Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05021224 |
| Other study ID # |
829538 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2022 |
| Est. completion date |
January 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
