Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening

Overview

The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are: * Does the patient and provider support increase the number of patients who complete lung cancer screening? * Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening? * Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening. Primary care provider participants will: * Receive the provider support session and educational materials, or follow usual practice * Answer a baseline survey and a follow-up survey in 6 months * Answer additional survey questions regarding the acceptability of the provider support session if they receive it Patient participants will * Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care * Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.

Detailed description

Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).

The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.

Interventions

• Behavioral FIX-SDM
  Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
• Behavioral Usual Care
  PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care

Primary outcome measures

• Completion of Lung Cancer Screening (LCS) within 3 months [Time frame: 3 months after the index visit]

Secondary outcome measures (12)

• Completion of LCS within 6 months [Time frame: 6 months after the index visit]
• LCS order [Time frame: 3 and 6 months after the index visit]
• LCS appointment [Time frame: 3 and 6 months after the index visit]
• Patient-reported LCS discussion [Time frame: Within 10 days after the index visit]
• Content of LCS discussion [Time frame: Within 10 days after the index visit]
• Patient perceived quality of LCS discussion [Time frame: Within 10 days after the index visit]
• Patient-reported shared decsion making (SDM) for LCS [Time frame: Within 10 days after the index visit.]
• Patient knowledge of LCS [Time frame: Within 10 days after the index visit.]
• Patient decisional conflict [Time frame: Within 10 days after the index visit and 3 months after the index visit]
• Patient acceptability of FIX-SDM [Time frame: Within 10 days after the index visit.]
• Patient decision satisfaction [Time frame: 3 months after the index visit]
• Patient decision regret [Time frame: 3 months after the index visit]

Eligibility criteria

Primary care provider (PCP) participants:

Inclusion criteria

• PCPs (physicians or advanced practitioners)
• Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
• Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria
• Participation in the previous study to co-develop the provider intervention (to avoid bias)

Patient participants

Inclusion criteria

• Adults between the ages of 50 and 77
• Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
• Has a smartphone with texting capability
• English-speaking
• Has a scheduled PCP visit in the next \~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study

Exclusion criteria

• Prior LCS
• Chest CT within the last 12 months
• History of lung cancer
• Active cancer requiring treatment
• Supplemental oxygen use
• Pregnancy
• Participation in the previous study to co-develop the patient intervention (to avoid bias)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• University of Massachusetts Chan Medical School — Worcester

Identifiers

NCT: NCT07517692 · STUDY00001107 · 5K08CA283304

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