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| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control Arm | Participants in this group will not receive any educational materials. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention Deficit Hyperactivity Disorder Treatment Decision Aid | Behavioral | 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). |
| 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) |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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.
Data will be available within 3 months after the main results have been published.
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.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Control Arm | Participants in this group will not receive any educational materials. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants provided enough information to calculate the shared decision making process score (primary outcome of interest). Participants were not included in the analytic dataset if they provided inconsistent answers (e.g. indicating their main decision was to start taking medication but they reported their child was not on medication currently and had not been on medication in the past)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of adult caregiver |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline survey (reflecting on the last 24 months) |
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Responses were revised within 1 month of completion for evidence of adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen R. Sepucha | Massachusetts General Hospital | 617-724-3350 | KSEPUCHA@mgh.havard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2023 | Sep 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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 |
| BG001 | Control Arm | Participants in this group will not receive any educational materials. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Arm | Participants in this group will not receive any educational materials. |
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| Secondary | 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. | participants who completed at least 60% of the knowledge questions. Only 478/498 participants provided sufficient information to calculate a knowledge score. | Posted | Mean | Standard Deviation | percentage of correct answers | baseline survey |
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| Secondary | 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. | participants who answered all 4 items of the decisional conflict scale. Only 485/498 provided sufficient information to calculate a SURE score. | Posted | Count of Participants | Participants | baseline survey |
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| Secondary | 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. | Participants who answered the single-item regret question. Only 497/498 participants provided sufficient information to calculate regret. | Posted | Count of Participants | Participants | baseline survey |
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| Secondary | Treatment Choice | 1 item that asked parents if their child is currently taking medication to treat their ADHD. | Participants who answered the question. All 498 participants provided sufficient information for treatment choice. | Posted | Count of Participants | Participants | baseline survey |
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| Secondary | 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 | Participants provided sufficient information to calculate a total score. Only 483/498 participants provided sufficient information | Posted | Mean | Standard Deviation | score on a scale | baseline survey |
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| Secondary | 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 | Participants who answered the single-item question. Only 497/498 participants provided sufficient information. | Posted | Count of Participants | Participants | baseline survey |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after completing the baseline survey |
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| Other Pre-specified | 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?" | 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 | Posted | Count of Participants | Participants | baseline survey |
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| 0 |
| 242 |
| 0 |
| 242 |
| 0 |
| 242 |
| EG001 | Control Arm | Participants in this group will not receive any educational materials. | 0 | 256 | 0 | 256 | 0 | 256 |
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| Probably No |
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| Definitely No |
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| You and the provider made the decision together |
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| Mainly someone else |
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| Sometimes |
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| Usually |
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| Almost Always |
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| Always |
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