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Engaging Suicidal Patients in Mental Health Treatment

Leveraging Behavioral Economics and Implementation Science to Engage Suicidal Patients in Mental Health Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05021224
Enrollment
29
Registered
2021-08-25
Start date
2022-03-07
Completion date
2024-01-12
Last updated
2025-06-08

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

Conditions

Suicide, Depression, Mental Health Impairment, Suicidal Ideation, Suicidal

Brief summary

The investigators will identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral using administrative data. Then, the investigators will apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment attendance for individuals at risk of suicide. Using established procedures from implementation science and behavioral economics, the investigators will then leverage the insights gleaned from Aims 1 and 2, relevant theories and frameworks, and the extant literature to develop preliminary strategies to support attendance at first mental health visit. Strategies will be developed in collaboration with a team of experts in suicide, implementation science, and behavioral economics. These preliminary strategies will then be iteratively tested and refined. The investigators also will assess putative mechanism using behavioral tasks and self-report tools.

Detailed description

In 2017, there were more than 800,000 deaths by suicide worldwide. Patients at high risk for suicide are less likely to die by suicide if they engage in psychotherapy. However, despite the development of evidence-based practices (EBPs) for suicide prevention, rates of suicide in the U.S. have increased by approximately 30% over the past two decades. One way to lower these rates would be to increase treatment initiation among those at risk. Suicidal individuals have difficulty engaging in mental health services, yet no studies have systematically developed and tested strategies to increase treatment initiation for suicidal patients. Nearly two-thirds of people who die by suicide interact with a primary care clinician in the year prior to death, making primary care an optimal setting in which to identify individuals at risk for suicide and connect them to mental health care. Yet only half of those referred by primary care providers attend an initial mental health visit, even when referred to care within the same practice. Various strategies to increase attendance at first appointment, including reminder calls and texts, motivational and informational interventions, and case management, have demonstrated small to moderate effects. Even when these strategies are implemented, approximately 40% of patients do not initiate treatment, suggesting that additional work is needed. The primary objective of this study is to develop acceptable, feasible, low-cost, and effective strategies that increase patients' treatment initiation (i.e., attendance at a first mental health visit) following identification of suicide risk in primary care. The investigators will partner with a large, diverse health system to rapidly prototype and test promising strategies to achieve this objective. Rapid prototyping involves a series of rigorous tests to optimize operations in the early-study stages. Industries outside of health care commonly use this approach to learn quickly and de-risk decision-making on a short timeline prior to a large roll-out. To maximize generalizability, the investigators will use rapid prototyping to develop strategies for increasing attendance in both collaborative care and outpatient specialty mental health. The strategies the investigators develop and test will be informed by behavioral economics and implementation science methods, leveraging the University of Pennsylvania's P50 ALACRITY center. In accordance with an experimental medicine approach to behavior change, the investigators will also identify and target mechanisms of action that impede treatment attendance. The specific aims are to: Aim 1. Identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral. The sample will include adults 18 years and older, including Medicare, Medicaid, and commercial insurance enrollees, who are referred for mental health services after an initial screening in primary care identified suicidal ideation. Using medical records, the investigators will compare characteristics of patients who initiate treatment to those patients who do not. When possible, the investigators will utilize insurance claims data to identify any mental health services utilization that occurred outside the health system. The investigators also will explore data from patients who report suicidal ideation in primary care and are not referred to mental health services. Aim 2. Apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment attendance for individuals at risk of suicide. The investigators will use direct observation and brief interviews with key stakeholders, including leaders (n = 12), primary care providers (n = 12), behavioral health providers (n = 12), mental health intake coordinators (n = 5), and patients who do (n = 12) and do not (n = 12) attend a first mental health visit following referral from primary care to understand key structural and behavioral barriers, facilitators, and mechanisms to engaging patients at risk for suicide in mental health services. The investigators also will use behavioral tasks and self-report measures to assess putative mechanisms of action in patient stakeholders. Aim 3. Rapidly prototype and test strategies to optimize engagement. Using established procedures from implementation science and behavioral economics, the investigators will leverage the insights gleaned from Aims 1 and 2, relevant theories and frameworks (e.g., EAST, Science of Behavior Change), and the extant literature to develop preliminary strategies to support attendance at first mental health visit. Based on the literature and their previous work, the investigators anticipate that strategies that target temporal discounting (e.g., incentives) and foster perceived social support (e.g., Caring Contacts) will be needed. Strategies will be developed in collaboration with a team of experts in suicide, implementation science, and behavioral economics. The investigators will then iteratively test and refine these preliminary strategies. Throughout this process, the investigators expect to uncover additional barriers and facilitators that will allow us to further refine and optimize implementation strategies. The investigators will assess putative mechanism using behavioral tasks and self-report tools. The primary output will be a menu of promising and feasible implementation strategies that directly address barriers to the initiation of mental health services for patients at risk of suicide. These strategies will be tested in a subsequent multisite R01. The long-term goal is to reduce deaths by suicide by increasing engagement in evidence-based mental health services for individuals at risk of suicide.

Interventions

BEHAVIORALCaring Contacts

Non-demanding message sent from the care team

BEHAVIORALReminders

Appointment reminders sent electronically

BEHAVIORALInformational Poster

An informational poster linking to an infographic

BEHAVIORALMotivational Interviewing

Motivational interviewing training for intake coordinators

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 years and older * Elevated suicidal ideation per item 9 of the Patient Health Questionnaire (PHQ item score ≥ 1) completed during a primary care visit * Able to read and understand English

Exclusion criteria

* Current psychotic episode requiring emergency services and/or precluding ability to provide informed consent * Documented diagnosis of dementia in the past 2 years. The rationale for this criteria is that these individuals may have difficulty understanding the study information provided to them, including how to opt out of the study * No patients will be excluded on the basis of sex, race, or ethnicity * Primary care provider notes that participation is not indicated * Already received a study engagement strategy following a different primary care visit.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Intervention Measure (AIM)6 monthsA reliable and valid 4-item tool to assess perceptions of the acceptability of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater acceptability.
Intervention Appropriateness Measure (IAM)6 monthsA reliable and valid 4-item tool to assess perceptions of the appropriateness of engagement strategies to the context. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater appropriateness.
Feasibility of Intervention Measure (FIM)6 monthsA reliable and valid 4-item tool to assess perceptions of the feasibility of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater feasibility.
Attendance at First Mental Health Visit6 monthsDerived from the electronic health record, defined as patient did or did not attend first mental health visit following referral.

Countries

United States

Participant flow

Participants by arm

ArmCount
Caring Contacts
Non-demanding message sent from the care team
14
Reminders
Appointment reminders sent electronically
5
Informational Poster
An informational poster linking to an infographic
2
Motivational Interviewing
Motivational interviewing training for intake coordinators
8
Total29

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDid not complete all survey items4102

Baseline characteristics

CharacteristicCaring ContactsRemindersInformational PosterMotivational InterviewingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants2 Participants1 Participants1 Participants5 Participants
Age, Categorical
Between 18 and 65 years
13 Participants3 Participants1 Participants7 Participants24 Participants
Age, Continuous40.71 years
STANDARD_DEVIATION 12.34
49.60 years
STANDARD_DEVIATION 18.53
54.00 years
STANDARD_DEVIATION 21.21
41.75 years
STANDARD_DEVIATION 14.8
43.45 years
STANDARD_DEVIATION 14.49
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants5 Participants2 Participants8 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants3 Participants2 Participants2 Participants16 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
White
5 Participants1 Participants0 Participants5 Participants11 Participants
Region of Enrollment
United States
14 participants5 participants2 participants8 participants29 participants
Sex: Female, Male
Female
13 Participants5 Participants1 Participants6 Participants25 Participants
Sex: Female, Male
Male
1 Participants0 Participants1 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 50 / 20 / 8
other
Total, other adverse events
0 / 140 / 50 / 20 / 8
serious
Total, serious adverse events
0 / 140 / 50 / 20 / 8

Outcome results

Primary

Acceptability of Intervention Measure (AIM)

A reliable and valid 4-item tool to assess perceptions of the acceptability of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater acceptability.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Caring ContactsAcceptability of Intervention Measure (AIM)3.96 score on a scaleStandard Deviation 0.86
RemindersAcceptability of Intervention Measure (AIM)4.40 score on a scaleStandard Deviation 0.55
Informational PosterAcceptability of Intervention Measure (AIM)3.88 score on a scaleStandard Deviation 0.18
Motivational InterviewingAcceptability of Intervention Measure (AIM)3.34 score on a scaleStandard Deviation 0.83
Primary

Attendance at First Mental Health Visit

Derived from the electronic health record, defined as patient did or did not attend first mental health visit following referral.

Time frame: 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Caring ContactsAttendance at First Mental Health VisitAttended visit5 Participants
Caring ContactsAttendance at First Mental Health VisitDid not attend visit6 Participants
Caring ContactsAttendance at First Mental Health VisitMissing/could not be determined3 Participants
RemindersAttendance at First Mental Health VisitDid not attend visit2 Participants
RemindersAttendance at First Mental Health VisitMissing/could not be determined1 Participants
RemindersAttendance at First Mental Health VisitAttended visit2 Participants
Informational PosterAttendance at First Mental Health VisitAttended visit0 Participants
Informational PosterAttendance at First Mental Health VisitMissing/could not be determined0 Participants
Informational PosterAttendance at First Mental Health VisitDid not attend visit2 Participants
Motivational InterviewingAttendance at First Mental Health VisitAttended visit3 Participants
Motivational InterviewingAttendance at First Mental Health VisitMissing/could not be determined2 Participants
Motivational InterviewingAttendance at First Mental Health VisitDid not attend visit3 Participants
Primary

Feasibility of Intervention Measure (FIM)

A reliable and valid 4-item tool to assess perceptions of the feasibility of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater feasibility.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Caring ContactsFeasibility of Intervention Measure (FIM)3.77 score on a scaleStandard Deviation 0.86
RemindersFeasibility of Intervention Measure (FIM)4.30 score on a scaleStandard Deviation 0.67
Informational PosterFeasibility of Intervention Measure (FIM)4.00 score on a scaleStandard Deviation 0
Motivational InterviewingFeasibility of Intervention Measure (FIM)3.16 score on a scaleStandard Deviation 1.25
Primary

Intervention Appropriateness Measure (IAM)

A reliable and valid 4-item tool to assess perceptions of the appropriateness of engagement strategies to the context. Each item is rated using a 5-point ordinal response options, ranging from 1= completely disagree to 5=completely agree and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater appropriateness.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Caring ContactsIntervention Appropriateness Measure (IAM)3.88 score on a scaleStandard Deviation 0.81
RemindersIntervention Appropriateness Measure (IAM)4.40 score on a scaleStandard Deviation 0.89
Informational PosterIntervention Appropriateness Measure (IAM)4.00 score on a scaleStandard Deviation 0
Motivational InterviewingIntervention Appropriateness Measure (IAM)3.25 score on a scaleStandard Deviation 1.14

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026