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临床试验/NCT04506164
NCT04506164已完成不适用

Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Compare Rate of PTSD Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

研究概览

简要总结

Electronic screening is effective for timely detection of, and intervention for, suicidal ideation and other mental health symptoms. The VA eScreening program is a patient self-report electronic screening system that has shown promise for the efficient and effective collection of mental and physical health information among Veterans. However, additional effectiveness and implementation research is warranted to evaluate the impact of eScreening within VHA. This study addresses questions of the impact of eScreening compared to screening as usual, while evaluating a multi-component implementation strategy (MCIS) for optimal enterprise rollout of eScreening in VA Transition Care Management clinics.

详细描述

This mixed methods hybrid 2, effectiveness-implementation, stepped-wedge (SW) trial evaluates the effectiveness and implementation of an electronic screening program called eScreening compared to standard of care paper and/or verbal screening methods in VHA Transition Care Management (TCM) programs. eScreening is a VHA program that allows Veterans to answer self-report screening questions via an iPad connected to the VHA secure Wi-Fi. eScreening reads from and writes to the VHA EMR. The highlighted features of eScreening include: 1) the ability for Veterans to enter screening information directly without the involvement of a clinician; 2) immediate scoring of measures; 3) an editable note generated in the EMR; and 4) clinician alerts for positive mental health screens that require follow-up for suicide risk.

Aim 1 involved evaluating eScreening, compared to paper and verbal screening (Screening As Usual), guided by the RE-AIM outcomes of PRISM in 8 VHA Transition Care Management (TCM) programs, using a cluster randomized, stepped wedge design. This stepped-wedge trial relied on sequential roll-out of eScreening to participating sites over time, while using other sites as controls until they began implementation. The 8 participating sites were stratified by size (a combination of number of TCM staff and average number of post-9/11 Veterans enrolled per month) and block randomized to four step/crossover cohorts of two sites each. All step/crossover cohorts went through a 3-month pre-implementation phase which served as the Screening As Usual comparison condition, as eScreening was not yet being implemented. This phase was followed by a 9-month active implementation using our eScreening MCIS. The eScreening MCIS will began with a 3-month period that included eScreening software provision, training, RPIW, and blended facilitation followed by 6 months of ongoing blended facilitation (9 months total). After the active implementation, all sites had a 9-month sustainment period.

Below is a detailed description of each phase:

Pre-implementation phase (Screening As Usual condition): lasted 3 months during which the research team worked with the internal facilitators to: 1) gather pre-implementation information including detailed information on the processes in place for TCM screening upon enrollment ; 2) identify points of contact for iPads and other logistical needs; 3) establish communication with TCM staff and others working with the TCM staff; 4) recruit staff participants for the study; and 5) begin ongoing tracking of process data. TCM staff names, clinic names, note titles, scheduling the RPIW, and clinical reminders completed by program staff were gathered and used for subsequent development of user accounts and content customization during the implementation phase. The implementation team also provided psychoeducation to the staff on the importance of screening. During pre-implementation, TCM teams continued usual screening procedures. These involve interview or self-report, paper-based collection of post-9/11 screening measures, including the system-wide standardized assessments of depression, PTSD and alcohol use (PHQ-2, PCPTSD, and Audit-C, respectively). Patients who score positive on the PHQ-2 and PCPTSD were then administered the Columbia Suicide Severity Rating Scale (C-SSRS), which collects more information regarding risk of suicide. Veterans who are positive on C-SSRS then receive a Comprehensive Suicide Risk Evaluation and are referred for appropriate follow-up. A detailed description and flow map of the current screening process at each site were developed by the external facilitator (research team) and internal facilitator (site staff) with information from the TCM staff prior to the implementation phase.

