Refining the Shared Decision Making Process Survey in ADHD Medication Decisions

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 Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid

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.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decision Aid Arm; Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.	Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid; The parent pre-visit cards from the Cincinnati Children's Hospital's Attention Deficit Hyperactivity Disorder (ADHD) Treatment for School Age Children Decision Aid were used in this study. The 6 pre-visit cards provide an overview of ADHD treatment options, the respective benefits and downsides of each option, and questions to elicit goals/preferences. The four different treatment options presented were: (1) watchful waiting, (2) behavioral treatment, (3) medication treatment, and (4) combined treatment (behavioral and medication together).
Control Arm; Participants in this group will not receive any educational materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared Decision Making Process Score	The Shared Decision Making Process scale is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.	baseline survey (reflecting on the last 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD Knowledge	Multiple choice knowledge items are scored correct/incorrect and a total knowledge score (0-100%) is calculated with higher scores indicating higher knowledge.	baseline survey
Decisional Conflict Tool (SURE)	Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 4 indicates no decisional conflict. The number who get score of 4 is reported indicating no decisional conflict. This reports number of participants were reported no decision conflict.	baseline survey
Single-item Measure of Decision Regret	Single item asking "If you knew then what you know now, do you think you would make the same decision. Response options are: Definitely yes, Probably yes, Probably no, Definitely no.	baseline survey
Treatment Choice	1 item that asked parents if their child is currently taking medication to treat their ADHD.	baseline survey
National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale	8 items that ask parents to rate their child's performance in school overall, in individual subjects such as reading, relationships with others such as parents and peers, and their participation in organized activities. There were 5 response options: Excellent, above average, average, somewhat of a problem, and problematic. Total scores range from 8 to 40 with higher scores indicating more problematic behavior	baseline survey
Adapted Controlled Preference Scale	Single item asking the parent who made the ultimate decision. The categorical response options are 1) the parent made the decision, 2)the child's provider made the decision, 3) both parent and provider made the decision together, or 4) the decision as made by someone else	baseline survey
Shared Decision Making Process Measure Retest	The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.	2 weeks after completing the baseline survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	1 item measure of adherence to medication for sample of participants who indicated their child was taking medicine. The question asked "in the last 30 days, how often did your child take their ADHD medicine in the way they were supposed to?"	baseline survey

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Center for Survey Research, University of Massachusetts, Boston
• Investigators: Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): April 13, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: shared decision making
• Other Study ID Numbers: 2019P001434-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will create a complete, cleaned, de-identified copy of the final dataset. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
• IPD Sharing Time Frame: Data will be available within 3 months after the main results have been published.
• IPD Sharing Access Criteria: Investigators from other sites will be able to request the data from the principal investigator and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No