The long-term goal of Lung Sequential Multiple Assignment Randomized Trial (LungSMART) Utah is to increase the reach of Low-Dose Computed Tomography (LDCT) screening for lung cancer (hereafter referred to as Lung Cancer Screening or LCS) at scale in low-resource healthcare settings.
LungSMART is a Sequential Multiple Assignment Randomized Trial (SMART) conducted in Utah Community Health Centers (CHCs). The SMART design is structured in two sequential stages: Stage 1 aims to increase uptake of Lung Cancer Screening (LCS) eligibility assessment, while Stage 2 aims to increase LCS completion. In Stage 1, the Eligibility Assessment Stage, LungSMART Utah uses Azara, a population health management software, to identify potentially eligible patients from participating CHCs. Patients who are enrolled in the study will be randomized to digital health interventions and connected with a centralized hub (Hub) for eligibility assessment and shared decision making (SDM) with a qualified registered nurse (RN). In Stage 2, the LCS Completion Stage, participants referred for LCS receive access to a Chatbot and are randomized to receive reactive (patient needs to request navigation) vs proactive (navigator proactively calls the patient) patient navigation (PN) delivered via telehealth by a community health worker (CHW) at the Hub to address logistical barriers and hesitancy in completing LCS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
18,894
A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Access to a chatbot for frequently asked questions about LCS
An educational video about LCS
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Stage 1: Completion of eligibility assessment
To evaluate patient-level interventions with respect to increasing completed assessments in Stage 1. The outcome measure will report the proportion of participants who complete the LCS eligibility assessment.
Time frame: up to 18 weeks
Stage 2: Completion of LCS
To evaluate patient-level interventions with respect to increasing completed LCS in Stage 2. The outcome measure will report the proportion of participants who complete LCS.
Time frame: up to 30 weeks
Cost-effectiveness: Incremental Cost
To evaluate the cost-effectiveness of the interventions in Stage 1 and Stage 2. Incremental cost-effectiveness ratios (ICER) will be constructed for Stage 1 and 2 among participants. The ICER estimates the additional resource consumption needed to successfully attain an additional unit of an outcome (e.g., completed assessment in Stage 1, completed LCS in Stage 2) using one intervention relative to another. Cost-Effectiveness Analysis (CEA) will determine the most cost-effective combination of strategies to increase reach across Stages.
Time frame: up to 30 weeks
Cost-effectiveness: Incremental Effectiveness
To evaluate the cost-effectiveness of the interventions in Stage 1 and Stage 2. Incremental cost-effectiveness ratios (ICER) will be constructed for Stage 1 and 2 among participants. The ICER estimates the additional resource consumption needed to successfully attain an additional unit of an outcome (e.g., completed assessment in Stage 1, completed LCS in Stage 2) using one intervention relative to another. CEA will determine the most cost-effective combination of strategies to increase reach across Stages.
Time frame: up to 30 weeks
Proportion of patients who engage with interventions
The outcome measure will report the proportion of participants who engage with interventions. This outcome measure is only applicable in Stage 1.
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RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
Proactive patient navigation to help complete the LCS appointment. PPN does not require the participant to initiate the PN request and instead is a proactive call to the participant.
Time frame: up to 18 weeks
Proportion of patients who reply opting out of receiving interventions
The outcome measure will report the proportion of participants who reply to opt out of receiving interventions.
Time frame: up to 30 weeks
Proportion of patients who complete SDM
The outcome measure will report the proportion of participants who complete SDM. This outcome measure is only applicable in Stage1.
Time frame: up to 18 weeks
Proportion of patients who request to speak with a patient navigator
The outcome measure will report the proportion of participants who request to speak with a patient navigator. This outcome measure is only applicable in Stage 2.
Time frame: up to 30 weeks
Proportion of patients who speak with a patient navigator
The outcome measure will report the proportion of participants who speak with a patient navigator. This outcome measure is only applicable in Stage 2.
Time frame: up to 30 weeks