Tools for Optimizing Medication Safety (TOP-MEDS) (Illinois)

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Tools for Optimizing Medication Safety (TOP-MEDS) - 2012

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS11-004: Centers for Education and Research on Therapeutics (CERTs) (U19)
  • Grant Number: 
    U19 HS 021093
  • Project Period: 
    September 2011 – September 2016
  • AHRQ Funding Amount: 
    $711,643
  • PDF Version: 
    (PDF, 195.36 KB)

Summary: The Centers for Education and Research on Therapeutics (CERTs) demonstration program is a national initiative to conduct research and provide education to advance the optimal use of therapeutics such as drugs, medical devices, and biological products. The program consists of six research centers and a CERTs Scientific Forum and is funded and run as a cooperative agreement by the Agency for Healthcare Research and Quality in consultation with the U.S. Food and Drug Administration.

Drug therapy is the most common medical service patients receive, but it is plagued by risks and hazards. Newly released medications may cause patient side effects that were not identified in pre-marketing research. High-risk commonly used drugs such as opioid analgesics are frequently selected and dosed improperly. Drug name confusion causes patients to receive the wrong drugs. Consumers use drugs unsafely because drug information is limited and confusing. The need to prevent or mitigate medication-related harm is great.

This project is developing Tools for Optimizing Medication Safety (TOP-MEDS) to address these issues by developing, testing, deploying, and disseminating tools and training materials in four key areas: 1) statistical methods for large-scale studies of comparative drug safety and effectiveness; 2) opioid prescribing and dosing for acute pain; 3) methods for preventing and detecting drug name confusion errors; and 4) patient-centered, language-concordant drug information.

Research findings will be disseminated through a network of cooperating organizations with local and national reach. The TOP-MEDS CERT will emphasize education in two of its four aims by engaging in broad outreach activities at conferences for health professionals; developing Web-based training programs for in-house staff; creating continuing education programs; producing Web-based content related to the four key areas; and using social media—especially Facebook, Twitter, and YouTube—to disseminate its work. Project staff will work with payers, accreditors, policymakers, and legislators to identify policy levers that can increase the adoption of patient-safety best practices.

Specific Aims:

  • Develop and apply a multivariate person-time logistic regression model for large-scale adverse drug event screening. (Ongoing)
  • Improve the safety and effectiveness of inpatient acute pain care by developing and validating a Web-based simulator to train prescribers in the proper selection and dosing of opioids. (Ongoing)
  • Refine a standard battery of tests for pre-market safety screening of drug names, and develop and test methods for preventing and detecting drug name confusion errors in clinical databases. (Ongoing)
  • Evaluate an electronic health care-based, low-literacy strategy for promoting safe, effective prescription drug use among English and Spanish-speaking patients in an urban primary care setting. (Ongoing)

2012 Activities: Because each aim represents a distinct research project, activities are listed by aim:

Aim 1: The project team established contracts with vendors, developed the project software, and began data collection. The team has concentrated on the development of two new statistical methods: one allowing time-varying propensity scores; the other able to treat the drug-adverse event linkage as a cluster in certain pharmacological designs.

Aim 2: The scientific protocol for the institutional review board (IRB) was completed. The protocol delineates the measurement strategy in the inpatient setting. The primary research and input to development of the protocol was accomplished through a review of relevant literature. A functioning prototype of the simulator has been completed and is undergoing design refinements. The simulator is a Web-based application, which makes it highly functional on mobile platforms. IRB approval was obtained to extract data related to developing an electronic version of opiod events. Development of a didactic curriculum for residents was initiated.

Aim 3: Analytic methods were under development as were a battery of tests to identify drug names that are confusing. The team is beginning to refine the set of tests and retrospective detection for premarket screening on drug name confusion. The drug name confusion project has two aspects: 1) the preapproval screening methods; and 2) a retrospective detection of drug errors at the hospital. The team negotiated with organizations to obtain data regarding rates of confusion. Large health systems were concerned about liability but the team worked with a patient-safety organization to negotiate obtaining the data.

Aim 4: The team is focusing on start-up activities such as protocol establishment. The IRB paperwork has been completed.

Preliminary Impact and Findings: This project has no findings to date.

Target Population: Adults, Low Literacy, Low-SES/Low Income*, Racial or Ethnic Minorities*: African-Americans, Hispanics

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

* This target population is one of AHRQ’s priority populations.

Tools for Optimizing Medication Safety (TOP-MEDS) - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS11-004: Centers for Education and Research on Therapeutics (CERTs) (U19)
  • Grant Number: 
    U19 HS 021093
  • Project Period: 
    September 2011 - September 2016
  • AHRQ Funding Amount: 
    $711,643
  • PDF Version: 
    (PDF, 190.17 KB)

Summary: The Centers for Education and Research on Therapeutics (CERTs) demonstration program is a national initiative to conduct research and provide education to advance the optimal use of therapeutics such as drugs, medical devices, and biological products. The program consists of six research centers and a CERTs Scientific Forum, and is funded and run as a cooperative agreement by the Agency for Healthcare Research and Quality (AHRQ), in consultation with the U.S. Food and Drug Administration (FDA).

