Shared Decision Making to Improve Care and Outcomes for Children With Autism
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Neurology, Neurology, Psychiatric, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 4 - 15 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | July 2015 |
Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that
may be improved with pharmacotherapy, including difficulties with sleep, attention,
hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings,
self-injury, and aggression. While 34-58% of children with ASD take medication for such
behaviors, there is wide practice variation nationally and a lack of evidence to support the
use of most commonly prescribed agents. Complex clinical situations such as this where there
is no clear "best choice" regarding which behaviors to target and which medications to use
lend themselves well to the use of a Shared Decision Making (SDM) tool to ensure that
well-informed parent preferences shape every treatment plan.
The primary goal of this study is to modify a previously published decision aid about use of
medication to manage challenging behaviors in children with autism to make it easy to
implement in practice and then evaluate this version in terms of proximal decisional
outcomes and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral
Pediatric clinic will be enrolled and randomly allocated to intervention or control
(treatment as usual) groups. Initially, providers randomized to the intervention group will
test and refine the modified intervention. Once the intervention is finalized, eligible
patients of participating providers will be enrolled in the randomized controlled trial to
test the efficacy of the intervention. Following the trial, control group providers will be
crossed over and receive the intervention. Both proximal decisional outcomes (e.g. parent
decisional conflict, provider amount of SDM, parent knowledge of treatment options) and
outcomes 3 months later (e.g. parenting stress, decisional conflict, and change in child
behavioral symptoms) will be assessed.
Approximately 10 providers and 240 of their patients with autism will be included in the
study. Chart reviews, parental surveys, and recordings of provider-parent-patient
interactions during the index visit will be collected at baseline (prior to physician
allocation), during the intervention trial, and after the control group has crossed over.
Between- and within-group analyses will examine factors associated with parental decisional
conflict and whether the intervention produces significant improvements in outcomes over and
above typical autism care. Analyses will include multiple linear regression modeling and
general linear models / repeated measure models, accounting for data clustered by provider.
may be improved with pharmacotherapy, including difficulties with sleep, attention,
hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings,
self-injury, and aggression. While 34-58% of children with ASD take medication for such
behaviors, there is wide practice variation nationally and a lack of evidence to support the
use of most commonly prescribed agents. Complex clinical situations such as this where there
is no clear "best choice" regarding which behaviors to target and which medications to use
lend themselves well to the use of a Shared Decision Making (SDM) tool to ensure that
well-informed parent preferences shape every treatment plan.
The primary goal of this study is to modify a previously published decision aid about use of
medication to manage challenging behaviors in children with autism to make it easy to
implement in practice and then evaluate this version in terms of proximal decisional
outcomes and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral
Pediatric clinic will be enrolled and randomly allocated to intervention or control
(treatment as usual) groups. Initially, providers randomized to the intervention group will
test and refine the modified intervention. Once the intervention is finalized, eligible
patients of participating providers will be enrolled in the randomized controlled trial to
test the efficacy of the intervention. Following the trial, control group providers will be
crossed over and receive the intervention. Both proximal decisional outcomes (e.g. parent
decisional conflict, provider amount of SDM, parent knowledge of treatment options) and
outcomes 3 months later (e.g. parenting stress, decisional conflict, and change in child
behavioral symptoms) will be assessed.
Approximately 10 providers and 240 of their patients with autism will be included in the
study. Chart reviews, parental surveys, and recordings of provider-parent-patient
interactions during the index visit will be collected at baseline (prior to physician
allocation), during the intervention trial, and after the control group has crossed over.
Between- and within-group analyses will examine factors associated with parental decisional
conflict and whether the intervention produces significant improvements in outcomes over and
above typical autism care. Analyses will include multiple linear regression modeling and
general linear models / repeated measure models, accounting for data clustered by provider.
SDM involves clinicians sharing information about treatment options and parents sharing
their goals, concerns, and preferences to ensure that treatment plans are based on what
matters most to well-informed parents. SDM often incorporates use of decision aids, which
are balanced sources of information about treatment options for a particular condition.
Decision aids consistently increase knowledge, improve treatment expectations, increase
active participation in decision making, reduce uncertainty about the appropriate course of
action, and help patients reach decisions that are more aligned with their stated values.
their goals, concerns, and preferences to ensure that treatment plans are based on what
matters most to well-informed parents. SDM often incorporates use of decision aids, which
are balanced sources of information about treatment options for a particular condition.
Decision aids consistently increase knowledge, improve treatment expectations, increase
active participation in decision making, reduce uncertainty about the appropriate course of
action, and help patients reach decisions that are more aligned with their stated values.
Inclusion Criteria:
Providers
- Providers must be a licensed professional, either a physician (MD) or a nurse
practitioner (APN) in the Division of Developmental and Behavioral Pediatrics at
Cincinnati Children's Hospital.
- Provider must regularly treat patients within the age range and for the diagnoses of
interest in this study (Autism Spectrum Disorders).
Parents
- Participants must be a parent or legal guardian who self-identifies as the primary
caregiver of a child or adolescent with Autism Spectrum Disorder cared for by an
enrolled provider in the Division of Developmental and Behavioral Pediatrics at
Cincinnati Children's Hospital.
- Participants must be able to speak and read English in order to complete the surveys
Children
- Child or adolescent must have a clinical diagnosis of Autism Spectrum Disorder
including one of the following diagnoses: a) Pervasive Developmental Disorder (PDD),
b) Asperger's Syndrome, c) Autism Spectrum Disorder, d) Autism, e) Infantile Autism
- Child or adolescent must be between the ages of 4 years 0 months and 15 years 11
months
- Child or adolescent must be scheduled for a follow up visit with a
Developmental-Behavioral Pediatric provider enrolled in the study.
Exclusion Criteria:
-Parents who are unable to speak and read English are not eligible for the study.
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