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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05110014

Enrollment

23026

Registered

2021-11-05

Start date

2019-06-24

Completion date

2020-02-27

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Fall risk, Intimate partner violence

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.

Interventions

OTHERPrimary Care Office Visits

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	2 months prior to use of 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.
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	2 months after use of 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.

Secondary

Measure	Time frame	Description
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)	2 months before and 2 months after using intervention	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.	2 months before and 2 months after using intervention	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 Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)	2 months before and 2 months after using intervention	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 Fall Risk at Home in All Practices	2 months before and 2 months after using intervention	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	2 months before and 2 months after using intervention	Screen positive for safety concerns at home. In addition, the outcome below will be assessed: * Report that conflicts turn into fights
Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices	2 months before and 2 months after using intervention	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 Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)	2 months before and 2 months after using intervention	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	12,239
Primary Care Office Visits - After 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	10,787
Total	23,026

Baseline characteristics

Characteristic	Primary Care Office Visits - After mPATH	Primary Care Office Visits - Before mPATH	Total
Age, Continuous	59.0 years	60.2 years	59.7 years
Ethnicity (NIH/OMB) Hispanic or Latino	357 Participants	387 Participants	744 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10287 Participants	11677 Participants	21964 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	143 Participants	175 Participants	318 Participants
Primary Care Practices Practice A	1730 Participants	1935 Participants	3665 Participants
Primary Care Practices Practice B	1868 Participants	1574 Participants	3442 Participants
Primary Care Practices Practice C	1877 Participants	1943 Participants	3820 Participants
Primary Care Practices Practice D	1873 Participants	2866 Participants	4739 Participants
Primary Care Practices Practice E	2170 Participants	2215 Participants	4385 Participants
Primary Care Practices Practice F	1269 Participants	1706 Participants	2975 Participants
Primary Health Insurance Commercial	4962 Participants	5382 Participants	10344 Participants
Primary Health Insurance Medicaid	377 Participants	401 Participants	778 Participants
Primary Health Insurance Medicare	4817 Participants	5705 Participants	10522 Participants
Primary Health Insurance Other	264 Participants	289 Participants	553 Participants
Primary Health Insurance Uninsured	367 Participants	462 Participants	829 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	163 Participants	161 Participants	324 Participants
Race (NIH/OMB) Black or African American	1458 Participants	1640 Participants	3098 Participants
Race (NIH/OMB) More than one race	143 Participants	175 Participants	318 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	357 Participants	387 Participants	744 Participants
Race (NIH/OMB) White	8666 Participants	9876 Participants	18542 Participants
Region of Enrollment United States	10787 participants	12239 participants	23026 participants
Sex: Female, Male Female	6312 Participants	7030 Participants	13342 Participants
Sex: Female, Male Male	4475 Participants	5209 Participants	9684 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.

Time frame: 2 months after use of intervention

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice A	509 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice B	463 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice C	235 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice D	242 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice E	418 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use	Practice F	235 Participants

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.

Time frame: 2 months prior to use of intervention

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice A	224 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice B	94 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice C	55 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice D	165 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice E	265 Participants
Primary Care Practices	Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use	Practice F	264 Participants

Secondary

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.

Time frame: 2 months before and 2 months after using intervention