Robert Schnoll, Ph.D.

This grant also includes a pragmatic trial to assess impact of implementation strategies delivered to clinicians and patients on referral for or engagement in tobacco treatment. Given the substantial practice gap concerning the use of tobacco treatments for smokers with HIV and the opportunities to use implementation science and behavioral economics to reduce this gap, the study will: 1) use formative research to devise the content for clinician- and patient-directed nudges to engage with tobacco treatment in the HIV medical context (i.e., test the optimal bias to address within a nudge), and 2) pilot-test use of these nudges (alone or combined) to increase tobacco treatment engagement. New approaches to increasing tobacco treatment for PWH could lead to benefits at the patient and population levels. Insights from this study could be applied in other clinical settings to increase tobacco treatment, and thus improve patient outcomes in other populations.

This grant includes a pilot study to assess the translational use of the nicotine metabolite ratio (NMR) for increasing clinician prescription and patient use of medications for nicotine dependence. Using formative research methods to assess barriers to integrating nicotine dependence treatment into primary care, including the NMR, and a pre/post design with independent patient cohorts, we will establish rates of physician prescribing and patient use of medications for nicotine dependence when treatment as usual is standardized as Ask, Advise, Connect (AAC; Ask patients about smoking, Advise smokers to quit, and Connect smokers with treatment), then integrate NMR testing (AAC+NMR), and reassess physician prescribing and patient use rates.

The Penn Implementation Science Center in Cancer Control (ISC3) is a $4.9 million, five-year grant from the National Cancer Institute that is part of the national network of ISC3s. Our goal is to apply insights from behavioral economics to rapidly accelerate the pace at which evidence-based practices for cancer care are deployed and the extent to which they are delivered equitably, thereby increasing their reach and impact on the health and health equity of individuals with cancer.

Penn ISC3 implements projects across an Implementation Laboratory that spans Penn Medicine’s geographic footprint. This includes 6 hospitals, 12 outpatient oncology clinics, and 18 radiation centers with over 400 physicians and advanced practice providers serving patients from Pennsylvania, New Jersey, and Delaware. Penn ISC3 is composed of Signature Projects focused on increasing the uptake of evidence-based practices, as well as Methods Projects focused on refining implementation strategy design; conducting mixed methods analysis of potential implementation mechanisms; and centering our projects on equitable implementation.

Tobacco cessation (Signature Project 1): Tobacco use limits the effectiveness of cancer treatment, so our first signature project focuses on helping people stop using tobacco. This project tests behavioral economics-informed multilevel implementation strategies to increase Tobacco Use Treatment Service (TUTS) referral and engagement. It aims to conduct a 4-arm pragmatic cluster randomized clinical trial (RCT) to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both to increase TUTS referral and to conduct a quantitative evaluation to identify moderators of implementation effects on TUTS referral.

Our research objective is to identify a simple, pragmatic, innovative way of enhancing Tobacco Use Treatment (TUT) rates within medical care, including oncology. To investigate this possibility, we propose methods that will allow us to: 1) evaluate the impact of standing orders to initiate a varenicline management protocol within inpatient cancer and non-cancer treatment workflow and 2) assess the potential for an electronic health record (EHR)-based intervention to affect patient TUT behaviors. To achieve all our research objectives, we plan to conduct a two-arm randomized clinical trial (RCT) pilot study of a clinical decision support (CDS) intervention, exposing half of our clinician sample to the TUT Service+Varenicline Management (VM) condition during clinical workflow, and comparing important outcome measures to those observed among the half exposed to the current usual care condition, TUT Service alone. A third aim will assess implementation preferences and barriers influencing effectiveness of usual care tobacco use treatment (TUT Service) + varenicline management (VM) applied within the cancer center.

Facilitating the adoption and sustainability of evidence-based practice for TUD within public mental healthcare clinics requires an organization-level intervention to address barriers that hinder effective care. Preliminary studies by members of the research team in community mental healthcare settings have shown that an organization-level intervention reduces barriers to providing evidence-based TUD treatment and improves clinician adherence to treatment guidelines. Thus, with a cluster-randomized design and 16 community mental healthcare agencies (N=320 personnel, N=800 clients), this study will evaluate the Addressing Tobacco Through Organizational Change (ATTOC) model for: 1) improving provider adherence to guidelines for treating TUD; and 2) reducing client smoking rates, vs. usual care (UC). Non-inferiority testing will determine if the ATTOC model adversely affects client mental health functioning, vs. UC, and the cost-effectiveness of the ATTOC intervention will be assessed. We will also explore changes in barriers as mediators of the effects of the ATTOC model on provider adherence to treatment guidelines and patient smoking and identify key ATTOC components linked to improved outcomes that can be more easily disseminated. If this trial shows that ATTOC can promote evidence-based care for TUD and reduce smoking rates for those with an SMI – and without worsening mental health and in a cost- effective manner – this organizational change model may represent a critical initiative to address tobacco use in an under-served sub-group of smokers and help to attain Healthy People 2020 tobacco use goals.

This project will test a novel smoking cessation intervention for HIV+ smokers in an LIC setting, a group at high risk of complications from smoking. It will leverage the infrastructure of HIV clinics to identify smokers, be personalized to the individual’s behavioral reinforcers and utilize mobile phones to interface with participants. Simultaneously, it will assess the generalizability of the behavioral activation framework for smoking cessation by testing it for the first time outside of a HIC setting and with HIV+ smokers and yield important information about depression as a moderator of behavioral activation and conceptual mediators of behavioral activation, information that will greatly advance knowledge in HICs. The success of this project has the potential to greatly impact the emerging problem of nicotine dependence and decrease the burden of non-communicable diseases in this already heavily medically impacted population.

The number of medical conditions for which the results of genetic testing change the medical management of patients is exponentially increasing. However, a minority of eligible patients receive genetic testing, despite the implications for downstream care. System- (methods to identify eligible patients and return results), clinician- (e.g., knowledge, limited workforce), and patient- (e.g., concerns about costs and adverse effects) level barriers foster uncertainty and a tendency to rely on the status quo - failing to use genomic information to guide medical care. Implementation science methods and frameworks are ideal for addressing this practice gap, especially those that consider multi-level barriers and the role of human decision-making in contexts with uncertainty. Our team has built the infrastructure to address system-barriers to delivering genetic testing across our health system - an integrated system within the electronic health record (EHR) that enables direct ordering and resulting of genetic tests as structured data – now with multiple requests for dissemination. Our team also is using behavioral economics as an implementation science framework to improve healthcare by using nudges (EHR defaults, patient priming) to overcome clinician and patient barriers, concurrently addressing health disparities (e.g., higher practice gaps among racial minorities). Merging these areas, we propose a highly innovative project that will evaluate, for the first time, the use of nudges to clinicians (EHR defaults for either: 1) referring to genetics clinic or 2) ordering for genetic testing) and/or nudges to patients (communication to prime patients about the benefits of genetic testing prior to appointment).

In Aim 1, we will develop electronic phenotyping algorithms for 10 clinical conditions, which will drive diagnosis-specific genetics referral and testing; we will refine our nudges working with a Stakeholder Advisory Council. In Aim 2, we will conduct a hybrid type 3 implementation study, using a cluster randomized design with 228 clinicians (physician, Advanced Practice Practitioners) as the unit of randomization (N=120 clusters) and 16,500 patients with one of the 10 conditions to examine the impact on the rate of genetic testing of: the patient priming nudge, the two clinician nudges, combining the patient and each of the clinician nudges, vs. a generic best practice alert (BPA) (no clinician or patient nudge). We will examine patient (e.g., race), clinician (e.g., specialty), and system (e.g., community vs. academic center) moderators of nudge effects on genetic testing rate and assess an effectiveness outcome (rate of clinician action following identification of a pathogenic variant). In Aim 3, we will engage in systematic methods to disseminate our EHR integration of genetic testing, EHR-based algorithms, and other materials and systems built for the clinical trial through Epic, PheKB, NHGRI’s AnVIL, and GitHub. Our study will be immensely impactful, as it will yield a novel, effective, and transferrable EHRbased infrastructure that enables the sustainable delivery of genomic medicine, greatly advancing the field.