Decreasing Harms and Improving Child Health

Part of paid clinical trials in Hanover, New Hampshire.

Sponsor
Glyn Jones-Elwyn
Study ID
NCT07392489
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • AWARE Shared Decision Making Medication Review — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 16, 2023
Status verified
Feb 2026
Primary completion
Dec 12, 2024
Completion
Feb 12, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: AWARE Medication Review
    All eligible participants and their parent/caregiver take part in the AWARE intervention - a shared decision making comprehensive medication review with the participant's clinician.

Primary Outcome Measure

Feasibility [ Time Frame: Baseline through 30-week follow-up ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dartmouth CollegeHanoverNew Hampshire03755-
Dartmouth HealthLebanonNew Hampshire03766-
Cayuga County Community Mental Health CenterAuburnNew York13021-
Clinton County Mental Health & Addiction ServicesPlattsburghNew York12903-

Find similar trials in Hanover, NH

By research site
Dartmouth College· Hanover, NHDartmouth Health· Lebanon, NHCayuga County Community Mental Health Center· Auburn, NYClinton County Mental Health & Addiction Services· Plattsburgh, NY

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