Leveraging Behavioral Economics and Implementation Science to Engage Suicidal Patients in Mental Health Treatment
Phase: NA
Conditions: Suicide, Depression, Mental Health Impairment, Suicidal Ideation, Suicidal
Sponsor: University of Pennsylvania

 
 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
Engaging Suicidal Patients in Mental Health Treatment 
NCT05021224  
May 2, 2025 
 
 

The full study protocol for this trial is published here:  
Khazanov GK, Jager-Hyman S, Harrison J, Candon M, Buttenheim A, Pieri MF, Oslin DW, 
Wolk CB. Leveraging behavioral economics and implementation science to engage 
patients at risk for suicide in mental health treatment: a pilot study protocol. Pilot 
Feasibility Stud. 2022 Aug 13;8(1):181. doi: 10.1186/s40814-022-01131-y. PMID: 35964151; 
PMCID: PMC9375238. 
We report Aim 3 results in clinicaltrials.gov. Thus, the information that follows pertains 
speciﬁcally to study Aim 3 and is reproduced from Khazanov et al. (2022).  
Protocol for Aim 3 for the Engaging Suicidal Patients in Mental Health Treatment Study 
Aim 3 of the Engaging Suicidal Patients in Mental Health Treatment study is a multi-aim, 
non-randomized feasibility trial in which we rapidly prototyped and tested strategies to 
optimize engagement by using a series of rigorous, iterative tests.  
We will develop preliminary strategies to support attendance at initial mental health visits 
and iteratively test and reﬁne these strategies through rapid prototyping. Secondarily, we 
will explore the role of two potential mechanisms, self-regulation and social support, in the 
use of engagement strategies and attendance at initial mental health visits. 
Sample 
Each strategy will be tested with approximately 5 patients. All patients must be (1) 18 years 
and older and able to communicate in English and (2) present with elevated suicidal 
ideation on item 9 of the PHQ-9 (item score ≥1) completed during a primary care visit. In 
addition, patients must not (1) currently be experiencing a psychotic episode requiring 
emergency services and/or precluding their ability to provide informed consent, (2) have a 
documented diagnosis of dementia in the past 2 years, (3) have primary care provider 
notes demonstrating that participation is not indicated, and (4) have already received a 
study engagement strategy following a different primary care visit. We will leverage the 
infrastructure of the Resource Center to recruit from the pool of patients who were referred 
for a mental health intake following a positive screen for depression or suicide risk in 
primary care based on the EHR. This provides a mechanism for recruiting patients while 
also ensuring that there is appropriate clinical screening and expertise to triage individuals 
in need of acute services. We anticipate that 25 patients will complete the temporal 
discounting and social support behavioral task and self-report measures, though 
additional patients may receive the strategies. Attendance data will be available from any 
individual who receives a strategy as part of routine care quality assurance. 
 

Procedure 
A team of experts in implementation science (n = 2), behavioral economics (n = 2), suicide 
(n= 2), and primary care and behavioral health (n = 4, total N = 10) will convene a half-day 
retreat to guide Aim 3 activities and develop strategies for rapid prototyping. This team will 
review key barriers and facilitators to attendance at initial mental health visits identiﬁed in 
Aims 1 and 2 and then generate strategies for facilitating treatment initiation that address 
barriers and leverage facilitators. The EAST framework will guide the selection of strategies 
(Service et al., 2014). We will also favor simple, established strategies (Mehta, 2018) with 
freely available resources (e.g., Caring Contacts templates from Now Matters Now) to 
promote scalability (Center for Health Care Innovation, 2019), but will also consider other 
potential implementation strategies as indicated (Dopp et al., 2019). We will explore both 
low- and high-tech (e.g., EHR integration) strategies to maximize relevance across contexts. 
Based on the literature, previous work, and our conceptual model, we hypothesize that 
strategies that counteract delayed discounting tendencies (e.g., incentives) and foster 
emotional social support (e.g., Caring Contacts) will be needed (Comtois et al., 2018). 
We will then use rapid prototyping to test and reﬁne the strategies identiﬁed by the team of 
experts (Dopp et al., 2019), a process that has been applied successfully at Penn over the 
past 6 years (Asch et al., 2014; Asch & Rosin, 2015; Thaler & Sustein, 2009; Whiteside et 
al., 2014). The goal of rapid prototyping is to determine the best strategies for broader 
implementation in a subsequent trial. Prototype strategy designs will be validated through 
rapid-cycle tests in this real-world context and in a manner that is quick and inexpensive. 
This will allow us to fail fast and learn quickly. As we deploy strategies and learn from our 
experiences, we will adapt and iterate to reﬁne promising strategies. 
Strategies will be rolled out in the PIC Resource Center over 6 months. During this period, 
strategies will be implemented by an embedded mental health intake coordinator as part of 
routine care. Consent to receive strategies is, therefore, not required. However, because 
participants will complete measures assessing acceptability and feasibility of these 
strategies, as well as temporal discounting and social support, we will employ an IRB-
approved modiﬁed consent procedure prior to implementing strategies that includes a 
waiver of written consent. The modiﬁed consent procedure will consist of (1) a brief 
description of the study purpose, procedures, and potential risks; (2) notiﬁcation that the 
strategy is part of a research project for which participation is voluntary; and (3) 
instructions on declining further participation. This modiﬁed approach will allow us to 
circumvent potential confounds associated with limiting a trial examining engagement to 
those who provide active, written informed consent to receive engagement strategies. By 
waiving the requirement of traditional, written informed consent, we will minimize the 
likelihood of a biased sample and maximize the validity and generalizability of our results 

(Simon et al., 2016; Zelen, 1990). We anticipate that each strategy will be tested with ≥5 
patients, but this is ﬂexible; additional tests will be implemented as needed. 
Measures 
After testing each strategy, we will quantitatively assess patients’ perceptions of its 
feasibility, acceptability, and appropriateness using three brief, validated questionnaires: 
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), 
and Feasibility of Intervention Measure (FIM), that were developed to better evaluate and 
monitor implementation outcomes (Weiner et al., 2017). Each questionnaire consists of 
four items (total of 12 items) rated on a 1–5 Likert-type scales ranging from “Completely 
disagree” to “Completely agree.” The total score ranges from 4 to 20 for each measure, with 
higher scores indicating greater acceptability, appropriateness, or feasibility, respectively. 
Reliability was demonstrated with Cronbach’s alphas of .85 for acceptability, .91 for 
appropriateness, and .89 for feasibility, and test-retest reliability was demonstrated with 
correlations of .80 for acceptability, .73 for appropriateness, and .88 for feasibility. 
Statistical Analysis Plan for Aim 3 of the Engaging Suicidal Patients in Mental Health 
Treatment Study 
Data analysis plan for primary outcomes: Descriptive statistics will be used to describe 
feasibility, acceptability, and appropriateness of strategies as assessed with the AIM, IAM, 
and FIM. We will also use logistic regressions to examine the impact of engagement 
strategies on attendance at initial mental health visits using attendance information 
derived from the administrative data (did/did not attend). These analyses will provide us 
with a preliminary estimate of the effectiveness of each engagement strategy. Finally, we 
will use descriptive analyses to examine attendance at initial mental health visits. These 
analyses are exploratory to inform mechanisms to investigate in future trials. 
Power analyses: Consistent with recommendations for pilot studies (e.g., Leon et al., 
2010), we have not conducted power analyses for Aim 3. We instead focus on exploring the 
data at this stage, as well as examining the feasibility and acceptability of strategies to 
support attendance at initial mental health visits. Analyses will be oriented towards 
identifying promising strategies and mechanisms to focus on in subsequent studies. 
 
 
 

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