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Patient Safety

Overview of Patient Safety Learning Laboratory (PSLL) Projects

Introduction

Patient safety learning laboratories (PSLLs) take a systems engineering approach to allow researchers and practitioners to evaluate clinical processes and enhance work and information flow to improve patient safety. The learning laboratories use cross-disciplinary teams to address the patient safety-related challenges providers face. This approach can involve evaluating the physical (built) environment, technological factors such as health information technology (IT), and clinical workflow processes relevant to the patient's condition. Emphasis is placed on the system-level confluence of these multiple factors in producing better patient safety.

AHRQ supports the PSLLs through the Agency's patient safety program. In 2014 and 2015, AHRQ funded 13 multiyear demonstration grants through the P30 mechanism to evaluate the use and effectiveness of various systems engineering approaches and the role they can play in improving the safety and quality of healthcare delivery.

In 2018 and 2019, AHRQ funded 17 additional PSLL grants (9 in 2018, and 8 in 2019) through the R18 mechanism and expanded the focus to include projects that aim to improve diagnosis and treatment issues. Below are brief summaries of these projects. Each summary includes the project title, principal investigator and organization, AHRQ grant number, project start and end dates, and a description of the focus and goals of the project. Contact information for each principal investigator is at the end, after all the summaries.

AHRQ’s PSLLs have the potential to improve the safety of healthcare by allowing healthcare practitioners to acquire valuable experience in a variety of clinical settings, reducing patient risk and improving safety. These newly funded projects will inform providers, health educators, payers, policymakers, patients, and the public about the effective use of systems engineering approaches in improving patient safety.

Project Descriptions

P30 Projects Funded in 2014 and 2015

Brain Health Patient Safety Learning Laboratory (Brain Safety Lab)

Principal Investigator: Christopher Callahan, M.D., Indiana University, Indianapolis, IN
AHRQ Grant No.: HS24384
Project Period: 09/30/15–03/31/20
Description: The Brain Safety Lab was a collaboration between the Indiana University School of Medicine, the Indiana University School of Informatics and Computing, the Indiana University School of Nursing, the Purdue University Schools of Biomedical and Industrial Engineering, the Purdue College of Pharmacy, the Regenstrief Institute, Inc., and a safety-net healthcare system (Eskenazi Health).

The specific aim of this project was to:

  1. Prevent harms to brain health among an AHRQ priority population at high risk for avoidable harm.

This learning lab focused on patient safety harms related to the use of medications among older adults. It focused on older adults because they are the largest reservoir of medication use, overuse, and misuse and are particularly vulnerable to brain safety concerns.

Building an Ambulatory Patient Safety Learning Laboratory for Diverse Populations (ASCENT)

Principal Investigator: Urmimala Sarkar, M.D., University of California-San Francisco, San Francisco, CA
AHRQ Grant No.: HS023558
Project Period: 09/30/14–09/29/2020
Description: The overall goal of this project is to examine the epidemiology of patient safety in ambulatory care settings that care for diverse, low-income populations.

The specific aims are to:

  1. Develop feasible, timely, and accurate electronic measures of patient safety notification and monitoring gaps in an ambulatory care setting for high-risk subpopulations and characterize the extent of disparities in patient safety.
  2. Conduct a root cause analysis of patient safety notification/monitoring gaps in five public ambulatory care settings to identify factors contributing to these disparities.
  3. Evaluate the pilot implementation of patient safety monitoring methodologies developed from Aims 1 and 2 across five diverse ambulatory healthcare settings.

The design and development components of this project address issues such as: (a) test results management; (b) outpatient monitoring for high-risk conditions; and (c) enhanced medication comprehension to reduce adverse drug events. The approach emphasizes an implementation sciences methodology with a quasi-experimental design to assess outcomes.

Caregiver Innovations to Reduce Harm in Neonatal Intensive Care

Principal Investigator: Eric J. Thomas, M.D., University of Texas, Houston, TX
AHRQ Grant No.: HS24459
Project Period: 09/30/15–09/29/20
Description: The goal of the University of Texas Patient Safety Learning Laboratory (UTPSLL) is to create an environment of collaborative learning focused on reducing all-cause preventable harm by 50 percent in the neonatal intensive care unit (NICU).

The specific aims are to:

  1. Increase parent engagement.
  2. Improve staff training on nutrition and respiratory care in neonates.

The learning lab plans to achieve its goals and aims by using five cores of experts in robust process improvement (methods of Lean, Six Sigma, and change management); electronic health records (EHRs); parent engagement; patient safety measurement; and project administration and leadership. These experts collaborate with clinician leaders, frontline caregivers, and parents from Memorial Hermann Health System NICUs to reduce all preventable harms.

Engineering Highly Reliable Learning Lab

Principal Investigator: Sara Singer, Ph.D., Harvard University, Cambridge, MA
AHRQ Grant No.: HS24453
Project Period: 09/30/15–09/29/20
Description: The goal of this learning lab is to enhance capacity for innovation and develop highly reliable systems that address communication and coordination challenges that pose patient safety risks at the intersection of primary and specialty care. A five-stage innovation cycle, including problem analysis, design, development, implementation, and evaluation, drives learning lab efforts to develop highly reliable systems within 19 Harvard-affiliated primary care practices and their specialty care partners.

The specific aims are to:

  1. Transform a highly functioning collaborative into a Primary Care Learning Laboratory (PCLL) to increase capacity for innovation and to address key patient safety challenges in primary care settings.
  2. Apply systems engineering and operations management theory and methodologies to design and develop innovative solutions for improving safety for patients at risk for cancer and for patients at risk for a variety of harms due to complex medical and/or psychosocial circumstances.
  3. Implement and evaluate redesigned systems across PCLL practices.
  4. Assess the impact of the PCLL on practice, team, provider, and patient outcomes.

Three synergistic projects engage health system-based reengineering and design teams in problem analysis and hands-on development, testing, and implementation of highly reliable closed-loop systems for high-priority primary to specialty care referrals; coordination systems for children with medical complexity undergoing surgery; and diagnosis and management systems for new medical conditions in adults with complex care needs.

