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

NCT03985813 | Completed Results

• 2 other identifiers: STUDY18110137P50MH115838-02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Personalized Referral

  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 to determine if provider made referral as recommended on intervention report. This initial outcome has been modified as a result of the changes in study design.

  Baseline (in office) visit

Secondary Outcomes (7)

• Number of Participants Who Utilized the Screening Wizard Application

  Baseline (phone) visit

• Service Use (Number of Participants at Baseline)

  At Baseline phone visit

• Service Use (Number of Participants at 4 Week Follow-up)

  Week 4 follow-up after Baseline

• Service Use (Number of Participants at 12 Week Follow-up)

  Week 12 follow up after Baseline

• Usability & Satisfaction

  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.

Study Arms (1)

Screening Wizard

EXPERIMENTAL

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

Interventions

Screening Wizard BEHAVIORAL

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.

Screening Wizard

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth aged 12-26 yo
• Biological or adoptive parent is willing to provide informed consent for teen to participate
• Youth speaks and understands English

You may not qualify if:

• Non English speaking
• No parent willing to provide informed consent
• Is currently experiencing acute mania or psychosis, evidence of an intellectual or developmental disorder (IDD), life threatening medical condition that requires immediate treatment, or other cognitive or medical condition preventing youth from understanding study and/or participating.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Kaiser Foundation Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC

Cranberry Township, Pennsylvania, 16066, United States

Location

Children's Hospital of Pittsburgh Department of Neurology

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Limitations and Caveats

The study design changed from a stepped wedge design to an open trial. As a feasibility trial, the study was not adequately powered to detect significant effects. In some cases, minor issues with the SW decision tree algorithm led to providers in the SW arm receiving guidance for a higher level of care than was necessary. It's possible that some documentation reviewed in the EHR was missing during the consensus and matching process between the EHR referral data and the SW report.

Results Point of Contact

• Title: Oliver Lindhiem
• Organization: University of Pittsburgh

lindhiemoj@upmc.edu

4122465909

Study Officials

• Oliver Lindhiem, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Ana Radovic, MD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to 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.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 14, 2019
• Study Start: August 13, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: July 15, 2022
• Results First Posted: November 10, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (4)