Clinical trial NCT02765412: PrOVE QUERI Project #1
Official title: Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention and Control
Keywords: decision support
patient preferences
risk adjustment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-06
Enrollment: 17033
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm
timeFrame: post implementation, an average of 15 months
measure: Patient Satisfaction With Decision and Process
timeFrame: Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data
Secondary outcomes:
measure: Number of Tool Assessments Where Patient Decision Aid Was Printed
timeFrame: post implementation, up to 25 months
measure: Number of Times Dynamic Pictograph Depicting Personalized Benefit and Harm Was Opened for Display
timeFrame: post implementation, up to 25 months
measure: Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool
timeFrame: At least one year post-implementation of Lung Decision Precision web-site
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Tanner Caverly, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.