Decreasing harms and improving child health: An intervention to reduce inappropriate use of antipsychotics and polypharmacy

Key Words: Child and adolescent mental health, Deprescribing, Shared decision-making, Clinical outcomes, Antipsychotics, Polypharmacy, Off-label, Treatment evaluation, Mixed-methods, Community-based participatory research, Side effects, Implementation, Decision aids, Practice guidelines

The use of antipsychotics and polypharmacy (3 or more medications) in children has rapidly increased in recent years. Parents, schools, and clinical prescribers may have unrealistic expectations for these medications and want quick relief. However, they may not consider serious and common side effects and long-term problems that come with the medication’s use. Nearly all use of antipsychotics and polypharmacy in children goes against Food and Drug Administration guidance (called “off-label”). These medications can have serious side effects, including major weight gain, diabetes, neurocognitive problems, sleepiness, restlessness, and tremors or tics. We do not know the long-term effects of these medications on the developing brain and body. Government agencies, oversight groups, and media sources are concerned with this issue. Professional organizations, lawmakers, and medical leaders are looking for ways to solve this problem and reduce harm to children. Many parents and clinical prescribers also want to reduce the dose or stop these medications (“deprescribe”). However, there is no standard practice to guide clinicians and families on how to do this. Some clinical prescribers are worried about trying to deprescribe without more guidance.

Our research team, led by Erin Barnett, Ph.D., Assistant Professor in Psychiatry and Jennifer McLaren, M.D., Associate Professor in Psychiatry, has developed tools that help clinical prescribers and parents make thoughtful decisions about mental health medications. And, where possible, safely reduce or stop them (“deprescribe”) in a careful way. In this study, we want to improve the intervention, including the use of Fora Health to digitally enabled key steps of the intervention, and test how it works with 40 children. We will work with clinical prescribers in three outpatient children’s mental health clinics in the northeast. We will collaborate with clinical prescribers and parents to make sure our intervention will work in the real world. We will examine whether it is practical and easy to use. We will look for changes in medications and doses. We will assess whether parents felt like they shared in the decisions about medications. We will look for changes in child functioning, mental health and mood symptoms, adverse events, and side effects.

Our research team is well-connected to many psychiatric and mental health associations and leaders. We have a proven record of sharing our results quickly with mental health leaders, clinicians, and the public. In this project we will also be using Fora Health to support the caregiver and patient and help them prepare for discussions with their caregivers and make shared decisions. After testing the intervention, we will make our tools free for use by clinicians anywhere. About 1.3 million children in the U.S. receive an unapproved “off-label” antipsychotic or polypharmacy. All of these children would be eligible for the intervention. The intervention could also be used and tested by pediatricians, and eventually, could be adapted for other high-risk medications.

Overall, we want to help clinical prescribers and parents make shared decisions and support only the safe and effective use of mental health medications. The project’s goals fit with the Hood Foundation’s goals by reducing the use of inappropriate high-risk medications. Reducing these medications reduces their known harms such as weight gain, diabetes, and neurocognitive problems. By doing so, we promote children’s health and well-being. Given these medications’ serious risks and side effects, the intervention could have a big impact on children’s mental health, physical health, and overall well-being.

About:

The Dartmouth Institute for Health Policy & Clinical Practice: https://tdi.dartmouth.edu

Fora Health: Shared decision-making: https://fora.health