Clinical trial NCT05048186: Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
Official title: Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Keywords: shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2021-09-17
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample was an online non-probability panel of adults living in the United States. Marketing Systems Group, the sample vendor, invited potential respondents from an online panel of adults who had a child with ADHD, and who discussed treatment options for their child's ADHD in the past 2 years.

Brief summary: This is a retrospective observational survey study. We will survey a sample of adult parents or legal guardians who have a child who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and who discussed ADHD treatment options for their child with a health care provider within the last 2 years. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions parents make about their children with ADHD. A third goal is to assess the impact of a Decision Aid on participant knowledge of ADHD treatment options. Participants will be randomized to one of two arms: participants in the intervention arm will review a Decision Aid (patient educational tool) partway through the survey and those in the control arm will not receive any educational materials. All participants will complete survey that includes the Shared Decision Making process survey along with a few other measures. A subset of respondents will also complete a retest survey about two weeks after the initial survey.

Detailed description: This is a retrospective observational survey study. We will survey a sample of adult parents or legal guardians who have a child who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and who discussed ADHD treatment options for their child with a health care provider within the last 2 years. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions parents make about their children with ADHD. A third goal is to assess the impact of a Decision Aid on participant knowledge of ADHD treatment options. Participants will be randomized to one of two arms: participants in the intervention arm will review a Decision Aid (patient educational tool) partway through the survey and those in the control arm will not receive any educational materials. All participants will complete survey that includes the Shared Decision Making process survey along with a few other measures. A subset of respondents will also complete a retest survey about two weeks after the initial survey.

Study staff are working with a national sampling firm to recruit subjects and obtain 500 responses. The sample size was determined to ensure 80% power to detect difference of 0.25SD at 0.05 significant between intervention and control arm on participant knowledge scores. The decision aid intervention consists of a set of pre-visit summary cards for parents that cover the different treatment options and was developed by the Cincinnati Children's Hospital Medical Center.

For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items and knowledge scores for the two arms. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.

Eligibility criteria: Inclusion Criteria:

* Adult parent or legal guardian of a child between the ages of 5 and 13 who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)
* Read English
* Have talked with a health care provider about medication for treatment of ADHD for the child in the past 2 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Shared Decision Making Process Score
timeFrame: baseline survey (reflecting on the last 24 months)
Secondary outcomes:
measure: ADHD Knowledge
timeFrame: baseline survey
measure: Decisional Conflict Tool (SURE)
timeFrame: baseline survey
measure: Single-item Measure of Decision Regret
timeFrame: baseline survey
measure: Treatment Choice
timeFrame: baseline survey
measure: National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale
timeFrame: baseline survey
measure: Adapted Controlled Preference Scale
timeFrame: baseline survey
measure: Shared Decision Making Process Measure Retest
timeFrame: 2 weeks after completing the baseline survey
Other outcomes:
measure: Adherence
timeFrame: baseline survey
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: