Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care

BACKGROUND: Insights from behavioral economics, or how individuals\u27 decisions and behaviors are shaped by finite cognitive resources (e.g., time, attention) and mental heuristics, have been underutilized in efforts to increase the use of evidence-based practices in implementation science. Using the example of firearm safety promotion in pediatric primary care, which addresses an evidence-to-practice gap in universal suicide prevention, we aim to determine: is a less costly and more scalable behavioral economic-informed implementation strategy (i.e., Nudge ) powerful enough to change clinician behavior or is a more intensive and expensive facilitation strategy needed to overcome implementation barriers? METHODS: The Adolescent and child Suicide Prevention in Routine clinical Encounters (ASPIRE) hybrid type III effectiveness-implementation trial uses a longitudinal cluster randomized design. We will test the comparative effectiveness of two implementation strategies to support clinicians\u27 use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems. All pediatric practices in the two health systems will receive S.A.F.E. Firearm materials, including training and cable locks. Half of the practices (k = 16) will be randomized to receive Nudge; the other half (k = 16) will be randomized to receive Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge+). The primary implementation outcome is parent-reported clinician fidelity to the S.A.F.E Firearm program. Secondary implementation outcomes include reach and cost. To understand how the implementation strategies work, the primary mechanism to be tested is practice adaptive reserve, a self-report practice-level measure that includes relationship infrastructure, facilitative leadership, sense-making, teamwork, work environment, and culture of learning. DISCUSSION: The ASPIRE trial will integrate implementation science and behavioral economic approaches to advance our understanding of methods for implementing evidence-based firearm safety promotion practices in pediatric primary care. The study answers a question at the heart of many practice change efforts: which strategies are sufficient to support change, and why? Results of the trial will offer valuable insights into how best to implement evidence-based practices that address sensitive health matters in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04844021 . Registered 14 April 2021

“My Name’s on Their Chart, My Name Is on That Money”: Nurse Practitioners’ Perceptions of the Acceptability of Financial Incentives for Health-Related Behavior Change

Financial incentives directed to patients for health-related behavior change are promising interventions to improve health. Understanding stakeholders’ perceptions of the acceptability of financial incentives is essential for implementation. The proposed inquiry is a qualitative study that addresses two aims: 1) Explore nurse practitioners’ perceptions of the acceptability of financial incentives for health-related behavior change in primary and specialty care, and 2) Characterize how nurse practitioners’ perceptions of the effectiveness of financial incentives for health-related behavior change shape perceptions of acceptability, including the benefits and burdens. This inquiry uses an abductive approach to anchor analytic claims and develop a coherent explanation that best fits the data. Using purposive sampling with snowball techniques, a sample of 30 NPs was recruited from Penn Medicine. Participants reviewed 3 vignettes on financial incentive programs developed from clinical studies in the NIH Research Portfolio Online Reporting Tool, then participated in semi-structured interviews to explore their perceptions of financial incentive acceptability. The abductive analysis generated 5 themes, each of which included subthemes. In Facilitating Health Outcomes, participants identified needing more tools to help their patients, favoring incentives for health promotion and preventative care, making a difference amidst major financial challenges, and spurring engagement and accountability for health. In Compromising Relational Norms, participants expressed concern that incentives could erode trust within the nurse practitioner-patient relationship, shift care delivery to a transactional exchange, push patients toward decisions not aligned with their wishes, and cause harm. Participants suggested that education should not be divorced from incentive interventions and implicit messages matter in their Firm Provisos. Implementation Preferences revealed preferences for third party administrators and specifics related to the timing of the incentive offer. Lastly, participants highlighted that Demonstrable Effectiveness is Important when considering incentives’ acceptability. Participants often equated effectiveness with sustainability, associated effectiveness with perceived ethicality, and identified research data as a mitigator of ambivalence. The findings suggest that incentives’ complexity is not limited to their specific design features but also inclusive of embedded ethical considerations. Modifying design features alone may not impact acceptability. These insights generate future directions for investigation within behavioral economics, implementation science, bioethics, and nursing

Increasing the Acceptability of Lethal Means Safety Counseling for Firearms: Tips and Scripts for Clinicians, Health System Leaders, and Researchers

