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

NCT05110014 | Completed Results DMC

• 2 other identifiers: IRB00048919.subR01CA218416
• Study Type: interventional
• Target: 23,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Fall risk; Intimate partner violence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (1)

Primary Care Office Visits

OTHER

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

Interventions

Primary Care Office Visits OTHER

mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

Primary Care Office Visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Requiring a language interpreter for a language other than Spanish

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Health Sciences

eswright@wakehealth.edu

336-713-3103

Study Officials

• David Miller, MD, MS

  Wake Forest Baptist Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: June 24, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: April 13, 2023
• Results First Posted: April 5, 2022

Record last verified: 2022-02

Locations

US (1)