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Refining the Shared Decision Making Process Survey in ADHD Medication Decisions

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ClinicalTrials.gov Identifier: NCT05048186
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Center for Survey Research, University of Massachusetts, Boston
Information provided by (Responsible Party):
Karen Sepucha, Massachusetts General Hospital

Tracking Information
First Submitted Date March 29, 2021
First Posted Date September 17, 2021
Last Update Posted Date September 17, 2021
Actual Study Start Date February 24, 2021
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2021)
Shared Decision Making Process score [ Time Frame: baseline survey, up to 24 months ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 9, 2021)
  • ADHD Knowledge [ Time Frame: baseline survey, up to 24 months ]
    Multiple choice knowledge items are scored correct/incorrect and a total knowledge score (0-100%) is calculated with higher scores indicating higher knowledge.
  • Decisional Conflict tool (SURE) [ Time Frame: baseline survey, up to 24 months ]
    Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 0 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict.
  • Single-item Measure of Decision Regret [ Time Frame: baseline survey, up to 24 months ]
    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.
  • Treatment choice [ Time Frame: baseline survey, up to 24 months ]
    3 items that asked parents how they wanted to treat their child's ADHD. Items allowed parents to choose more than one type of treatment option.
  • National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance sub-scale [ Time Frame: baseline survey, up to 24 months ]
    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
  • Adapted Controlled Preference Scale [ Time Frame: baseline survey, up to 24 months ]
    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
  • Shared Decision Making Process Measure retest [ Time Frame: 2 weeks after completing the baseline survey ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2021)
Adherence [ Time Frame: baseline survey, up to 24 months ]
1 item measure of adherence to medication for sample of participants who indicated their child was taking medicine
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
Official Title Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition ADHD
Intervention 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).
Study Groups/Cohorts
  • 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.
    Intervention: Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid
  • Control Arm
    Participants in this group will not receive any educational materials.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 9, 2021)
512
Original Actual Enrollment Same as current
Actual Study Completion Date April 13, 2021
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05048186
Other Study ID Numbers 2019P001434-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: Data will be available within 3 months after the main results have been published.
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.
Responsible Party Karen Sepucha, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Center for Survey Research, University of Massachusetts, Boston
Investigators
Principal Investigator: Karen Sepucha, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2021