UG3 Pilot Clinical Trial

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Other: Conversational Agent (CA); Other: Proactive Patient Navigation (PPN); Other: Reactive Patient Navigation (RPN); Other: Repeated Text Messages (TM+); Other: Educational Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07073898

HCI177308

UG3CA287109-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

LungSMART Utah utilizes a Population Health Management (PHM) approach that addresses key barriers to Lung Cancer Screening (LCS) implementation by deploying a centralized Hub infrastructure for eligibility assessment, individualized risk assessment and Shared Decision Making (SDM), LCS referral, and screening completion assistance, thereby increasing LCS reach at scale among Community Health Centers (CHCs) patients across the state of Utah.

Full description

LungSMART Utah is a Sequential Multiple Assignment Randomized Trial (SMART) that promotes the reach of lung cancer screening (LCS) among patients who receive medical services at Utah Community Health Centers (CHCs). The study design consists of two sequential stages: an Eligibility Assessment phase to identify and engage individuals at risk to participate in a shared decision-making (SDM) session to assess LCS eligibility, recommendation, and preference, followed by an LCS Completion phase to promote follow-through with recommended screening.

In this pilot trial, 50 current or former tobacco users aged 50-80 who receive medical services at the Mountainlands CHC and have no recorded history of lung cancer and have not participated in a SDM about LCS will be identified for the study. In the Eligibility Assessment Phase, patients will be assessed for LCS eligibility through digital health interventions and, if eligible, will engage with a qualified registered nurse (RN) at a centralized "Hub" for a SDM session, with and be offered a referral for LCS if screening is recommended and preferred. Phase 1 interventions include repeated text messaging (TM+), conversational agent (CA), and educational video (VID) to engage patients in a SDM session. The LCS Completion phase evaluates telehealth interventions designed to address logistical barriers and hesitancy among referred patients in completing LCS. Interventions include CA and either proactive- or reactive-patient navigation (PN) to increase LCS completion among CHC patients. Clinic staff will also be queried to examine if further refinement of research workflow and procedures is needed. Mountainlands CHC has agreed to partner with us to recruit patient participants for this pilot study.

Enrollment: 65 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is currently a patient at Mountainlands CHCs
• Speak English or Spanish
• Current or former male or female smokers
• Age 50-80
• Have a phone that can receive text messages
• Electronic health records indicate they have not opted out of receiving text contact from the clinic

Exclusion criteria

• Persons with lung cancer or previous SDM

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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65 participants in 6 patient groups

Repeated Text Messages (TM+)

Other group

Description:

Repeated text messages notifying patients that they may be eligible for Lung Cancer Screening (LCS).

Treatment:

Other: Repeated Text Messages (TM+)

Repeated Text Messages plus a Conversational Agent (TM+, CA)

Other group

Description:

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an automated, scripted, and interactive CA.

Treatment:

Other: Repeated Text Messages (TM+)

Other: Conversational Agent (CA)

Repeated Text Messages plus a Video (TM+, Video)

Other group

Description:

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to their cell phone.

Treatment:

Other: Educational Video

Other: Repeated Text Messages (TM+)

Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)

Other group

Description:

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to the patient's cell phone, along with a conversational agent to answer frequently asked LCS questions. Additionally, patients will receive an educational video sent directly to the patient's cell phone and a chatbot to answer frequently asked LCS questions.

Treatment:

Other: Educational Video

Other: Repeated Text Messages (TM+)

Other: Conversational Agent (CA)

CA/PPN

Other group

Description:

A conversational agent to answer frequently asked LCS questions. In addition to proactive patient navigation.

Treatment:

Other: Proactive Patient Navigation (PPN)

Other: Conversational Agent (CA)

CA/RPN

Other group

Description:

A conversational agent to answer frequently asked LCS questions. In addition to reactive patient navigation.

Treatment:

Other: Reactive Patient Navigation (RPN)

Other: Conversational Agent (CA)