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Decision Support for Parents Receiving Information About Child's Rare Disease (DSD DST)

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ClinicalTrials.gov Identifier: NCT01875640
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : February 20, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Virginia Commonwealth University
Temple University
University of California, Los Angeles
Seattle Children's Hospital
Information provided by (Responsible Party):
David E. Sandberg, PhD, University of Michigan

May 30, 2013
June 12, 2013
February 20, 2018
June 2013
May 2016   (Final data collection date for primary outcome measure)
In-clinic communications [ Time Frame: 2.5 years ]
To assess characteristics of communications between parents/caregivers of young children with DSD and the children's healthcare providers by audio-recording standard-of-care appointments at DSD clinic.
Qualitative Assessment of Focus Groups, Usual Care and DST Implementation [ Time Frame: 2.5 years ]
To assess characteristics of communications during focus groups and between health care providers and parents before and during the implementation of the DST audiofiles will be coded and analyzed using SCCAP (Siminoff Communication Content & Affect Program). SCCAP© is a new computerized coding scheme used to facilitate, organize, and code health communication data. It is designed so that coders can code directly from audio recordings, allowing the coder to take advantage of the vocalic cues inherent in speech intonations. Transcriptions can also be uploaded and coded so specific text can be viewed and tagged for future use.
Complete list of historical versions of study NCT01875640 on ClinicalTrials.gov Archive Site
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Decision Support for Parents Receiving Information About Child's Rare Disease
Decision Support for Parents Receiving Information About Child's Rare Disease

The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the DSD. And, even when the tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. Instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. Adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family.

To support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (DST). The DST will help educate families about typical and atypical sex development of the body, the process by which DSD are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. The DST will be used by parents of young children together with their child's health care provider.

The investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with DSD to share their experiences. Participants of this network will be involved at each stage of creating the DST, revising it, and putting it into practice. At the end of this project, the investigators will have a fully formed DST that will be available for parents to use with their child's healthcare team as they are first learning their child may have a DSD.

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Observational
Observational Model: Other
Time Perspective: Prospective
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Non-Probability Sample
DSD
  • Disorder of Sex Development
  • Intersex Conditions
  • Congenital Adrenal Hyperplasia
  • Hypospadias
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  • Usual Care
    After obtaining consent, we will audio-record standard clinical consultations with specialists represented on the DSD team. These appointments will not utilize the Decision Support Tool. A qualitative analysis of these recordings will assess quality assurance and provide guidance for the development of the Decision Support Tool.
  • Use of Decision Support Tool
    After obtaining consent, we will audio-record standard clinical consultations with specialists represented on the DSD team. These appointments will utilize the Decision Support Tool (DST). A qualitative analysis of these recordings will assess the practicality of use and possible benefits of the DST's implementation.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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December 2017
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be a parent/caregiver of a patient who is newborn through 5 years old (i.e., 5.9 yrs).
  • Patient clinical diagnosis of ambiguous genitalia (eg, 46,XX,Prader 2+; proximal hypospadias with uni/bilateral undescended testes) or sex chromosomes discordant with genital phenotype.
  • Condition must be newly ascertained where decisions regarding surgical procedures (internal or external genitalia), diagnostic testing, and/or other aspects of clinical management have yet to be made.

Exclusion Criteria:

  • Turner syndrome, Klinefelter syndrome, bladder or cloacal exstrophy.
Sexes Eligible for Study: All
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01875640
1360
13-PAF00134 ( Other Identifier: University of Michigan )
HUM72007 ( Other Identifier: University of Michigan )
No
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David E. Sandberg, PhD, University of Michigan
University of Michigan
  • Patient-Centered Outcomes Research Institute
  • Virginia Commonwealth University
  • Temple University
  • University of California, Los Angeles
  • Seattle Children's Hospital
Principal Investigator: David E Sandberg, PhD University of Michigan
University of Michigan
February 2018