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Using Connected Health to Increase Lung Cancer Screening (CH-LCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612946
Recruitment Status : Completed
First Posted : November 3, 2020
Last Update Posted : February 7, 2022
Sponsor:
Collaborator:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE October 27, 2020
First Posted Date  ICMJE November 3, 2020
Last Update Posted Date February 7, 2022
Actual Study Start Date  ICMJE February 10, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Connected Health to Increase Lung Cancer Screening
Official Title  ICMJE Using Connected Health to Increase Lung Cancer Screening: Single Center Randomized Pilot Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants 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
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Referral to Telemedicine LCS Counseling Visit
  • 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.
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2021)
137
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2020)
600
Actual Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04612946
Other Study ID Numbers  ICMJE 844390
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
Current Responsible Party University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Abramson Cancer Center of the University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Katharine A Rendle, PhD,MSW,MPH University of Pennsylvania
Principal Investigator: Anil Vachani, MD, MS University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP