Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety

Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Primary Care Office Visits

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.

• Study Type: Interventional
• Enrollment (Actual): 23026
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

Other: Primary Care Office Visits; mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	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.	2 months prior to use of intervention
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	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.	2 months after use of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)	The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. Screen positive for depression using the PHQ-2 items. PHQ-2 score obtained by adding score for each question (total points). A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely.	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)	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.	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)	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.	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.	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.	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	This is measured by the screening question on suicide risk on the PHQ-9: "Thoughts that you would be better off dead or of hurting yourself in some way."	2 months before and 2 months after using intervention
Number of Participants Screening Positive for Fall Risk at Home in All Practices	Screen positive for fall risk at home. In addition, the outcomes below will be assessed: Have fallen in last 6 months; Have had a fall with injury	2 months before and 2 months after using intervention
Number of Participants Screening Positive for Intimate Partner Violence in All Practices	Screen positive for safety concerns at home. In addition, the outcome below will be assessed: Report that conflicts turn into fights	2 months before and 2 months after using intervention

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David Miller, MD, MS, Wake Forest Baptist Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Intimate partner violence; Fall risk
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: IRB00048919.sub; R01CA218416 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No