Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Nudge sent to the patient through text messaging.

Nudge sent to both provider through EHR, and to patient through text messaging.

Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts

Patient nudge

Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts

Provider nudge

Anne Marie McCarthy, PhD

The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black and White women.

Women with dense breasts have 3-5-fold increased risk for breast cancer as women without dense breasts. Dense breast tissue can "mask" small tumors, leading to reduced mammography sensitivity. Recent randomized controlled trials demonstrate that supplemental breast MRI screening improves detection of small, invasive cancers that are not detected by mammography. In January 2022, a Pennsylvania law went into effect mandating insurance coverage of supplemental screening for women with extremely dense breasts. Currently only a small fraction of eligible women with extremely dense breasts are receiving supplemental breast MRI screening. Clinical pathways to identify patients who are eligible for insurance coverage of supplemental breast MRI screening and communicate this option to patients and providers are needed to ensure equitable access to supplemental screening. This study therefore proposes a stepped wedge cluster randomized clinical trial to determine whether electronic health record (EHR) and secure text message nudges increase utilization of supplemental breast MRI screening among eligible women with extremely dense breasts.

Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts

Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.

Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.

Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.

Whether an MRI is completed within 6 months of receiving a nudge

False-positive rate among those women who schedule and undergo MRI

Cancer detection rate among those women who schedule and undergo MRI

Abramson Cancer Center at Penn Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up.

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up

Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up.

Patients will receive usual care.

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up.

Clinicians will receive usual care.

Patients and clinicians in this arm will receive usual care.

Brief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message.

Patient Nudge

EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

Clinician Nudge

Katharine Rendle, PhD,MSW,MPH

Jocelyn Wainwright, MS

Hannah Toneff, MSW, MA

Anil Vachani, MD

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.

Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.

At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).

Increasing Adherence to Lung Cancer Screening

Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up

Defined as having a positive LDCT and no subsequent lung cancer diagnosis within 6 months of the LDCT date

Biopsy confirmed lung cancer diagnosis measured using EHR data

Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines.

Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan.

Reach defined by proportion of patients who receive patient nudges and by the proportion of patients whose clinician acts upon clinician nudge (i.e., signs pended orders)

National Comprehensive Cancer Network

AstraZeneca

Substance Related Disorders

Behaviors and Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

All Drugs and Chemicals

Nicotine

Clinicians and patients will receive no further interventions beyond usual practice.

Clinicians will receive a nudge via Best Practice Alert within the EMR

Patients will receive a message sent through myPennMedicine following establishment of their smoking status.

Both strategies described above will be used.

Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Tobacco Use Treatment Service (TUTS) referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing TUTS referral and engagement in cancer patients who smoke, vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

Continued tobacco smoking negatively impacts survival among patients with cancer. Routinely delivered evidence-based tobacco use treatment (TUT) would minimize cancer-specific and all-cause mortality, reduce treatment-related toxicity, and improve quality of life. About 50% of cancer patients who smoked prior to their diagnosis continue to smoke after diagnosis and during treatment. The National Comprehensive Cancer Network, American Society of Clinical Oncology, and American Association for Cancer Research, call for implementation of TUT within oncology care. In 2015, TUT received an "A" recommendation from the US Preventive Services Task Force, given the high level of certainty of resulting benefit. The approval specifically focused on clinicians asking all adults about smoking, prescribing FDA-approved cessation medications for smokers, and offering appropriate behavioral interventions.

Despite the importance of TUT, only half of cancer centers consistently identify patient tobacco use, and few cancer centers employ systematic mechanisms to refer patients to evidence-based cessation services. Acknowledging this gap, the National Cancer Institute (NCI) launched the Cancer Center Cessation Initiative (C3I) as part of the Moonshot to help centers develop effective ways to identify and engage patients who smoke. Penn ISC3 MPI Dr. Schnoll was a member of the NCI advisory board that developed this initiative, and Penn Medicine's Abramson Cancer Center (ACC) was in the first funded cohort. Because clinician expertise in TUT is a known barrier, the initial strategy used an automatic "default" electronic medical record (EMR) referral to the ACC Tobacco Use Treatment Service (TUTS). Engagement increased, but clinicians turned off the default 60% of the time, implicating additional important barriers to change.

