TELESCOPE- TELEhealth Shared Decision-making COaching

Study Overview
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Brief Summary
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Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers. Hypothesis 2: The investigators expect that a booster coaching session will increase adherence to repeat lung cancer screening (LCS).

Detailed Description
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The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening. Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.

Official Title
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TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Inclusion Criteria Cluster Randomized Trial (N=420) Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must: Be 50 to 77 years of age Be a current or former smoker having quit within the past 15 years Have at least a 20 pack-year smoking history Be scheduled for a non-acute care visit at one of the study sites. Interviews (N=50) Participants completing the semi-structured interviews will be: A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3) Age 18 or older Fluent in English Online surveys (N=130) Providers completing online PRISM construct surveys will be: A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator Age 18 or older Fluent in English Exclusion Criteria: - Cluster Randomized Trial (N=420) Excluded will be patients who: Do not speak English Have a history lung cancer Were screened for lung cancer within the past 12 months Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider Are unable to provide informed consent Interviews (N=50) Providers/administrators will be excluded if they: Are unable to provide informed consent Online surveys (N=130) Are unable to provide informed consent Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quantitative measures of the PRISM constructs will be collected via internet surveys from the patient and nurse navigators, clinic directors, and clinicians (n = 130 surveys), and through medical record review. Participants followed at the TELESCOPE arm sites will also complete a measure of intervention acceptability at the one week survey for Aim 2. Semi-structured interviews will be conducted for Aim 2 with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All 10 study navigators, and 20 clinicians from the TELESCOPE arm sites will also be interviewed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TELESCOPE intervention<br>Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators. | Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention<br>* The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed<br>|
| No Intervention: Enhanced usual care (EUC)<br>Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess shared decision making | Semi-structured interviews (qualitative data) | The change in baseline, three months and five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco treatment referral | Semi-structured interviews (qualitative data) | The change in baseline, three months and five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer screening, Shared decision making