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

NCT ID: NCT05110014

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23026 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-02-27

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Primary Care Office Visits

Intervention Type: OTHER

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

Interventions

Primary Care Office Visits

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Sciences

Locations

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01CA218416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00048919.sub

Identifier Type: -

Identifier Source: org_study_id