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临床试验/NCT04489667
NCT04489667撤回不适用

HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)

University of Alabama at Birmingham5 个研究点 分布在 1 个国家开始时间: 2021年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
5
主要终点
Percentage of patients completing PROs

研究概览

简要总结

This study will examine the impact of using a multicomponent intervention (patient reported outcomes, training, and telemedicine) to assist with the management of Mental Health (MH) and Substance Use Disorders (SUD) among people living with HIV (PLWH) engaged in care at UAB HIV Clinic, University of Alabama Family Clinic (Birmingham, AL), Thrive Federally Qualified Health Services Center (Huntsville), Health Services Center (Anniston), and Medical Advocacy and Outreach (Montgomery). The study will employ a hybrid type 2 implementation design. Because this intervention will be employed as the new standard of care at participating sites, all PLWH receiving care at the sites will receive this intervention. Patient-reported outcomes (PROs) will be integrated into routine care to screen PLWH for substance use and mental health disorders during routine clinical encounters. Training will be delivered to frontline clinicians so that they receive targeted knowledge on best practices for treatment of MH and SUD along with clinic-specific protocols for response to PROs on MH and SUD including treatment and referrals. Telemedicine services for MH and SUD will be offered to patients in need of expanded access to services due to a lack of clinic-level resources or additional barriers to traditional clinic visits such transportation, stigma, or substance using behaviors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

  • 18 years or older and receiving HIV care at one of the five participating sites

排除标准

  • Below 18 years of age

研究组 & 干预措施

+STEP Implementation

Other

All patients will receive +STEP as new standard of care at their clinic. This intervention will include staff training, PROs as part of routine care to screen for substance use and mental health disorders, and telemedicine for health care delivery.

干预措施: +STEP Implementation (Other)

结局指标

主要结局

Percentage of patients completing PROs

时间窗: Year 4 through Year 5

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of staff participating in training

时间窗: Year 4 through Year 5

We will use attendance logs to determine how many staff at each site complete training

Percentage of patients receiving a referral to a mental health or substance use service

时间窗: Year 4 through Year 5

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients receiving mental health or substance use service based on attendance

时间窗: Year 4 through Year 5

We will use EMR and scheduling data to determine the number of visits attended

Percentage of patients completing PROs

时间窗: Baseline through Year 1

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of patients completing PROs

时间窗: Year 1 through Year 2

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of patients completing PROs

时间窗: Year 2 through Year 3

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of patients completing PROs

时间窗: Year 3 through Year 4

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of staff participating in training

时间窗: Baseline through Year 1

We will use attendance logs to determine how many staff at each site complete training

Percentage of staff participating in training

时间窗: Year 1 through Year 2

We will use attendance logs to determine how many staff at each site complete training

Percentage of staff participating in training

时间窗: Year 2 through Year 3

We will use attendance logs to determine how many staff at each site complete training

Percentage of staff participating in training

时间窗: Year 3 through Year 4

We will use attendance logs to determine how many staff at each site complete training

Percentage of patients receiving mental health or substance use service based on attendance

时间窗: Year 2 through Year 3

We will use EMR and scheduling data to determine the number of visits attended

Percentage of patients receiving mental health or substance use service based on attendance

时间窗: Year 3 through Year 4

We will use EMR and scheduling data to determine the number of visits attended

Percentage of patients receiving a referral to a mental health or substance use service

时间窗: Baseline through Year 1

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients receiving a referral to a mental health or substance use service

时间窗: Year 1 through Year 2

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients receiving a referral to a mental health or substance use service

时间窗: Year 2 through Year 3

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients receiving a referral to a mental health or substance use service

时间窗: Year 3 through Year 4

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients receiving mental health or substance use service based on attendance

时间窗: Baseline through Year 1

We will use EMR and scheduling data to determine the number of visits attended

Percentage of patients receiving mental health or substance use service based on attendance

时间窗: Year 1 through Year 2

We will use EMR and scheduling data to determine the number of visits attended

次要结局

  • Percentage engaged in HIV care(Year 4 through Year 5)
  • Percentage receiving antiretroviral therapy for HIV(Year 4 through Year 5)
  • Number of Patients Achieving a Viral Load Suppression(Year 4 through Year 5)
  • Percentage engaged in HIV care(Baseline through Year 1)
  • Percentage engaged in HIV care(Year 1 through Year 2)
  • Percentage engaged in HIV care(Year 2 through Year 3)
  • Percentage engaged in HIV care(Year 3 through Year 4)
  • Percentage receiving antiretroviral therapy for HIV(Baseline through Year 1)
  • Percentage receiving antiretroviral therapy for HIV(Year 1 through Year 2)
  • Percentage receiving antiretroviral therapy for HIV(Year 2 through Year 3)
  • Percentage receiving antiretroviral therapy for HIV(Year 3 through Year 4)
  • Number of Patients Achieving a Viral Load Suppression(Baseline through Year 1)
  • Number of Patients Achieving a Viral Load Suppression(Year 1 through Year 2)
  • Number of Patients Achieving a Viral Load Suppression(Year 2 through Year 3)
  • Number of Patients Achieving a Viral Load Suppression(Year 3 through Year 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Eaton

Assistant Professor

University of Alabama at Birmingham

研究点 (5)

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