Adherence Strategies for Lung Cancer Screening
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Disqualifiers: Highly suspicious baseline LDCT
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on lung cancer screening adherence, so it's unlikely that your medications will be affected, but you should confirm with the trial coordinators.
What data supports the effectiveness of the treatment Clinician Nudge, Patient and Clinician Nudge Strategies, Patient Nudge, Patient Reminder, Adherence Strategy for lung cancer screening?
Research shows that using nudges, which are gentle prompts or reminders, can effectively improve adherence to medical guidelines and increase the completion of important health conversations, like those about serious illness. These strategies have been successful in other areas of healthcare, suggesting they could also help improve adherence to lung cancer screening.
12345How does this treatment for lung cancer screening differ from other treatments?
This treatment focuses on improving adherence to lung cancer screening recommendations, which is crucial for reducing mortality. It involves strategies like centralized programs and decision aids to ensure patients follow through with annual screenings, unlike traditional treatments that may not emphasize adherence as strongly.
678910Eligibility Criteria
This trial is for patients aged 50-80 with a history of significant smoking who haven't been diagnosed with lung cancer and are non-adherent to lung cancer screening. It's also for clinicians in the University of Pennsylvania Health System who treat such patients and have not opted out.Inclusion Criteria
I have chosen to participate in the study.
I am between 50-80 years old with a history of heavy smoking.
You are still able to receive lung cancer screening during the trial enrollment period.
+6 more
Exclusion Criteria
My initial lung scan shows a high suspicion of cancer.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive patient and/or clinician nudge strategies to increase adherence to lung cancer screening and diagnostic follow-up
3 months
Ongoing virtual interactions via text messaging and EHR prompts
Follow-up
Participants are monitored for adherence to lung cancer screening and diagnostic follow-up, as well as for any lung cancer diagnoses
6 months
Data collection through EHR
Participant Groups
The study tests whether 'nudges' (gentle encouragements) can improve how well both doctors and patients stick to recommended lung cancer screenings. The effectiveness will be measured, followed by interviews to understand barriers or enhancers.
4Treatment groups
Experimental Treatment
Active Control
Group I: Patient Nudge OnlyExperimental Treatment1 Intervention
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.
Group II: Clinician Nudge OnlyExperimental Treatment1 Intervention
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.
Group III: Clinician Nudge + Patient NudgeExperimental Treatment2 Interventions
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
Group IV: Usual care (no nudges)Active Control1 Intervention
Patients and clinicians in this arm will receive usual care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
National Comprehensive Cancer NetworkCollaborator
AstraZenecaIndustry Sponsor
References
Nudging within learning health systems: next generation decision support to improve cardiovascular care. [2022]The increasing volume and richness of healthcare data collected during routine clinical practice have not yet translated into significant numbers of actionable insights that have systematically improved patient outcomes. An evidence-practice gap continues to exist in healthcare. We contest that this gap can be reduced by assessing the use of nudge theory as part of clinical decision support systems (CDSS). Deploying nudges to modify clinician behaviour and improve adherence to guideline-directed therapy represents an underused tool in bridging the evidence-practice gap. In conjunction with electronic health records (EHRs) and newer devices including artificial intelligence algorithms that are increasingly integrated within learning health systems, nudges such as CDSS alerts should be iteratively tested for all stakeholders involved in health decision-making: clinicians, researchers, and patients alike. Not only could they improve the implementation of known evidence, but the true value of nudging could lie in areas where traditional randomized controlled trials are lacking, and where clinical equipoise and variation dominate. The opportunity to test CDSS nudge alerts and their ability to standardize behaviour in the face of uncertainty may generate novel insights and improve patient outcomes in areas of clinical practice currently without a robust evidence base.
Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. [2022]Serious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics ("nudges") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer.
Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. [2023]Background: Early serious illness conversations (SICs) about goals of care and prognosis improve mood, quality of life, and end-of-life care quality. Algorithm-based behavioral nudges to oncologists increase the frequency and timeliness of such conversations. However, clinicians' perspectives on such nudges are unknown. Design: Qualitative study consisting of semistructured interviews among medical oncology clinicians who participated in a stepped-wedge cluster randomized trial of Conversation Connect, an algorithm-based intervention consisting of behavioral nudges to promote early SICs in the outpatient oncology setting. Results: Of 79 eligible oncology clinicians, 56 (71%) were approached to participate in interviews and 25 (45%) accepted. Key facilitators to algorithm-based nudges included prompting documentation of conversations, peer comparisons, performance reports, and validating norms around early conversations. Barriers included cancer-specific heterogeneity in algorithm performance and the frequency and tone of text messages. Areas of improvement included utilizing different information channels, identifying patients earlier in the disease trajectory, and incorporating patient-targeted messaging that emphasizes the value of early conversations. Conclusions: Oncology clinicians identified key facilitators and barriers to Conversation Connect. These insights inform future algorithm-based supportive care interventions in oncology. Controlled trial (NCT03984773).
Effectiveness of nudges as a tool to promote adherence to guidelines in healthcare and their organizational implications: A systematic review. [2022]The shift in the United States in recent years toward value-based healthcare delivery models has brought renewed pressure on healthcare organizations to improve adherence to clinical and administrative guidelines designed to deliver high quality care at lower costs. However, getting clinicians to adhere to these guidelines remains a persistent problem for many organizations. The use of nudges has emerged as a popular intervention in healthcare settings to promote adherence to both sets of guidelines. This systematic review aims to assess the empirical evidence base on the use of various types of nudges and their effectiveness as a tool to promote this adherence and to identify the boundary conditions under which they are effective. In our assessment of 83 empirical studies, we found compelling evidence that nudges are an effective tool for promoting adherence to guidelines. However, much of this evidence relies heavily on studies focused on three types of nudges (increasing salience, providing feedback, and default). Other types of nudges (anticipated error reduction, structuring of complex problems, and understanding mapping) received far less attention. We also found that this literature is primarily focused on whether nudge interventions work, with little consideration for organizational issues such as cost effectiveness, impact on healthcare workers, and disruptions of established workflows and routines. We offer observations and recommendations on how research at the intersection of organizational studies and health services can improve our understanding of nudge interventions.
Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. [2022]Medication adherence is generally low and challenging to address because patient actions control healthcare delivery outside of medical environments. Behavioral nudging changes clinician behavior, but nudging patient decision-making requires further testing. This trial evaluated whether behavioral nudges can increase statin adherence, measured as the proportion of days covered (PDC).
Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. [2018]Assess patient adherence to radiologist recommendations in a clinical CT lung cancer screening program.
An Evaluation of Annual Adherence to Lung Cancer Screening in a Large National Cohort. [2022]Lung cancer screening reduces mortality in large RCTs where adherence is high. Unfortunately, recently published adherence rates do not replicate those seen in trials. Previous publications support a centralized approach to ensure patient eligibility and improve adherence.
Adherence to Annual Lung Cancer Screening in a Centralized Academic Program. [2023]Adherence to lung cancer screening (LCS) protocols is critical for achieving mortality reductions. However, adherence rates, particularly for recommended annual screening among patients with low-risk findings, are often sub-optimal. We evaluated annual LCS adherence for patients with low-risk findings participating in a centralized screening program at a tertiary academic center.
Barriers and facilitators to uptake of lung cancer screening: A mixed methods systematic review. [2023]Numerous factors contribute to the low adherence to lung cancer screening (LCS) programs. A theory-informed approach to identifying the obstacles and facilitators to LCS uptake is required. This study aimed to identify, assess, and synthesize the available literature at the individual and healthcare provider (HCP) levels based on a social-ecological model and identify gaps to improve practice and policy decision-making. Systematic searches were conducted in nine electronic databases from inception to December 31, 2020. We also searched Google Scholar and manually examined the reference lists of systematic reviews to include relevant articles. Primary studies were scored for quality assessment. Among 3938 potentially relevant articles, 36 studies, including 25 quantitative and 11 qualitative studies, were identified for inclusion in the review. Fifteen common factors were extracted from 34 studies, including nine barriers and six facilitators. The barriers included individual factors (n = 5), health system factors (n = 3), and social/environmental factors (n = 1). The facilitators included only individual factors (n = 6). However, two factors, age and screening harm, remain mixed. This systematic review identified and combined barriers and facilitators to LCS uptake at the individual and HCP levels. The interaction mechanisms among these factors should be further explored, which will allow the construction of tailored LCS recommendations or interventions for the Chinese context.
Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]The Centers for Medicare and Medicaid Services has mandated in-person shared decision-making (SDM) counseling with the use of one or more decision aids (DAs) prior to lung cancer screening. We developed a single-page, paper-based, encounter DA (EDA) to be used within a clinician-patient encounter for lung cancer screening and conducted a pre-post pilot intervention study to evaluate its feasibility and effects on patient decisional conflict. Patients referred to a pulmonary practice-based lung cancer screening program were surveyed before and after an SDM visit with a pulmonologist, who used the EDA to counsel the patient. Patient knowledge of the mortality benefit from screening and the frequency of abnormal screening test results was evaluated after the visit, while decisional conflict was measured before and after the visit using the Decisional Conflict Scale (DCS). Twenty-three patients participated (mean age = 65.8 years; 43% female; mean smoking history = 57.8 pack-years; 48% currently smoking). Following the visit, 28% of participants correctly understood the mortality benefit of lung cancer screening, while 82% understood the frequency of abnormal screening tests. The mean total DCS score decreased from 35.0 to 0.2 after the visit (p