PrOVE QUERI Project #1

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prevention and Control

Intervention / Treatment
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* Other: Webinar, Promotion, and Tool Access
* Other: LEAP
* Other: Audit and Feedback
* Other: Academic Detailing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| standard implementation<br>Webinar, Promotion, Tool Access, academic detailing + Audit and Feedback | Other: Webinar, Promotion, and Tool Access<br>* 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.<br>Other: Audit and Feedback<br>* 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).<br>* Other names: A&F;Other: Academic Detailing<br>* All sites will be offered an academic detailing approach to implementation of Lung Decision Precsion. 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.<br>* Other names: AD;|
| intensive implementation<br>Webinar, Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP | Other: Webinar, Promotion, and Tool Access<br>* 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.<br>Other: LEAP<br>* 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).<br>Other: Audit and Feedback<br>* 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).<br>* Other names: A&F;Other: Academic Detailing<br>* All sites will be offered an academic detailing approach to implementation of Lung Decision Precsion. 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.<br>* Other names: AD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision decision making | Screening utilization aligning with Veterans' potential screening benefit. This will be estimated by inputting CDW data into a validated model. | June 2016 - September 2019 | 
| High quality decision making | Obtained from patient surveys, defined as 1) adequate knowledge about the benefits and harms, and 2) values consistent with the screening decision | June 2016 - September 2019 | 
| Patient Satisfaction with decision and process | Obtained from patient surveys | June 2016 - September 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tool assessments where patient decision aid was printed | Collected as para data from Decision Precision website | November 2016 - September 2019 | 
| Number of tool assessments where dynamic pictograph depicting personalized benefit and harm was opened for display | Collected as para data from Decision Precision website | November 2016 - September 2019 | 
| 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. | November 2018 - March 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision support, patient preferences, risk adjustment