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

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Reducing Missed Appointments for neurodevelopmental disorders?

Research shows that mobile phone messaging reminders, like text messages, can help reduce missed healthcare appointments by addressing forgetfulness, which is a common reason for no-shows. This approach has been effective in various settings, including among low-income women and in primary care, suggesting it could also be beneficial for neurodevelopmental disorders. ^{1 2 3 4 5}

How does the treatment using reminder messages and patient navigation for neurodevelopmental disorders differ from other treatments?

This treatment is unique because it uses reminder messages and patient navigation to improve adherence to healthcare appointments and medication schedules, which is not a standard approach for neurodevelopmental disorders. It leverages mobile phone messaging as a cost-effective way to reduce missed appointments and enhance patient engagement, which is different from traditional treatments that may not focus on these aspects. ^{1 6 7 8 9}

Research Team

luther G kalb, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile phone messaging reminders for attendance at healthcare appointments. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Autism Navigator on Access to Services. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Improving communication with low-income women using today's technology. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Using Nudges to Reduce Missed Appointments in Primary Care and Mental Health: a Pragmatic Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Potential Limitations of E-mail and Text Messaging in Improving Adherence in Glaucoma and Ocular Hypertension. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

"Necesita una vacuna": what Spanish-speakers want in text-message immunization reminders. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The utility of providing automated medication dose reminders to young children on chronic medication. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Mobile phone messaging reminders for attendance at healthcare appointments. [2022]