HPARSS Alert System for Childhood Cancer Survivors

Recruiting at 1 trial location

Overseen By Robert J. Hayashi

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Active cancer treatment, Late Effects Program, others

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

Compensation: Varies

Number of Visits: Unknown

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to speed up the screening process for potential sensory problems, such as hearing or vision issues, in childhood cancer survivors. These issues might result from past cancer treatments. The study will use an alert system, the HPARSS (EHR-based CDS Alert System for Sensory Deficit Screening), to help doctors identify which children need these tests based on their previous cancer therapies. It targets children who had cancer before age 18, completed treatment 6 months to 2 years ago, and are currently between 7 and 17 years old. Participants must be part of a specific pediatric oncology program and speak English. As an unphased trial, this study offers a unique opportunity to improve long-term care for childhood cancer survivors.

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.

What prior data suggests that the HPARSS Alert System is safe for childhood cancer survivors?

Research shows that the HPARSS Alert System helps doctors identify childhood cancer survivors who might have sensory issues, such as hearing or vision problems. This system analyzes electronic health records (EHRs) to highlight patients who may need further testing. The aim is to enable doctors to quickly recognize children who might require additional care for these issues.

Although specific data on the safety of the HPARSS system is not available, similar systems in healthcare have been used safely. For instance, an alert system using EHRs has identified children at risk for sepsis, demonstrating both effectiveness and safety. These alert systems are generally well-tolerated because they do not involve physical procedures or medications; they simply assist doctors in making better decisions.

In summary, using an EHR-based alert system like HPARSS is generally considered safe, as it aids doctors in managing patient care. No direct risks to patients have been reported from using such systems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HPARSS Alert System for childhood cancer survivors because it uses an innovative, EHR-based Clinical Decision Support (CDS) system to proactively identify patients at risk for sensory deficits. Unlike traditional methods that might rely on periodic check-ups or patient-reported symptoms, this system leverages electronic health records to highlight at-risk individuals based on their treatment history, aiming for early detection and intervention. This proactive approach not only enhances the ability to screen for sensory issues more efficiently but also potentially improves long-term outcomes by facilitating timely referrals for diagnostic testing or therapy.

What evidence suggests that the HPARSS Alert System is effective for screening sensory deficits in childhood cancer survivors?

Research has shown that electronic health record (EHR) alerts, such as the HPARSS (Highlighting Patients at Risk for Sensory Screening) system, can enhance patient care by prompting doctors to take specific actions. In this trial, the HPARSS system will identify childhood cancer survivors at risk for sensory deficits based on their past treatments. In locations where similar alert systems have been implemented, healthcare providers have been more likely to follow recommended screening practices. Early findings suggest that HPARSS may help doctors quickly identify childhood cancer survivors who need checks for sensory issues. This system links past cancer treatments with potential risks for sensory problems, aiding doctors in deciding when additional tests or treatments are necessary. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert J. Hayashi

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors aged 7-17, who finished treatment between 6 months and 2 years ago at Washington University School of Medicine. They must speak English and not have had sensory deficit screening or therapy before.

Inclusion Criteria

I am receiving or have received chemotherapy or radiation therapy.

I am between 7 and 17 years old.

I was diagnosed with cancer before turning 18.

Exclusion Criteria

I have had tests or therapy for a condition that wasn't my main illness.

You or your parents cannot read or write.

In foster care or without a legal guardian

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sensory Deficit Screening

Sensory deficit screening will be completed in the clinic for childhood cancer survivors identified as at risk based on prior treatment

9 months

Regular clinic visits as needed

Follow-up

Participants are monitored for safety and effectiveness after sensory deficit screening

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EHR-based CDS Alert System for Sensory Deficit Screening

Trial Overview The study tests a new system called HPARSS designed to help doctors identify kids at risk of sensory deficits after cancer treatment, prompting timely screening and intervention.

How Is the Trial Designed?

Group I: Patients: Highlighting Patients at Risk for Sensory Screening (HPARSS) Experimental Treatment 1 Intervention

* The primary oncology team will utilize the HPARSS to identify patients who are at risk for sensory deficits based on prior treatment. The HPARSS will constitute a file of that will contain eligible patients based upon their past treatment and their corresponding risk for a particular sensory deficit based upon that treatment. The patient and parent/guardian will be approached to participate in the study. * Sensory deficit screening will be completed in the clinic and any screening results that indicate the need for referral for diagnostic testing or therapy will be scheduled by the primary treatment team staff.

Group II: Providers: Highlighting Patients at Risk for Sensory Screening (HPARSS) Active Control 1 Intervention

-Providers will complete a survey regarding their views of the HPARSS. The Acceptability of Intervention Measure has 4 questions and the Feasibility of Intervention Measure has 4 questions.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

A child abuse clinical decision support system (CA-CDSS) was successfully developed and implemented in two different electronic health record (EHR) systems, Epic and Allscripts, across multiple hospitals, demonstrating the feasibility of adapting such systems for different platforms.

The implementation process revealed significant variations in the types of triggers and alerts used in each EHR, highlighting the need for tailored adaptations and extensive usability evaluations to ensure effective integration and support for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of child abuse clinical decision support: Moving beyond a single electronic health record. McGinn, T., Feldstein, DA., Barata, I., et al.[2023]

Clinical decision support (CDS) systems integrated into electronic medical records are effective in detecting medication errors and adverse drug events, particularly in critically ill patients who are at higher risk.

Advancing CDS by using trajectory analyses and incorporating biomarkers can enhance alert systems, allowing for proactive adjustments in medication therapy to prevent adverse drug-related events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support for drug related events: Moving towards better prevention. Kane-Gill, SL., Achanta, A., Kellum, JA., et al.[2022]

The Southern California Pediatric and Adolescent Cancer Survivorship (SC-PACS) consortium successfully enrolled 127 participants (65 childhood/adolescent cancer survivors and 62 parents/caregivers) to assess the survivorship needs of this population, highlighting the importance of monitoring and care for cancer survivors.

A significant majority (78%) of participants found the survivorship information useful, with 83% feeling they received adequate information about their cancer, indicating a strong demand for comprehensive survivorship care and education tailored to the unique needs of diverse cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Southern California Pediatric and Adolescent Cancer Survivorship (SC-PACS): Establishing a Multi-Institutional Childhood, Adolescent, and Young Adult Cancer Survivorship Consortium in Southern California. Lin, C., Baca, N., Yun, C., et al.[2022]

The transition to a commercial electronic health record (EHR) system resulted in a significant increase in both the number of clinical decision support (CDS) alerts and the rate of overrides, particularly for drug-allergy and drug-drug interaction alerts, indicating potential challenges in alert management.

Despite the higher override rates in the commercial system, a review of overridden contraindicated drug-drug interactions found no adverse drug events, suggesting that the overrides did not lead to immediate harm, but highlighting the need for improved alert presentation and knowledge base to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Overridden Medication-related Clinical Decision Support in the Intensive Care Unit between a Commercial System and a Legacy System. Wong, A., Wright, A., Seger, DL., et al.[2018]

The remote clinical decision support (CDS) service integrated with the Epic electronic health record showed a mean execution time of 0.74 seconds, indicating it can provide rapid recommendations for physicians treating children with minor blunt head trauma.

The CDS system was responsible for generating 60% of physician-initiated and 99% of nurse-initiated recommendations, demonstrating its effectiveness in supporting clinical decision-making in a multicenter trial setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a remote clinical decision support service for a multicenter trial to implement prediction rules for children with minor blunt head trauma. Goldberg, HS., Paterno, MD., Grundmeier, RW., et al.[2018]

A new dataset has been developed to standardize the follow-up of childhood cancer survivors, focusing on the late effects of pediatric oncology treatments, through collaboration among multiple medical institutions in the Netherlands.

The PLEKsys computerized documentation system will be implemented across all Dutch pediatric oncology centers to facilitate the collection and evaluation of data on late effects, supporting the establishment of a National Pediatric Oncology Follow-up Registry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a new information model for a pediatric cancer registry on late treatment sequelae in The Netherlands. Jaspers, MW., Caron, H., Behrendt, H., et al.[2004]

A study involving 29 participants, including childhood cancer survivors and their caregivers, found that there is a high interest in using electronic personal health records (ePHRs) for managing health information, with 100% of survivors expressing interest.

Despite concerns about data security and privacy, most participants felt these issues would not hinder their willingness to adopt ePHRs, indicating a positive attitude towards digital health management tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Personal Health Records for Childhood Cancer Survivors: An Exploratory Study. Sharp, LK., Carvalho, P., Southward, M., et al.[2021]

The Decision Support System for Making Personalized Assessments and Recommendations Concerning Breast Cancer Patients (DPAC) effectively uses a Bayesian network to recommend optimal treatments, leading to significantly better 5-year metastasis-free probabilities for patients who followed its recommendations compared to those who did not.

In a 5-fold cross-validation, patients advised by DPAC had higher probabilities of being metastasis-free across various treatments, indicating its potential efficacy in guiding personalized breast cancer treatment, although some recommendations, like those regarding chemotherapy for node-negative patients, remain controversial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical decision support system learned from data to personalize treatment recommendations towards preventing breast cancer metastasis. Jiang, X., Wells, A., Brufsky, A., et al.[2020]

The SPARK web-based application was developed through three phases, involving 90 children aged 8-18, and showed significant improvements in usability and navigation, making it suitable for children undergoing cancer treatment.

In high-fidelity testing, 100% of participants understood how to use SPARK for symptom screening and found it easy to use, indicating its potential effectiveness in facilitating access to supportive care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial development of Supportive care Assessment, Prioritization and Recommendations for Kids (SPARK), a symptom screening and management application. Cook, S., Vettese, E., Soman, D., et al.[2020]

Routine symptom screening in pediatric cancer care can enhance communication between patients and healthcare providers, potentially improving quality of life and even survival rates, as suggested by evidence from adult oncology.

Automating the reporting of adverse events through electronic health records (EHRs) could improve accuracy and reduce the workload for healthcare providers, which is crucial for managing both symptom and nonsymptom toxicities in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving symptom control and reducing toxicities for pediatric patients with hematological malignancies. Sung, L., Miller, TP., Phillips, R.[2021]

A new alert system for inpatients successfully notified physicians about serious clinical conditions, with a high response rate of 70.2% to 1730 alerts over a 6-month period.

Physicians acted quickly, responding to 82.5% of alerts within 15 minutes, and indicated they would take action in 71.5% of cases, suggesting the system is effective in facilitating timely medical responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting alerts, notifying the physician, and offering action items: a comprehensive alerting system. Kuperman, GJ., Teich, JM., Bates, DW., et al.[2018]

A systematic review of 24 studies found that electronic clinical decision support (CDS) systems in oncology generally improve key outcomes, including reducing prescribing errors and medication-related safety events, particularly in computerized chemotherapy order entry.

Despite the positive findings, there is a significant lack of rigorous data on the effectiveness of CDS systems in oncology, highlighting the need for further research to fully understand their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Clinical Decision Support Systems for Clinical Oncology Practice. Pawloski, PA., Brooks, GA., Nielsen, ME., et al.[2022]

The Appy CDS clinical decision support tool was developed to help identify pediatric patients at risk for appendicitis, successfully capturing similar populations with appendicitis rates of approximately 11.8% and 10.6% across two different health systems.

The tool is currently being evaluated in a pragmatic trial to reduce the need for advanced diagnostic imaging, indicating its potential to improve diagnosis and management of appendicitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Clinical Decision Support System for Pediatric Abdominal Pain in Emergency Department Settings Across Two Health Systems Within the HCSRN. Ekstrom, HL., Kharbanda, EO., Ballard, DW., et al.[2022]

The ADEAS system generated 2650 safety alerts for 931 patients over a 5-month period, with hospital pharmacists successfully contacting healthcare professionals in 10% of cases to prevent potential adverse drug events (ADEs).

The overall effectiveness of the clinical rules in ADEAS was low, with a rule effectiveness of 0.10 and a positive predictive value (PPV) of 0.08, indicating a need for refinement of the rules to improve their clinical relevance and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of rule effectiveness and positive predictive value of clinical rules in a Dutch clinical decision support system in daily hospital pharmacy practice. Rommers, MK., Zwaveling, J., Guchelaar, HJ., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-childhood-cancers-11-2022-54e1e

HPARSS Alert System for Childhood Cancer Survivors This trial is for childhood cancer survivors aged 7-17, who finished treatment between 6 months and 2 years ago at Washington University School of Medicine.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05582551?cond=%22Neuromuscular+Disorders%22&term=%22Washington+University+School+of+Medicine+in+St.+Louis%22+OR+%22Washington+University+in+St.+Louis%22+OR+%22St.+Louis+Children%27s+Hospital%22+OR+%22Barnes-Jewish+Hospital%22

Patients At Risk for Sensory Screening (HPARSS) to ... The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05582551/patients-at-risk-for-sensory-screening-hparss-to-enhance-sensory-deficit-screening-in-childhood-cancer-survivors

Patients At Risk for Sensory Screening (HPARSS) to ... The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood ...

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Patients At Risk for Sensory Screening (HPARSS) to Enhance ... Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors ... Outcome data and publication updates.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05582551?keyword=%22Electronic%20Medical%20Record%22

Patients At Risk for Sensory Screening (HPARSS) to ... The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9925095/

Development of an EHR-based Alert to Improve Sepsis ... An automated screening algorithm with an EHR-based alert can appropriately identify immunocompromised children with sepsis, though with a relatively high false ...

7. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/search/download?page&_format=csv

https://digital.ahrq.gov/ahrq-funded-projects/sear... ... systems engineering. Develop a prototype guide for the safe and effective integration of ADSs into primary care. The researchers will leverage data from an ...

8. researchgate.net researchgate.net/publication/360867597_Clinical_Decision_Support_Stewardship_Best_Practices_and_Techniques_to_Monitor_and_Improve_Interruptive_Alerts

Clinical Decision Support Stewardship: Best Practices and ... In this review, we discuss the evidence for effective alert stewardship as well as practices and methods we have found useful to assess interruptive alert ...