Enhancing Patient Safety Through Cognition and Communication (M-Safety Lab)

Principal Investigator: Sanjay Saint, M.D., University of Michigan, Ann Arbor, MI
AHRQ Grant No.: HS24385
Project Period: 09/30/15–12/31/19
Description: The goal of this learning lab was to increase communication and cognition among healthcare workers to improve the safety of hospitalized patients. To achieve this goal, the learning lab developed two projects: (1) an alert system to reduce pressure ulcers in hospitalized patients; and (2) cognitive processes that contribute to errors in diagnosis and treatment.

The specific aim was to:

  1. Establish a cohesive M-Safety Lab composed of multidisciplinary, collaborating teams of investigators supported by a robust infrastructure, including an Innovation, Development, Evaluation, and Administration (IDEA) Core that will help oversee the development and successful completion of both projects from problem analysis to evaluation, and will provide methodological, technical, and administrative support for the M-Safety Lab.

The M-Safety Lab focused on developing and testing novel approaches—using healthcare engineering—to enhance medical decision making through cognition and communication to reduce hospital-acquired complications. The learning lab’s work was significant because the projects integrated relevant disciplines to improve patient safety and could be scaled up if evidence suggested these approaches were effective.

Failure to Rescue Patient Safety Learning Lab (FTR PSLL)

Principal Investigator: George Blike, M.D., Dartmouth-Hitchcock, Lebanon, NH
AHRQ Grant No.: HS24384
Project Period: 09/30/15–03/31/20
Description: The FTR PSLL was focused on creating the ideal hospital rescue system. Minimizing FTR (i.e., death following a major complication) is critical to reducing mortality in hospitalized patients. Successful rescue hinges on early recognition and timely management of serious complications once they occur.

The specific aims were to:

  1. Target gaps in understanding the technology factors behind ideal risk assessment and risk surveillance.
  2. Support early detection of complications and the human factors that support the ideal individual and team response in effectively managing these complications.

A novel translation approach was used to rapidly support reliable “early” rescue. Ultimately, the ideal integrated rescue system has potential to reduce both the mortality and the harm currently associated with FTR.

Institute for the Design of Environments Aligned for Patient Safety (IDEA4PS)

Principal Investigator: Susan Moffatt-Bruce, M.D., The Ohio State University, Columbus, OH
AHRQ Grant No.: HS24379
Project Period: 09/30/15–09/29/20
Description: The goal of IDEA4PS is to improve workflows and information transfers in the healthcare environment.

The specific aims are to:

  1. Explore how cardiac alarms affect healthcare provider decision making.
  2. Conduct surveillance of healthcare-acquired infections in real time.
  3. Implement and evaluate secure messaging in EHRs.

This learning lab integrates systems engineering, design, human factors, organizational behavior, evaluation, and data analysis to explore the way feedback of information is incorporated into the adaptation of work systems to enhance patient safety. The intent is to frame how all kinds of data, both those currently collected and newly acquired, are leveraged to actionable information and linked to patient outcomes.

Making Acute Care More Patient-Centered

Principal Investigator: David Bates, M.D., Brigham & Women’s Hospital, Boston, MA
AHRQ Grant No.: HS23535
Project Period: 09/30/14–09/29/19
Description: The goal of this learning laboratory was to develop tools to engage patients, families, and professional care team members by reliably identifying, assessing, and reducing patient safety threats in real time, before they manifested in actual harm.

The project aims were to:

  1. Engage patients and their family caregivers in the design of health information technology (IT) tools to prevent patient falls and related injuries during an acute hospitalization.
  2. Engage healthcare providers and patients in the design and development of a Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication.
  3. Iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and foster a learning health system.

This PSLL created and implemented an English and Spanish version of the Fall TIPS (Tailoring Interventions for Patient Safety) toolkit, which reduced falls by 25 percent in acute care hospitals. Today, the toolkit is used in more than 100 hospitals across the United States and internationally.

The lab launched the Patient SatisfActive® Model. This proactive, patient-centered care program uses a suite of health IT tools—patient safety dashboard, bedside display, and patient portal—to engage patients, families, and healthcare providers in improving patient safety. The creation of English and Spanish versions of a web-based, mobile-enabled application, called MySafeCare, is allowing patients and families to submit safety concerns and events in real time.

This PSLL’s work has resulted in:

  • At least 23 peer-reviewed journal publications, with more than 150 citations in other publications.
  • More than 12 presentations at institutions and conferences across the United States to help other organizations bridge the gap between health IT and patient and provider needs.
  • Two new websites (http://www.patientsafetyresearch.org/PSLL/home.html and http://www.falltips.org/); and
  • Laminated posters and paper tools to meet the needs of diverse hospital environments.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications are available.

Publications

Optimizing Safety of Mother and Neonate in a Mixed Methods Learning Laboratory

Principal Investigator: Louis Halamek, M.D., Stanford University, Stanford, CA
AHRQ Grant No.: HS023506
Project Period: 09/30/14–09/29/19
Description: The goal of this project was to establish a PSLL to advance patient safety for neonates and mothers before, during, and after delivery. The laboratory carried out four interrelated projects to:

  1. Develop and test an optimal neonatal resuscitation data display.
  2. Develop and test an optimal maternal data display
  3. Develop a process to recognize and prevent maternal clinical deterioration, and
  4. Develop the optimal physical design of a labor and delivery suite.

The project aims were to:

  1. Study how flow of communication may affect patient safety. In this context, the flow of communication usually referred to the passing of information (in either direction) between clinicians and others, primarily other clinicians.
  2. Examine how physical design elements may affect patient safety. These elements ranged from design of physical devices and organization of patient beds and storage spaces to layout of a patient room.
  3. Develop a systematic method to study patient safety using a stepwise approach of problem analysis through qualitative research, design, development, implementation, and evaluation.

This PSLL developed, piloted, and tested innovative designs that resulted in the creation of:

  • A maternal data display for the obstetrical team designed to improve situation awareness and enhance care in times of crisis. The display is linked to the electronic medical record (EMR) and provides easily recognizable visual cues (e.g., color-coding).
  • A neonatal data display designed to show key neonatal physiologic variables, such as heart rate and minute-to-minute changes in hemoglobin-oxygen saturation, in a manner that supports decision making.
  • A delayed cord-clamping cart (DCCC) designed to provide a stable platform for the neonate while still connected to the umbilical cord. A patent was filed for the DCCC in 2018.
  • A labor and delivery room designed to provide comfort and privacy for women in labor that also meets the needs of healthcare professionals caring for these women and their newborns, even during a crisis. This room was designed to facilitate safe, effective, and efficient patient care.
  • A pelvic lift cushion designed to provide a comfortable, effective, reusable, inexpensive, and portable option for these women when gynecological beds (with stirrups) were not available.

Knowledge gained from this PSLL has been disseminated via at least 10 peer-reviewed publications, presentations at multiple conferences, and several posters. A sample of their publications is listed below. A longer description of this lab’s work and associated publications are available.

Publications

Patient Imaging Quality and Safety Laboratory (PIQS Lab)

Principal Investigator: Leora Horwitz, M.D., New York University (NYU), New York, NY
AHRQ Grant No.: HS24376
Project Period: 09/30/15–06/30/20
Description: The goal of the PIQS Lab is to be a dynamic learning environment focused on improving safety and outcomes for patients. The multidisciplinary PIQS Lab connects experienced clinicians in the NYU departments of Radiology, Emergency Medicine, Medicine, Orthopedics, Surgery, and Urology with operations, human factors, and management experts at NYU Langone Medical Center (NYULMC), the NYU Wagner School of Public Policy, and the NYU Stern School of Business; and with design experts at the design firm IDEO.

The specific aims are to:

  1. Redesign the radiology ordering process in the outpatient setting to minimize inappropriate or unnecessary radiology tests.
  2. Redesign the inpatient consultation process to improve patient safety.
  3. Enhance the follow-up of radiology test results to improve patient outcomes.

Projects examine radiology imaging failures through similar conceptual lenses of shared sense making (making sense of dynamic and ambiguous information without oversimplifying or ignoring discordant data) and sociotechnical systems (nature of the work, human-system interfaces, organization, environment, management). PIQS Lab faculty take a design and engineering approach to clinical redesign, beginning with indepth problem analysis, then proceeding through design (brainstorming), development (prototyping), implementation, and evaluation phases.

Realizing Improved Patient Care Through Human-Centered Design in the Operating Room (RIPCHD.OR)

Principal Investigator: Anjali Joseph, Ph.D., Clemson University, Clemson, SC
AHRQ Grant No.: HS24380
Project Period: 09/30/15–08/31/20
Description: The overarching goal of RIPCHD.OR is to develop an evidence-based framework and methodology for the design and operation of a general surgical operating room to improve safety.

The specific aims are to:

  1. Improve the usability of anesthesia-related alarms in the Operating Room (OR).
  2. Understand and improve traffic flow in the OR.
  3. Incorporate modern technology into OR designs.

RIPCHD.OR uses a multidisciplinary human-centered approach that incorporates evidence-based design, human factors, and systems engineering principles. The design, process, and technology solutions that emerge from this learning lab will be implemented and tested in the new Medical University of South Carolina Ambulatory Surgery Center in Charleston.

Transdisciplinary Learning Lab to Eliminate Patient Harm and Reduce Waste

Principal Investigator: Adam Sapirstein, M.D., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: HS23553
Project Period: 09/30/14–03/29/19
Description: The goal of the Johns Hopkins Armstrong Institute Learning Lab was to use systems engineering methods to partner with patients, patients’ families, and others to eliminate preventable harm, optimize patient outcomes and experience, and reduce waste in healthcare.

The project aims were to:

  1. Develop high-level design requirements for an ideal intensive care unit (ICU), using design thinking and systems engineering methods.
  2. Leverage open-application programming interfaces to engineer interoperability between electronic health records and infusion pumps.
  3. Develop and implement an indicator of unit-level stress in an engineered care system to predict and mitigate risk.

The lab achieved its aims in the following ways. It:

  • Created a graphic roadmap for using the quality function deployment process to share with organizations that want to become high-reliability hospitals.
  • Automated and validated the nurse-managed insulin infusion protocol at Johns Hopkins to illustrate the potential of optimizing safety, efficiency, and workload via system interoperability; and
  • Conducted the first application of statistical and machine learning techniques to develop a prediction model for the susceptibility of ICU patients to preventable harms.

This PSLL’s work has resulted in at least six peer-reviewed journal publications, as well as posters and presentations at conferences across the United States.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications are available.

Publications

Yale Center for Healthcare Innovation, Redesign, and Learning (CHIRAL)

Principal Investigator: Sarwat Chaudhry, M.D., Yale University, New Haven, CT
AHRQ Grant No.: HS23554
Project Period: 09/30/14–09/29/19
Description: The goal of CHIRAL was to improve transitions of care. Patients being transferred from one setting to another or one clinical team to another are at increased risk for a host of failures. These include identification errors, delayed or missed diagnoses, redundant testing, treatment delays or errors, medication errors, and unexpected clinical deterioration.

The project aims were to:

  1. Improve patient safety at the time of transition through redesign of transfers of patients into Yale New Haven Hospital (YNHH) from outside hospitals and emergency departments (EDs).
  2. Redesign transfers within YNHH between the ED or intensive care unit (ICU) and general hospital units.
  3. Redesign transfers out of YNHH to skilled nursing facilities (SNFs).

This PSLL created a framework to improve intra- and interhospital transfers that can guide the intervention work of departments within a hospital and at other facilities to address the domains of the transfer process, dimensions of the hospital context, and outcomes of transfers. To support this work, the lab developed the following products:

  • Multiple survey instruments.
  • A new measure tool to assess staff experience of intrahospital patient transfers.
  • Real-time dashboards.
  • Redesigned call-in templates in Epic, and
  • Training programs for staff.

CHIRAL conducted a multimodal study to improve the quality and safety of interhospital transfer for clinically ill patients. Results included a reduced mortality rate of patients with atraumatic intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH) from 29 percent before intervention to 11 percent postintervention.

This PSLL’s work has resulted in:

  • At least 10 peer-reviewed journal publications—4 in 2019—with nearly 30 citations in other publications.
  • Nearly a dozen presentations at institutions and conferences across the United States.
  • A new website (https://medicine.yale.edu/chiral/); and
  • Thirteen posters describing the studies conducted.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications are available.

Publications

R18 Projects Funded in 2018

Acute Care Learning Laboratory—Reducing Threats to Diagnostic Fidelity in Critical Illness

Principal Investigator: Brian Pickering, M.B., B.CH., Mayo Clinic, Rochester, Rochester, MN
AHRQ Grant No.: HS26609
Project Period: 09/30/18–07/31/22
Description: This learning lab will use mixed-methods and systems engineering research approaches to understand the interplay of the multiple factors contributing to diagnostic error and delay. The lab’s work will address ineffective implementation of diagnostic improvement strategies that focus on the healthcare team’s role but failed to incorporate the complexity of the organizational and systems processes within the clinical environment. The “Control Tower” system will be the staging ground for the in situ learning laboratory and will be built on top of a well-established clinical informatics infrastructure and hospital environment open to innovation and practice change.

The specific aims are to:

  1. Develop and validate automated phenotypes of diagnostic error and delay that can be applied in near-real time to medical record data.
  2. Engage stakeholders in the mixed-methods and systems engineering approach to identify factors contributing to diagnostic error and delay. Then design and develop applicable system-based interventions.
  3. Evaluate the feasibility and preliminary effectiveness of learning laboratory interventions on the rate of diagnostic error and delay in patients with emerging critical illness.

Ambulatory Pediatric Safety Learning Lab

Principal Investigator: Kathleen Elizabeth Walsh, M.D., M.Sc., Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
AHRQ Grant No.: HS26644
Project Period: 09/30/18–09/29/22
Description: The Ambulatory Pediatric Safety Learning Lab is focusing on preventable harm in children caused by healthcare, specifically on management of chronic conditions with families. The overarching goal is to redesign systems of care and coordination between the clinic and home to eliminate harm due to healthcare in these settings.

The specific aims are to:

  1. Redesign processes for adjustment of medication dosing based on clinical information gathered by the patient/family to prevent medication errors. (This process will be studied in type 1 diabetes.)
  2. Create processes for patient/family medication monitoring and communication with the clinic to prevent adverse drug events. (This process will be studied in children with autism spectrum disorder on antipsychotics.)
  3. Design a workflow to plan for, detect, and prompt management of serious illness among children with chronic conditions at home. (This process will be studied in both populations.)

This learning lab draws on design expertise from the Mad*Pow design agency, systems engineering expertise from the University of Wisconsin Systems Engineering Initiative, and patient-centered research and implementation expertise from the Cincinnati Children’s Hospital. Upon completion of the project, lab researchers plan to scale the interventions nationally through the Solutions for Patient Safety (SPS) Network and improve pediatric ambulatory safety across the United States.

Cancer Patient Safety Learning Laboratory (CaPSLL): Preventing Clinical Deterioration in Outpatients

Principal Investigator: Matthew Weinger, M.D., Vanderbilt University Medical Center, Nashville, TN
AHRQ Grant No.: HS26616
Project Period: 09/30/18–09/29/22
Description: CaPSLL addresses the problem of effective clinical surveillance, early recognition, timely notification of the appropriate clinician, and effective intervention to prevent and mitigate clinical deterioration in medically complex (e.g., cancer) patients. To address the specific safety failure of FTR, hospitals have introduced new tools and processes (e.g., continuous monitoring, early warning systems, rapid response teams).

The specific aims are to:

  1. Create and refine software tools and a predictive model for a surveillance-and-response system to prevent harm from unexpected all-cause clinical deterioration in outpatients receiving cancer treatment.
  2. Create and refine processes and training that engage patients and their caregivers as active and reliable participants in detecting and reporting potential clinical deterioration. Researchers will apply high-reliability organizational principles and theories to develop processes and training for the relevant team, the cancer patients, their caregivers, and the clinicians who need to respond to signals from the surveillance system.
  3. Implement in the operational environment and formally evaluate the integrated detection and response tools and processes.

CaPSLL is a collaboration between the Vanderbilt-Ingram Cancer Center, human factors and systems engineering faculty in the Center for Research and Innovation in Systems Safety, and faculty in the Schools of Engineering and Management. The lab partners with surgeons, oncologists, nurses, staff, adult patients with lung and head or neck cancer recovering from and/or undergoing treatment as outpatients, and their lay caregivers to more reliably detect and respond more effectively to unexpected clinical deterioration.

Connected Emergency Care Patient Safety Learning Lab (CEC PSLL)

Principal Investigator: Scott Levin, M.S., Ph.D., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: HS26640
Project Period: 09/30/18–07/31/22
Description: The goal of the CEC PSLL is to reduce health and financial harm for patients with lower respiratory tract infection (LRTI) caused by a fragmented emergency care system. Using advanced data science methods and EHR-integrated clinical decision support (CDS), researchers will establish a connected (closed-loop) emergency care system.

The specific aims are to:

  1. Optimize diagnostic performance for patients with suspected LRTI by: (a) minimizing overuse of avoidable imaging and laboratory testing; and (b) expediting detection of patients with severe LRTI.
  2. Increase the specificity of antibiotic treatment for patients with LRTI by: (a) reducing inappropriate prescribing; and (b) enabling targeted antibiotic therapy, indication, spectrum, and dose.
  3. Improve transition of care outcomes after the ED encounter is complete by reducing: (a) unnecessary hospitalizations and sudden care-level changes for those admitted; and (b) 30-day postencounter acute care utilization for those discharged.

The lab uses a systems engineering approach to CDS development that connects ED clinicians to the patient’s pre-encounter context, postencounter outcomes, and intraencounter current and projected state. The lab plans to accomplish this goal by increasing the use of longitudinal, contextual assessments considering the time pressure and excessive cognitive loading in the ED.

