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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

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.

Condition or disease Intervention/treatment
ADHD 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.

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Study Type : Observational
Actual Enrollment : 512 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Refining the Shared Decision Making Process Survey in ADHD Medication Decisions
Actual Study Start Date : February 24, 2021
Actual Primary Completion Date : March 23, 2021
Actual Study Completion Date : April 13, 2021

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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

  6. 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

  7. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048186


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Center for Survey Research, University of Massachusetts, Boston
Investigators
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Principal Investigator: Karen Sepucha, PhD Massachusetts General Hospital
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Responsible Party: Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05048186    
Other Study ID Numbers: 2019P001434-3
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Sepucha, Massachusetts General Hospital:
shared decision making