In lethal means safety counseling (LMSC), clinicians encourage patients to limit their access to common and lethal means of suicide, especially firearms. However, clinicians may hesitate to deliver this evidence-based intervention. By conducting a systematic review of the growing number of qualitative studies examining stakeholder perspectives on LMSC, we identified stakeholder-recommended strategies for clinicians, health system leaders, and researchers to increase LMSC acceptability. We conducted a pre-registered, comprehensive search for studies up to February 2021 using PubMed and PsycInfo. Thematic synthesis, with an inductive and iterative approach, was used to analyze findings. Eighteen studies examined the perspectives of a various stakeholders across multiple clinical settings on LMSC for firearms. Using relevant themes, we describe strategies and present scripts, rationales, and resources that may increase LMSC acceptability. Clinicians may approach LMSC in a nonjudgmental manner with awareness of their own biases, demonstrate cultural competency by acknowledging the role of firearms in patient’s lives, and adapt LMSC to patients’ previous experiences with firearms, safety, and injury. Clinicians can contextualize and provide a rationale for LMSC, decide whether or not to ask about access to firearms, and recommend a range of storage options tailored to the patient. Free locking devices or coupons for purchasing devices may be distributed. These strategies for potentially increasing the acceptability of LMSC for firearms are the first to be based on a comprehensive set of studies generated by diverse stakeholders. Future efforts should focus on testing them empirically and considering them alongside other relevant outcomes (e.g., feasibility, efficacy)

A Mixed Methods Evaluation of Parents’ Perspectives on the Acceptability of the S.A.F.E. Firearm Program

Statement of Purpose: Pediatric firearm access is a significant risk factor for unintentional injury and suicide. This study investigated parents’ perspectives on an adapted firearm safety program, S.A.F.E. Firearm, to ensure acceptability and optimize effectiveness prior to the launch of an upcoming hybrid effectiveness-implementation trial. Methods/Approach: We administered a cross-sectional survey with a convenience sample of U.S. parents to measure the acceptability of S.A.F.E. Firearm and other key variables (e.g., relationship with pediatrician) that may impact our implementation approach. The sample included 97 participants (52 firearm-owning and 45 non-owning) from across the country. We also conducted semi-structured interviews using a Think Aloud exercise with 11 survey participants that were analyzed with directed content analysis. Results: The mean acceptability score was 4.35 [SD 0.52] on a 1-5 Likert scale, indicating that participants viewed S.A.F.E. Firearm as highly acceptable. Most participants (84%) either agreed or completely agreed with recommending that a friend receive S.A.F.E. Firearm. No significant differences in acceptability scores were found by firearm ownership status, gender, race and ethnicity, or region of residence. Parent-pediatrician depth of relationship was associated with acceptability (r= 0.21, p=.038). Interviews indicated that a collaborative approach to decision-making, neutral messaging, and provision of tangible resources were key factors that contributed to the program’s overall high acceptability scores. Conclusion & Significance: The present study served as the final check in our process of adapting an evidence-based safe firearm storage program to increase reach and effectiveness as a universal suicide prevention strategy in pediatric primary care. Convergent parent feedback confirms that S.A.F.E. Firearm is highly acceptable and ready for implementation. Moreover, our findings suggest that family-centeredness may be enhanced through explicit integration of parents’ needs and preferences into program refinements. Use of qualitative Think Aloud exercises with end user groups can add value when actual implementation of firearm safety programs can only be approximated

Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study

Attention to health equity is critical in the implementation of firearm safety efforts. We present our operationalization of equity-oriented recommendations in preparation for launch of a hybrid effectiveness-implementation trial focused on firearm safety promotion in pediatric primary care as a universal suicide prevention strategy. In Step 1 of our process, pre-trial engagement with stakeholders and literature review alerted us that delivery of a firearm safety program may vary by patients\u27 medical complexity, race, and ethnicity. In Step 2, we selected the Health Equity Implementation Framework to inform our understanding of contextual determinants (i.e., barriers and facilitators). In Step 3, we leveraged an implementation pilot across 5 pediatric primary care clinics in 2 health system sites to study signals of inequities. Eligible well-child visits for 694 patients and 47 clinicians were included. Our results suggested that medical complexity was not associated with program delivery. We did see potential signals of inequities by race and ethnicity but must interpret with caution. Though we did not initially plan to examine differences by sex, we discovered that clinicians may be more likely to deliver the program to parents of males than females. Seven qualitative interviews with clinicians provided additional context. In Step 4, we interrogated equity considerations (e.g., why and how do these inequities exist). In Step 5, we will develop a plan to probe potential inequities related to race, ethnicity, and sex in the fully powered trial. Our process highlights that prospective, rigorous, exploratory work is vital for equity-informed implementation trials