CH-LCS: Using Connected Health to Increase Lung Cancer Screening

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT04612946

Collaborator

Abramson Cancer Center of the University of Pennsylvania (Other)

137

Enrollment

Location

Arms

10.6

Actual Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Behavioral: Referral to Telemedicine LCS Counseling Visit Behavioral: Usual Care	N/A

Detailed Description

In 2013, the United States Preventive Services Task Force (USPSTF) provided a Grade "B" recommendation for annual lung cancer screening (LCS) for asymptomatic adults aged 55-80 who are or have been heavy smokers (≥30 pack-years of smoking and quit-date < 15 years ago), and are able to undergo surgery. In 2015, The Centers for Medicare and Medicaid Services (CMS) issued national coverage for LCS requiring that LCS counseling, which must include shared decision-making and tobacco cessation counseling, occur prior to LCS. CMS also provides reimbursement for LCS counseling to further support providers to engage in meaningful, collaborative conversations about LCS with patients. Despite widespread support, uptake and implementation of LCS across the United States has been low (estimated 3-5% screening-eligible population screened). Locally, since the onset of the Penn Medicine LCS Program in 2014, over 3,500 individual patients have received LCS; however, documentation and reimbursement of LCS counseling are limited.

Challenges of implementing LCS include substantial barriers to identifying screening-eligible patients, supporting high-quality decision-making, and remaining uncertainties regarding risks and benefits. For other types of cancer screening, insights from behavioral science have been applied to understand how cognitive biases and beliefs impact screening uptake. Yet for LCS, there is limited evidence on how these beliefs may affect screening behaviors in routine practice. Given the complexities of LCS, in which the benefits do not clearly outweigh the harms, understanding how these biases impact screening can help inform development of intervention strategies that both support informed decision-making and increase uptake among eligible patients. Leveraging an existing EMR-based data warehouse, this study will combine insights from behavioral economics and connected health strategies to pilot test connected health approaches including direct patient outreach and telemedicine visits to improve LCS counseling, and to explore individual-level moderators of LCS screening intention and uptake. The long-term goal is to decrease lung cancer burden by increasing utilization of LCS and providing clinicians and patients with effective strategies to deliver high-quality, patient-centered care. This study will also advance scientific understanding of the mechanisms that drive or hinder health behavior in the context of cancer prevention.

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Screening

Official Title:

Using Connected Health to Increase Lung Cancer Screening: Single Center Randomized Pilot Trial

Actual Study Start Date :

Feb 10, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm 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 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.
Active Comparator: Control Arm 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 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.

Arm

Intervention/Treatment

Experimental: Intervention Arm

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

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.

Active Comparator: Control Arm

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

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.

Outcome Measures

Primary Outcome Measures

Completion of LCS counseling [Initial measurement will occur within 8 weeks of baseline survey]
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.

Secondary Outcome Measures

Completion of LDCT scan for LCS [Within 6 months following baseline survey]
The secondary outcome is completion of LDCT scan for LCS as captured in the EHR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Katharine A Rendle, PhD,MSW,MPH, University of Pennsylvania
Principal Investigator: Anil Vachani, MD, MS, University of Pennsylvania