PrOVE QUERI Project #1

NCT02765412 | Completed Results

• 2 other identifiers: QUX 16-003QUE 15-286
• Study Type: observational
• Target: 17,033
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Prevention and Control

Keywords

decision support; patient preferences; risk adjustment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Number of Tool Assessments Where Patient Decision Aid Was Printed

  post implementation, up to 25 months

• Number of Times Dynamic Pictograph Depicting Personalized Benefit and Harm Was Opened for Display

  post implementation, up to 25 months

• Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool

  At least one year post-implementation of Lung Decision Precision web-site

Study Arms (2)

standard implementation

Webinar, Promotion, Tool Access, academic detailing + Audit and Feedback

Other: Webinar, Promotion, and Tool Access; Other: Audit and Feedback; Other: Academic Detailing

intensive implementation

Webinar, Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP

Other: Webinar, Promotion, and Tool Access; Other: LEAP; Other: Audit and Feedback; Other: Academic Detailing

Interventions

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.

intensive implementation; standard implementation

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).

intensive implementation

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).

Also known as: A&F

intensive implementation; standard implementation

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.

Also known as: AD

intensive implementation; standard implementation

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (8)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (1)

• 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.

  PMID: 35363144 DERIVED

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Angela Larkin
• Organization: VA Ann Arbor Healthcare System

angela.larkin@va.gov

734-845-3612

Study Officials

• Tanner Caverly, MD MPH

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 6, 2016
• Study Start: November 15, 2016
• Primary Completion: March 10, 2020
• Study Completion: May 31, 2020
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)