PrOVE QUERI Project #1

Prevention and Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765412
• Other study ID #: QUX 16-003
• Secondary ID: QUE 15-286
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: November 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74022
• Est. completion date: May 31, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prevention and Control

Intervention

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.
• 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
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
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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Utah
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	Cincinnati VA Medical Center, Cincinnati, OH	Cincinnati	Ohio
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient Satisfaction with decision and process	Obtained from patient surveys	June 2016 - September 2019
Secondary	Number of tool assessments where patient decision aid was printed	Collected as para data from Decision Precision website	November 2016 - September 2019
Secondary	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
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.	November 2018 - March 2019