This study aims to produce dramatic change within oncology by refining and testing implementation strategies informed by behavioral economics. The investigators' work has identified specific cognitive biases among clinicians and patients that prevent TUTS referral and engagement, including clinician pessimism regarding the ability to help patients stop using tobacco, misconceptions about patient resistance to treatment, and implicit biases regarding the capacity for patients to volitionally alter the course of illness. These motivators are related to clinician willingness to invest effort in help giving and may prevent acquisition of new knowledge and skills. From the patient perspective, several studies identify unique challenges that individuals with cancer face when engaging in tobacco cessation efforts, including low self-efficacy, low perceived benefits of quitting, and perceived risk of treatment. Thus, this study focuses on addressing these barriers, in a pragmatic and innovative way, to increase TUTS referral and engagement in cancer care.

The investigators' objectives are to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing in TUTS referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct this study with at least 100 clinicians and at least 900 smokers across Penn Medicine's ACC (the clinician sample size may increase with additional clinicians joining Penn and the patient sample size may be higher given the pragmatic design and delay between determination of eligibility \[i.e., patient smokes\] and nudge delivery at a subsequent visit). They expect the study to yield essential insights into the effectiveness of nudges as an implementation strategy to speed the uptake of high value evidence-based TUT within cancer care, and to advance the understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how cancer care settings can ensure that patients with cancer who smoke are engaged with evidence-based TUT and may lead to a future R01 focused on scaling-up this approach across other cancer centers involved in the C3I.

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

Defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion)

Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of the seven pharmacotherapies within 30 days of the initial oncology visit, divided by the total number of referred patients

Defined as the number of patients who receive a quit-line referral or in-person or telephone cessation counseling, divided by the total number of TUTS-engaged patients

Defined as the number of TUTS-referred patients who make any quit attempt, divided by the total number of TUTS-referred patients

Defined as the total number of TUTS-referred patients self-reporting 7-day point prevalence abstinence at a 90-day follow-up assessment, divided by the total number of TUTS-referred patients

National Cancer Institute (NCI)

University of Pennsylvania

Director, Comprehensive Smoking Treatment Program Professor, Critical Care and Pulmonology

Adverse events were only monitored for patients, not for clinicians.

Usual Care

Clinicians will receive a nudge via Best Practice Alert within the EMR

Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patients will receive a message sent through myPennMedicine following establishment of their smoking status.

Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Both strategies described above will be used.

Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Clinician and Patient Nudge

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Marital Status

Clinician Type (seen by patients)

Clinician Specialty (seen by patients)

Days between arm assignment and engagement

The following baseline characteristics are for patients only.

Robert Schnoll, PhD

Outcome measures were not collected for clinicians.

Penetration (Rate of Referral to TUTS or Medication Prescription)

This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

Treatment Engagement Rates (Medication)

Treatment Engagement Rate (Behavioral)

This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts	NCT05787249	Breast Cancer	Patient nudge Provider nudge	40 Years - 74 Years	Abramson Cancer Center at Penn Medicine
Increasing Adherence to Lung Cancer Screening	NCT05832008	Lung Cancer Adherence, Pati...	Patient Nudge Clinician Nudge	50 Years - 80 Years	Abramson Cancer Center at Penn Medicine
Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke	NCT04737031	Cancer Smoking Tobacco Use Nicotine Depend...	Clinician Nudge Patient Nudge	-	Abramson Cancer Center at Penn Medicine
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts	NCT05787249	Breast Cancer	Patient nudge Provider nudge	40 Years - 74 Years	Abramson Cancer Center at Penn Medicine

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