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临床试验/NCT07519083
NCT07519083Enrolling By Invitation不适用

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

Outcome Referrals, Inc.1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
600
试验地点
1
主要终点
Participant average score on the Clinical Scale of the Treatment Outcome Package (TOP-CS)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Express Access

Experimental

干预措施: Express Access (Behavioral)

Standard Referral Processes

No Intervention

结局指标

主要结局

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

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

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.

次要结局

  • 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))

研究者

发起方
Outcome Referrals, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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