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Clinical Trials/NCT05832008
NCT05832008
Active, not recruiting
Not Applicable

Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up

Abramson Cancer Center at Penn Medicine1 site in 1 country825 target enrollmentOctober 18, 2023

Overview

Phase
Not Applicable
Intervention
Patient Nudge
Conditions
Lung Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
825
Locations
1
Primary Endpoint
Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2).
Status
Active, not recruiting
Last Updated
3 months ago

Overview

Brief Summary

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) & diagnostic follow-up across eligible primary care clinicians & patients. Following the trial, a subsample of patients & clinicians will be invited to one-time semi-structured interview & survey to identify individual & system-level factors that may restrict or enhance the impact of strategies.

Detailed Description

Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.

Registry
clinicaltrials.gov
Start Date
October 18, 2023
End Date
June 1, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katharine Rendle

PI

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

Inclusion Criteria

  • Clinicians will be eligible if they:
  • are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System;
  • care for patients who completed LCS via LDCT in 2019-2023; and
  • do not opt-out of study participation.
  • Patients will be eligible if they:
  • are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years)
  • completed LCS via LDCT in 2019-2023;
  • have not been diagnosed with lung cancer;
  • meet criteria for non-adherence;
  • remain eligible for LCS during the trial enrollment period; and

Exclusion Criteria

  • Patients will be excluded if they:
  • a) have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group

Arms & Interventions

Clinician Nudge + Patient Nudge

An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up

Intervention: Patient Nudge

Clinician Nudge + Patient Nudge

An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up

Intervention: Clinician Nudge

Clinician Nudge Only

Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up. Patients will receive usual care.

Intervention: Clinician Nudge

Patient Nudge Only

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up. Clinicians will receive usual care.

Intervention: Patient Nudge

Usual care (no nudges)

Patients and clinicians in this arm will receive usual care.

Outcomes

Primary Outcomes

Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2).

Time Frame: Initial measurement will occur 3 months after randomization

Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines.

Number of completed recommended diagnostic follow-up scans or procedures in patients with a positive baseline screen (Lung-RADS 3 or 4a).

Time Frame: Initial measurement will occur 3 months after randomization

Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan.

Secondary Outcomes

  • Reach(Initial measurement will occur 3 months after randomization)

Study Sites (1)

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