Clinical trial NCT02831439: A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
Official title: A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Choosing Wisely
Breast cancer
Controlled trial
High-value health care
Health services research
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Wisconsin Collaborative for Healthcare Quality
name: National Cancer Institute (NCI)
First posted: 2016-07-13
Enrollment: 400415
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Challenged by public opinion, peers and the Congressional Budget Office, a number of specialty societies have recently begun to develop "Top Five" lists of relatively expensive procedures that do not provide meaningful benefit to at least some categories of patients for whom they are commonly ordered. The Choosing Wisely® campaign is the most visible example. The extent to which the development of these lists has influenced the behavior of physicians or patients, however, remains unknown.

In this study, investigators partner with the Wisconsin Collaborative for Healthcare Quality (WCHQ), a statewide consortium of hospitals, medical practices and health systems, to examine the effectiveness of two organizational interventions in reducing unproven or ineffective breast cancer care. Two interventions will be tested: (a) A "basic" public reporting intervention which summarizes on a public website practice-level statistics regarding use of targeted ineffective or unproven interventions for breast cancer and (ii) an "enhanced" intervention, augmenting public reporting with a smart phone-based application (App) that gives providers just-in-time information, decision-making tools, and personalized patient education materials that support reductions in the use of breast cancer interventions targeted based upon Choosing Wisely® or national oncology society guidelines. Specifically, the aims are: (1) To examine whether basic public reporting reduces use of targeted breast cancer practices among a contemporary cohort of patients with incident breast cancer in the intervention state relative to usual care in comparison states, using Marketscan and Medicare claims data while adjusting for possible confounders and temporal trends; (2) To examine the effectiveness of the enhanced intervention relative to the basic intervention; and (3) To simulate cost savings forthcoming from nationwide implementation of both interventions (relative to each other and to usual care) and to describe the implications of these findings for reimbursement policy and program initiatives.

The results will provide rigorous evidence regarding the effectiveness of a unique all-payer, all-age public reporting system for influencing provider behavior that may be easily exportable to other states. Findings will be further relevant to the ACO environment, which is expected to provide financial disincentives for providing ineffective or unproven care.

Eligibility criteria: Inclusion Criteria:

I. Health care providers: Health care providers (regardless of age, gender or race/ethnicity) in participating WCHQ practices who will provide breast cancer care to about 9,000 women who had an incident breast cancer surgery between 2014-2017.

II. Patients: Medicare and Marketscan women who had an incident breast cancer surgery between 2014-2017. No exclusions will be made by age or race/ethnicity. The focus on women is dictated by the very low prevalence of breast cancer among men.

Identification of incident breast cancer surgery in these datasets will be done using a validated algorithm developed by Nattinger et al.

Exclusion Criteria:

* Male patients are excluded from this analysis due to the low prevalence of breast cancer among males.

Primary outcomes:
measure: Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386).
timeFrame: Date of surgery plus 180 days
measure: Percent of Women had a CPM
timeFrame: Date of ipsilateral mastectomy surgery plus 1 day. Excluded from denominator if had any genetic predisposition counseling, testing, or family history codes within 180-days prior to surgery.
measure: Percentage of Women who received Tumor Biomarker Blood Testing for Surveillance (defined as CPT 82378 (CEA); 86300 (CA 15-3)
timeFrame: From 181 days post-date of surgery up to 4 years
measure: Percentage of Women who received PET Scan or PET-CT Scan for Surveillance (defined as CPT 78811-78816; HCPCS G0235, G0252, S8085)
timeFrame: From 181 days post-date of surgery up to 4 years
measure: Percentage of Women who received CT Scan for Surveillance (defined as CPT 71250, 71260, 71270, 72192-72194, 74150, 74160, 74170, 74176-74178)
timeFrame: From 181 days post-date of surgery up to 4 years
measure: Percentage of Women who received Bone Scan for Surveillance (defined as CPT 78306)
timeFrame: From 181 days post-date of surgery up to 4 years
measure: Percentage of Women who received Breast MRI for Surveillance (defined as CPT 77058, 77059; HCPCS C8903-8908)
timeFrame: From 181 days post-date of surgery up to 4 years
measure: Percentage of Women who received Follow-Up Mammograms More Frequently than Annually for Patients Treated with Breast Conserving Surgery & Radiotherapy (defined as CPT 77051, 77052, 77055-77057, 77061-77063 HCPCS G0202, G0204, G0206, G0279)
timeFrame: From 365 days post-surgery to 730 days post-surgery
Secondary outcomes:
measure: Secondary costs associated with breast cancer care
timeFrame: From date of initial diagnosis up to 24 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Ann Nattinger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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