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History of Changes for Study: NCT04612946
Using Connected Health to Increase Lung Cancer Screening (CH-LCS)
Latest version (submitted February 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 27, 2020 None (earliest Version on record)
2 November 23, 2020 Study Status, Study Description and Study Identification
3 January 21, 2021 Study Status
4 February 8, 2021 Study Design, Study Description, Study Status and Arms and Interventions
5 February 12, 2021 Recruitment Status, Study Status, Document Section, Contacts/Locations and Oversight
6 September 8, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 February 4, 2022 Recruitment Status and Study Status
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Study NCT04612946
Submitted Date:  October 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 54321
Brief Title: Using Connected Health to Increase Lung Cancer Screening (CH-LCS)
Official Title: Using Connected Health to Increase Lung Cancer Screening: Single Center Randomized Pilot Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: November 1, 2020
Primary Completion: December 31, 2021 [Anticipated]
Study Completion: December 31, 2021 [Anticipated]
First Submitted: October 27, 2020
First Submitted that
Met QC Criteria:
October 27, 2020
First Posted: November 3, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 27, 2020
Last Update Posted: November 3, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Pennsylvania
Responsible Party: Sponsor
Collaborators: Abramson Cancer Center of the University of Pennsylvania
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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 knowledge and preferences before and after exposure to the information. All interventions will be administered using a secure, web-based platform.
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 economics have been applied to understand how cognitive biases such as risk preference, time orientation, and ambiguity aversion impact screening uptake. Yet for LCS, there is limited to no evidence on how these biases may affect screening behaviors. 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, we 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.

Open or close this module Conditions
Conditions: Lung Cancer
Keywords: telemedicine
behavioral economics
connected health strategies
lung cancer screening
patient outreach
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Screening
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Participants will be randomized (1:1) intervention or usual care
Number of Arms: 2
Masking: Double (Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 in order to help schedule an appointment. They will also be given the option to directly call to schedule a telehealth appointment. Telemedicine counseling visits will be conducted using established clinical procedures for virtual or telephone visits at Penn Medicine and as recommended by the American College of Radiology for LCS. 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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Completion of LCS counseling
[ Time Frame: 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:
1. Completion of LDCT scan for LCS
[ Time Frame: Within 6 months following baseline survey ]

The secondary outcome is completion of LDCT scan for LCS as captured in the EHR.
Open or close this module Eligibility
Minimum Age: 55 Years
Maximum Age: 77 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Aged <55 or >77 years
  2. Did not have a primary care visit at the healthcare system within the last 24 months
  3. History of lung cancer
  4. Smoking history of <30 pack years
  5. No access to phone and internet
  6. Inability to speak English
  7. Does not have an assigned primary care provider at recruiting practices
  8. History of LCS within the healthcare system
Open or close this module Contacts/Locations
Central Contact Person: Katharine A Rendle, PhD,MSW,MPH
Telephone: 215-662-9147
Email: Katharine.Rendle@pennmedicine.upenn.edu
Central Contact Backup: Jocelyn V Wainwright, MS
Telephone: 215-662-9128
Email: Jocelyn.Wainwright@pennmedicine.upenn.edu
Study Officials: Katharine A Rendle, PhD,MSW,MPH
Principal Investigator
University of Pennsylvania
Anil Vachani, MD, MS
Principal Investigator
University of Pennsylvania
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
We do not have any plans to share IPD at this time, but we are open to sharing de-identified data with other researchers as allowed and approved by our institutional review board and following our planned analysis and publications.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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