Reminder Messages and Patient Navigation for Neurodevelopmental Disorders

Overseen By luther G kalb, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 3

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

Disqualifiers: Age >18

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce missed appointments for individuals with neurodevelopmental disorders, such as autism, by testing various reminder messages and the assistance of patient navigators. Researchers seek to determine which reminder strategies are most effective and whether a dedicated assistant (patient navigator) increases appointment attendance. The trial includes several groups, each receiving different combinations of reminder messages and navigator support, to identify the most effective approach. Those who might benefit include individuals scheduled for evaluations at centers specializing in autism or psychological assessments and who frequently miss appointments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking solution for improving appointment adherence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that reminder messages and patient navigation can safely and effectively help people attend their medical appointments. Studies have found that text message reminders greatly improve attendance. For instance, one study found that attendance rates increased to 85.7% with SMS reminders.

Patient navigation programs are generally well-received. They guide patients through the healthcare system by providing support and information, leading to higher satisfaction.

Both reminder messages and patient navigation are non-invasive, involving no physical procedures and generally safe. These methods aim to improve patient interaction with healthcare services, with minimal risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to reduce missed appointments for individuals with neurodevelopmental disorders. Unlike the usual reminder systems that simply provide basic appointment details, this trial tests enhanced reminder messages crafted from scientific literature, aiming to better engage patients. Additionally, some trial arms include personal assistance with appointment navigation, offering an extra layer of support that could significantly boost attendance. By comparing these various approaches, the study seeks to uncover the most effective strategies for ensuring patients attend their appointments, which is critical for their ongoing care and management.

What evidence suggests that this trial's treatments could be effective for reducing missed appointments in neurodevelopmental disorders?

Research has shown that reminder messages, especially through mobile phones, can help reduce missed healthcare appointments. One study found that text message reminders were the most effective, significantly lowering the number of missed appointments. Another review highlighted that technology-based reminders reduced missed appointments by 5–10%.

In this trial, participants will receive different types of reminder messages. Some will receive enhanced messages, while others will receive standard messages. Additionally, certain arms will include patient navigation, where personal guidance and assistance are provided. Studies suggest this offers extra benefits, especially for families at risk of missing appointments. Overall, combining reminder messages with patient navigation has shown promise in improving attendance and reducing missed appointments. ^{1 3 6 7 8}

Who Is on the Research Team?

luther G kalb, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for individuals with neurodevelopmental disorders who often miss their medical appointments. Specific eligibility criteria are not provided, but typically participants would need to have a confirmed diagnosis and be able to receive communications for reminders.

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

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

Exclusion Criteria

There are no exclusion criteria above and beyond the overall exclusion criteria already established as part of routine care, which will not be overridden (e.g., if a patient has multiple visits scheduled for the same day, they will only receive a reminder for the first appointment of the day).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive different appointment reminder messages and patient navigation services to reduce missed appointments

6 months

Ongoing contact through messaging and navigation services

Follow-up

Participants are monitored for appointment attendance and barriers to attendance are assessed

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reducing Missed Appointments

Trial Overview

The study is testing whether different types of reminder messages and the help of a patient navigator can improve attendance at medical appointments. It also aims to identify barriers families face in keeping these appointments.

How Is the Trial Designed?

Group I: Standard message with navigator Experimental Treatment 1 Intervention

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

Group II: Enhanced message #2, no navigator Experimental Treatment 1 Intervention

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.

Group III: Enhanced message #2 with navigator Experimental Treatment 1 Intervention

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

Group IV: Enhanced message #1, no navigator Experimental Treatment 1 Intervention

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

Group V: Enhanced message #1 with navigator Experimental Treatment 1 Intervention

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

Group VI: Standard message, no navigator Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

93

Recruited

25,200+

Published Research Related to This Trial

Parents of children with Medicaid who received early access to an Autism Patient Navigator (APN) found the assessment significantly more useful, indicating that the APN may enhance the support for families navigating autism services.

Children with early access to the APN were more successful in scheduling and completing appointments for necessary services, suggesting that timely support can improve access to care for children diagnosed with autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Autism Navigator on Access to Services. Roth, BM., Kralovic, S., Roizen, NJ., et al.[2019]

Citations

1.

withpower.com

withpower.com/trial/reminder-messages-and-patient-navigation-for-neurodevelopmental-disorders-d9ce8

Reminder Messages and Patient Navigation for ...

Research shows that mobile phone messaging reminders, like text messages, can help reduce missed healthcare appointments by addressing forgetfulness, which is a ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10356735/

Using Nudges to Reduce Missed Appointments in Primary ...

An Israeli study found several messages effective at reducing missed appointments, the most effective being a text message appointment reminder ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4831598/

Appointment reminder systems are effective but not optimal

This study explores the effectiveness of reminder systems for promoting attendance, cancellations, and rescheduling of appointments across all health care ...

4.

thepermanentejournal.org

thepermanentejournal.org/doi/10.7812/TPP/21.078

Pragmatic Randomized Study of Targeted Text Message ...

Missed clinic appointments can be reduced through appointment reminders sent via text messages. Our randomized study at KPWA examined ...

5.

legacy.himss.org

legacy.himss.org/resources/using-technology-reduce-missed-appointments

Using Technology to Reduce Missed Appointments

This review revealed that notification systems help reduce missed appointment significantly. Many studies produced a 5 -10% decrease in the missed appointment ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5227159/

Text Message Reminders Increase Appointment ...

A systematic review also showed that text messages improved patients' medication adherence, especially in those with chronic diseases such as HIV, asthma, ...

7.

etd.ohiolink.edu

etd.ohiolink.edu/acprod/odb_etd/ws/send_file/send?accession=kent1669764346571207&disposition=inline

USING ADDITIONAL SMS REMINDERS TO IMPROVE ...

Results: The attendance rate to scheduled appointments increased to 85.7% with SMS reminders for the month of August which was significantly ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01676337

NCT01676337 | Text Message Appointment Reminders

This project proposes administer and evaluate via a randomized controlled trail a text message-based appointment reminder system to promote attendance at clinic ...