Behavioral Health Referrals Study

NCT07519083 | Enrolling By Invitation

• 1 other identifier: 2R44MH132156-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Stepped Wedge Cluster Randomized Trial (SW-CRT) to evaluate Express Access -- a new behavioral health referral application to support PCP referrals to behavioral health therapists. The hypotheses are that clients who use Express Access for behavioral health referrals will have better overall well-being (primary outcome), as well as higher satisfaction with the referral process and faster speed to behavioral health care (secondary outcomes), than those who experience the usual standard referral processes.

Conditions

Mental Illness

Outcome Measures

Primary Outcomes (1)

• Participant average score on the Clinical Scale of the Treatment Outcome Package (TOP-CS)

  TOP is a comprehensive well-being assessment that is used in behavioral health settings. The Adult TOP-CS is a 58-item scale for individuals aged 18 and over that assesses the client's past 2-week experience on 12 domains (e.g., quality of life, depression, anxiety, and suicidality). The z-scores (standard deviation units relative to the general population mean for each domain) will be averaged together to create one summary score. Higher scores suggest higher severity.

  Baseline and a TOP-CS every month up to Month 3.

Secondary Outcomes (2)

• Satisfaction score

  Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks

• Number of days until first therapist appointment

  Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks)

Study Arms (2)

Express Access

EXPERIMENTAL

Behavioral: Express Access

Standard Referral Processes

NO INTERVENTION

Interventions

Express Access BEHAVIORAL

Patients will access Express Access via a QR code on a flyer that their PCP will give them. When they open the application, patients will be asked to select the name of the PCP who referred them and then complete a behavioral health assessment to help to identify therapists who treat patients with similar behavioral health needs.

Express Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults seeking behavioral health referrals from licensed primary care providers.

You may not qualify if:

• None

Sponsors & Collaborators

• Outcome Referrals, Inc.: lead
• American Academy of Family Physicians: collaborator
• SUNY Research Foundation: collaborator
• University of Massachusetts, Amherst: collaborator

Study Sites (1)

Outcome Referrals, Inc.

Framingham, Massachusetts, 01701, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial (SW-CRT) is a preferred approach when it is difficult to randomize individual patients within a clinical practice (cluster) to a specific condition (e.g., Li \& Wang, 2022). In this SW-CRT, all new patients requesting, or recommended for, behavioral health referrals from their PCPs will be exposed to the Control condition (standard behavioral health referral processes) at the start of the study. Over time each PCP individual or practice (cluster) is randomized to a specific sequence (i.e., "step" or time point); all subsequent new patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access) at the beginning of the sequence to which each PCP was randomized.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)