Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
5000 participants
INTERVENTIONAL
2026-01-01
2027-12-01
Brief Summary
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Detailed Description
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Aim 2: To determine the added benefit of receiving patient navigation services for families at elevated risk of missing their appointment, and to understand the barriers to child neurodevelopmental evaluation appointments for the purposes of informing future interventions. Throughout the intervention trial, the patient navigator will continuously gather qualitative information on the barriers to appointment attendance faced by families identified to be at elevated risk of missing their evaluation appointment. Understanding these barriers will be critical to the development of future intervention efforts. Hypothesis 2a: Patient navigation services will be superior to enhanced or standard messaging alone in reducing missed appointments. Hypothesis 2b: Most families contacted by the patient navigator will face more than one barrier to attendance, and most barriers will fall into thematic categories that can be used to develop targeted interventions.
Aim 3: To examine the factors related to missed appointments. While the study team has previously identified families that are high-risk for missing their child's appointment, how those family and child-related factors replicate in a novel clinic is unknown. Hypothesis 3: The missing appointment factors will generally reproduce in an independent clinic, Center for Autism (n\~3600 yearly diagnostic evaluation appointments), and generally reproduce in the updated data within Center for Neuropsychological and Psychological Assessment (n\~6,200 yearly diagnostic evaluation appointments). This will allow the investigators to determine if the intervention is effective particularly for families at elevated risk of missing their appointment (Aim 4).
Aim 4: To examine if the missing appointment interventions increase the socioeconomic diversity of Kennedy Krieger patients. Previous research shows families from less advantaged socioeconomic backgrounds are more likely to miss their appointments. The goal of the intervention is to increase equity among Kennedy Krieger patients, rather than sacrificing equity at the expense of higher show rates (e.g., using punitive procedures). Hypothesis 4: More families at elevated risk of missing their appointments will attend their appointments when receiving the enhanced messages compared to standard messages, and further supported via patient navigation.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Standard message, no navigator
This arm represents the standard operating procedures. It includes basic appointment information and no personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Standard message with navigator
This arm represents the standard pre-appointment reminder message. This arm will include personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Enhanced message #1, no navigator
This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will not include personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Enhanced message #1 with navigator
This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Enhanced message #2, no navigator
This arm represents a second novel pre-appointment reminder message based on existing scientific literature. This arm will not include personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Enhanced message #2 with navigator
This arm represents a second novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.
Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Interventions
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Reminder message and patient navigation
This study will evaluate the combination of pre-appointment messages and patient navigation services.
Eligibility Criteria
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Inclusion Criteria
* Patients who are at elevated risk within the center for neuropsychological and psychological assessment are automatically enrolled in the patient navigator portion of the intervention trial.
Exclusion Criteria
* For patient navigation, patients \>18 years of age will be excluded.
1 Month
24 Years
ALL
No
Sponsors
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Responsible Party
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Principal Investigators
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luther G kalb, PhD
Role: PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Locations
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Kennedy Krieger Institute
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Luke Kalb
Role: primary
References
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Gornik AE, Northrup RA, Kalb LG, Jacobson LA, Lieb RW, Peterson RK, Wexler D, Ludwig NN, Ng R, Pritchard AE. To confirm your appointment, please press one: Examining demographic and health system interface factors that predict missed appointments in a pediatric outpatient neuropsychology clinic. Clin Neuropsychol. 2024 Feb;38(2):279-301. doi: 10.1080/13854046.2023.2219421. Epub 2023 Jun 8.
Kalb LG, Freedman B, Foster C, Menon D, Landa R, Kishfy L, Law P. Determinants of appointment absenteeism at an outpatient pediatric autism clinic. J Dev Behav Pediatr. 2012 Nov-Dec;33(9):685-97. doi: 10.1097/DBP.0b013e31826c66ef.
Berliner Senderey A, Kornitzer T, Lawrence G, Zysman H, Hallak Y, Ariely D, Balicer R. It's how you say it: Systematic A/B testing of digital messaging cut hospital no-show rates. PLoS One. 2020 Jun 23;15(6):e0234817. doi: 10.1371/journal.pone.0234817. eCollection 2020.
Other Identifiers
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IRB00455545
Identifier Type: -
Identifier Source: org_study_id