CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400,415 enrolled
Drug / intervention
Basic public reporting +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02831439
NCT02831439N/ACompleted

A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care

Medical College of Wisconsin·interventional·Posted Jul 13, 2016·Updated Jan 22, 2020

In Brief

A clinical study evaluating Basic public reporting, Enhanced intervention, and 1 other intervention for Breast Cancer. Completed, enrolled 400,415 participants across 1 site.

Detailed Summary

The goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 13, 2016
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.0 years ago

Interventions

Basic public reportingbehavioral

The basic intervention will comprise public reporting through the WCHQ website. Individual-level, claims data submitted for billing to third party payers by participating healthsystems will be used to (i) identify cohorts of women with incident breast cancer at the practice-level and (ii) construct the metrics for public reporting and individual benchmarking information. These data are consistent with Medicare and Marketscan claims in both format and content thereby ensuring seamless application of the validated algorithm as well as construction of outcome variables as proposed in Aims 1 and 2 of the study.

Enhanced interventionbehavioral

The enhanced intervention adds an app comprising a decision tool, patient education and communication information that will be delivering concise, readily accessible information about the main components of the intervention. Specifically, physicians in participating practices will be provided a smartphone-based, point-of-care application that will include i) a list of the unproven/ineffective interventions with statements about a) scientifically proven appropriate use; b) proven or suspected downsides to inappropriate use; ii) clinical calculators that allow physician to input individual patients' clinical/tumor characteristics for each test; iii) practice-specific summary of publicly reported results; and iv) printable patient information adapted from the ASCO Choosing Wisely website.

Control group - observationalbehavioral

Comparison states will be used to evaluate the interventions in light of possible secular trends in the region and the nation. The design strategy will enable estimates of the effectiveness of the basic intervention (Aim 1) by comparing (i) the pre-intervention rates to post-intervention rates as well as by comparing (ii) changes between the pre- and post-intervention periods for the "treatment" state (WI) relative to comparison states, neighboring states and others. A similar approach will be used in Part II to provide estimates of the enhanced intervention's impact relative to the basic intervention and contemporary usual care provided in control states, thereby enabling the cost-savings analyses proposed as part of Aim 3.