Adherence Strategies for Lung Cancer Screening

Overseen By Jocelyn Wainwright, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Highly suspicious baseline LDCT

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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.

Research Team

Katharine A Rendle, PhD,MSW,MPH

Principal Investigator

University of Pennsylvania

Anil Vachani, MD MS

Principal Investigator

University of Pennsylvania

Eligibility 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.

Exclusion Criteria

My initial lung scan shows a high suspicion of cancer.

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

Treatment Details

Interventions

• Clinician Nudge
• Patient Nudge

Trial Overview 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.

Participant Groups

Group I: Patient Nudge Only Experimental Treatment 1 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 Only Experimental Treatment 1 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 Nudge Experimental Treatment 2 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 Control 1 Intervention

Patients and clinicians in this arm will receive usual care.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

The use of nudge theory in clinical decision support systems (CDSS) could help bridge the gap between existing healthcare evidence and actual clinical practice, potentially improving patient outcomes.

Integrating nudges with electronic health records and artificial intelligence may enhance clinician adherence to guidelines, especially in areas lacking robust evidence, by standardizing behavior in uncertain clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging within learning health systems: next generation decision support to improve cardiovascular care. Chen, Y., Harris, S., Rogers, Y., et al.[2022]

This study will evaluate the effectiveness of both clinician- and patient-directed nudges to increase the completion of serious illness conversations (SICs) among high-risk cancer patients, involving 166 clinicians and approximately 5500 patients.

The primary outcome will be the time to SIC documentation, with secondary outcomes including palliative care referrals and the use of aggressive end-of-life care, aiming to improve patient outcomes and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Takvorian, SU., Bekelman, J., Beidas, RS., et al.[2022]

A qualitative study involving 25 oncology clinicians revealed that algorithm-based nudges effectively promote early serious illness conversations (SICs), which are crucial for improving patient mood and end-of-life care quality.

Clinicians noted that while these nudges helped with documentation and peer comparisons, challenges such as cancer-specific differences and the nature of communication methods need to be addressed to enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. Parikh, RB., Manz, CR., Nelson, MN., et al.[2023]

A systematic review of 83 studies found that nudges are effective in promoting adherence to clinical and administrative guidelines in healthcare, particularly through methods like increasing salience, providing feedback, and setting defaults.

Despite the effectiveness of nudges, there is a lack of research on their cost-effectiveness and impact on healthcare workers, indicating a need for further studies that consider organizational factors and workflow disruptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of nudges as a tool to promote adherence to guidelines in healthcare and their organizational implications: A systematic review. Nwafor, O., Singh, R., Collier, C., et al.[2022]

In a 12-month study involving 182 adult patients with coronary disease, personalized behavioral nudges significantly increased statin adherence, with a proportion of days covered (PDC) of 0.742 in the nudge group compared to 0.639 in the control group (P = 0.042).

The nudge group also had a higher percentage of adherent subjects (66.3% with PDC ≥80%) compared to controls (50.5%, P = 0.036), indicating that AI-driven nudges can effectively enhance medication adherence without significant differences in serious health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. Horne, BD., Muhlestein, JB., Lappé, DL., et al.[2022]

In a study of 901 high-risk patients undergoing CT lung cancer screening, 85.7% adhered to radiologist follow-up recommendations, indicating that high adherence rates are achievable in clinical settings.

The main reasons for nonadherence included patient refusal for follow-up exams (66.7%) and difficulties in contacting patients (20.9%), highlighting areas for improvement in patient engagement and communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. Alshora, S., McKee, BJ., Regis, SM., et al.[2018]

In a study of 30,166 lung cancer screening patients across 14 health systems, only 48.4% adhered to follow-up screenings in the first year, and this dropped to 44.4% in the second year, indicating a significant gap in adherence despite eligibility.

Among the eligible patients, 93 were diagnosed with lung cancer, mostly during the first follow-up, highlighting the importance of improving adherence to screening programs to maximize their potential mortality benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Annual Adherence to Lung Cancer Screening in a Large National Cohort. Smith, HB., Schneider, E., Tanner, NT.[2022]

In a study of 337 patients with low-risk Lung-RADS scores, 73.5% of those with a score of 1 and 75.0% with a score of 2 adhered to annual lung cancer screening, indicating a high adherence rate in a centralized screening program.

Medicaid coverage was identified as a significant factor affecting adherence, with Medicaid patients being less likely to complete annual screenings compared to those with private insurance, highlighting potential socioeconomic barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Annual Lung Cancer Screening in a Centralized Academic Program. Lee, G., Hill, LP., Schroeder, MC., et al.[2023]

A systematic review of 36 studies identified 15 common factors affecting lung cancer screening (LCS) adherence, including nine barriers (like individual and health system factors) and six facilitators (primarily individual factors).

Understanding these barriers and facilitators can help develop tailored recommendations for improving LCS uptake, particularly in the Chinese context, highlighting the need for further exploration of how these factors interact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to uptake of lung cancer screening: A mixed methods systematic review. Lin, YA., Hong, YT., Lin, XJ., et al.[2023]

A single-page, paper-based encounter decision aid (EDA) used during shared decision-making visits for lung cancer screening significantly reduced patient decisional conflict, as indicated by a drop in the Decisional Conflict Scale score from 35.0 to 0.2 (p < 0.001).

While 28% of patients understood the mortality benefit of lung cancer screening after the visit, a much higher percentage (82%) grasped the frequency of abnormal screening results, highlighting the need for improved patient education on the mortality benefits of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. Ito Fukunaga, M., Balwan, A., Janis, JA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Nudging within learning health systems: next generation decision support to improve cardiovascular care. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of nudges as a tool to promote adherence to guidelines in healthcare and their organizational implications: A systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

An Evaluation of Annual Adherence to Lung Cancer Screening in a Large National Cohort. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adherence to Annual Lung Cancer Screening in a Centralized Academic Program. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to uptake of lung cancer screening: A mixed methods systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]