Trial Outcomes & Findings for Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety (NCT NCT05110014)
NCT ID: NCT05110014
Last Updated: 2023-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23026 participants
Primary outcome timeframe
2 months prior to use of intervention
Results posted on
2023-04-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12239
|
10787
|
|
Overall Study
COMPLETED
|
12239
|
10787
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety
Baseline characteristics by cohort
| Measure |
Primary Care Office Visits - Before mPATH
n=12239 Participants
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
|
Primary Care Office Visits - After mPATH
n=10787 Participants
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
|
Total
n=23026 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Primary Care Practices
Practice C
|
1943 Participants
n=99 Participants
|
1877 Participants
n=107 Participants
|
3820 Participants
n=206 Participants
|
|
Age, Continuous
|
60.2 years
n=99 Participants
|
59.0 years
n=107 Participants
|
59.7 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7030 Participants
n=99 Participants
|
6312 Participants
n=107 Participants
|
13342 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5209 Participants
n=99 Participants
|
4475 Participants
n=107 Participants
|
9684 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
387 Participants
n=99 Participants
|
357 Participants
n=107 Participants
|
744 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11677 Participants
n=99 Participants
|
10287 Participants
n=107 Participants
|
21964 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
175 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
161 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
324 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1640 Participants
n=99 Participants
|
1458 Participants
n=107 Participants
|
3098 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9876 Participants
n=99 Participants
|
8666 Participants
n=107 Participants
|
18542 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
175 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
387 Participants
n=99 Participants
|
357 Participants
n=107 Participants
|
744 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12239 participants
n=99 Participants
|
10787 participants
n=107 Participants
|
23026 participants
n=206 Participants
|
|
Primary Health Insurance
Commercial
|
5382 Participants
n=99 Participants
|
4962 Participants
n=107 Participants
|
10344 Participants
n=206 Participants
|
|
Primary Health Insurance
Medicaid
|
401 Participants
n=99 Participants
|
377 Participants
n=107 Participants
|
778 Participants
n=206 Participants
|
|
Primary Health Insurance
Medicare
|
5705 Participants
n=99 Participants
|
4817 Participants
n=107 Participants
|
10522 Participants
n=206 Participants
|
|
Primary Health Insurance
Uninsured
|
462 Participants
n=99 Participants
|
367 Participants
n=107 Participants
|
829 Participants
n=206 Participants
|
|
Primary Health Insurance
Other
|
289 Participants
n=99 Participants
|
264 Participants
n=107 Participants
|
553 Participants
n=206 Participants
|
|
Primary Care Practices
Practice A
|
1935 Participants
n=99 Participants
|
1730 Participants
n=107 Participants
|
3665 Participants
n=206 Participants
|
|
Primary Care Practices
Practice B
|
1574 Participants
n=99 Participants
|
1868 Participants
n=107 Participants
|
3442 Participants
n=206 Participants
|
|
Primary Care Practices
Practice D
|
2866 Participants
n=99 Participants
|
1873 Participants
n=107 Participants
|
4739 Participants
n=206 Participants
|
|
Primary Care Practices
Practice E
|
2215 Participants
n=99 Participants
|
2170 Participants
n=107 Participants
|
4385 Participants
n=206 Participants
|
|
Primary Care Practices
Practice F
|
1706 Participants
n=99 Participants
|
1269 Participants
n=107 Participants
|
2975 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 months prior to use of interventionPopulation: 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.
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.
Outcome measures
| Measure |
Primary Care Practices
n=12239 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice A
|
224 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice B
|
94 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice C
|
55 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice D
|
165 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice E
|
265 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Practice F
|
264 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 months after use of interventionPopulation: Positive screenings for composite outcomes (depression, fall risk, intimate partner violence) were reported in individual medical practices - 3 family medicine and 3 internal medicine practices. The count of participants = 2,102 is the overall number of participants that were positive out of the 10,787 after mPATH intervention.
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.
Outcome measures
| Measure |
Primary Care Practices
n=10787 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice A
|
509 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice B
|
463 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice C
|
235 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice D
|
242 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice E
|
418 Participants
|
—
|
|
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Practice F
|
235 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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.
Outcome measures
| Measure |
Primary Care Practices
n=23026 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
Before intervention
|
188 Participants
|
—
|
|
Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
After intervention
|
450 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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.
Outcome measures
| Measure |
Primary Care Practices
n=23026 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
Before Intervention
|
82 Participants
|
—
|
|
Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
After intervention
|
206 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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.
Outcome measures
| Measure |
Primary Care Practices
n=23026 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
Before intervention
|
28 Participants
|
—
|
|
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
After intervention
|
86 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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.
Outcome measures
| Measure |
Primary Care Practices
n=23026 Participants
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
|
Primary Care Office Visits (Post 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
|
|---|---|---|
|
Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
Before Intervention
|
63 Participants
|
—
|
|
Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
After intervention
|
139 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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."
Outcome measures
| Measure |
Primary Care Practices
n=1067 Participants
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
|
Primary Care Office Visits (Post Intervention)
n=2102 Participants
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
|
|---|---|---|
|
Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices
|
39 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
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
Outcome measures
| Measure |
Primary Care Practices
n=1067 Participants
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
|
Primary Care Office Visits (Post Intervention)
n=2102 Participants
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
|
|---|---|---|
|
Number of Participants Screening Positive for Fall Risk at Home in All Practices
|
907 Participants
|
1692 Participants
|
SECONDARY outcome
Timeframe: 2 months before and 2 months after using interventionPopulation: The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants.
Screen positive for safety concerns at home. In addition, the outcome below will be assessed: * Report that conflicts turn into fights
Outcome measures
| Measure |
Primary Care Practices
n=1067 Participants
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
|
Primary Care Office Visits (Post Intervention)
n=2102 Participants
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
|
|---|---|---|
|
Number of Participants Screening Positive for Intimate Partner Violence in All Practices
|
10 Participants
|
310 Participants
|
Adverse Events
Primary Care Office Visits (Pre Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Care Office Visits (Post Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place