The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care
Rachel Hess,
Angela Fagerlin,
Devin Mann,
Tanner Caverly,
Yue Zhang,
Guilherme Del Fiol,
Jorie Butler,
Michael Flynn,
Kensaku Kawamoto,
Douglas Martin,
Chelsey R Schlechter,
Haojia Li,
Polina Kukhareva,
Christian Balbin,
Elizabeth Stevens,
Victoria Tiase,
Kim Kaphingst,
Chakravarthy Reddy,
Phillip Warner,
Joshua Choi,
Claude Nanjo,
Quyen Metzger
Affiliations
Rachel Hess
9 Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA
Angela Fagerlin
professor and chair
Devin Mann
2 Department of Population Health, NYU Grossman School of Medicine, New York City, New York, USA
Tanner Caverly
4 Department of Learning Health Sciences, University of Michigan, Ann Arbor, Michigan, USA
Yue Zhang
1 Department of Oncology, People`s Liberation Army The General Hospital of Western Theater Command, Chengdu, Sichuan, China
Guilherme Del Fiol
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Jorie Butler
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Michael Flynn
10 Community Physicians Group, University of Utah Health, Salt Lake City, Utah, USA
Kensaku Kawamoto
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Douglas Martin
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Chelsey R Schlechter
7 Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA
Haojia Li
8 Study Design and Biostatistics Center, University of Utah, Salt Lake City, Utah, USA
Polina Kukhareva
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Christian Balbin
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Elizabeth Stevens
2 Department of Population Health, NYU Grossman School of Medicine, New York City, New York, USA
Victoria Tiase
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Kim Kaphingst
6 Department of Communication, University of Utah, Salt Lake City, Utah, USA
Chakravarthy Reddy
9 Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA
Phillip Warner
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Joshua Choi
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Claude Nanjo
1 Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Quyen Metzger
11 Department of Health Systems Science, Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, California, USA
Introduction Early lung cancer screening (LCS) through low-dose CT (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centred intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision-making.Methods and analysis MyLungHealth is a multisite pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centred design process, informed by patient and provider focus groups and interviews. The intervention’s effectiveness will be evaluated through a patient-randomised trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused shared decision-making intervention) against DecisionPrecision+ alone. The first study hypothesis is that among patients aged 50–79 with uncertain LCS eligibility (eg, 10–19 pack-years or unknown pack-years or unknown quit date for individuals who used to smoke), MyLungHealth eligibility questionnaires will result in increased identification of LCS-eligible patients (n~26 729 patients). The second study hypothesis is that among patients aged 50–79 with documented LCS eligibility (20+ pack-years, quit within the last 15 years if individuals who used to smoke, and no recent screening or screening discussion), MyLungHealth education will result in increased LDCT ordering (n~4574 patients). Primary outcomes will be identification of LCS-eligible patients among individuals with uncertain LCS eligibility and LDCT ordering rates among individuals with documented LCS eligibility.Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board (# 00153806). The patient data collected for this study will not be shared publicly due to the sensitive nature of the patient health information and the fact that we will not be obtaining written informed consent to allow public sharing of their data. Results will be disseminated through peer-reviewed publications.Trial registration number Clinicaltrials.gov, NCT06338592.
