Multilevel Interventions for Lung Cancer Screening Adherence

(Larch Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Lung cancer, Positive scan, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people maintain their lung cancer screening routine. Researchers aim to determine if educational videos (Patient Education) and reminder systems (Stepped Reminders) can increase annual return rates for lung scans. Early detection of lung cancer can enhance treatment effectiveness. Suitable participants have had a recent negative lung scan, have no lung cancer diagnosis, and can understand English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could improve early detection and save lives.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these interventions are safe for improving lung cancer screening adherence?

Research shows that educating patients and using reminder systems are generally safe in healthcare. Studies on patient education have found that providing information about lung cancer screening does not cause harm. Instead, it helps patients understand the benefits and risks of screening better.

For reminder systems, research indicates that sending reminders can help patients keep up with health screenings, such as those for lung cancer. While these reminders have proven effective for other cancer screenings, like breast and cervical cancer, they haven't been specifically tested for lung cancer screening. However, no evidence suggests that reminders cause any negative effects.

Overall, both patient education and reminder systems are considered safe and helpful in encouraging adherence to screening guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to help people stick to their lung cancer screening schedules. Unlike the standard care that relies mainly on routine doctor reminders, this trial tests educational videos and personalized reminders. The "Patient Video" offers a unique, engaging way to educate patients about the importance of screenings. Meanwhile, "Stepped Reminders" use a proactive approach with tailored reminders, potentially increasing adherence to screening schedules. This combination of education and personalized follow-ups could make a big difference in early lung cancer detection, leading to better outcomes.

What evidence suggests that this trial's interventions could improve adherence to lung cancer screening?

This trial will compare different interventions to improve adherence to lung cancer screening. Research has shown that educational videos and regular reminders can significantly help people maintain their lung cancer screening schedules. Participants may receive a patient-focused video, which has increased the number of people returning for yearly lung scans. Alternatively, some participants will receive reminders, such as scheduled messages from medical staff, which have helped more patients stay on track with their screening schedule. These methods have proven effective in detecting lung cancer early, when treatment is easier. Thus, these approaches are promising ways to ensure people receive their yearly lung checks. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen Wernli, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-78 who have had a negative lung screening scan, speak English or Spanish, and meet US Preventive Services Task Force guidelines. They must be members of KPWA. People with previous lung cancer diagnoses or those needing an interpreter other than for Spanish are excluded.

Inclusion Criteria

You had a recent scan that did not show any signs of lung cancer.

I am between 50 and 78 years old.

Meet US Preventive Services Task Force guidelines

Exclusion Criteria

Patients who have an indicator for interpreter services, except for Spanish

I was previously diagnosed with lung cancer.

Patients who have a positive result on a scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive patient education and reminders to improve adherence to lung cancer screening

8 weeks

1 visit (in-person), multiple virtual interactions

Follow-up

Participants are monitored for adherence to repeat annual lung cancer screening

9-15 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Education
• Stepped Reminders

Trial Overview The study is examining the effectiveness of patient education combined with stepped reminders to improve adherence to annual lung cancer screenings among eligible participants.

How Is the Trial Designed?

Group I: Stepped Reminders only Experimental Treatment 1 Intervention

Prior to patient's next LDCT scan is due, MA begins Stepped Reminders intervention: MA pends LDCT orders to PCP to sign. MA sends reminders to patient when order is placed and follows up by phone if patient has not scheduled LDCT.

Group II: Patient Video only Experimental Treatment 1 Intervention

About 3 weeks after the index LDCT, the study Medical Assistant (MA) will deliver a link to the Patient Voices Video, an educational video about lung cancer screening.

Group III: Patient Video and Stepped Reminders Experimental Treatment 2 Interventions

See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.

Group IV: Usual Care Active Control 1 Intervention

Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Published Research Related to This Trial

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]

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 2089 members from Kaiser Permanente Washington, only 26.4% adhered to on-time repeat lung cancer screenings after an initial negative low-dose computed tomography (LDCT) scan, which improved to 43.1% for subsequent scans, highlighting significant gaps in screening adherence.

Key factors for improving adherence included making screenings more personalized and convenient, providing consistent reminders, enhancing patient knowledge about the screening process, and implementing both financial and non-financial incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening. Wernli, KJ., Tuzzio, L., Brush, S., et al.[2022]

In a study involving 2757 postmenopausal women with hormone receptor-positive early-stage breast cancer, educational materials did not improve treatment compliance with aromatase inhibitors over a 2-year period, with compliance rates remaining similar between groups (82% for both).

The main reason for treatment discontinuation (9% of patients) was side effects related to aromatase inhibitors, highlighting that patient experiences and side effects significantly influence compliance and persistence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. Markopoulos, C., Neven, P., Tanner, M., 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38467273

A pragmatic randomized clinical trial of multilevel interventions ... We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11065591/

A pragmatic randomized clinical trial of multilevel interventions ... We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders)

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000697

A pragmatic randomized clinical trial of multilevel ... We developed two patient-centered evidenced-based multimedia-based interventions, a Patient Voices Video and Stepped Reminders, to improve annual LCS adherence ...

4. annfammed.org annfammed.org/content/22/Supplement_1/7039

Silent, Urgent, Deadly: The Effects of a Patient Outreach ... Context Lung cancer screening (LCS) is crucial for early detection and improved survival rates, yet its uptake remains suboptimal.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730420303466

Improving Utilization of Lung Cancer Screening Through ... In this randomized, controlled trial, we examined the effectiveness of online LCS education among individuals who currently smoke who attended at least 1 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6543473/

Impact of a Lung Cancer Screening Information Film ... Explaining the benefits and harms of screening in a way that is balanced and comprehensible to individuals with various levels of education is essential.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000380

Novel Platforms of Education to Engage Black and African ... Adherence to lung cancer screening among Black/Africa-Americans remains low (23.6%). •. Patient from community can reduce smoking stigma and boost trust in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10162485/

Using User-Centered Design to Facilitate Adherence ... Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can detect lung cancer in the early stages when curative and less-invasive treatment ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11920840/

Adherence to Annual Lung Cancer Screening and Rates of ... In this study, adherence to annual LCS was associated with an increased lung cancer detection rate but decreased annually after baseline screening.

10. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.201902-152RL

Patient Reminders and Longitudinal Adherence to Lung ... Although our overall adherence rate was 50%, it was 0% in patients who did not receive a reminder. Independent of reminder status, we found that demographic ...