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| ID | Type | Description | Link |
|---|---|---|---|
| QUE 15-286 | Other Grant/Funding Number | HSR&D QUERI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard implementation | Webinar, Promotion, Tool Access, academic detailing + Audit and Feedback |
| |
| intensive implementation | Webinar, Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Webinar, Promotion, and Tool Access | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions for initial lung cancer screening clinical reminders:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tanner Caverly, MD MPH | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States | ||
| Minneapolis VA Health Care System, Minneapolis, MN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363144 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | post implementation, an average of 15 months |
|
Adverse event data were not systematically collected. The intervention involved staff training and no contact with Veteran participants.
Adverse event data were not systematically collected. The intervention involved staff training and no contact with Veteran participants. We maintained a log of any participant complaints for the duration of the project. There were a total of 3, but we do not know which group the participants were in. The group was determined by which facility the Veteran received care from. Had there been a breach of data, we would have considered this an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Larkin | VA Ann Arbor Healthcare System | 734-845-3612 | angela.larkin@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2020 | Apr 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| LEAP | Other | 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 | Other | 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). |
|
|
| Academic Detailing | Other | 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. |
|
|
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 |
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Travel Distance | Distance from Veteran's home to the VAMC where their Pack Year Clinical Reminder was completed (based on longitude and latitude). | Median | Inter-Quartile Range | miles |
|
| OG000 |
| 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. |
| OG001 | 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. |
|
|
|
| Primary | 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)]. | 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)]. | Posted | Median | Inter-Quartile Range | units on a scale | Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data |
|
|
|
|
| Secondary | 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. | Unable to complete - para data from website did not collect this information as planned. | Posted | post implementation, up to 25 months |
|
|
| Secondary | 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 | The para data from the website is not reliable - unable to assess this planned outcome. | Posted | post implementation, up to 25 months |
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | At least one year post-implementation of Lung Decision Precision web-site |
|
|
|
| 482 |
| 5,275 |
| 0 |
| 5,275 |
| 0 |
| 5,275 |
| EG001 | 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. | 855 | 11,758 | 0 | 11,758 | 0 | 11,758 |
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