PrOVE QUERI Project #1

Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)

The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

Study Overview

• Status: Completed
• Conditions: Prevention and Control
• Intervention / Treatment: Other: Webinar, Promotion, and Tool Access; Other: Audit and Feedback; Other: LEAP; Other: Academic Detailing

Detailed Description

The overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the Decision Precision lung cancer screening tool. The investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will have a human subjects research component to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

• Study Type: Observational
• Enrollment (Actual): 17033

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System, Minneapolis, MN
  • New York
    • New York, New York, United States, 10010
      • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center, Durham, NC
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Medical Center, Cincinnati, OH
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VA Medical Center, Providence, RI
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients at participating sites, age 55 to 80 years, who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.

Description

Inclusion Criteria:

• Patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period

Exclusion Criteria:

Exclusions for initial lung cancer screening clinical reminders:

• history of lung, pancreatic, liver or esophageal cancer
• a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest CT in the past 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
standard implementation; Webinar, Promotion, Tool Access, academic detailing + Audit and Feedback	Other: Webinar, Promotion, and Tool Access; All sites will receive a professionally developed, 15-minute webinar that describes the tool's development (e.g., how the algorithm was designed) and a tutorial on how to use the web-site. The investigators will promote the webinar and using the tool through key local leaders. A web-link to use the tool will be placed within the lung cancer screening clinical reminder.; Other: Audit and Feedback; Providers at all sites will have access to this system. It will provide feedback on the screening and shared decision making process (e.g., number of provider's eligible patients screened for lung cancer, use of the tool, patient knowledge and satisfaction from patient surveys).; Other Names: A&F; Other: Academic Detailing; All sites will be offered an academic detailing approach to implementation of Lung Decision Precision. A trained detailer will travel to all sites who agree to a visit. The detailer will meet with individual primary care providers whenever possible, and groups of providers as necessary. He will present evidence for a risk-based approach to screening and how to use the tool with patients to make tailored screening recommendations.; Other Names: AD
intensive implementation; Webinar, Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP	Other: Webinar, Promotion, and Tool Access; All sites will receive a professionally developed, 15-minute webinar that describes the tool's development (e.g., how the algorithm was designed) and a tutorial on how to use the web-site. The investigators will promote the webinar and using the tool through key local leaders. A web-link to use the tool will be placed within the lung cancer screening clinical reminder.; Other: Audit and Feedback; Providers at all sites will have access to this system. It will provide feedback on the screening and shared decision making process (e.g., number of provider's eligible patients screened for lung cancer, use of the tool, patient knowledge and satisfaction from patient surveys).; Other Names: A&F; Other: LEAP; Sites randomized to intensive implementation will be offered participation in the LEAP program. LEAP (Learn. Engage. Act. Program) is a multi-week, online learning collaborative using systems redesign techniques to help sites identify and overcome barriers to implementation of shared decision making (use of the Decision Precision tool).; Other: Academic Detailing; All sites will be offered an academic detailing approach to implementation of Lung Decision Precision. A trained detailer will travel to all sites who agree to a visit. The detailer will meet with individual primary care providers whenever possible, and groups of providers as necessary. He will present evidence for a risk-based approach to screening and how to use the tool with patients to make tailored screening recommendations.; Other Names: AD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm	First, we estimated screening's net benefit for an individual based on their baseline lung cancer risk, as estimated using the Bach et. al. annual lung cancer incidence model. Patients are considered "high benefit" if their annual lung cancer risk is between 0.3%-1.3%. Patients outside this range are considered "preference sensitive". We fit a multilevel logistic regression model where receipt of screening is the outcome. Precision decision making is reflected in the association between baseline lung cancer risk and screening utilization: an increase in screening utilization for those at higher lung cancer risk indicates some degree of precision decision making. The primary outcome for the cluster-randomized design assesses the difference in precision decision making in the standard vs. intensive implementation arms. This is estimated as the effect on screening receipt of the interaction between risk and implementation arm.	post implementation, an average of 15 months
Patient Satisfaction With Decision and Process	Obtained from patient surveys (for the subset of the overall participants who returned surveys). The unit of measurement is one unit on the scale [scale of 0 (very poor) to 10 (very good)].	Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Tool Assessments Where Patient Decision Aid Was Printed	Number of times during study duration where patient decision aid was printed from the Lung Decision Precision web-site.	post implementation, up to 25 months
Number of Times Dynamic Pictograph Depicting Personalized Benefit and Harm Was Opened for Display	Number of times dynamic pictograph depicting personalized benefit and harm was opened for display in the Lung Decision Precision web-site during the study period, collected as para data from Decision Precision web-site	post implementation, up to 25 months
Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool	Qualitative analysts will conduct telephone interviews with providers at each site who identify themselves as participating in shared decision making process with patients regarding lung cancer screening. Reporting for this report is number of interviews completed of number interviews requested.	At least one year post-implementation of Lung Decision Precision web-site

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Tanner Caverly, MD MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

General Publications

• Lowery J, Fagerlin A, Larkin AR, Wiener RS, Skurla SE, Caverly TJ. Implementation of a Web-Based Tool for Shared Decision-making in Lung Cancer Screening: Mixed Methods Quality Improvement Evaluation. JMIR Hum Factors. 2022 Apr 1;9(2):e32399. doi: 10.2196/32399.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimated): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: decision support; patient preferences; risk adjustment
• Other Study ID Numbers: QUX 16-003; QUE 15-286 (Other Grant/Funding Number: HSR&D QUERI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No