search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Office Visits
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Fall risk, Intimate partner violence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest Baptist Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Primary Care Office Visits

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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."
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
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

Full Information

First Posted
October 26, 2021
Last Updated
March 17, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05110014
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Fall risk, Intimate partner violence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23026 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Office Visits
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Primary Care Office Visits
Intervention Description
mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence
Primary Outcome Measure Information:
Title
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Description
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.
Time Frame
2 months prior to use of intervention
Title
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Description
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.
Time Frame
2 months after use of intervention
Secondary Outcome Measure Information:
Title
Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
Description
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.
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
Description
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.
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
Description
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.
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
Description
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.
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices
Description
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."
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants Screening Positive for Fall Risk at Home in All Practices
Description
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
Time Frame
2 months before and 2 months after using intervention
Title
Number of Participants Screening Positive for Intimate Partner Violence in All Practices
Description
Screen positive for safety concerns at home. In addition, the outcome below will be assessed: Report that conflicts turn into fights
Time Frame
2 months before and 2 months after using intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Miller, MD, MS
Organizational Affiliation
Wake Forest Baptist Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs