Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

Participating health systems in Wisconsin. Interventions include: Basic public reporting and the enhanced intervention (app)

Health systems in comparison states. Control includes: Cost savings comparison

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.

Basic public reporting

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.

Enhanced intervention

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.

Control group - observational

Ann Nattinger, MD, MPH

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.

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.

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

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.

(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.

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).

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.

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.

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.

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.

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.

Direct medical care costs for the initial diagnosis and evaluation, initial treatment as well as any neoadjuvant, adjuvant and surveillance care received during the first 24 months post-diagnosis will be calculated using Marketscan and Medicare claims data.

Wisconsin Collaborative for Healthcare Quality

National Cancer Institute (NCI)

Medical College of Wisconsin

Senior Associate Dean for Research, Lady Riders Professor of Breast Cancer Research, Professor of Medicine

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Epilepsy

Lung Diseases

Pain

Lung Diseases, Interstitial

Respiratory Tract Diseases

Participants will receive the MyDignio app for individualized follow-up for 6 months.

Participants in the control group will receive follow-up at the outpatient clinic as per their needs.

The intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients.

Elements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations.

Dignio Digital Remote Care intervention group

Usual Care Control group

Erik Fosse, PhD

Heidi Holmen

More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.

The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.

The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.

Digital Outpatient Services

Digital Outpatient Services - a Controlled Multicenter Study

Qualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.

The HLQ is a standardized measure of health literacy, and the investigators will apply five of the nine domains; 1 Feeling understood and supported by healthcare providers; 2 Having sufficient information to manage my health; 3 Actively managing my health; 6 Ability to actively engage with healthcare providers; and 9 Understanding health information well enough to know what to do. the HLQ is is translated and validated in Norwegian.

(Osborne et al. 2013; Wahl et al. 2020)

The investigators will apply the eHLQ to measure level of digital health literacy. The eHLQ contains 35 items summarized in seven domains: 1) using technology to process health information, 2) understanding of health concepts and language, 3) ability to actively engage with digital services, 4) feel safe and in control, 5) motivated to engage with digital services, 6) access to digital services that work, and 7) digital services that suit individual needs. Higher scores indicate better digital health literacy. Domains 1-5 consist of 5 items, domain 6 consists of 6 items, and domain 7 consists of 4 items.

(Kayser et al. 2018)

To assess the patient reported health or quality of life the investigators will use the 12-Item Short Form Survey from the RAND Medical Outcomes Study (RAND-12) (Ware et al. 1996). The items summarizes into two scales; mental component score and Physical component score. Higher scores indicate better health, and the instruments is translated and validated in Norwegian.

To assess the participants self-perceived safety in the pandemic the investigators will apply the item: "How anxious are you to be infected with Covid-19 (corona)?" with responses on a 5 point Likert scale from "Not anxious" to "Very anxious" .

The Service User Technology Acceptability Questionnaire (SUTAQ) is an instrument that can be used to measure user beliefs about the acceptability of digital services, and has the ability to discriminate and predict individual differences in beliefs and behaviour.

(Hirani et al 2016; Torbjørnsen et al. 2018)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care	NCT02831439	Breast Cancer	Basic public re... Enhanced interv... Control group -...	18 Years -	Medical College of Wisconsin
Digital Outpatient Services	NCT05068869	Epilepsy Cancer Interstitial Lu... Long Term Pain	Dignio Digital ... Usual Care Cont...	18 Years -	Oslo University Hospital
A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care	NCT02831439	Breast Cancer	Basic public re... Enhanced interv... Control group -...	18 Years -	Medical College of Wisconsin
A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care	NCT02831439	Breast Cancer	Basic public re... Enhanced interv... Control group -...	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for controlled trial