Clinical trial NCT05743712: Pilot Test of a Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination
Official title: A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Services
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2023-02-24
Enrollment: 59
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This SBIR Phase I study will test the acceptability and feasibility of a novel measurement and feedback system tailored to Wraparound service model (WSM) for emotional disorders to produce a feasible, cost-efficient, and scalable software system to meet the pressing public health need for Measurement-based Care in care coordination for youth behavioral health.

Detailed description: The goal of this SBIR is to test a novel mobile and text-based measurement and feedback system tailored to WSM. Investigators will recruit 10 care teams (50 care team members total: 10 managers/administrators, 10 supervisors, and 30 care coordinators), 30 caregivers, and 15 youth/young adults (14+ yo) with SED currently enrolled in WSM. Caregivers of minor children aged 5-17 and caregivers of young adults 18-26 will be invited to participate. However, only parents with youth aged 14-17 will be invited to consider participation for their children, as well, and young adults age 18-26 will have the opportunity to participate without a caregiver If a caregiver has multiple children enrolled in Wraparound, we will select one child to invite to participate. Of those eligible, investigators will select 30 caregivers and up to 15 youth/young adults (14+) that have access to a mobile device. These participants will be informed of the project by members of their care team and asked to complete a consent to contact if they are interested in learning more about the research study. Interested families will be asked to review consent materials and sign up online. Caregivers and youth/young adults will participate in a 30-minute study orientation meeting and then interact independently with the system over a 4-week period. During this time, care team members will have access to the SMART-Wrap website, where they can view the survey feedback from their families. Care team members will be expected to interact with the system throughout the test period and may adjust care based on the feedback they receive. Within 5 days of the last text message, caregivers and youth/young adults will complete a brief survey evaluating the prototype in the following areas of usability, acceptability, and feasibility, as well as complete the 10-item System Usability Survey (SUS). Care team members will complete a similar survey that asks about these same areas, but also includes items about compatibility with existing wraparound treatment planning and implementation, interoperability with existing electronic record management systems, duplicative vs. complementary with existing systems, and added value over existing methods. Following completion of their evaluation, participants will be invited to take part in 45-minute interviews or virtual focus groups (separately for care team members, caregivers, and youth/young adults). Of the participants that agree, 10 care team members, 10 caregivers, and 10 youth/young adults will be selected to complete the virtual focus group.

Eligibility criteria: Inclusion Criteria:

* Wraparound Service Model Care teams (each consisting of 1 manager or administrator, 1 supervisor, and up to 3 care coordinators) must coordinate the care of one youth/young adult (ages 5-26).
* Wraparound Service Model enrolled families can consist of either (a) a caregiver of a youth/young adult age 5-26 (participating without their child), (b) a caregiver of a youth/young adult age 14-26 (participating with their child - adult children sign separate consent to contact forms and enroll separately), or (c) a young adult age 18-26 participating without their caregiver.

Exclusion Criteria:

* youth/young adults known to providers to have expressed risk of harm to themselves or others within the 6 months prior to the recruitment period

Primary outcomes:
measure: Prototype Evaluation for Families
timeFrame: 5-week follow-up post messaging protocol
measure: Prototype Evaluation for Care Team Members
timeFrame: 5-week follow-up post messaging protocol
measure: System Usability Survey
timeFrame: 5-week follow-up post messaging protocol
Secondary outcomes:
measure: Results from Caregiver Text Message Items
timeFrame: 4-item sets of survey items administered weekly over a 4-week period
measure: Results from Youth Text Message Items
timeFrame: 2-item sets of surveys items administered weekly over a 4-week period
measure: Usage Metrics from the SMART-Wrap system for families
timeFrame: 4-week period
measure: Usage Metrics from the SMART-Wrap system for care team members
timeFrame: the period in which any families served by the care team are interacting with the SMART-Wrap system, approximately 8-weeks
measure: Results from focus groups / interviews with families
timeFrame: 45-minutes, completed after the test of the SMART-Wrap system
measure: Results from focus groups / interviews with care team members
timeFrame: 45-minutes, completed after the test of the SMART-Wrap system
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3C Institute
name: Melissa DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Eric Bruns, PhD
role: PRINCIPAL_INVESTIGATOR
References: