TELESCOPE- TELEhealth Shared Decision-making COaching

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Lung Neoplasms

Treatments: Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05491213

132207

1R01HL158850-01A1 (U.S. NIH Grant/Contract)

Pro2022000340 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

TELESCOPE intervention

Experimental group

Description:

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.

Treatment:

Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

Enhanced usual care (EUC)

No Intervention group

Description:

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.