Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety
Phase: NA
Conditions: Depression
Sponsor: Wake Forest University Health Sciences

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
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*** Confidential *** 
 
Principal Investigator: 
 
David P. Miller, M.D. 
 
 
 
 
 
Department of Internal Medicine 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
 
Co-Investigator(s):  
 
Kristie Foley, Ph.D. 
Department of Social Sciences and Health Policy 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
Anna Snavely, PhD 
Department of Biostatistical Sciences  
Wake Forest University School of Medicine 
Medical Center Blvd.  
Winston-Salem, NC 27157 
 
 
Ajay Dharod, M.D. 
Department of Internal Medicine 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
Mark Dignan, PhD 
University of Kentucky 
Internal Medicine 
800 Rose Street 
Lexington, KY 40536 
 
Holly Brower, PhD 
Wake Forest University School of Business 
1834 Wake Forest Road 
 
Geoffrey Curran, PhD 
University of Arkansas 
Center for Implementation Research 
4301 West Markham Street 
Little Rock, AR 72205 
 
Jennifer Troyer, PhD 
University of North Carolina at Charlotte 
Belk School of Business 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
Page 2 of 7 
*** Confidential *** 
 
9201 University City Blvd 
Charlotte, NC 28223 
 
Biostatistician: 
Anna Snavely, PhD 
Department of Biostatistical Sciences  
Wake Forest University School of Medicine 
Medical Center Blvd.  
Winston-Salem, NC 27157 
 
 
Study Coordinator:  
 
Elena Wright 
 
 
 
 
 
 
Regulatory Contact:  
 
Elena Wright 
 
 
 
 
 
 
Protocol Editor: 
 
 
Mac Robinson, PhD 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
Participating Institution(s):  
Wake Forest Baptist Health 
 
 
 
 
 
University of Kentucky 
 
 
Version Date: 
 
 
February 12, 2018 
 
 
Amended: 
 
 
 
July 29, 2021 
 
 
 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
Page 3 of 7 
*** Confidential *** 
 
Appendix D – Effect of mPATH on Screening for Depression, Fall Risk, and 
Safety 
 
Wake Forest policy requires primary care clinics to screen patients aged 18 and older 
for depression, fall risk, and safety at home at each provider visit. Nursing staff conduct 
this screening during the rooming process by asking patients standardized questions 
and recording their responses in the electronic health record. 
 
We designed mPATH to save staff time by having patients answer these same 
screening items on an iPad and then transmitting their answers to WakeOne. It is 
possible that mPATH will increase detection of depression, fall risk, and safety concerns 
because: 1) mPATH systematically asks these screening items of all patients, and 2) 
patients may feel more comfortable answering these items in an iPad survey than 
during an in-person interview. 
 
To determine the effect of mPATH on the performance of this screening, we 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, we will exclude the first two weeks following the 
launch of mPATH. 
 
Study Population 
We will create a limited use dataset containing patients who are seen in one of the first 
six Wake Forest Baptist Health primary care clinics that are participating in the mPATH 
Effectiveness and Implementation trial. 
 
Patient 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 
 
Patient exclusion criteria: 
 Requiring a language interpreter for a language other than Spanish 
 
Experimental Methods 
The limited use dataset will contain the following data elements for each completed 
patient visit: 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
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*** Confidential *** 
 
 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 
WakeOne (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 
 
The study dataset will be maintained using the procedures outlined in Section 8.0 
(Confidentiality and Privacy). Of note, we are taking the following additional 
safeguards to further protect patient confidentiality: 
1. Dates of clinic visits will be designated using numbers relative to each clinic’s 
launch date, rather than using the actual date 
2. Clinics will be designated with a unique study clinic identifier instead of clinic 
name 
3. Nursing staff will be designated with a unique study identifier instead of actual 
name 
 
Definition of Time Periods 
 The day a clinic  launches mPATH will be designated as that clinic’s Day 0 
 The “pre” time period will be Days -60 to -1 (the 60 day period before mPATH 
Launch) 
 The “post” time period will be days 14 to 73 (the 60 day period commencing 2 
weeks after mPATH Launch) 
 
Outcome Measures 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
Page 5 of 7 
*** Confidential *** 
 
Primary outcome: 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 safety 
concerns at home. 
 
Secondary outcomes: Secondary outcomes will include the proportion of patients in 
each time period who: 
 Screen positive for depression using the PHQ-2 items. In addition, the outcomes 
below will be assessed: 
o Have a PHQ9 score >14 (indicating moderately severe depression or 
severe depression) 
o Have a PHQ9 score >19 (indicating severe depression) 
o Have a PHQ9 score >14 and are not currently taking a medication for 
depression 
o Have thoughts of self-harm 
 Screen positive for fall risk at home. In addition, the outcomes below will be 
assessed: 
o Have fallen in last 6 months  
o Have had a fall with injury 
 Screen positive for safety concerns at home. In addition, the outcome below will 
be assessed: 
o Report that conflicts turn into fights 
 
Analytic plan 
Our primary analysis will compare the proportion of patients seen in the “pre” time 
period to the “post” time period who screen positive for either depression, fall risk, or 
safety at home. If a patient is seen more than once in a given time period, only the 
patient’s first visit in that time period will be included in the analyses. We will estimate 
the proportion who screen positive for each time period and report along with 95% 
confidence intervals. A chi-square test will be used to provide an unadjusted 
comparison between the “pre” and “post” proportions. Logistic regression models will 
then be used to compare the “pre” and “post” proportions while controlling for clinic and 
patient demographic variables. We will use the same analytic methods for our 
secondary outcomes. We will also conduct a sensitivity analysis for our primary 
outcome where we consider all patients’ visits during a given time period (and not limit 
analyses to a patient’s first visit in the time period only). For this sensitivity analysis, we 
will compare the proportion of patients who meet our primary outcome definition at any 
visit during the “pre” and “post” time periods.   
 
Analytic adjustments due to COVID19 pandemic: Due to the COVID19 pandemic, all 
practices stopped using mPATH in March 2020, which is prior to the closure of the 60-
day “post” time period for clinics #5 and #6 in our sample. Therefore, we will truncate 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
Page 6 of 7 
*** Confidential *** 
 
the “post” time period for these two clinics to 30 days. To determine if this truncated 
time period affected our overall results, we will conduct the following sensitivity 
analyses: (1) limiting the analyses to only the first 4 clinics to enroll, and (2) limiting data 
collection to 30-days post- for all 6 clinics. 
 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
Protocol version date 
7/29/2021 
 
 
 
 
 
 
Page 7 of 7 
*** Confidential ***