Electronic Medical Record Linked Clinical Alerts to Enhance Sensory Deficit Screening in Childhood Cancer Survivors

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05582551
Collaborator
St. Jude Children's Research Hospital (Other)
159
1
3
21
7.6

Study Details

Study Description

Brief Summary

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 cancer survivors (CCS). Using a cross sectional design study, the investigators will implement an electronic medical record (EMR) alert system that will link therapy related risks for sensory deficits to specific screening procedures prompting the primary oncology provider to implement screening, diagnostic testing, and therapy.

Condition or Disease Intervention/Treatment Phase
  • Other: EHR-based CDS Alert System for Sensory Deficit Screening
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
159 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Electronic Medical Record Linked Clinical Alerts to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
Anticipated Study Start Date :
Dec 31, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients: CDS Alert System for Sensory Deficit Screening

The primary oncology team will utilize the CDS alert system to identify patients who are at risk for sensory deficits based on prior treatment. The alert system will generate a report of 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.

Other: EHR-based CDS Alert System for Sensory Deficit Screening
-An alert system sent out via the Electronic Health Record to alert physicians of possible sensory deficits that may need screening

No Intervention: Providers: CDS Alert System for Sensory Deficit Screening

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

No Intervention: Parents: CDS Alert System for Sensory Deficit Screening

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with at risk for sensory deficits identified by the alert [Through completion of enrollment for all patients (estimated to be 9 months)]

  2. Percentage of at risk patients who fail the assigned screening test [Through completion of enrollment for all patients (estimated to be 9 months)]

  3. Percentage of patients in need of referral for screen test results who participate in formal diagnostic testing and/or treatment [Through 1 year after the completion of screening test for all participants (estimated to be 1 year and 9 months)]

Secondary Outcome Measures

  1. Number and types of barriers to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening [At approximately 2 months following the patient's screening]

  2. Number and types of facilitators to participation in formal diagnostic testing and therapy in CCS failing to engage in sensory screening [At approximately 2 months following the patient's screening]

  3. Acceptability of CDS Alert as measured by the Acceptability of Intervention Measure (AIM) [To be completed at the time of enrollment completion (approximately 9 months)]

    -4 questions inquiring about the acceptability of CDS alert with answers ranging from completely disagree=1 to completely agree=5. The higher the score indicates higher acceptability of the CDS Alert

  4. Feasibility of intervention as measured by Feasibility of Intervention Measure (FIM) [To be completed at the time of enrollment completion (approximately 9 months)]

    -4 questions inquiring about the feasibility of CDS alert with answers ranging from completely disagree=1 to completely agree=5. The higher the score indicates higher feasibility of the CDS Alert

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with a diagnosis of pediatric cancer (diagnosis at <18 years of age)

  • Treatment including chemotherapy and/or radiation therapy

  • Completion of all cancer therapy for at least 6 months and less than 2 years

  • Followed in the Division of Pediatric Hematology/Oncology Program at the Washington University School of Medicine

  • Current age between 7 and 17 years of age (age where all of the screening tests are both valid and have been successfully performed by our group)

  • English speaking

Exclusion Criteria:
  • Undergoing active cancer treatment

  • Patient under the care of the Late Effects Program at St. Louis Children's Hospital

  • Received previous diagnostic testing or rehabilitative therapy for a secondary deficit eligible for screening.

  • Parents and/or patient illiteracy

  • No contact with treatment team in the past two years

  • In foster care or without a legal guardian

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Louis Children's Hospital - Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Robert J Hayashi, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05582551
Other Study ID Numbers:
  • 202208066
First Posted:
Oct 17, 2022
Last Update Posted:
Oct 19, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine

Study Results

No Results Posted as of Oct 19, 2022