Trial record 7 of 48 for:    LEAP

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02765412
First received: May 5, 2016
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
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. The investigators will also determine the effect of allowing providers to design their own risk threshold algorithms into a lung cancer screening decision aid, Decision Precision. 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.

Condition Intervention
Prevention and Control
Other: Webinar, Promotion, and Tool Access
Other: LEAP
Other: Risk Threshold Tailoring
Other: Audit and Feedback

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Patient level participation rate [ Time Frame: June 2016 - September 2019 ] [ Designated as safety issue: No ]
    Proportion of patients eligible for lung cancer screening with documented tool use after screening discussion noted in the Computerized Patient Record System (CPRS)

  • Precision decision making [ Time Frame: June 2016 - September 2019 ] [ Designated as safety issue: No ]
    Screening utilization aligning with Veterans' potential screening benefit. This will be estimated by inputting CDW data into a validated model.

  • High quality decision making [ Time Frame: June 2016 - September 2019 ] [ Designated as safety issue: No ]
    Obtained from patient surveys, defined as 1) adequate knowledge about the benefits and harms, and 2) values consistent with the screening decision

  • Patient Satisfaction with decision and process [ Time Frame: June 2016 - September 2019 ] [ Designated as safety issue: No ]
    Obtained from patient surveys


Secondary Outcome Measures:
  • Number of tool assessments for each provider [ Time Frame: November 2016 - September 2019 ] [ Designated as safety issue: No ]
    Collected as para data from Decision Precision website

  • Percentage of provider's eligible patients with documented tool use [ Time Frame: November 2016 - September 2019 ] [ Designated as safety issue: No ]
    Number of tool assessments for provider divided by number of provider's patients eligible for tool use according to medical record data

  • Number of tool assessments where patient decision aid was printed [ Time Frame: November 2016 - September 2019 ] [ Designated as safety issue: No ]
    Collected as para data from Decision Precision website

  • Number of tool assessments where shared decision making documentation was copied [ Time Frame: November 2016 - September 2019 ] [ Designated as safety issue: No ]
    Collected as para data from Decision Precision website

  • Number of tool assessments where dynamic pictograph depicting personalized benefit and harm was opened for display [ Time Frame: November 2016 - September 2019 ] [ Designated as safety issue: No ]
    Collected as para data from Decision Precision website

  • Formative evaluation to determine the factors most important for successful implementation of Decision Precision tool [ Time Frame: November 2018 - March 2019 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60000
Study Start Date: June 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
standard implementation
Webinar, Promotion, and Tool Access + Audit and Feedback
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.
Other: Risk Threshold Tailoring
Providers at all sites will determine their own risk thresholds for making personalized recommendations within the Decision Precision tool. This will be done in a stepped-wedge design and will add a new site every two months until providers at all sites have been given the opportunity to tailor their thresholds. After completing a risk tailoring tutorial, providers will identify two risk thresholds: 1) a low risk/low benefit threshold below which the provider would generally suggest that most patients not get screened and 2) a high risk/high benefit threshold above which the provider would generally suggest that most patients get screened. In between these two thresholds is a gray zone where screening and not screening are presented as equally good options. Once a provider has completed this module, their personal thresholds will be applied each time they log in.
Other Name: RTT
Other: 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).
Other Name: A&F
intensive implementation
Webinar, Promotion, and Tool Access + Audit and Feedback + LEAP
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.
Other: 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).
Other: Risk Threshold Tailoring
Providers at all sites will determine their own risk thresholds for making personalized recommendations within the Decision Precision tool. This will be done in a stepped-wedge design and will add a new site every two months until providers at all sites have been given the opportunity to tailor their thresholds. After completing a risk tailoring tutorial, providers will identify two risk thresholds: 1) a low risk/low benefit threshold below which the provider would generally suggest that most patients not get screened and 2) a high risk/high benefit threshold above which the provider would generally suggest that most patients get screened. In between these two thresholds is a gray zone where screening and not screening are presented as equally good options. Once a provider has completed this module, their personal thresholds will be applied each time they log in.
Other Name: RTT
Other: 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).
Other Name: A&F
No risk threshold tailoring
Tool access will be provided with default risk thresholds
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.
Other: 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).
Other: 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).
Other Name: A&F
Risk threshold tailoring
Tool access will be provided, including a module where providers can set their own risk thresholds.
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.
Other: 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).
Other: Risk Threshold Tailoring
Providers at all sites will determine their own risk thresholds for making personalized recommendations within the Decision Precision tool. This will be done in a stepped-wedge design and will add a new site every two months until providers at all sites have been given the opportunity to tailor their thresholds. After completing a risk tailoring tutorial, providers will identify two risk thresholds: 1) a low risk/low benefit threshold below which the provider would generally suggest that most patients not get screened and 2) a high risk/high benefit threshold above which the provider would generally suggest that most patients get screened. In between these two thresholds is a gray zone where screening and not screening are presented as equally good options. Once a provider has completed this module, their personal thresholds will be applied each time they log in.
Other Name: RTT
Other: 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).
Other Name: A&F

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. Secondly, the investigators will determine the effect on tool use of allowing providers to design their own risk threshold algorithms by enrolling sites in a step wedge design into risk tailoring. Thirdly, 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

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02765412

Contacts
Contact: Angela R Larkin, AA BA (734) 845-3612 angela.larkin@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Not yet recruiting
San Francisco, California, United States, 94121
Contact: James K Brown    415-221-4810 ext 26464    james.brown4@va.gov   
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Janet G Adams-Watson, MHSA BA    734-845-3604    jan.adams-watson@va.gov   
Principal Investigator: Angela Fagerlin, PhD MA         
Principal Investigator: Tanner Caverly, MD MPH         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Active, not recruiting
Minneapolis, Minnesota, United States, 55417
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Not yet recruiting
New York, New York, United States, 10010
Contact: Patrick Malloy    212-686-7500 ext 7854    patrick.malloy2@va.gov   
United States, North Carolina
Durham VA Medical Center, Durham, NC Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Scott Shofer    919-286-0411    scott.shofer@va.gov   
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: Dennis McGraw    513-861-3100    dennis.mcgraw@va.gov   
United States, Oregon
VA Portland Health Care System, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Christopher Slatore    503-220-8262 ext 52018    christopher.slatore@va.gov   
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Not yet recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Nichole Tanner    843-789-5885    tripici@musc.edu   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Angela Fagerlin, PhD MA VA Ann Arbor Healthcare System, Ann Arbor, MI
Principal Investigator: Tanner Caverly, MD MPH VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02765412     History of Changes
Other Study ID Numbers: QUX 16-003  QUE 15-286 
Study First Received: May 5, 2016
Last Updated: May 6, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
decision support
patient preferences
risk adjustment

ClinicalTrials.gov processed this record on May 26, 2016