PrOVE QUERI Project #1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 55 to 80 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

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.

Trial locations and contacts

8 sites in 1 country.

About this study

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

Conditions

Prevention and Control

Being tested

Webinar, Promotion, and Tool Access, LEAP, Audit and Feedback, Academic Detailing

Keywords

decision support, patient preferences, risk adjustment

Medical subject headings

Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Webinar, Promotion, and Tool AccessOther

  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.

• LEAPOther

  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 FeedbackOther

  Also called A&F

  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 DetailingOther

  Also called AD

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: post implementation, an average of 15 months

2. 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)].

   Measured: Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 May 2016 (estimated)
2. Study start15 Nov 2016
3. Primary completion10 Mar 2020
4. Study completion31 May 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Prevention and ControlStudies of the same condition, open and under way.
• More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.