NCT06915480

Brief Summary

There are four goals of this project: (1) To examine the impact of different appointment reminder messages on appointment attendance; (2) to determine the added benefit of a patient navigator reaching out in advance of appointments to families at elevated risk of missing their appointment, and determine the most common barriers families face in appointment attendance; (3) to evaluate which patients are at highest risk of missing their appointment, and to determine the effectiveness of the intervention trial across different patient risk levels; and (4) to examine if the missing appointment interventions increase the socioeconomic diversity patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for phase_3

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

March 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

December 29, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 31, 2025

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient appointment no-show

    Proportion of appointments that are neither kept nor cancelled

    6 months

Secondary Outcomes (1)

  • Patient appointment cancel

    6 months

Study Arms (6)

Standard message, no navigator

ACTIVE COMPARATOR

This arm represents the standard operating procedures. It includes basic appointment information and no personal assistance with appointment navigation.

Behavioral: Reminder message and patient navigation

Standard message with navigator

EXPERIMENTAL

This arm represents the standard pre-appointment reminder message. This arm will include personal assistance with appointment navigation.

Behavioral: Reminder message and patient navigation

Enhanced message #1, no navigator

EXPERIMENTAL

This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will not include personal assistance with appointment navigation.

Behavioral: Reminder message and patient navigation

Enhanced message #1 with navigator

EXPERIMENTAL

This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.

Behavioral: Reminder message and patient navigation

Enhanced message #2, no navigator

EXPERIMENTAL

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.

Behavioral: Reminder message and patient navigation

Enhanced message #2 with navigator

EXPERIMENTAL

This arm represents a second novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.

Behavioral: Reminder message and patient navigation

Interventions

This study will evaluate the combination of pre-appointment messages and patient navigation services.

Enhanced message #1 with navigatorEnhanced message #1, no navigatorEnhanced message #2 with navigatorEnhanced message #2, no navigatorStandard message with navigatorStandard message, no navigator

Eligibility Criteria

Age1 Month - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None for the messaging portion of the study
  • For patient navigation, patients \>18 years of age will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 37291078BACKGROUND
  • 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.

    PMID: 23095496BACKGROUND
  • 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.

    PMID: 32574181BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • luther G kalb, PhD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

luther G kalb, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Families and providers will be fully masked to condition. The investigators will know about condition as they orchestrate the study.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: All families will be randomized to one of three pre-appointment reminder messages. Additionally, families who are at high risk of experiencing a missed appointment will receive patient navigation services in one of the two departments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 8, 2025

Study Start

December 29, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations