Behavioral Health Referrals Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mental Illness
• Intervention / Treatment: Behavioral: Express Access

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Framingham, Massachusetts, United States, 01701
      • Outcome Referrals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Express Access	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.
No Intervention: Standard Referral Processes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction score	Satisfaction will be measured with this item: "How frustrated are you with the search methods you used during the past week compared to other things you have tried in the past?" Response options are: 1=A lot more frustrated; 2=A little more frustrated; 3=No difference in frustration; 4=A little less frustrated; 5=Much less frustrated. Scores range between 1 and 5 (higher scores indicate higher satisfaction).	Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks
Number of days until first therapist appointment	Days between study start and report of first scheduled therapist appointment (fewer days indicate faster speed to treatment).	Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks)

Collaborators and Investigators

• Sponsor: Outcome Referrals, Inc.
• Collaborators: University of Massachusetts, Amherst; American Academy of Family Physicians; SUNY Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2R44MH132156-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data generated in this SBIR Phase II project is considered proprietary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No