Tribally Engaged Approaches to Lung Screening (TEALS)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the United States Preventive Services Task Force now recommends LCS for men and women aged 55-80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most healthcare systems, and LCS implementation among AI/AN has never been studied. To address this knowledge, we prose the Tribally Engaged Approaches to Lung Screening (TEALS) study, which is a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center. Over the course of 5 years, TEALS will: 1. Conduct focus groups and semi-structured interviews with CNHSA patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS; 2. Develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable; 3. Measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and 4. Disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system. System-level interventions for guideline implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN communities.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• adults aged 50-80

• 30 pack-year smoking history

• currently smoke or quit in the past 15 years.

Locations
United States
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 480
Treatments
Experimental: Control 1-1
Patients and clinicians in control practices will receive usual Electronic Health Record (EHR) reminders for lung cancer screening (LCS).
Experimental: Intervention 1-1
In addition to control group improvements, patients and clinicians in the intervention group will also receive an LCS Care Coordinator.
Experimental: Control 1-2
Patients and Clinicians in control practices will have access to existing LCS services, smoking cessation, and lung cancer treatment services, but no additional system improvements will be introduced.
Experimental: Intervention 1-2
In addition to control group improvements, patients and clinicians in the intervention group will also receive quality of care benchmarking and feedback academic detailing.
Experimental: Intervention 1-3
In addition to control group improvements, patients and clinicians in the intervention group will also receive practice facilitation.
Experimental: Intervention 1-4
In addition to control group improvements, patients and clinicians in the intervention group will also receive the opportunity to participate in a learning collaborative.
Experimental: Intervention 1-5
In addition to control group improvements, patients and clinicians in the intervention group will also receive information technology support.
Related Therapeutic Areas
Sponsors
Collaborators: Choctaw Nation of Oklahoma
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov