The Department of Health and Human Services, Office of the Assistant Secretary forHealth and

The Center for Medicare and Medicaid Services

Pilot Project to Reduce Disparities in Adverse Drug Events

Information Sheet

Background

Since the publication of the Institute of Medicine’s (IOM) report, Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare,[1] there is an increased focus on assessing and understanding the causes of disparities in the quality of, and access to, care of diverse populations. Race/ethnicity, primary language, cultural differences, age, gender, literacy, and other factors including provider as well as patient biases and stereotyping have been identified as aspects in clinical decision making and patient compliance that result in disparities in health outcomes. However, despite the efforts of the healthcare community to address the issues that cause these disparities, more work is needed.

Recently, the Office of the Assistant Secretary of Health (OASH) and Office of Disease Prevention and Health Promotion (ODPHP) published, The National Action Plan for the Prevention of Adverse Drug Events[2], which provides an outline of current efforts and opportunities for eliminating preventableAdverse Drug Events(ADEs) across all patients receiving medical care. The focus of the Action Plan is on three drug categories: anti-coagulants, diabetes agents (hypoglycemic events), and opioids, which have a disproportionate number of negative outcomes in sub-groups compared to the general population. In addition to ADEs, OASH ODPHP is actively engaged in reducing disparities in healthcare associated infections (HAI) and 30-day readmissions. These three preventable adverse events have a significant impact on patient lives and the cost of care.

To better understand and effectively address factors contributing to disparities related to ADEs, the Centers forMedicare and Medicaid Services (CMS) in partnership with OASH/ODPHP and the MITRE Corporation are engaging hospitals and hospital networks/ systems that wereparticipants in the Hospital Engagement Network (HEN) program to partner in an innovative root cause analysis designed to help hospitals identify contributing factors. Through this partnership, organizations will gain new insights into the disparities experienced by their patients, the effectiveness of programs they and others have instituted to reduce disparities, and lessons learned from other leading healthcare providers.

Goal of the Pilot Project

Selected organizations will be invited to participate in the analysis of key drivers causing disparities in adverse healthcare associated outcomes, including ADEs,HAIs, and 30-day readmissions by providing data on disparities and potential interventions. The analysis will inform future HHS actions to reduce disparities, improve quality of care, and support best practices.

Benefits of Participation

Participating hospitals will receive continued technical support from OASH to advance their organization’s efforts to reduce disparities in ADEs, and garner national support and recognition asleaders in reducing ADEs for patient populations. Below are some of the benefits of participating in this effort:

  • Participation in a peer-to-peer learning collaborative with other participating organizations from across the nation to share best approaches and resources for addressing disparities in ADEs and other adverse healthcare associated outcomes.
  • Participants will work in collaboration with the OASH/ODPHP to share results and recommendations that will inform the national action plans for improving the quality and safety for all patients as well as address improvements in national data sources.
  • Participants may gain a more robust understanding of unrealized factors contributing to disparities, resulting in practices that will reduce costly avoidable adverse events – e.g., early death, disability, and hospitalizations - thus further improving the quality of the care provided to all.
  • Participants will be provided with the results of an advanced/cutting edge analysis of their data that may yield new insights and guide development of effective interventions.The pilot also offers technical assistance to participants in preparing peer reviewed articles for publication of their approaches and its impact on reducing disparities.
  • Participation may lead to the identification of additional financial support for efforts to reduce disparitiesin adverse healthcare associated outcomes.

Minimal Effort Required

  • The only data that will be shared is data currently being collected by the hospital/network/system. OASH will not require organizations to report on measures not currently used by the organization for adverse event reporting and tracking.

