Trial Outcomes & Findings for Refining the Shared Decision Making Process Survey in ADHD Medication Decisions (NCT NCT05048186)
NCT ID: NCT05048186
Last Updated: 2024-11-21
Results Overview
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.
COMPLETED
512 participants
baseline survey (reflecting on the last 24 months)
2024-11-21
Participant Flow
Eligible participants were recruited through a national sampling firm, but the sample itself was not a national probability sample. The survey was administered between February 2021 and March 2021. A subset of participants were invited to complete a brief follow-up survey to examine short term test-retest reliability.
Eligible participants were caregivers who self-identified as having at least one child between the ages of 5 and 13 years old with ADHD and who had talked with a health care provider about starting, stopping, or changing an ADHD medicine in the last 2 years.
Participant milestones
| Measure |
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
260
|
|
Overall Study
COMPLETED
|
242
|
256
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
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.
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.
|
|---|---|---|
|
Overall Study
inconsistent answers for main decision for adhd treatment
|
9
|
0
|
|
Overall Study
did not have sufficient information to calculate the SDM Process score (primary outcome)
|
1
|
4
|
Baseline Characteristics
Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
Baseline characteristics by cohort
| Measure |
Decision Aid Arm
n=242 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=256 Participants
Participants in this group will not receive any educational materials.
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
166 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
75 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic Only
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non Hispanic
|
168 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
242 participants
n=5 Participants
|
256 participants
n=7 Participants
|
498 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline survey (reflecting on the last 24 months)Population: participants who provided enough information to calculate a shared decision making process score (primary outcome of interest). 498/498 patients provided an answer to this question.
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.
Outcome measures
| Measure |
Decision Aid Arm
n=242 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=256 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Shared Decision Making Process Score
|
2.83 units on a scale
Standard Deviation 1.06
|
2.77 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: participants who completed at least 60% of the knowledge questions. Only 478/498 participants provided sufficient information to calculate a knowledge score.
Multiple choice knowledge items are scored correct/incorrect and a total knowledge score (0-100%) is calculated with higher scores indicating higher knowledge.
Outcome measures
| Measure |
Decision Aid Arm
n=239 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=239 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
ADHD Knowledge
|
68.37 percentage of correct answers
Standard Deviation 22.85
|
59.9 percentage of correct answers
Standard Deviation 18.99
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: participants who answered all 4 items of the decisional conflict scale. Only 485/498 provided sufficient information to calculate a SURE score.
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.
Outcome measures
| Measure |
Decision Aid Arm
n=235 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=250 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Decisional Conflict Tool (SURE)
|
164 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: Participants who answered the single-item regret question. Only 497/498 participants provided sufficient information to calculate 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.
Outcome measures
| Measure |
Decision Aid Arm
n=242 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=255 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Single-item Measure of Decision Regret
Definitely Yes
|
100 Participants
|
102 Participants
|
|
Single-item Measure of Decision Regret
Probably Yes
|
116 Participants
|
123 Participants
|
|
Single-item Measure of Decision Regret
Probably No
|
18 Participants
|
25 Participants
|
|
Single-item Measure of Decision Regret
Definitely No
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: Participants who answered the question. All 498 participants provided sufficient information for treatment choice.
1 item that asked parents if their child is currently taking medication to treat their ADHD.
Outcome measures
| Measure |
Decision Aid Arm
n=242 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=256 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Treatment Choice
taking medication
|
151 Participants
|
146 Participants
|
|
Treatment Choice
not taking medication
|
91 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: Participants provided sufficient information to calculate a total score. Only 483/498 participants provided sufficient information
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
Outcome measures
| Measure |
Decision Aid Arm
n=235 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=248 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale
|
22.46 score on a scale
Standard Deviation 6.38
|
21.07 score on a scale
Standard Deviation 6.26
|
SECONDARY outcome
Timeframe: baseline surveyPopulation: Participants who answered the single-item question. Only 497/498 participants provided sufficient information.
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
Outcome measures
| Measure |
Decision Aid Arm
n=241 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=256 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Adapted Controlled Preference Scale
Mainly you
|
109 Participants
|
119 Participants
|
|
Adapted Controlled Preference Scale
Mainly your child's healthcare provider
|
22 Participants
|
27 Participants
|
|
Adapted Controlled Preference Scale
You and the provider made the decision together
|
108 Participants
|
110 Participants
|
|
Adapted Controlled Preference Scale
Mainly someone else
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after completing the baseline surveyPopulation: A subset of participants who completed the baseline survey were re-contacted approximately 2 weeks post baseline survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis. 208/215 provided both consistent and sufficient information.
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.
Outcome measures
| Measure |
Decision Aid Arm
n=98 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=110 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Shared Decision Making Process Measure Retest
|
2.84 score on a scale
Standard Deviation 1.01
|
2.60 score on a scale
Standard Deviation 1.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline surveyPopulation: only parents who stated their child was currently taking medicine was included in this analysis. 297 parents said their child was taking medicine, and 290/297 provided information on 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?"
Outcome measures
| Measure |
Decision Aid Arm
n=149 Participants
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
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
n=141 Participants
Participants in this group will not receive any educational materials.
|
|---|---|---|
|
Adherence
Never
|
5 Participants
|
5 Participants
|
|
Adherence
Almost Always
|
30 Participants
|
34 Participants
|
|
Adherence
Rarely
|
8 Participants
|
8 Participants
|
|
Adherence
Sometimes
|
21 Participants
|
17 Participants
|
|
Adherence
Usually
|
16 Participants
|
16 Participants
|
|
Adherence
Always
|
69 Participants
|
61 Participants
|
Adverse Events
Decision Aid Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place