Mental Health Among Patients, Providers, and Staff During the COVID-19 Era (MHAPPS)

St. Luke's Health System, Boise, Idaho

Status: Completed

Conditions: Covid19; Mental Health

Treatments: Other: Caring Contacts without an introductory phone call (CC); Other: Caring Contacts Plus Introductory Phone Call (CC+)

Study type: Interventional

Funder types: Other

Identifiers

NCT04700137

20-0052

PCORI HIS-2018C3-14695 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 666 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Aim 1:

• Provider & Employee Inclusion Criteria

  • Provider or Employee at St. Luke's Health System
  • Adults ≥ 18 years of age
  • Proficient in spoken and written English language

• Patient Inclusion Criteria

  • Patient at a St. Luke's Health System primary care site
  • Current MyChart account user
  • Adults ≥18 years of age
  • Minors 12-17 years of age
  • Proficient in spoken and written English language

Aim 2:

• Provider & Employee Inclusion Criteria

  • Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression:

    • NIH Toolkit Loneliness raw score of 13 or greater or
    • C-SSRS score of 3 or greater; or
    • NIH Toolkit Perceived Stress raw score of 31 or greater for adults; or
    • GAD7 score of 11 or greater; or
    • PHQ9 score of 10 or greater

  • 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:

    • NIH Toolkit Loneliness raw score of 13 or greater for adults or 16 or greater for adolescents; or
    • C-SSRS score of 3 or greater; or
    • GAD7 score of 11 or greater; or
    • PHQ9 score of 10 or greater; or
    • NIH Toolkit Stress raw score of 31 or greater for adults or 33 or greater for adolescents
    • [Note: validated youth versions of the NIH Toolkit assessments (loneliness and perceived stress), and PHQ-A tools will be used for adolescents; the C-SSRS and GAD7 tools are validated for use with both adults and adolescents.]

  • 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

  • Individuals who are unable or unwilling to provide informed consent to participate
  • Individuals who are study staff for this study or the SPARC Trial

• Patient Exclusion Criteria

  • Individuals who are unable or unwilling to provide informed consent to participate.
  • Individuals who are participants in the SPARC Trial
  • Individuals who have not had a primary care visit in the past 12 months

Aim 2:

• Provider & Employee Exclusion Criteria

  • Individuals who are unable or unwilling to provide informed consent to participate
  • Individuals who are in acute crisis as determined by the person conducting the consent process
  • Individuals who are study staff for this study or the SPARC Trial
  • Individuals who are enrolled as participants in the SPARC comparative effectiveness clinical trial (SPARC Aim 1). Providers or employees who received training related to SPARC and/or who completed the SPARC provider satisfaction survey are not excluded from participating in MHAPPS

• Patient Exclusion Criteria

  • Patients who are unable or unwilling to provide informed consent/assent to participate (or whose legally authorized representative is unable or unwilling to provide consent in the case of adolescents). Examples may include but are not limited to patients who present with acute or chronic cognitive impairment that would preclude their ability to consent (i.e. acute psychosis, intoxication, or intellectual disability).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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666 participants in 2 patient groups

Caring Contacts + Introductory Phone Call (CC+)

Active Comparator group

Description:

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.

Treatment:

Other: Caring Contacts Plus Introductory Phone Call (CC+)

Caring Contacts (without phone call) (CC)

Active Comparator group

Description:

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.

Treatment:

Other: Caring Contacts without an introductory phone call (CC)