Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23,026
- 试验地点
- 1
- 主要终点
- Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
研究概览
简要总结
This is a sub-study for data analysis of data collected as part of the larger randomized controlled trial "Effectiveness and Implementation of mPATH-CRC" (NCT03843957) to determine if self-administered screening with an iPad increases the detection of patients with depression, falls, and intimate partner violence.
详细描述
As part of the parent study (NCT0343957), investigators developed an iPad program called mPATH that patients use at their primary care clinician's office to encourage colorectal cancer screening. To encourage practices to use mPATH with every patient, the investigators included in the program the health system's required screening items for depression, fall risk, and intimate partner violence, thereby offloading this routine task from clinical staff. It is possible that mPATH will increase detection of depression, fall risk, and intimate partner violence because: 1) mPATH systematically asks these screening items of all patients, and 2) patients may feel more comfortable answering these items on an iPad survey than during an in-person interview.
To determine the effect of mPATH on the performance of this screening, investigators will examine a limited use dataset comparing the 2 months before a clinic started using mPATH to the 2 months after the clinic began using mPATH. Because clinics may need some time to fully adopt mPATH, investigators will exclude the first two weeks following the launch of mPATH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age 18 or older
- •Completed a provider visit at the study clinic during the 60 days prior to the clinic launching the mPATH program (the "pre" time period), or completed a provider visit at the study clinic during days 14 - 73 after the launch of mPATH (the "post" time period)
- •Have a preferred language of English or Spanish
排除标准
- •Requiring a language interpreter for a language other than Spanish
研究组 & 干预措施
Primary Care Office Visits
The limited use dataset will contain the following data elements for each completed patient visit:
- Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)
- Clinic (designated by a unique study clinic identifier)
- Type of visit completed (for example, new patient visit, return patient visit, annual exam)
- Patient age
- Patient gender
- Patient race/ethnicity
- Patient primary insurance
- Nursing staff who roomed the patient (designated by a unique study identifier)
- Whether patient used mPATH-CheckIn program (Y/N)
- Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)
- Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)
- Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)
- Results of depression screening items
- Results of fall risk screening items
- Results of safety at home screening items
干预措施: Primary Care Office Visits (Other)
结局指标
主要结局
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
时间窗: 2 months prior to use of intervention
The primary outcome will be the proportion of patients seen in each time period ("pre" vs. "post") who screen positive for depression, fall risk, or intimate partner violence. The "pre" time period will be Days -60 to -1 (the 60 day period before mPATH Launch). Screening positive for depression will be a score of 3 or greater on the Patient Health Questionnaire-2. Screening positive for fall risk will be answering "yes" to having a device to assist with mobility and/or having fallen in the last year. Screening positive for intimate partner violence will be answering yes to any of the health system's three questions about safety in the home.
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
时间窗: 2 months after use of intervention
The primary outcome will be the proportion of patients seen in each time period ("pre" vs. "post") who screen positive for depression, fall risk, or intimate partner violence. The "post" time period will be days 14 to 73 (the 60 day period commencing 2 weeks after mPATH Launch). Screening positive for depression will be a score of 3 or greater on the Patient Health Questionnaire-2. Screening positive for fall risk will be answering "yes" to having a device to assist with mobility and/or having fallen in the last year. Screening positive for intimate partner violence will be answering yes to any of the health system's three questions about safety in the home.
次要结局
- Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)(2 months before and 2 months after using intervention)
- Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)(2 months before and 2 months after using intervention)
- Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)(2 months before and 2 months after using intervention)
- Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.(2 months before and 2 months after using intervention)
- Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices(2 months before and 2 months after using intervention)
- Number of Participants Screening Positive for Fall Risk at Home in All Practices(2 months before and 2 months after using intervention)
- Number of Participants Screening Positive for Intimate Partner Violence in All Practices(2 months before and 2 months after using intervention)