Eligibility Criteria

Eligibility criteria for voluntary participation among the current Partnership for Patients HENS in a subsequent pilot study of racial/ethnic and other (age, sex, socioeconomic status, geography, health literacy, primary language) disparities in adverse healthcare-associated outcomes (HAIs, ADEs, and 30-day readmissions) are as follows:

  • Participant must have a long-term sustainment planbeyond the current termination date of December 2014 for Partnership for Patients for ensuring the continued participation of hospitals within their network, that includes the collection and sharing of aggregate data for tracking purposes.
  • Participant has an established system for tracking and monitoring hospital progress towards operational metrics and improvement metrics amongst participating hospitals. The system must collect a minimum of patient level data on age, sex, race, and ethnicity. Optional data fields include health literacy, zip code, or census tract of residence,education status, income data, and language data (whether English is primary language).
  • Participating hospital networks must be currently engaged in stratifying patient demographic data to identify disparities in various adverse healthcare-associated outcomes (HAI, ADE, and 30-day readmissions). In addition, certain hospitals may also wish to address Adverse Drug Events (ADEs) orengage in collecting aggregated data on ADEs or other adverse healthcare-associated outcomes for a vulnerable population.
  • Participants must be currently engaged in implementing data driven quality improvement activities designed to reduce racial/ethnic and other disparities in adverse healthcare-associated outcomes (HAI, ADE, and 30-day readmissions) through quality improvement approaches. Alternatively, participants may be engaged in quality improvement activities designed to identify appropriate metrics and care management approaches to prevent ADEs.
  • Participating networks must include hospitals that serve racially and ethnically diverse patient populations.
  • Participants must have the ability to commit to participating in the pilot project for at least one year, preferably longer if future support becomes available. Participants must also be able to share their network data with the OASH contractor, MITRE, for the project period.

Roles and Responsibilities for Participants:

  • Participation in the pilot requires a commitment from the hospital (or hospitals within a health system or former hospital engagement network) to complete the 12 month project period.
  • Ideal candidates will be currently engaged in addressing disparities in ADEs or other adverse healthcare associated outcomes (HACs, HAIs, or 30-day readmissions) or addressing ADE prevention in a vulnerable population not currently addressed by the National ADE Action Plan.
  • Participating organizations must have a data collection system in place that enables them to stratify ADE and other targeted adverse healthcare associated outcomes incidence by race, ethnicity, language, and other patient data.
  • Participants will be required to share their data with the OASH contractor who will analyze their data for root causes (or analyze the results of their root cause analysis).

Additional Clarifying Questions:

Q:Are you looking for any hospital size/hospital type?

A:Yes. We are interested in diverse types of organizations, but are primarily focused on care settings where HAIs, ADEs and 30-day readmissions could occur, and where they types of data described below, are being collected.

Q:Will participating hospitals be required to submit patient level data to you for this project?

A: Yes, we are very interested in patient level data, as this allows for the most rigorous analysis to occur. However, if other types of data exist, we are open to learning about them to see if they still might be relevant. MITRE would develop a data use agreement with any partners providing data. This would include detailed information on the secure, HIPPA-compliant storage and analytic environment MITRE operates.

Q:How often will this data need to be submitted?

A:For this first year of the project, we are currently interested in historic data. A complete dataset would only need to be submitted once.

Q:Is there an application for this or will any hospital that is interested be accepted into the project?

A:There is no application to complete. However, once hospitals identify interest, we have a series of evaluative questions to ask about the type, quality and relevance of their data. Based on the results of this evaluation, we will make a recommendation to ODPHP on whether they should consider acquiring the data for the project. There may be some modest resources available to participating organizations to help offset their costs of providing the data.

Q: Is there a maximum number of hospitals that you will take for this and when is the deadline for submitting the hospital's name to your team?

A:There is no fixed number of hospitals we are willing to work with. Rather, we will work to strike to achieve a balance between the number of hospitals, the type of data they are able to share and our ability to best answer our research questions. Priority will likely be given to those hospitals who come forward early. We are eager to develop data use agreements and take possession of data ASAP, optimally by the end of this month/early February.

1 of 3

[1]Smedley BD, Stith AY, Nelson AR, editors. Institute of Medicine, Committee on Understanding and Eliminating

Racial and Ethnic Disparities in Health Care. Unequal treatment: confronting racial and ethnic disparities in health care. Washington: National Academies Press; 2002.

[2]U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.(2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author.