Trial Outcomes & Findings for PrOVE QUERI Project #1 (NCT NCT02765412)
NCT ID: NCT02765412
Last Updated: 2024-12-31
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
17033 participants
Primary outcome timeframe
post implementation, an average of 15 months
Results posted on
2024-12-31
Participant Flow
Eight VA sites participated in this Quality Improvement Project. Four were randomized to each arm. The number of participants in each arm reflects how many Veterans at the sites randomized to each arm who were eligible for lung cancer screening according to CDW data between October 2016 and December 2019.
Participant milestones
| Measure |
Standard Implementation
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5275
|
11758
|
|
Overall Study
COMPLETED
|
4793
|
10903
|
|
Overall Study
NOT COMPLETED
|
482
|
855
|
Reasons for withdrawal
| Measure |
Standard Implementation
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
|---|---|---|
|
Overall Study
Death
|
482
|
855
|
Baseline Characteristics
PrOVE QUERI Project #1
Baseline characteristics by cohort
| Measure |
Standard Implementation
n=5275 Participants
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
n=11758 Participants
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Total
n=17033 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2373 Participants
n=5 Participants
|
6303 Participants
n=7 Participants
|
8676 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2902 Participants
n=5 Participants
|
5455 Participants
n=7 Participants
|
8357 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
848 Participants
n=7 Participants
|
1044 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5079 Participants
n=5 Participants
|
10910 Participants
n=7 Participants
|
15989 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4904 Participants
n=5 Participants
|
10951 Participants
n=7 Participants
|
15855 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
312 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
954 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
60 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
27 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
314 Participants
n=5 Participants
|
1903 Participants
n=7 Participants
|
2217 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4369 Participants
n=5 Participants
|
8788 Participants
n=7 Participants
|
13157 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
472 Participants
n=5 Participants
|
807 Participants
n=7 Participants
|
1279 Participants
n=5 Participants
|
|
Travel Distance
|
37.8 miles
n=5 Participants
|
45.9 miles
n=7 Participants
|
43.8 miles
n=5 Participants
|
PRIMARY outcome
Timeframe: post implementation, an average of 15 monthsFirst, 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.
Outcome measures
| Measure |
Standard Implementation
n=5275 Participants
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
n=11758 Participants
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
|---|---|---|
|
Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm
|
1.03 odds ratio
Interval 0.89 to 1.19
|
1.53 odds ratio
Interval 1.41 to 1.61
|
PRIMARY outcome
Timeframe: Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative dataPopulation: Surveys were sent to eligible Veterans, the overall number of participants analyzed is a reflection of the subset of the overall participants who returned surveys. The unit of measurement is one unit on the scale \[scale of 0 (very poor) to 10 (very good)\].
Obtained from patient surveys (for the subset of the overall participants who returned surveys). The unit of measurement is one unit on the scale \[scale of 0 (very poor) to 10 (very good)\].
Outcome measures
| Measure |
Standard Implementation
n=649 Participants
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
n=1451 Participants
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
|---|---|---|
|
Patient Satisfaction With Decision and Process
|
7 units on a scale
Interval 3.0 to 9.0
|
7 units on a scale
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: post implementation, up to 25 monthsPopulation: Unable to complete - para data from website did not collect this information as planned.
Number of times during study duration where patient decision aid was printed from the Lung Decision Precision web-site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post implementation, up to 25 monthsPopulation: The para data from the website is not reliable - unable to assess this planned outcome.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least one year post-implementation of Lung Decision Precision web-sitePopulation: Of sites randomized to each Arm, the number of providers involved in lung cancer screening who were completed an interview about DecisionPrecision and the risk-based approach of the number of providers who were asked to complete an interview.
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.
Outcome measures
| Measure |
Standard Implementation
n=48 Participants
Promotion, Tool Access, academic detailing + Audit and Feedback
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
Intensive Implementation
n=40 Participants
Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP
Promotion, and Tool Access: All sites will be given access to a You Tube video 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.
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).
Audit and Feedback: Sites will be provided with reports to provide feedback on the screening and shared decision making process. Site teams were encouraged to send these reports to providers.
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.
|
|---|---|---|
|
Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool
|
25 Participants
|
13 Participants
|
Adverse Events
Standard Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 482 deaths
Intensive Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 855 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place