Pilot Test of a Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination

Mental Health Services Clinical Trial

— SMART-Wrap  

Official title:

A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743712
• Other study ID #: 3CG079Pilot
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: 3-C Institute for Social Development
• Contact: Melissa DeRosier, PhD
• Phone: 9196770102
• Email: derosier[@]3cisd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Services

Intervention

Other:
• SMART-Wrap
This intervention, SMS (short message system)-based augmentation, seeks to improve the impact and approach of the Wraparound service model by utilizing SMS, which has been shown to increase treatment adherence and sustained engagement. This intervention will facilitate regular, repeated evaluation of intermediate outcomes through self-report assessments.

Locations

Country	Name	City	State
United States	3C Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
3-C Institute for Social Development	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prototype Evaluation for Families	Caregivers, youth, and young adults will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the SMART-Wrap system. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Completely Disagree) to 5 (Completely Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.	5-week follow-up post messaging protocol
Primary	Prototype Evaluation for Care Team Members	Care team members will complete this 34-item measure, rating the extent to which they agree with statements about the SMART-Wrap system. The measure includes 7 open-ended items, one yes/no item, and 26 Likert-scale items about the usability, acceptability, and feasibility of the system, and items about the system's interoperability with existing electronic record management systems, whether it is duplicative or complementary with existing systems, and its added value over existing methods of collecting feedback from families in Wraparound. Responses to the Likert items range from 1 (Completely Disagree) to 5 (Completely Agree). Total scores are based on the Likert items and range from 0 to 130. Higher scores reflect more positive opinions.	5-week follow-up post messaging protocol
Primary	System Usability Survey	Caregivers, youth, young adults, and care team members will complete this 10-item measure, rating the extent to which they agree with statements about the usability of the SMART-Wrap system. Responses range from 1 (Completely Disagree) to 5 (Completely Agree). For items 1, 3, 5, 7, and 9, higher scores reflect more positive outcomes. For items 2, 4, 6, 8, and 10, higher scores reflect more negative outcomes. Items 2, 4, 6, 8, and 10 are reverse coded, and all survey items are rescaled from 0 to 4 and multiplied by 2.5 to calculate total scores, which range from 0 to 100.	5-week follow-up post messaging protocol
Secondary	Results from Caregiver Text Message Items	Caregivers will complete this 16-item measure, rating the extent to which they agree with statements about therapeutic alliance with their Wraparound care team, their satisfaction with Wraparound, the care team's fidelity to the Wraparound care model, and their outcomes because of participating in Wraparound. Responses range from 0 (Not at All) to 4 (Absolutely). Total scores range from 0 to 64. Higher scores reflect greater satisfaction, therapeutic alliance, and fidelity and better outcomes.	4-item sets of survey items administered weekly over a 4-week period
Secondary	Results from Youth Text Message Items	Youth and young adults will complete this 8-item measure, rating the extent to which they agree with statements about their satisfaction with Wraparound and their outcomes as a result of participating in Wraparound. Responses range from 0 (Not at All) to 4 (Absolutely). Total scores range from 0 to 32. Higher scores reflect greater satisfaction and better outcomes.	2-item sets of surveys items administered weekly over a 4-week period
Secondary	Usage Metrics from the SMART-Wrap system for families	The SMART-Wrap software will track whether each text message is opened, the length of time between delivery and opening, and length of time between opening and submission of item response. These metrics are measured in seconds. In all cases, a shorter time span indicates more positive outcomes.	4-week period
Secondary	Usage Metrics from the SMART-Wrap system for care team members	The SMART-Wrap software will track usage of the SMART-Wrap dashboard by the care team, including number of logins, amount of time spent (in seconds), and number/type of technical assistance requests. Number of logins and number of technical requests are measured as counts. Higher numbers of logins indicates a more positive outcome, higher time spent indicates a more positive outcome, and lower number of technical requests represents a more positive outcome.	the period in which any families served by the care team are interacting with the SMART-Wrap system, approximately 8-weeks
Secondary	Results from focus groups / interviews with families	10 caregivers and 10 youth/young adults will participate in either focus groups or individual interviews. They will be asked about their experience with the SMART-Wrap system, strengths and weaknesses of SMART-Wrap, and challenges to using SMART-Wrap. Comments will be combined and grouped based on themes in a qualitative summary.	45-minutes, completed after the test of the SMART-Wrap system
Secondary	Results from focus groups / interviews with care team members	10 care team members will participate in either focus groups or individual interviews. They will be asked about strengths and weaknesses of SMART-Wrap, and challenges to using SMART-Wrap, and recommendations for revisions to SMART-Wrap. Comments will be combined and grouped based on themes in a qualitative summary.	45-minutes, completed after the test of the SMART-Wrap system