Engineering Safe Care Journeys for Vulnerable Older Adults

Principal Investigator: Pascale Carayon, Ph.D., University of Wisconsin (UW), Madison, WI
AHRQ Grant No.: HS26624
Project Period: 09/30/18–07/31/22
Description: This learning lab aims to develop a transdisciplinary project focusing on care for vulnerable older patients over 65 who are diagnosed with a fall or a suspected urinary tract infection in the ED. In order for older adults to transition safely in their journey that begins in the ED, researchers propose creating a “patient safety passport” that will provide opportunities for error detection and recovery, for anticipating patient safety issues in the subsequent steps of the journey, and for improving communication and coordination. Researchers use the Systems Engineering Initiative for Patient Safety (SEIPS) model as the conceptual framework for addressing multiple patient safety issues and healthcare-associated harms experienced by older adults during their care journey.

The lab’s transdisciplinary team of engineers, health services researchers, nurses, physicians, and pharmacists collaborate with UW Health, a large health system with both academic and community EDs, to create and evaluate a system of care that supports the safe journey of older adults after presentation in the ED.

The specific aims are to:

  1. Use a systematic analysis, design, develop, implement, and evaluate a system of care (identified as the patient safety passport) that supports the safe journey of older adults after ED presentation.
  2. Develop a transdisciplinary PSLL aimed at engineering safe care journeys for vulnerable patients, including older adults.

Identifying and Reducing Errors in Perioperative Anesthesia Medication Delivery

Principal Investigator: Ken Catchpole, Ph.D., Medical University of South Carolina, Charleston, SC
AHRQ Grant No.: HS26625
Project Period: 09/30/18–07/30/22
Description: This learning lab is conducting a study of anesthesia medication safety systems. The lab uses a multidisciplinary team of anesthesiologists, human factors professionals, biomedical engineers, pharmacists, and certified registered nurse anesthesiologists to engineer reductions in anesthesia medication errors in operating rooms in order to address three sources of failure: preparation and delivery errors (Failures of Execution); decision making involved in diagnosing and prescribing (Failures of Intention); and complexity of the working environment, physical workspace, or safety culture (Performance Shaping Factors).

The specific aims are to:

  1. Explore solutions to failures in diagnosis, selection, and prescribing of intraoperative anesthesia medication.
  2. Develop methods to reduce failures in the preparation, administration, and recording of intraoperative anesthesia medication.
  3. Understand and improve workspace design and safety culture to influence anesthesia medication selection and delivery.

Improving Diagnosis in Emergency and Acute Care: A Learning Laboratory (IDEA-LL)

Principal Investigator: Prashant Mahajan, M.D., M.P.H., M.B.A., University of Michigan, Ann Arbor, MI
AHRQ Grant No.: HS26622
Project Period: 09/30/18–07/31/22
Description: IDEA-LL plans to address diagnostic decision making, associated cognitive processes, and uncertainty in Emergency Department (EDs). To reduce diagnostic errors in the ED, researchers will use methods that illustrate the dynamics of human-system interaction during diagnostic processes. The lab’s goal is to create a program for diagnostic safety surveillance and intervention using actionable, patient-centered data obtained from both frontlines of care and EHRs.

The specific aims are to:

  1. Understand the detailed process of diagnostic decision making and identify potential factors that lead to diagnostic errors using mixed methods-grounded theory (i.e., combining qualitative data [participant observations, indepth participant interviews] and mining of historical data).
  2. Develop a comprehensive list of patient, provider/care team, and system-level contributory factors and identify interventions to be studied using consensus methods.
  3. Test the effectiveness and impact of the interventions at the four EDs using mixed methods (i.e., quantitative and qualitative measures).

IDEA-LL will use multidisciplinary approaches to design, implement, and evaluate interventions to improve diagnostic safety. The investigative team, led by a unique physician-engineer partnership, will form a transdisciplinary environment of clinicians, nurses, patients, engineers, informaticians, and designers as an integral aspect of the learning laboratory to address both pediatric and adult emergency care in academic and community EDs.

Improving the Safety of Diagnosis and Therapy in the Inpatient Setting

Principal Investigator: David Bates, M.D., Brigham & Women’s Hospital, Boston, MA
AHRQ Grant No.: HS26613
Project Period: 09/01/18–06/30/21
Description: This learning lab focuses on improving diagnosis and linking that diagnosis to the correct treatment in acute care. To address this overall issue, the lab uses rigorous systems engineering and human factors methods to guide its approach.

The specific aims are to:

  1. Problem Analysis – Use systems engineering methods to analyze the problem of diagnostic and therapeutic error and identify system and cognitive factors for a set of morbid, costly common conditions and undifferentiated symptoms.
  2. Design and Development – Use human factors methods and rapid, iterative prototyping to design and develop potential solutions, and develop a set of interventions to engage the care team and patient/caregivers to ensure treatment trajectories match the anticipated course for working diagnoses or symptoms, ensuring alignment with patient and clinician expectations.
  3. Implementation and Evaluation – Pilot test, train clinical staff, implement the intervention in the acute care setting, assess impact on diagnostic errors that lead to patient harm (stepped wedge), and perform quantitative and qualitative evaluations.

From the current PSLL and other work, lab investigators have built a variety of technological approaches used to interact with patients and providers. For example, they will use a safety dashboard, integrated with the health system’s EHR, which is routinely used as a checklist to ensure safety during delivery of care at Brigham & Women’s Hospital. The lab will also ask patients (and their caregivers as appropriate) whether they are concerned that their diagnosis or treatment may not be correct and will share that concern with the care team.

Pediatric Patient Safety Learning Laboratory to Reengineer Continuous Physiologic Monitoring Systems

Principal Investigator: Christopher Bonafide, M.D., M.S.C.E., Children’s Hospital of Philadelphia (CHOP), Philadelphia, PA
AHRQ Grant No.: HS26620
Project Period: 09/30/18–07/31/22
Description: The PSLL at CHOP has the goal of analyzing and reengineering hospital and home physiologic monitoring systems to maximize alarm informativeness; reduce alarm fatigue; and improve critical illness detection, diagnosis, and treatment. The lab seeks to assess current monitoring systems used to continuously monitor children’s vital signs in hospital ward and home settings, and evaluate the alarms intended to warn caregivers and nurses in the hospital and parents at home of conditions that warrant their immediate attention.

The specific aims are to:

  1. Reengineer the system of monitoring hospitalized children on acute care wards, with a focus on reducing noninformative alarms and accelerating nurse responses to critical events.
  2. Reengineer the system of monitoring infants with bronchopulmonary dysplasia at home, with a focus on reducing noninformative hypoxemia alarms and improving clinicians’ access to usable longitudinal pulse oximetry data to inform supplemental oxygen treatment.

This PSLL brings together expertise from CHOP, University of Pennsylvania, and the ECRI Institute in diverse areas, including patient safety, pediatric hospital medicine, neonatology, nursing, systems engineering, human factors, design, medical device development, EHR CDS, cognitive informatics, simulation, and biostatistics. This project uses a framework based on the SEIPS model and Dual Process Theory, and will apply innovative methods such as forensic accident investigation, video alarm analysis, and in situ simulation to analyze and evaluate monitoring systems.

R18 Projects Funded in 2019

Open Wide Learning Lab (OWLL): Improving Patient Safety in Dentistry

Principal Investigator: Muhammad Walji, Ph.D., University of Texas Health Science Center at Houston, Houston, TX
AHRQ Grant No.: HS027264
Project Period: 09/09/19–09/08/23
Description: The OWLL addresses the problem of adverse events (AEs) in dentistry—a field that routinely performs highly technical and risky procedures in complex environments—using systems engineering to identify and reduce potential threats and improve patient safety.

Investigators will apply the lessons learned from two previous projects (R01 DE022628 and R01 HS024406) that supported (1) the development and testing of a Patient Safety Toolkit and creation of a data repository to collect, organize, and classify data; and (2) large-scale chart reviews to determine the incidence of dental AEs and impact on populations facing disparities.

The project’s aims are to:

  1. Identify and understand the contributing factors (conduct problem analysis) for commonly occurring dental AEs.
  2. Design and develop improvement strategies to prevent AEs using a systems-based human-centered design process.
  3. Implement and evaluate improvement strategies at two institutions and evaluate their impact on proximal and distal outcomes using a stepped-wedge, clustered randomized control trial.

With current funding, the OWLL will identify, assess, and address patient safety incidents at two large academic dental institutions in Texas and California, where investigators will systematically identify threats to dental patient safety and iteratively test improvement strategies to prevent them.

Patient Safety Learning Laboratory to Enhance the Value and Safety of Neonatal Interfacility Transfers in a Regional Care Network

Principal Investigator: Rachel Umoren, MBBCH, M.S., University of Washington, Seattle, WA
AHRQ Grant No.: HS027259
Project Period: 09/03/19–09/02/23
Description: The goal of this project is to establish a PSLL to advance patient safety for critically ill newborns during medical ground or air transport from one hospital to another within a regional network. The project will use a five-stage innovation cycle (problem analysis, design, development, implementation, and evaluation) to identify and address the salient issues and risks of regional neonatal transportation for which new and innovative approaches are needed.

The project’s aims are to:

  1. Collaboratively analyze current workflow processes, transport records (local and statewide databases), and facilities at referral and receiving facilities to develop a complete understanding of system issues and to define the current and ideal states.
  2. Redesign clinical workflow processes to optimize regional consultation, triage, and transport of newborns to facilities with the appropriate level of care and availability of space and staffing.
  3. Design and develop a novel, secure Transport Monitoring and Communications (T-MAC) system to enhance video communication while on transport via input of clinical transport team staff and stakeholders with systems engineers.
  4. Repeatedly test and revise the T-MAC system to ensure it can functionally and efficiently facilitate information flow between the medical control physician, referring facility, and transport team.
  5. Develop robust documentation processes that can conveniently be used during the transport, including checklists that prompt safety behaviors, and provide a robust dataset for tracking adverse patient safety events.

In collaboration with transport providers, neonatologists, general pediatricians, nurses, parents, design specialists, engineers, and other stakeholders, investigators will analyze current workflow processes, transport records (local and statewide databases), and referral and receiving facilities to develop a complete understanding of system issues and to define the current and ideal states.

PROMIS Learning Lab: Partnership in Resilience for Medication Safety

Principal Investigator: Yan Xiao, Ph.D., University of Texas at Arlington, TX
AHRQ Grant No.: HS027277
Project Period: 09/11/19–09/10/23
Description: The objective of the PROMIS Learning Lab is to reduce preventable medication-related harm using behavioral science via a partnership approach, especially among patients 65 and older. A systems engineering approach will be used at two in situ lab clinics from a practice-based research network, where problem analysis, design, and evaluation will be conducted.

The project’s aims are to:

  1. Identify and define primary care work system design requirements to address commonly occurring medication-related safety hazards and to enable resilient performance through partnership.
  2. Improve the value of primary care services using work system design strategies, such as informational tools, task redesign, and space layout, to enable and build capacity for resilient performance.
  3. Implement and evaluate redesign work system components at two primary care clinics.

The PROMIS Lab includes community partners to involve older adults and their caregivers in design cycles, and a network of informant clinics for observations and learning. Investigators will provide extensive multidisciplinary expertise, including geriatric nursing, systems engineering, behavioral economics, and healthcare simulation, as well as offer expertise in pharmacology, family medicine, and health services research. Impact will be insights along with innovative yet practical tools, design guidelines, and collaboration support strategies for teamwork beyond clinic walls.

R18 Closed Loop Diagnostics: AHRQ R18 Patient Safety Learning Laboratories

Principal Investigator: Russell Phillips, M.D., Harvard University Medical School, Boston, MA
AHRQ Grant No.: HS027282
Project Period: 09/10/19–09/09/23
Description: This project addresses diagnostic errors in primary care often caused by failures to follow up (close the loop) on diagnostic tests, referrals, and symptoms. This research will use innovative, evidence-based systems engineering methods that have been used to develop highly reliable and robust processes in other industries but have not yet been widely adopted in healthcare. Key innovations of this project are the use of high reliability and human factors methods; inclusion of patients and clinicians from other practices throughout the engineering process; and combined use of statistical, qualitative, and computer modeling methods to estimate improvements both in the primary site and more broadly.

More specifically, the aims of this project are to:

  1. Design, develop, and refine highly reliable closed loop systems for diagnostic tests and referrals that ensure these occur within clinically and patient-important timeframes.
  2. Design, develop, and refine a highly reliable closed loop symptom-monitoring system to ensure clinicians receive information about evolving symptoms of concern.
  3. Ensure broader generalizability of results of Aims 1 and 2 by ensuring these new processes are effective in a community health center in an underserved community, a large telemedicine system, and a representative range of simulated other health system settings and populations.

Projected results include increased completion of high-risk diagnostic tests, referrals, and identification of concerning symptoms, in turn resulting in reduced diagnostic errors, negative health outcomes, and associated costs. Learning outcomes include improved understanding of closed loop diagnostic and monitoring problems in primary care, patient engagement in solutions to such problems, and utility of systems engineering for important healthcare problems.

Re-engineering for Accurate, Timely, and Communicated Diagnosis of Cardiovascular Disease in Women (DREAM Lab)

Principal Investigator: Christine Goeschel, Sc.D., M.P.A., M.P.S., R.N., MedStar Health Research Institute, Inc., Hyattsville, MD
AHRQ Grant No.: HS027280
Project Period: 09/12/19–09/11/23
Description: The goal of this learning lab is to apply a mixed-methods systems engineering approach to understand the complex interplay of factors contributing to cardiovascular disease (CVD) diagnostic error in women in the ambulatory care setting and to codesign and evaluate adaptive solutions.

Investigators will use a population health approach to evaluate factors including but not limited to the physical environment, social and economic determinants, clinical care, health IT, and health behaviors. Transdisciplinary teams leveraging systems engineering that uses novel tactics and rigorous evaluation techniques are positioned to successfully mitigate this complex problem.

The learning lab has the following specific aims:

  1. Identify the contributing factors leading to diagnostic errors and inappropriate clinical management of CVD in women.
  2. Develop pragmatic performance and improvement measures.
  3. Propose, prioritize, and co-design human-centered solutions to mitigate diagnostic risk.
  4. Evaluate the structure, process, and outcome effects of human-centered solutions on CVD diagnosis, clinical management, and communication in simulated and clinical environments.

This work will set up a clear pathway toward clinical implementation by systematically evaluating human-centered solutions in a simulated environment with input from practicing clinicians and patients as the end-users, followed by pilot testing promising solutions in the clinical environment.

Re-engineering Postnatal Unit Care and the Transition Home to Reduce Perinatal Morbidity and Mortality

Principal Investigator: Alison Stuebe, M.D., M.Sc., University of North Carolina, Chapel Hill, NC
AHRQ Grant No.: HS027260
Project Period: 08/30/19–08/29/23
Description: The goal of this learning lab is to identify underlying contributors to postnatal morbidity and mortality and codevelop more effective, sustainable, and scalable postnatal care. To achieve this goal, investigators plan to redesign systems of clinical maternity care by defining postnatal unit problems and creating an innovative, individualized delivery system for more effective mother-infant management during postnatal hospitalization and the discharge transition to home.

The University of North Carolina at Chapel Hill, in partnership with Systems Engineering at The Ohio State University and the North Carolina State University College of Design, will evaluate their systems redesign using the primary outcome of a 20 percent reduction in ED visits and readmission from discharge to 90 days postpartum for mothers and infants. To achieve this reduction, investigators plan to improve patient safety and care value in three intersecting domains: Mother/Baby Recovery, Precision Clinical Care, and Care Transition from Hospital to Home.

The specific aims are:

  1. Define priority areas by using mixed methods: Investigators will analyze current processes and procedures for maternal-infant dyadic evaluation and management during the postnatal unit stay and discharge transition through the lens of mothers, clinicians, EHR data, and other key stakeholders.
  2. Conduct iterative prototyping and evaluation of interventions: Building on identified design seeds, investigators will alternate between idea generation and evaluation until prototypes emerge that can be implemented and assessed in a low-stakes laboratory setting for refinement and then in the clinical setting.
  3. Implement and disseminate: In this phase, investigators will use Plan-Do-Study-Act (PDSA) cycles to fully implement “bundles” of successful innovations on the postnatal unit at North Carolina Women’s Hospital and evaluate the primary outcome of acute care utilization within 90 days postpartum. The result of this work will be a human-centered redesign of postnatal care to ensure safer transitions for growing families.

The project will enable a stronger start for mothers and their infants and will offer a more integrated, value-based model for care that can be shared with other hospitals for widespread implementation.

Targeted Healthcare Engineering for Systems Interventions in Stroke (THESIS)

Principal Investigator: Shyam Prabhakaran, M.D., M.S., University of Chicago, Chicago, IL
AHRQ Grant No.: HS027264
Project Period: 09/09/19–09/08/23
Description: The goal of this lab is to reduce diagnostic error and resulting treatment delays in the emergency department (ED) that contribute to missed opportunities to reduce death and disability in acute stroke patients.

Although recommendations and pathways for stroke evaluation and management exist, none of them have been systematically engineered, designed, or tested to identify and effectively address system failures, especially in diagnostic error.

The study aims will leverage three major health systems as a PSLL to:

  1. Conduct a multimodal problem analysis to understand latent failures, design constraints, and challenges that result in acute stroke diagnostic error.
  2. Intentionally design and develop an Acute Stroke Diagnostic Protocol to reduce acute stroke diagnostic error.
  3. Implement the Acute Stroke Diagnostic Protocol in patients presenting to the ED with potential acute stroke and evaluate its effect on diagnostic error and treatment times.

To achieve the lab’s goal, investigators plan to bring together a dynamic team of stroke neurology, emergency medicine, informatics, engineering, and health services experts at three large, diverse healthcare systems in Chicago with experience in the application of systems engineering, problem analysis, design and development, implementation, and evaluation methods. These methods will be used to identify and test solutions to reduce diagnostic error and resulting delays in evidence-based treatments for acute stroke patients in the ED.

