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Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties (DECADES)

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ClinicalTrials.gov Identifier: NCT02773706
Recruitment Status : Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
William E. Bennett, Jr., Indiana University

Brief Summary:
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.

Condition or disease Intervention/treatment Phase
Anxiety Depression Other: Automated Psychology Services Other: Notification of Subspecialist Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties
Estimated Study Start Date : December 18, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Usual Subspecialty Care

Once a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider.

Intervention: Depression / anxiety screen + clinician informed.

Other: Notification of Subspecialist
The automated screening tool determines a positive or negative screen, then informs the clinician.

Active Comparator: Integrated Psychology Care

Once a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider.

Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit.

Other: Automated Psychology Services
The automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit.




Primary Outcome Measures :
  1. Quality of life (baseline) [ Time Frame: Baseline ]

    Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures.

    PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)


  2. Quality of life (followup) [ Time Frame: Within 6 months ]

    Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures.

    PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)



Secondary Outcome Measures :
  1. Utilization of endoscopy [ Time Frame: Within 6 months ]
    The investigators will compare the use of endoscopy, radiologic testing, laboratory testing, emergency department utilization, and repeat gastroenterology outpatient visits. Frequency of each of these will be compared between control and intervention arms.

  2. Utilization of radiologic testing [ Time Frame: 6 months ]
    The electronic medical record will be queried by the RA and the total number of radiologic tests ordered over 6 months will be computed.

  3. Utilization of laboratory testing [ Time Frame: 6 months ]
    The electronic medical record will be queried by the RA and the total number of laboratory tests ordered over 6 months will be computed.

  4. Utilization of emergency department visits [ Time Frame: 6 months ]
    The electronic medical record will be queried by the RA and the total number of emergency department visits over 6 months will be computed.

  5. Utilization of outpatient gastroenterology [ Time Frame: 6 months ]
    The electronic medical record will be queried by the RA and the total number of outpatient gastroenterology visits over 6 months will be computed.



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.

Exclusion Criteria:

  • Patients over the age of 18 or under the age of 10.

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): NCT02773706


Contacts
Contact: William E Bennett, M.D. 317-278-9616 webjr@iu.edu

Sponsors and Collaborators
Indiana University
Agency for Healthcare Research and Quality (AHRQ)

Responsible Party: William E. Bennett, Jr., Assistant Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT02773706     History of Changes
Other Study ID Numbers: DECADES
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders