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

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 screenin...

Full description

Saved in:

Bibliographic Details
Published in:	Contemporary clinical trials Vol. 91; p. 105991
Main Authors:	Salazar, Ana S., Sekhon, Subhjit, Rohatgi, Karthik W., Nuako, Akua, Liu, Jingxia, Harriss, Courtney, Brennan, Ellen, LaBeau, Dareld, Abdalla, Ibrahim, Schulze, Christopher, Muenks, Jackie, Overlot, Dave, Higgins, Jeri Ann, Jones, Linda S., Swick, Colleen, Goings, Stacia, Badiu, Jennifer, Walker, Justin, Colditz, Graham A., James, Aimee S.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-04-2020
Subjects:	Early Detection of Cancer - methods Humans Implementation science Inservice Training LDCT Lung cancer screening Lung Neoplasms - diagnosis Lung Neoplasms - diagnostic imaging Primary care Primary Health Care - organization & administration Randomized Controlled Trials as Topic Referral and Consultation Stepped-wedge trial Tomography, X-Ray Computed LDCT Stepped-wedge trial Lung cancer screening Primary care Implementation science
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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 •Lung cancer screening with low-dose computed tomography (LDCT) reduces mortality, yet few eligible patients receive it annually.•A community-partnered Toolkit was developed to support primary care practices in making referrals for lung screening.•This trial uses a stepped-wedged cluster design where screening centers are randomized to enter the intervention phase.•Primary outcome is to increase the number of initial LDCT screenings per screening center.•Implementation outcomes are assessed through field-notes and activity logs.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1551-7144 1559-2030
DOI:	10.1016/j.cct.2020.105991