Drug therapy is the most common medical service patients receive, but it is plagued by risks and hazards. The need for solutions that can prevent or mitigate medication-related harm is critical. Newly released medications may cause unusual side effects in patients that were not identified in pre-marketing research. High-risk commonly used drugs such as opioid analgesics are frequently selected and dosed improperly. Drug name confusion causes patients to receive the wrong drugs. Consumers use drugs unsafely because drug information is limited and/or confusing. Therefore, this project is developing Tools for Optimizing Medication Safety (TOP-MEDS). The project is developing, testing, deploying, and disseminating tools and training materials in four key areas: 1) statistical methods for large-scale studies of comparative drug safety and effectiveness; 2) opioid prescribing and dosing for acute pain; 3) methods for preventing and detecting drug name confusion errors; and 4) patient-centered, language concordant drug information.

Research findings will be disseminated through a network of cooperating organizations with local and national reach. To achieve its educational objectives, the TOP-MEDS CERT will emphasize education in two of its four aims by engaging in broad outreach activities at conferences for health professionals; developing Web-based training programs for in-house staff; creating continuing education programs; producing Web-based content related to the four key areas; and using social media-especially Facebook, Twitter, and YouTube-to disseminate their work. Project staff will also work with payors, accreditors, policymakers, and legislators to identify policy levers that can increase the adoption of patient-safety best practices.

Specific Aims:

  • Develop and apply a multivariate person-time logistic regression model for large-scale adverse drug event screening. (Ongoing)
  • Improve the safety and effectiveness of inpatient acute pain care by developing and validating a Webbased simulator to train prescribers in the proper selection and dosing of opioids. (Ongoing)
  • Refine a standard battery of tests for pre-market safety screening of drug names, and develop and test methods for preventing and detecting drug name confusion errors in clinical databases. (Ongoing)
  • Evaluate an electronic health care-based, low-literacy strategy for promoting safe, effective prescription drug use among English and Spanish-speaking patients in an urban primary care setting. (Ongoing)

2011 Activities: The project began during the last quarter of 2011 and is in the start-up phase. Because each aim represents a distinct research project, activities are listed by aim: First aim: The study team is working to establish contracts, organize regular meetings, and develop and refine methods.

Second aim: The primary work has been on refining the scientific protocol for the institutional review board (IRB) to develop the measurement strategy in the inpatient setting.

Third aim: The development of the analytic methods and the battery of tests to identify which drug names are confusing were initiated. Subcontracts were executed and IRB approval was obtained.

Fourth aim: The IRB protocol is complete and will be submitted. The study staff is clarifying components of this aim for AHRQ.

Preliminary Impact and Findings: This project has no findings to date.

Target Population: Adults, Low Literacy, Low-SES/Low Income*, Racial or Ethnic Minorities*: African- American, Hispanics

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

* This target population is one of AHRQ's priority populations.

Tools for Optimizing Medication Safety (TOP-MEDS) - Final Report

Citation:
Lambert B. Tools for Optimizing Medication Safety (TOP-MEDS) - Final Report. (Prepared by Northwestern University under Grant No. U19 HS021093). Rockville, MD: Agency for Healthcare Research and Quality, 2017. (PDF, 1.01 MB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. (Persons using assistive technology may not be able to fully access information in this report. For assistance, please contact Corey Mackison)
Principal Investigator: 
Document Type: 
This project does not have any related event.
This project does not have any related resource.
This project does not have any related survey.
This project does not have any related project spotlight.
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This project does not have any related story.
This project does not have any related emerging lesson.

Project Details - Ended

Summary:

The US healthcare system has ongoing problems of underuse, overuse, and misuse of medications, leading to medication errors, adverse events, and less-than-optimal patient outcomes. For instance, medications with high risks, such as opioids, are frequently selected and dosed improperly; confusion around the names of medications may cause patients to receive the wrong drugs; and patient information regarding medications is generally poorly designed and confusing, leading to unsafe use by consumers.

To address these issues, AHRQ funded this patient safety Centers for Education and Research on Therapeutics (CERTs) project at Northwestern University focused on developing tools for safer medication use, called the Tools for Optimizing Medication Safety (TOP-MEDS). The CERTs demonstration program is a national initiative to conduct research and provide education that advances the optimal use of therapeutics including drugs, medical devices, and biological products. The TOP-MEDs CERT was funded to conduct numerous projects in four areas: statistical methods for studies of drug safety and effectiveness, opioid prescribing for acute pain, preventing and detecting drug name confusions, and patient-centered drug information.

The specific aims of the project were to:

  • Develop and apply a multivariate person-time logistic regression model for large-scale adverse drug event (ADE) screening. 
  • Improve the safety and effectiveness of inpatient acute pain care by developing and validating a web-based simulator to train prescribers in the proper selection and dosing of opioids. 
  • Refine a standard battery of tests for pre-market safety screening of drug names, and develop and test methods for preventing and detecting drug name confusion errors in clinical databases. 
  • Rigorously evaluate an electronic health record (EHR)-based, low literacy strategy for promoting safe, effective prescription drug use among English- and Spanish-speaking patients in an urban primary care setting. 

A variety of methods were used across the projects, including statistical analysis of claims data sets, retrospective review of EHRs, simulation studies, prospective and retrospective observational studies, randomized trials, and psychological experiments. The team reported success in the first project area, working toward creating a model for ADE screening for broader adoption and dissemination. At the end of the grant funding period, the opioid simulator had been developed and tested. In the initial analysis, it was shown to be effective as a teaching tool. In addition, early analysis for the health literacy trial suggested that there may be a small or null benefit to the patient.

The research team has been active in disseminating their findings through publications and presentations. In addition to the project's final report that includes associated publications, additional information on the progress of TOP-MEDs may be found via the National Patient Safety Foundation.