Using Connected Health to Increase Lung Cancer Screening

NCT04612946 | Completed

• 1 other identifier: 844390
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This study will consist of two primary aims designed to help advance quality and utilization of lung cancer screening (LCS) within an academic and community-based medical system. The objective of Aim 1 is to pilot test the effect and feasibility of using direct outreach and telemedicine to increase LCS counseling and LDCT uptake among screening-eligible patients. Patients who confirm eligibility and agree to participate will be randomized into two study arms: 1) usual care or 2) telemedicine LCS counseling referral. For Aim 2, each arm will first complete a baseline survey to explore how individual beliefs and knowledge impact screening intention and uptake. Patients in both arms will also receive brief information on lung cancer screening guidelines and be asked to report LCS-related preferences after exposure to the information. All interventions will be administered using a secure, web-based platform.

Conditions

Lung Cancer

Keywords

telemedicine; behavioral economics; connected health strategies; lung cancer screening; patient outreach

Outcome Measures

Primary Outcomes (1)

• Completion of LCS counseling

  The primary outcome measure is completion of LCS counseling, defined by completion of a telemedicine visit, in-person counseling visit (CPT G0296), or documentation of counseling in EHR provider notes.

  Initial measurement will occur within 8 weeks of baseline survey

Secondary Outcomes (1)

• Completion of LDCT scan for LCS

  Within 6 months following baseline survey

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Patients in the intervention arm will be invited to complete a telemedicine LCS counseling visit and asked for permission to be referred (name and phone number) to the LCS navigator at Penn Medicine to schedule a telemedicine visit. Patients will also be given the option to directly contact the LCS navigator.

Behavioral: Referral to Telemedicine LCS Counseling Visit

Control Arm

ACTIVE COMPARATOR

Patients in the usual care arm will be provided with contact information for the Penn LCS Program and encouraged to discuss LCS with their primary care providers.

Behavioral: Usual Care

Interventions

Referral to Telemedicine LCS Counseling Visit BEHAVIORAL

Patients in the intervention arm will be invited to complete a telemedicine LCS counseling visit, and asked for permission to be referred directly to the LCS navigator to help schedule an appointment. They will also be given the option to directly contact the LCS navigator. Telemedicine counseling visits will be conducted using established clinical procedures for virtual or telephone visits at Penn Medicine. In accordance with reimbursement policies for lung cancer screening, these visits will be conducted by a physician or nurse practitioner within the Lung Cancer Screening Program at Penn Medicine. Counseling visits are covered without co-pay as standalone visits according to USPSTF guidelines and costs will not be covered by the study. LCS is an evidence-based practice and considered standard of care for those who are eligible and desire to be screened. Clinicians retain full control on how to conduct LCS counseling or LDCT in this trial.

Intervention Arm

Usual Care BEHAVIORAL

Patients in the usual care arm will be provided with contact information for the Penn LCS Program and encouraged to discuss LCS with their providers.

Control Arm

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55-77
• Had a primary care visit at the healthcare system within the last 24 months
• No history of lung cancer
• Heavy smokers (30+ pack year and current smoker or quit within 15 years)
• Access to phone and internet
• English-speaking
• Have an assigned primary care provider at recruiting practices
• Never received LCS within the healthcare system

You may not qualify if:

• Aged \<55 or \>77 years
• Did not have a primary care visit at the healthcare system within the last 24 months
• History of lung cancer
• Smoking history of \<30 pack years
• No access to phone and internet
• Inability to speak English
• Does not have an assigned primary care provider at recruiting practices
• History of LCS within the healthcare system

Sponsors & Collaborators

• University of Pennsylvania: lead
• Abramson Cancer Center at Penn Medicine: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Rendle KA, Steltz JP, Cohen S, Schapira MM, Wender RC, Bekelman JE, Vachani A. Estimating Pack-Year Eligibility for Lung Cancer Screening Using 2 Yes or No Questions. JAMA Netw Open. 2023 Aug 1;6(8):e2327363. doi: 10.1001/jamanetworkopen.2023.27363.

  PMID: 37548980 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Katharine A Rendle, PhD,MSW,MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anil Vachani, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary analyst and statistician will be blinded to the randomization assignment. The investigators and research coordinators will be unblinded to facilitate coordination with telehealth referral. The analyst will create the randomization assignments on a master list (using Stata) and enter into REDCap using the randomization module (stratified by batch). Assignments will be maintained by the research coordinator on a password protected computer. The blind may be broken in the case of an emergency.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (1:1) intervention or usual care

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: February 10, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)