Health Literacy - Neurocognitive Screening in Pediatric SCD

Study Overview
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Brief Summary
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The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Given recent literature suggesting the need to be conscious of health literacy in populations with low socioeconomic status, this project is intended to provide a more health-literate appropriate format of neurocognitive evaluation feedback in the context of a routine screening program offered as a standard of care in the CHW pediatric sickle cell disease clinic. The specific aims is (1) to evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to control group and (2) to evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to control group.

Detailed Description
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Pediatric sickle cell disease (SCD) is a blood disorder affecting approximately 70,000 to 100,000 individuals in the United States. Approximately 80% of individuals affected by SCD are African American, with approximately one out of every 346 individuals in this racial group diagnosed. Sickle cell disease is associated with broad neurocognitive impairment. Compared to their healthy peers, children with SCD demonstrate deficits in intellectual functioning, verbal abilities, visual-motor, and visual-spatial skills, short-term memory, executive functioning, attention and focus, and processing speed. Neurocognitive deficits can result from primary disease-related factors including chronic anemia, hypoxemia, or cerebrovascular ischemia; as well as secondary factors such as missed school and a higher prevalence of socio-economic disadvantages in African American children. While direct neurological impact appears to be associated with neurocognitive performance, it was found that even children with no MRI abnormality evidence lower intellectual functioning skills than healthy controls, suggesting that biological, socioeconomic, and environmental factors are all implicated in neurocognitive impairment. Because of these deficits, children with SCD are more likely to be retained in school relative to other African American students at the local and national levels. In addition, poorer cognitive and academic performance is associated with a decrease in patient-reported quality of life and general psychosocial functioning. In turn, greater levels of stress and negative mood are correlated with higher levels of reported pain, greater health care utilization, and reduced physical activity. It appears that sickle cell disease not only contributes to poorer neurocognitive and social-emotional well-being, but that declines in these domains can further exacerbate sickle cell disease symptoms. Because of the deficits in neurocognitive functioning of children with SCD, routine screening is recommended to assess for cognitive deficits and provide appropriate recommendations. Unfortunately, prior research in SCD suggests limited follow-up on referrals and recommendations. For example, it was found that 25% of children with SCD evaluated by a neuropsychologist met the criteria for ADHD, but only 21% of the children subsequently diagnosed with ADHD were prescribed medication. In addition, it was found that children with SCD were not universally receiving appropriate school accommodations and interventions based on their cognitive deficits, despite the recommendation that school-based services be implemented immediately for children with SCD. The disconnect between the cognitive, emotional/behavioral, and academic deficits are typically seen in children with SCD and the actual support received may be due in part to low health literacy and the provision of complex reports following testing. Health literacy has been found to be low in adolescents and adults with sickle cell disease. Another study found that caregivers of children with SCD had a low level of baseline disease-related knowledge but that this knowledge did improve with in-person education; however, this knowledge appeared to decline over time. Unfortunately, materials developed to improve knowledge often do not fit criteria for broad population health literacy. One study found that patient education materials developed for patients with sickle cell disease and their families ranged from an 8th to 12th grade reading level, with limited potential to translate written recommendations into concrete actions. Broadly, research suggests the need for a change within the historical format of neurocognitive evaluation reports. It is noted as a need to make written reports provided to families more efficient, readable, and effective. Providing appropriate feedback to families appears essential, as it can improve health-related quality of life, coping, and understanding. An informal calculation of the current reports provided to families in our clinic's neurocognitive screening program suggested that reports averaged a reading level grade of 12.3 and approximately 17,500 words, standing in stark contrast to health literacy recommendations. Addressing the poor health literacy of neurocognitive feedback evaluations has two primary problems. First, these reports often have multiple intended audiences beyond caregivers, including teachers, school psychologists, physicians, and other professionals working with the child. These individuals may benefit from more detailed and technical information. In addition, some of the wording used in neurocognitive reports is standardized and can lose meaning or be technically incorrect if simplified. Thus, it appears essential to evaluate whether the addition of a health-literate passport card will help address disparities in understanding of results and patient/family follow-through after receiving a neurocognitive evaluation. This study is innovative in being the first to our knowledge to investigate the use of a tangible tool, namely a passport style printed card, to address health literacy concerns by conveying the most important findings and recommended follow-up after completion of a neurocognitive evaluation. In other contexts, healthcare passport cards have demonstrated the ability to improve communication among families and other providers, make information and recommendations portable, and enhance continuity of care. However, the use of passport cards has not been evaluated as a potential solution to the problem plaguing neuropsychological evaluations, namely the provision of overly lengthy and complex reports following testing.

Official Title
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Health Literacy: A Randomized Controlled Trial to Investigate a Novel Feedback Tool for Neurocognitive Screening in Pediatric Sickle Cell Disease

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Passport Card
* Behavioral: No Passport card


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will include English-speaking patients between the ages of 6 and 17 with pediatric sickle cell disease and their caregivers (46 patient-caregiver dyads). Exclusion Criteria: Patients will be excluded from participation if they have a history of significant neurological injury or impairment negating the benefit of a neurocognitive screening

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>Caregivers in the standard of care-arm will receive immediate verbal feedback by a psychologist on their neurocognitive testing results, recommendations, and guidance for implementing recommendations (e.g., sending a 504 Plan request to the school). This report will contain information regarding background, test results, a summary and impressions, and bullet-pointed recommendations. | Behavioral: No Passport card<br>* After receiving neurocognitive testing and verbal feedback from the psychologist, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback and evaluation report, but not the passport card.<br>|
| Experimental: Health Literacy<br>Participants randomized to the experimental health-literacy group will be provided with a color-coded passport (a two-sided wallet-sized card) highlighting key findings and recommendations of their neurocognitive testing results along with the full written report. The domains listed as either satisfactory or needing help listed on the passport card will directly correspond to those listed on the full report. | Behavioral: Passport Card<br>* After receiving neurocognitive testing, caregivers in the health-literacy group will be provided with a color-coded passport (a two-sided wallet-sized card) highlighting key findings and recommendations along with their written report. Then, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback passport card and evaluation report.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Understanding | Evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to the control group through the semi-structured interview. | 7-14 weeks post evaluation | 
| Caregiver Follow-through | Evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to the control group through the semi-structured interview. | 7-14 weeks post evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Literacy, Neuropsychology, Hematology, academic achievement