eScreening Implementation phase: during this 9 month phase, the MCIS was used to implement eScreening. This strategy consisted of eScreening software provision, user training, RPIW, and facilitation. Virtual and asynchronous eScreening training was provided and included a 1-hour instructional PowerPoint presented by the external facilitator. The PowerPoint was followed by an hour of tutorial videos showing all steps of (creating assessments, adding Veterans, saving to VistA, searching for assessments, creating scheduled appointment assessments, accessing reports). Hands-on training for users was available in group format or individually by the training staff as requested by the TCM site staff. Additional training materials could be accessed via the eScreening Pulse site which include a series of quick guides to address eScreening customization, assessment set-up and dashboard use. Frequently asked questions were also available on the Pulse site. The 3-day RPIW was facilitated virtually by the external facilitator with assistance from the onsite internal facilitator and included the TCM team, related staff (i.e., medical support staff, clerks), and other site stakeholders. The first day of the process trained participants in the RPIW principles and introduced a summary of the information gathered in the Pre-Implementation Phase, including a graphic of the current state process map which was then refined and finalized. The second day consisted of collective efforts to map a targeted future state, conduct a gap analysis, and identify relevant factors and barriers unique to the site. The third day was dedicated to the repetition of action planning, execution, and reevaluation to finalize the targeted state and identify clinically meaningful goals for improvement. Using a Plan-Do-Study-Act (PDSA) framework, the plans to achieve the target state are enacted with a detailed plan that includes who, what, when for each step in the plan. Due to the flexibility of eScreening and the implementation strategy, each TCM program could choose to integrate eScreening into their workflow based on the specific needs of their program, available resources, and other factors. This was followed by 6 months of ongoing facilitation, in which the primary external facilitator from the eScreening team worked with the site internal facilitator to schedule meetings, training sessions, and phone calls. The external facilitator was the main point of contact for implementation-related questions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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
是

入选标准

  • •Staff inclusion criteria:
  • •Direct or indirect involvement with implementation of eScreening at the site
  • •Capable of informed consent

排除标准

  • •Staff exclusion criteria:
  • •Not involved in or directly impacted by eScreening involvement at each site

研究组 & 干预措施

Screening As Usual/Pre-implementation

Active Comparator

During this 3 month pre-implementation period, usual screening methods were used (i.e., verbal and paper-based screening).

干预措施: Screening As Usual (Other)

eScreening Implementation

Experimental

During this 9 month active implementation phase, eScreening was implemented using the MCIS.

干预措施: eScreening (Other)

结局指标

主要结局

Compare Rate of PTSD Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase

Proportion of newly enrolled Veterans who received PTSD screening (i.e., The Primary Care PTSD Screen for DSM-5 \[PC-PTSD-5\]) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Compare Rate of Depression (PHQ-2) Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase

Proportion of newly enrolled Veterans who received depression screening (Patient Health Questionnaire-2; PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Compare Rate of Alcohol Screening (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase

Proportion of newly enrolled Veterans who received alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Compare Rate of Suicide Screening (CSSRS) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase.

Proportion of newly enrolled Veterans who received suicide screening (Columbia-Suicide Severity Rating Scale; CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Time to PTSD Screening (PC-PTSD-5) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase.

Number of days to receive PTSD screening (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Time to Depression (PHQ-2) Screening Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase.

Number of days to depression screening (PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Time to Alcohol Screening (AUDIT) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase.

Number of days to alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Time to Suicide Screening (CSSRS) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: within 30 days of enrollment at the VA study site during each phase.

Number of days to suicide screening (CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.

Change in Rate of Referral to Mental Health Care Following Positive PTSD Screen (PC-PTSD-5) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation.

时间窗: 30 days from the date the screener was administered during each phase.

Change in rate of referral to mental health follow up care (BHIP) following a positive PTSD screen (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.

Change in Rate of Referral to Mental Health Care Following Positive Depression Screen (PHQ-2) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: 30 days from the date the screener was administered during each phase.

change in rate of referral to mental health follow up care (BHIP) following a positive depression (PHQ-2) screen during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.

Change in Rate of Referral to Substance Use Treatment Following Positive Alcohol Screen (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation

时间窗: 30 days from the date the screener was administered during each phase

change in rate of referral to substance use treatment following a positive alcohol screen (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.

次要结局

  • PRISM Contextual Survey Instrument (PCSI)(Surveys were administered within 60 days of initiating each phase: pre-implementation, implementation, and sustainment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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