Clinical trial · Interventional
Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening
NCT04498052CI-TRIAL-00087569completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this project is to increase appropriate low-dose computed tomography (LDCT) lung cancer screening through the development and wide dissemination of patient-centered clinical decision support (CDS) tools that (1) are integrated with the electronic health record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when patients meet screening criteria, and (3) enable effective SDM using individually-tailored information on the potential benefits and harms of screening. The study will promote standard of care that is endorsed by the Centers for Medicare \& Medicaid Services (CMS) and the US Preventive Services Task Force (USPSTF).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Detection of Cancer | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients eligible for LDCT lung cancer screening
- description
- This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to 2013 USPSTF guidelines. The inclusion criteria are (i) \>= 55 years and \<= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken.
- interventionNames
- Other: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening
Primary outcomes (1)
- measure
- Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed
- timeFrame
- Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
- description
- The LCS care gap was considered closed if one or more of the following events occurred: (1) LDCT completion in the past year, (2) completion of another chest CT in the past year, or (3) SDM documentation in the past 3 years for eligible patients. To assess population care-gap closure levels at the end of each study period, we estimated the care-gap closure status for all patients who had primary care visits in the 12 months preceding the last day of the period. Using structured EHR data, SDM was considered documented if a clinician noted the need for LCS discussion was addressed, the patient declined screening, or LCS was not appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * receives care at University of Utah primary care clinics; * does not already have lung cancer; * meets USPSTF criteria for LDCT screening (currently, age \>= 55 years and \<= 80 years old at the time of the visit; 30+ pack-year smoking history and current smoker or quit in the past 15 years). Exclusion Criteria: * None
References
Publications (3)
- BACKGROUNDTammemagi MC, Katki HA, Hocking WG, Church TR, Caporaso N, Kvale PA, Chaturvedi AK, Silvestri GA, Riley TL, Commins J, Berg CD. Selection criteria for lung-cancer screening. N Engl J Med. 2013 Feb 21;368(8):728-36. doi: 10.1056/NEJMoa1211776. PMID 23425165
- DERIVEDKukhareva PV, Li H, Caverly TJ, Fagerlin A, Del Fiol G, Hess R, Zhang Y, Butler JM, Schlechter C, Flynn MC, Reddy C, Choi J, Balbin C, Warner IA, Warner PB, Nanjo C, Kawamoto K. Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415383. doi: 10.1001/jamanetworkopen.2024.15383. PMID 38848065
- DERIVEDKukhareva PV, Li H, Caverly TJ, Del Fiol G, Fagerlin A, Butler JM, Hess R, Zhang Y, Taft T, Flynn MC, Reddy C, Martin DK, Warner IA, Rodriguez-Loya S, Warner PB, Kawamoto K. Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts. Chest. 2023 Nov;164(5):1325-1338. doi: 10.1016/j.chest.2023.04.040. Epub 2023 May 3. PMID 37142092