one race, and 2% were another race. The average age was 30, and 93% were female.
Parents of patients completed surveys about study outcomes at baseline and three months after their visit with the clinician.
Patients, caregivers, clinicians, and community-based organizations helped design the study.
Results
At three months, parents in shared decision making clinics and parents in clinician guide clinics did not differ significantly in parent-reported decisional uncertainty about hydroxyurea treatment or in the level of shared decision making. In both groups of clinics, parents reported lower decisional uncertainty.
Compared with parents in shared decision making clinics, parents in clinician guide clinics:
- Reported more problems communicating with clinicians about their child’s SCD pain (p=0.023)
- Had higher odds of being offered hydroxyurea (80.7% versus 58.7%; p=0.01)
- Had higher odds of being prescribed hydroxyurea (48.2% versus 39.7%; p=0.01)
The two groups did not differ significantly in other secondary outcomes.
Limitations
Researchers had difficulty recruiting parents, leading to delays in study completion that lasted into the COVID-19 pandemic. Because of low recruitment, researchers could not implement the study as a randomized trial as planned.
Conclusions and Relevance
In this study, parent-reported decisional uncertainty about hydroxyurea did not differ significantly when clinics received a shared decision making intervention and when they received a clinician guide; decisional uncertainty decreased in both. Parents in the clinics receiving a clinician guide reported more problems communicating with clinicians about their child’s SCD pain and had higher odds of being offered hydroxyurea by a clinician and of receiving a hydroxyurea prescription.
Future Research Needs
Future research could compare the two approaches to supporting shared decision making for hydroxyurea treatment for SCD using a randomized controlled trial.
Final Research Report
This project's final research report is expected to be available by September 2024.
Journal Citations
Related Journal Citations
Peer-Review Summary
The Peer-Review Summary for this project will be posted here soon.