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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI HIS-2018C3-14695 | Other Grant/Funding Number | COVID-19 Enhancement Award, PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Idaho Crisis & Suicide Hotline | OTHER |
| University of Washington | OTHER |
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The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho.
The study will include:
Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and
Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.
Approximately 4,800 participants will complete the Aim 1 survey. The Caring Contacts intervention involves sending a series of brief, non-demanding, supportive text messages to the participant. One intervention arm will receive an introductory phone call and the caring text messages (CC+); the second intervention arm will only receive the same caring text messages (CC). The clinical trial will enroll a subset of 660 participants who report elevated levels of loneliness, suicide ideation, or other mental distress in the Aim 1 survey. Enrollment will be stratified by population (providers and employees; patients) with 165 per intervention arm in each stratum.
The investigators hypothesize that delivering the Caring Contacts intervention with an introductory phone call will yield better mental health outcomes than delivering the Caring Contacts intervention with no introductory phone call.
This will be the first published data directly comparing the effectiveness of two versions of the Caring Contacts intervention with individuals who report loneliness or other mental distress. The overall goal of the MHAPPS study is to better understand the mental health impact of COVID-19 and to determine how health systems can most effectively support mental health at scale among providers, staff, and patients in the COVID-19 era and beyond.
This research is being conducted by a team including health system-based researchers, clinicians, other frontline healthcare workers, and administrators; academic researchers; follow-up specialists and administrators at the Idaho Suicide Prevention Hotline, and an advisory board of people with lived experience with suicide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caring Contacts + Introductory Phone Call (CC+) | Active Comparator | Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call. Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call. |
|
| Caring Contacts (without phone call) (CC) | Active Comparator | Healthcare provider and staff participants who are randomized to only caring text messages. Adult and adolescent patient participants who are randomized to only caring text messages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Contacts Plus Introductory Phone Call (CC+) | Other | One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.7 or more (adults) or 60 or more (youth) indicates moderate to high levels of loneliness. | Baseline and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds "yes". For example, a score of 5 would be assigned to a participant who responded "yes" to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. C-SSRS screener scores range from 0 to 6, with higher scores indicative of higher suicide risk. Scores of 3 and higher indicate moderate to high risk for suicide. |
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Inclusion Criteria:
Aim 1:
Provider & Employee Inclusion Criteria
Patient Inclusion Criteria
Aim 2:
Provider & Employee Inclusion Criteria
Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression:
Access to a phone for the duration of the study with the ability to receive text messages and phone calls
Patient Inclusion Criteria
Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression:
Access to a phone for the duration of the study with the ability to receive text messages and phone calls
Exclusion Criteria:
Aim 1:
Provider & Employee Exclusion Criteria
Patient Exclusion Criteria
Aim 2:
Provider & Employee Exclusion Criteria
Patient Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anna K Radin, DrPH, MPH | St. Luke's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Health System | Boise | Idaho | 83712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36963515 | Derived | Radin AK, Shaw J, Brown SP, Torres J, Harper M, Flint H, Fouts T, McCue E, Skeie A, Pena C, Youell J, Doty-Jones A, Wilson J, Flinn L, Austin G, Chan KCG, Zheng Z, Fruhbauerova M, Walton M, Kerbrat A, Comtois KA. Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. J Affect Disord. 2023 Jun 15;331:442-451. doi: 10.1016/j.jad.2023.03.029. Epub 2023 Mar 22. |
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Data from this trial may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the PIs.
5 years following the completion of the primary endpoint
Data from this trial may be requested by other researchers 5 years after the completion of the primary endpoint by contacting the PI. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant).
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Randomization occurred once a potential participant joined a study enrollment phone call but before they consented to participate. This approach was practical given the electronic nature of the informed consent process and was recommended by the Data & Safety Monitoring Committee as a way to include a description in writing of the assigned intervention on the informed consent form while masking participants to the details of the intervention arm to which they were not assigned.
Recruitment occurred between January 2021 and July 2021. All recruitment was completed virtually, with invitations to participate sent via email and via the electronic health record messaging service.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients -- Caring Contacts (Without Phone Call) (CC) | Patients randomized to only caring text messages. Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages. |
| FG001 | Patients -- Caring Contacts + Introductory Phone Call (CC+) | Patients randomized to caring text messages and an introductory phone call. Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months. |
| FG002 | Healthcare Providers/Staff -- Caring Contacts (Without Phone Call) (CC) | Healthcare Providers and staff randomized to only caring text messages. Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages. |
| FG003 | Healthcare Providers/Staff -- Caring Contacts + Introductory Phone Call (CC+) | Healthcare providers and staff randomized to caring text messages and an introductory phone call. Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients - CC | Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm |
| BG001 | Patients - CC+ | Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.7 or more (adults) or 60 or more (youth) indicates moderate to high levels of loneliness. | Intention to treat population - all participants who were randomized and consented. | Posted | Mean | Standard Deviation | T-score | Baseline and 6 Months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients - CC | Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna K. Radin | St. Luke's Health System | 208/381-8460 | radina@slhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2020 | Apr 28, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2020 | Apr 1, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2020 | Jan 5, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000092862 | Psychological Well-Being |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Caring Contacts without an introductory phone call (CC) | Other | Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages. |
|
| Baseline and 6 Months |
| Depression as Measured by the Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major. | Baseline and 6 Months |
| Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety. | Baseline and 6 Months |
| Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress. | Baseline and 6 Months |
| Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63). Individuals provide a self-report response to each item ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB. | Baseline and 6 Months |
| Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion. | Baseline and 6 Months |
| Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19 | The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic. | Baseline and 6 Months |
| Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report. | 6 Months |
| Withdrawal by Subject |
|
| Death |
|
| BG002 | Healthcare Providers/Staff - CC | Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm |
| BG003 | Healthcare Providers/Staff - CC+ | Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health System Employee Type | Health system employee type was only assessed for healthcare providers and staff. | Count of Participants | Participants |
|
| OG001 | Patients - CC+ | Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm |
| OG002 | Healthcare Providers/Staff - CC | Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm |
| OG003 | Healthcare Providers/Staff - CC+ | Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm |
|
|
|
| Secondary | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds "yes". For example, a score of 5 would be assigned to a participant who responded "yes" to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. C-SSRS screener scores range from 0 to 6, with higher scores indicative of higher suicide risk. Scores of 3 and higher indicate moderate to high risk for suicide. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 Months |
|
|
|
|
| Secondary | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 Months |
|
|
|
|
| Secondary | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 Months |
|
|
|
|
| Secondary | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Mean | Standard Deviation | T-score | Baseline and 6 Months |
|
|
|
|
| Secondary | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63). Individuals provide a self-report response to each item ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 Months |
|
|
|
|
| Secondary | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Count of Participants | Participants | Baseline and 6 Months |
|
|
|
| Secondary | Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19 | The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Count of Participants | Participants | Baseline and 6 Months |
|
|
|
|
| Secondary | Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report. | The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
|
| 0 |
| 166 |
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | Patients - CC+ | Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm | 0 | 165 | 0 | 165 | 0 | 165 |
| EG002 | Healthcare Providers/Staff - CC | Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm | 1 | 168 | 0 | 168 | 0 | 168 |
| EG003 | Healthcare Providers/Staff - CC+ | Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm | 0 | 167 | 0 | 167 | 0 | 167 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Follow-up C-SSRS (6 months) |
|
| Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months). | Regression, Linear | Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. | 0.2 | p<0.05 = a priori threshold for statistical significance | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | 0.1 | Superiority |
| Follow-up PHQ-9 (6 months) |
|
|
Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months). |
| Regression, Linear |
Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. |
| 0.51 |
p<0.05 = a priori threshold for statistical significance |
| Median Difference (Final Values) |
| 0.3 |
| 2-Sided |
| 95 |
| -0.7 |
| 1.3 |
| Superiority |
|
| Follow-up GAD-7 (6 months) |
|
|
|
Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months). |
| Regression, Linear |
Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. |
| 0.04 |
p<0.05 = a priori threshold for statistical significance |
| Mean Difference (Final Values) |
| 1.0 |
| 2-Sided |
| 95 |
| 0.1 |
| 2.0 |
| Superiority |
|
| Follow-up Perceived Stress (6 months) |
|
|
| Change in Perceived Stress from Baseline to 6 months |
|
|
| Change in stress from baseline to 6 months among healthcare providers/staff. | Regression, Linear | Linear regression with robust standard errors. | 0.18 | p<0.05 = a priori threshold for statistical significance | Mean Difference (Final Values) | 1.5 | 2-Sided | 95 | -0.7 | 3.7 | T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk. | Superiority |
| Follow-up INQ Perceived Burdensomeness (6 months) |
|
| Baseline INQ Thwarted Belongingness |
|
| Follow-up INQ Thwarted Belongingness (6 months) |
|
| Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months). | Regression, Linear | Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. | 0.81 | p<0.05 = a priori threshold for statistical significance | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.8 | 1.0 | Superiority |
| Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months). | Regression, Linear | Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. | 0.73 | p<0.05 = a priori threshold for statistical significance | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -2.6 | 1.8 | Superiority |
| Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months). | Regression, Linear | Linear regression with robust standard errors, adjusting for the baseline score as a precision variable. | 0.24 | p<0.05 = a priori threshold for statistical significance | Mean Difference (Final Values) | 1.2 | 2-Sided | 95 | -0.8 | 3.2 | Superiority |
| Attempted suicide |
|
| Interrupted/aborted suicide |
|
|
| Increased alcohol use at follow-up (6 months) |
|
|
| Increased marijuana/cannabis use at follow-up (6 months) |
|
|
| Increased illicit drug use at follow-up (6 months) |
|
|
Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC |
| GLM |
Generalized linear model (GLM) with an identity link and binomial variance |
| 0.03 |
p<0.05 = a priori threshold for statistical significance |
| Risk Difference (RD) |
| -6.1 |
| 2-Sided |
| 95 |
| -11.5 |
| -0.7 |
| Superiority |
| Number of participants with increased alcohol use among patients randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.83 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | -1.1 | 2-Sided | 95 | -10.7 | 8.5 | Superiority |
| Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.67 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | 2.2 | 2-Sided | 95 | -8.0 | 12.5 | Superiority |
| Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.42 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | 2.9 | 2-Sided | 95 | -4.1 | 9.9 | Superiority |
| Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.53 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | -2.1 | 2-Sided | 95 | -8.7 | 4.5 | Superiority |
| Number of participants with increased illicit drug use among patients randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.20 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | -2.5 | 2-Sided | 95 | -6.3 | 1.4 | Superiority |
| Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC | GLM | Generalized linear model (GLM) with an identity link and binomial variance | 0.62 | p<0.05 = a priori threshold for statistical significance | Risk Difference (RD) | -0.7 | 2-Sided | 95 | -3.4 | 2.0 | Superiority |
|
Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months). |
| GLM |
Generalized linear model (GLM) with an identity link and binomial variance |
| 0.31 |
p<0.05 = a priori threshold for statistical significance |
| Risk Difference (RD) |
| 5.5 |
| 2-Sided |
| 95 |
| -5.2 |
| 16.2 |
| Superiority |