Decreasing Harms and Improving Child Health

Summary

The investigators are doing this study because they know from research and talking with caregivers that kids can be on a bunch of medications, and it's hard to keep track of what the medications are for and whether or not they are helping.

The other thing the investigators know is that some medications have very few side effects while others have many side effects, some of which can cause real health problems (severe weight gain, diabetes). Once someone is on a medication, they often just keep taking it without thinking much about whether they still need it.

the investigators are doing this study to look at the process of reviewing medications with the help of a handout that shows basic information about the most common types of medications, making a decision about keeping medications the same or lowering one, and following people to see how it goes.

If the caregiver and youth decide to lower a medication, the investigators have created a structured process for their child's prescriber to do this slowly and safely.

Slowly means kids are not likely to have any bad reactions. This process can be used to just lower the dose of a medication or to stop it altogether.

This is called the AWARE intervention and it has 2 parts:

1. Medication review using the handout \& making a decision
2. Prescribers' guide about lowering meds slowly for those who choose to do this The caregivers/youth do not have to lower a medication to be in the study.

Conditions

• Psychotropic Drugs
• Psychiatric Drugs
• Children
• Shared Decision Making
• Patient Decision Aid

Interventions

BEHAVIORAL

AWARE Shared Decision Making Medication Review

Participants, caregivers and clinicians use a shared decision making approach supported by a patient decision aid and smartphone app to review the youth's medications. This review includes discussing the original reason for the medication, how helpful the medication is, whether the youth has any side effects, the balance of side effects with effectiveness, and whether the medication is still needed. After reviewing all medications, a shared decision is made about whether to keep all medications the same or to attempt to deprescribe one of them. If the choice is to deprescribe, intervention includes a detailed, structured deprescribing protocol to support the prescribing clinician.

Sponsors & Collaborators

• Charles H. Hood Foundation

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Cayuga County Community Mental Health Center

  collaborator UNKNOWN

• Clinton County Mental Health & Addiction Services

  collaborator UNKNOWN

• Glyn Jones-Elwyn

  lead OTHER

Principal Investigators

• Glyn Elwyn, MD, PhD, MSc · The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-16

Primary Completion

2024-12-12

Completion

2025-02-12

Countries

• United States

Study Locations