NCT02765412

PrOVE QUERI Project #1

Completed Results posted Last updated 31 December 2024

What this trial tests

trial testing Webinar, Promotion, and Tool Access in Prevention and Control in 17,033 participants. Completed in 31 May 2020.

Timeline

15 November 2016

Primary endpoint
10 March 2020

31 May 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	17,033
Start date	15 November 2016
Primary completion	10 March 2020
Estimated completion	31 May 2020
Sites	8 locations across United States

Drugs / interventions tested

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

Conditions studied

• Prevention and Control — all drugs for Prevention and Control →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 55 to 80, any sex, with Prevention and Control. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm Primary · post implementation, an average of 15 months

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 highe

Group	Value	95% CI
Standard Implementation	1.03	0.89 – 1.19
Intensive Implementation	1.53	1.41 – 1.61

Patient Satisfaction With Decision and Process Primary · Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data

Obtained from patient surveys (for the subset of the overall participants who returned surveys). The unit of measurement is one unit on the scale \[scale of 0 (very poor) to 10 (very good)\].

Group	Value	95% CI
Standard Implementation	7	3 – 9
Intensive Implementation	7	4 – 10

Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool Secondary · At least one year post-implementation of Lung Decision Precision web-site

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.

Group	Value	95% CI
Standard Implementation	25
Intensive Implementation	13

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementation of a Web-Based Tool for Shared Decision-making in Lung Cancer Screening: Mixed Methods Quality Improvement Evaluation.
   Lowery J, Fagerlin A, Larkin AR, Wiener RS, et al · · 2022 · cited 21× · PMID 35363144 · DOI 10.2196/32399
2. Prediction-Augmented Shared Decision-Making and Lung Cancer Screening Uptake.
   Caverly TJ, Wiener RS, Kumbier K, Lowery J, et al · · 2024 · cited 7× · PMID 38949809 · DOI 10.1001/jamanetworkopen.2024.19624