Substudy of Protocol NCT03843957 - Effect of mPATH on Scr... | NCT05110014

NCT05110014

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
R01CA218416	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Name	Affiliation	Role
David Miller, MD, MS	Wake Forest Baptist Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest Baptist Health Sciences		Winston-Salem	North Carolina	27157	United States

Arm/Group Information

ID	Title	Description
FG000	Before mPATH Launch	The number of participants screened prior to the mPATH intervention. 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 Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence
FG001	After mPATH Launch	The number of participants screened after MPATH intervention. 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 Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Primary Care Office Visits - Before mPATH	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 Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	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.	Investigators prefer not to identify the practices by types: 1) Investigators do not hypothesize there will be any difference in effect by practice type and naming the clinics by type could make a reader assume investigators were looking for a 'practice-type' effect), and 2) not identifying which practices further protects the confidentiality of the practices. Overall number = 1,067 is the overall number of participants that were positive out of the 12,239 before mPATH intervention.	Posted		Count of Participants		Participants		2 months prior to use of intervention

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Primary Care Office Visits (Pre Intervention)	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 Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

Title	Organization	Phone	Extension	Email
Study Coordinator	Wake Forest Baptist Health Sciences	336-713-3103		eswright@wakehealth.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 29, 2021	Dec 23, 2021	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Nov 2, 2022	Mar 17, 2023	ICF_001.pdf

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Title	Description
OG000	Primary Care Practices	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 Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence