A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol

Casey Luce; Lorella Palazzo; Melissa L. Anderson; Lisa Carter-Bawa; Hongyuan Gao; Beverly B. Green; James D. Ralston; Kristine Rogers; Yu Ru Su; Leah Tuzzio; Matthew Triplette; Karen J. Wernli

doi:10.1016/j.cct.2024.107495

A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol

Casey Luce, Lorella Palazzo, Melissa L. Anderson, Lisa Carter-Bawa, Hongyuan Gao, Beverly B. Green, James D. Ralston, Kristine Rogers, Yu Ru Su, Leah Tuzzio, Matthew Triplette, Karen J. Wernli

Center for Discovery and Innovation

Hackensack Meridian School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Background: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence. Methods: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50–78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9–15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders. Discussion: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings. Registration: Trial is registered at clinicaltrials.gov (#NCT05747443).

Original language	English
Article number	107495
Journal	Contemporary Clinical Trials
Volume	140
DOIs	https://doi.org/10.1016/j.cct.2024.107495
State	Published - May 2024

ASJC Scopus subject areas

Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cct.2024.107495

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Luce, C., Palazzo, L., Anderson, M. L., Carter-Bawa, L., Gao, H., Green, B. B., Ralston, J. D., Rogers, K., Su, Y. R., Tuzzio, L., Triplette, M., & Wernli, K. J. (2024). A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol. Contemporary Clinical Trials, 140, Article 107495. https://doi.org/10.1016/j.cct.2024.107495

@article{cbb204acbd40499a935c721c6a1c6ef6,

title = "A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol",

abstract = "Background: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence. Methods: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50–78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9–15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders. Discussion: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings. Registration: Trial is registered at clinicaltrials.gov (#NCT05747443).",

author = "Casey Luce and Lorella Palazzo and Anderson, {Melissa L.} and Lisa Carter-Bawa and Hongyuan Gao and Green, {Beverly B.} and Ralston, {James D.} and Kristine Rogers and Su, {Yu Ru} and Leah Tuzzio and Matthew Triplette and Wernli, {Karen J.}",

note = "Publisher Copyright: {\textcopyright} 2024 Elsevier Inc.",

year = "2024",

month = may,

doi = "10.1016/j.cct.2024.107495",

language = "English",

volume = "140",

journal = "Contemporary Clinical Trials",

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Luce, C, Palazzo, L, Anderson, ML, Carter-Bawa, L, Gao, H, Green, BB, Ralston, JD, Rogers, K, Su, YR, Tuzzio, L, Triplette, M & Wernli, KJ 2024, 'A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol', Contemporary Clinical Trials, vol. 140, 107495. https://doi.org/10.1016/j.cct.2024.107495

TY - JOUR

T1 - A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study)

T2 - Study protocol

AU - Luce, Casey

AU - Palazzo, Lorella

AU - Anderson, Melissa L.

AU - Carter-Bawa, Lisa

AU - Gao, Hongyuan

AU - Green, Beverly B.

AU - Ralston, James D.

AU - Rogers, Kristine

AU - Su, Yu Ru

AU - Tuzzio, Leah

AU - Triplette, Matthew

AU - Wernli, Karen J.

PY - 2024/5

Y1 - 2024/5

N2 - Background: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence. Methods: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50–78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9–15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders. Discussion: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings. Registration: Trial is registered at clinicaltrials.gov (#NCT05747443).

AB - Background: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence. Methods: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50–78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9–15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders. Discussion: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings. Registration: Trial is registered at clinicaltrials.gov (#NCT05747443).

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DO - 10.1016/j.cct.2024.107495

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SN - 1551-7144

VL - 140

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

M1 - 107495

ER -

A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol

Abstract

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UN SDGs

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