Clinical trial NCT05110014: Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety
Official title: Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Fall risk
Intimate partner violence
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-05
Enrollment: 23026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

• Requiring a language interpreter for a language other than Spanish

Primary outcomes:
measure: Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
timeFrame: 2 months prior to use of intervention
measure: Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
timeFrame: 2 months after use of intervention
Secondary outcomes:
measure: Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants Screening Positive for Fall Risk at Home in All Practices
timeFrame: 2 months before and 2 months after using intervention
measure: Number of Participants Screening Positive for Intimate Partner Violence in All Practices
timeFrame: 2 months before and 2 months after using intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health Sciences
name: David Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: