A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400,415
- 试验地点
- 2
- 主要终点
- Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •II. Patients: Medicare and Marketscan women who had an incident breast cancer surgery between 2014-
- •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.
排除标准
- •Male patients are excluded from this analysis due to the low prevalence of breast cancer among males.
结局指标
主要结局
Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386).
时间窗: Date of surgery plus 180 days
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing IMRT, a 3-dimensional technique that has not been demonstrated to provide a significant clinical advantage over the standard 2-dimensional technique for whole breast radiation therapy after breast conserving surgery.
Percentage of Women who received Tumor Biomarker Blood Testing for Surveillance (defined as CPT 82378 (CEA); 86300 (CA 15-3)
时间窗: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing tumor biomarker blood tests (CA 15-3, CA 27.29, CEA) for breast cancer surveillance in asymptomatic women who have been treated with curative intent. Tumor markers may be indicated if there is concern for disease recurrence (development of symptoms or abnormal imaging findings).
Percentage of Women who received CT Scan for Surveillance (defined as CPT 71250, 71260, 71270, 72192-72194, 74150, 74160, 74170, 74176-74178)
时间窗: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a computerized tomography (CT or CAT) scan of the chest, abdomen or pelvis for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal CT scan finding.
Percentage of Women who received PET Scan or PET-CT Scan for Surveillance (defined as CPT 78811-78816; HCPCS G0235, G0252, S8085)
时间窗: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a positron emission tomography (PET) scan or a positron emission tomography-computed tomography (PET-CT) scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. PET/PET-CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal PET/PET-CT scan finding.
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)
时间窗: From 365 days post-surgery to 730 days post-surgery
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing routine follow-up mammograms more frequently than annually in asymptomatic patients treated with breast conserving surgery and radiotherapy, citing no clear advantage to shorter interval imaging.
Percent of Women had a CPM
时间窗: 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.
(CPT 19303 OR 19304 w/mod 50; OR ICD-9 85.35 OR 85.36 OR 85.42; OR two claims within 1 day with ICD-9 85.33 OR 85.34 OR 85.41 OR 85.43 OR 85.45 OR 85.47, EXCLUDING two 85.45 OR two 85.47 OR (85.45 AND 85.47); OR conditions (a) AND (b) The National Comprehensive Cancer Network and the Society of Surgical Oncology indicate that there are no proven survival benefits to performing a Contralateral Prophylactic Mastectomy (CPM: removal of the unaffected breast). Despite the lack of survival benefit, this procedure may be considered appropriate in cases where there is high risk of cancer occurring in the unaffected breast and/or radiographic surveillance of the unaffected breast would be difficult. Such factors may include genetic predisposition to breast cancer, strong family history of breast cancer, high-risk histology (atypical hyperplasia or lobular carcinoma in situ), prior radiation treatment to the chest, and dense breast tissue.
Percentage of Women who received Bone Scan for Surveillance (defined as CPT 78306)
时间窗: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a bone scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Bone scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal bone scan finding.
Percentage of Women who received Breast MRI for Surveillance (defined as CPT 77058, 77059; HCPCS C8903-8908)
时间窗: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology, the American Cancer Society and the American Society of Breast Surgeons recommend against performing a breast magnetic resonance imaging (MRI) for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Breast MRI is currently recommended only for women at very high risk for developing another breast cancer, such as BRCA1/2 mutation carriers, history of chest wall radiation therapy and women with a 20% or greater lifetime risk of developing another breast cancer. Breast MRI may be considered in patients with very dense breasts or a strong family history of breast cancer. Breast MRI may also be indicated for follow-up of a prior abnormal breast MRI finding.
次要结局
- Secondary costs associated with breast cancer care(From date of initial diagnosis up to 24 months)
研究者
Ann Nattinger
Senior Associate Dean for Research, Lady Riders Professor of Breast Cancer Research, Professor of Medicine
Medical College of Wisconsin