- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06915480
Reducing Missed Appointments
Reducing Appointment NoShow Through Targeted Pre-appointment Messaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1: To test messaging strategies aimed at reducing missed appointments, via a randomized trial, across two different Kennedy Krieger outpatient clinics. Using the reminder system timeline and contact strategy already in effect in these two centers, the investigators will trial alternative language in the reminders (i.e., enhanced message #1 and enhanced message #2) against the current standard of care language. Hypothesis 1: Enhanced messaging will be superior to the standard of care in terms of reducing missed appointments. The investigators do not make a priori hypotheses regarding which enhanced messaging strategy will be optimal, given the exploratory nature.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: luther G kalb, PhD
- Phone Number: 4439239439
- Email: kalb@kennedykrieger.org
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21211
- Recruiting
- Kennedy Krieger Institute
-
Principal Investigator:
- Luther Kalb, PhD
-
Contact:
- Luke Kalb
- Phone Number: 443-923-9439
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients who are scheduled to be seen within the center for autism or the center for neuropsychological and psychological assessment for evaluation appointments will be automatically enrolled in the reminder message portion of the intervention trial.
- 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:
- None for the messaging portion of the study
- For patient navigation, patients >18 years of age will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard message, no navigator
This arm represents the standard operating procedures.
It includes basic appointment information and no personal assistance with appointment navigation.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
|
Experimental: Standard message with navigator
This arm represents the standard pre-appointment reminder message.
This arm will include personal assistance with appointment navigation.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
|
Experimental: 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.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
|
Experimental: 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.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
|
Experimental: 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.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
|
Experimental: 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.
|
This study will evaluate the combination of pre-appointment messages and patient navigation services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient appointment no-show
Time Frame: 6 months
|
Proportion of appointments that are neither kept nor cancelled
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient appointment cancel
Time Frame: 6 months
|
Proportion of appointments that are cancelled (>48 hours of appointment date)
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: luther G kalb, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00455545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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