Towards a Model of Safety and Care for Trauma Room Design

Principal Investigator: Sara Bayramzadeh, Ph.D., Kent State University, Kent, OH
AHRQ Grant No.: HS027261
Project Period: 08/29/19–08/28/23
Description: The goal of this learning lab is to take a comprehensive approach to study the dynamics among people, tasks, technology, organization, and the physical environment in a trauma room, specifically as they relate to workflow, interruptions and disruptions, technology integration, and sensory attributes.

The specific aims are to:

  1. Identify factors related to the physical environment that influence patient safety and efficient care in trauma rooms.
  2. Develop a time- and cost-effective novel approach to capture observational data in an autonomous and confidential manner to study work system components within trauma rooms.
  3. Develop design strategies to address patient safety and efficient care and to integrate technology such that future adaptability is maximized, as new models of patient safety emerge over time.
  4. Test proposed design strategies.
  5. Develop an evidence-based model, as an end product, for designing trauma rooms that support efficient patient care while maintaining a safe environment.

This study is novel in its approach to data collection and analysis. Through a transdisciplinary collaboration between Kent State University’s Healthcare Design, Nursing, and Computer Science programs and Cleveland Clinic Akron General, investigators will use the SEIPS model to investigate obstacles to improved patient safety outcomes in trauma rooms. In the long run, the developed design guide model is expected to contribute to patient safety in trauma rooms by serving as a primary source to direct the design of the next generation of trauma rooms.

Contact Information

PI Name Email Address Phone Number Institution AHRQ Project Officer
Bates, David dbates@partners.org (301) 664-8767 Brigham and Women’s Hospital Rodrick, David
Chaudhry, Sarwat sarwat.chaudhry@yale.edu (203) 458-0604 Yale University Burgess, Denise
Halamek, Louis halamek@stanford.edu (650) 724-4444 Stanford University Chew, Emily
Sapirstein, Adam asapirs1@jhmi.edu (410) 502-3233 Johns Hopkins University Rodrick, David
Sarkar, Urmimala usarkar@medsfgh.ucsf.edu urmimala.sarkar@ucsf.edu (415) 206-4273 University of California-San Francisco Shofer, Margie
Blike, George george.t.blike@hitchcock.org (603) 653-9733 Dartmouth-Hitchcock Burgess, Denise
Callahan, Christopher ccallaha@iupui.edu ccallaha@iu.edu (317) 423-5600 Indiana University Rodrick, David
Horwitz, Leora leora.horwitz@nyumc.org (646) 501-2848 New York University Rodrick, David
Joseph, Anjali anjalij@clemson.edu (864) 656-2273
(404) 583-5760		 Clemson University Rodrick, David
Moffatt-Bruce, Susan susan.moffatt-bruce@osumc.edu (614) 293-4509 The Ohio State University Gray, Darryl
Saint, Sanjay saint@umich.edu (734) 615-8341 University of Michigan Rodrick, David
Singer, Sara ssinger@hsph.harvard.edu
mkrikorian@hsph.harvard.edu		 (617) 432-7139 Harvard University Rodrick, David
Thomas, Eric eric.thomas@uth.tmc.edu (713) 500-7958 University of Texas Burgess, Denise
Bonafide, Christopher bonafide@email.chop.edu

 

 Children’s Hospital of Philadelphia Rodrick, David
Carayon, Pascale pcarayon@wisc.edu (608) 265-0503 University of Wisconsin Madison Rodrick, David
Catchpole, Ken catchpol@musc.edu (843) 792-4955 Medical University of South Carolina Rodrick, David
Levin, Scott slevin33@jhmi.edu

 

 

 

 Johns Hopkins University Rodrick, David
Mahajan, Prashant pmahajan@med.umich.edu (734) 763-9849 University of Michigan Ann Arbor Rodrick, David
Pickering, Brian pickering.brian@mayo.edu

 

 Mayo Clinic, Rochester Burgess, Denise
Walsh, Kathleen Elizabeth kathleen.walsh@cchmc.org (513) 803-4588 Cincinnati Children’s Hospital Medical Center Perfetto, Deborah
Weinger, Matthew matt.weinger@vanderbilt.edu (615) 936-6598 Vanderbilt University Medical Center Rodrick, David
Bayramzadeh, Sara sbayramz@kent.edu (330) 672-0936 Kent State University Rodrick, David
Goeschel, Christine Chris.a.goeschel@medstar.net

 

 MedStar Research Institute, Inc. Chew, Emily
Phillips, Russell Russell_Phillips@hms.harvard.edu (617) 432-2222 Harvard University Medical School Rodrick, David
Prabhakaran, Shyam shyam1@uchicago.edu

 

 University of Chicago Gray, Darryl
Stuebe, Alison astuebe@med.unc.edu (919) 966-1601 University of North Carolina Chapel Hill Chew, Emily
Umoren, Rachel rumoren@uw.edu (206) 543-3200 University of Washington, Seattle Eldridge, Noel
Walji, Muhammad Muhammad.F.Walji@uth.tmc.edu (713) 486-4275 University of Texas Health Science Center Houston Burgess, Denise
Xiao, Yan yan.xiao@uta.edu

 

 University of Texas at Arlington Perfetto, Deborah

AHRQ Project Officer Email Addresses

For more specific information on AHRQ's research priorities and funding opportunities, please visit Funding and Grants.

For specific programmatic questions about Patient Safety Learning Laboratories and other patient safety topics, please contact:

David Rodrick, Ph.D.
Agency for Healthcare Research and Quality
5600 Fishers Lane
Rockville, MD 20857
Phone: 301-427-1876
Email: David.Rodrick@ahrq.hhs.gov

Page last reviewed June 2020
Page originally created December 2016

Internet Citation: Overview of Patient Safety Learning Laboratory (PSLL) Projects. Content last reviewed June 2020. Agency for Healthcare Research and Quality, Rockville, MD.
https://www.ahrq.gov/patient-safety/resources/learning-lab/index.html

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