A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP)

Ana S. Salazar, Subhjit Sekhon, Karthik W. Rohatgi, Akua Nuako, Jingxia Lu, Courtney Harriss, Ellen Brennan, Dareld LaBeau, Ibrahim Abdalla, Christopher Schulze, Jackie Muenks, Dave Overlot, Jeri Ann Higgins, Linda S. Jones, Colleen Swick, Stacia Goings, Jennifer Badiu, Justin Walker, Graham A. Colditz, Aimee S. James

Research output: Contribution to journalArticlepeer-review

Abstract

Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month “steps” with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2–3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253

Original languageEnglish
Article number105991
JournalContemporary Clinical Trials
Volume91
DOIs
StatePublished - Apr 2020

Keywords

  • Implementation science
  • LDCT
  • Lung cancer screening
  • Primary care
  • Stepped-wedge trial

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