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Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase

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ClinicalTrials.gov Identifier: NCT03985813
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Oliver Lindhiem, University of Pittsburgh

Brief Summary:
Screening Wizard (SW). Primary Care Providers (PCPs) are often uncertain about how to best refer adolescents who screen positive for depression or suicidality. Screen-positive youth who are either not in treatment, or express dissatisfaction with current treatment will be consented by an on-site research assistant (RA). Those parents and patients receiving SW will answer additional questions: adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania; perceived barriers; and preferences about treatment. SW generates recommendations for PCPs reflecting patient clinical needs and preferences.

Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Behavioral: Screening Wizard Behavioral: Treatment as usual Not Applicable

Detailed Description:

Screening Wizard will be delivered by Primary Care Providers (PCPs) at well child visits, beginning with screening occurring within the waiting room which will yield decision support guidance delivered and followed by the PCP at that same visit.

This study will utilize a stepped-wedge cluster randomized trial design. This stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.

Hypothesis: The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study will use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
Primary Purpose: Health Services Research
Official Title: Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Screening Wizard
Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.
Behavioral: Screening Wizard
Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.

Active Comparator: Treatment As Usual
Participants in this group will be studied as they proceed through treatment at their primary care providers office, per usual protocols at each office. Participants will engage in standard screening for depression and suicidal risk at well visits.
Behavioral: Treatment as usual
Participants in this group will receive usual care at their pediatric primary care practice. This involves receiving screening for depression using the Patient Health Questionnaire and clinical assessment/management by their primary care provider.




Primary Outcome Measures :
  1. Personalized Referral [ Time Frame: Baseline (in office) visit ]
    Expert opinion will be used to assess the match between Primary Care Providers referrals to Screening Wizard guidance. The rate of personalized referrals by primary care providers and treatment initiation among adolescents who screen positive for depression or suicidal ideation will be monitored.


Secondary Outcome Measures :
  1. Application Utilization [ Time Frame: Baseline (phone) visit ]
    Use of the technical components of Screening Wizard will be monitored. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

  2. Cost Effectiveness [ Time Frame: At Baseline phone visit ]
    The following information on the incremental cost effectiveness of Screening Wizard will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work).

  3. Cost Effectiveness [ Time Frame: Week 4 follow up after Baseline ]
    The following information on the incremental cost effectiveness of Screening Wizard will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work).

  4. Cost Effectiveness [ Time Frame: Week 12 follow up after Baseline ]
    The following information on the incremental cost effectiveness of Screening Wizard will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work).

  5. Usability & Satisfaction [ Time Frame: At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment. ]
    Satisfaction to Screening Wizard will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "If a friend were in need of a mental health referral, would you recommend Screening Wizard to him/her?; How satisfied are you with the amount of help you received?; Have the services you received helped you to deal more effectively with your problems?. The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.

  6. Usability & Satisfaction [ Time Frame: At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment. ]
    Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent participants will be ages 12-17.11
  • Parent/guardian willing to consent
  • English speaking
  • Possess adequate literacy to engage in study assessments and interventions.
  • All participants included in this study will screen positive for depression on the (Patient Health Questionnaire-9 items) PHQ-9 by a total score of > 11 or will score positively for suicidal ideation with a score on the PHQ-9 item 9 of > 1.

Exclusion Criteria:

  • Participants will be excluded if they have conditions that might impair their ability to effectively engage in Screening Wizard, i.e.
  • those in a current manic episode
  • those in a current psychotic episode
  • presence of a life-threatening medical condition requiring immediate treatment,
  • those with evidence of mental retardation or pervasive developmental disorder as known to the pediatrician by medical history.

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): NCT03985813


Contacts
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Contact: Brandie George-Milford, MA 4122465629 georgeba2@upmc.edu

Locations
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United States, Pennsylvania
Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Brian Czervionke, MD    724-776-4433      
Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Alejandrao Hoberman, MD    412-692-6000      
Sponsors and Collaborators
University of Pittsburgh
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Oliver Lindhiem, PhD University of Pittsburgh
Study Director: Ana Radovic, MD University of Pittsburgh

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Responsible Party: Oliver Lindhiem, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03985813     History of Changes
Other Study ID Numbers: STUDY18110137
P50MH115838-02 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All requests for study data will follow NIMH's data sharing and data use policies.

The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.

Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

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

Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms