NCT07519083

Behavioral Health Referrals Study

Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Outcome Referrals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The United States is experiencing a major mental health crisis. The gap between need and access to behavioral health services is rapidly increasing. Given that about \~50% of patients who have a behavioral health diagnosis will have had that condition first identified by a primary care physician (Hill et al., 2015; Reeves et al., 2011), the primary care setting is an ideal site to conduct an efficacy test of a new online behavioral health referral system called Express Access. 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 patients requesting, or recommended for, behavioral health referrals from their Primary Care Providers (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 patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access with TOP Match) at the beginning of the sequence to which each PCP was randomized. RECRUITMENT PROCEDURES The American Academy of Family Physicians (AAFP) will recruit PCPs from their membership to refer their patients to the study during routine visits (i.e., via verbal script or a flyer with a QR code linking to the consent form and study information). METHODS AND PROCEDURES Patients will review the study information by scanning the QR code provided by their PCP. Patients who sign the informed consent form will be sent weekly assessments (via email) until the patient reports that they found a therapist and scheduled an appointment. These assessments will ask about: how they searched for a therapist; satisfaction with the search method; challenges encountered during the search; confidence in finding a therapist within the next week (approximately 5-10 minutes per week). In addition, participants will complete the behavioral health well-being assessment (Treatment Outcome Package; TOP suite) at baseline and at one-month, two-month, and three-month intervals. The assessment includes demographic questions; questions about stressful life events, physical health, and medication use; ratings of behavioral health symptoms across 12 domains (approximately 10 minutes per assessment). PCPs will have access to this information to help connect the patient to a mental health provider. These data will remain confidential between the patient and their health treatment team to the extent allowed by law.

Conditions

• Mental Illness

Interventions

Type	Name	Description
BEHAVIORAL	Express Access	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.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States