Quality Assurance/quality Improvement Research Articles

Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial

BackgroundIn 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation.MethodsThe site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks.ResultsOver the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings.ConclusionsSite study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process.Trial registrationClinicalTrials.gov Identifier NCT03783546 (21/12/2018).

Delivering Evidence-Based Online Concussion Education to Medical and Healthcare Professionals: The Concussion Awareness Training Tool (CATT).

Background Medical and healthcare professionals report an important gap in their training and knowledge on concussion diagnosis and management. The Concussion Awareness Training Tool (CATT) for medical professionals provides evidenced-based training and resources, representing an important effort to fill this gap. The goal of the current article was to summarize and describe the general uptake of the 2018 relaunch of the CATT for medical professionals and to present results of a quality assurance/quality improvement (QA/QI) assessment including qualitative feedback from medical and healthcare professionals. Methodology. Tracking completions via certificates and Google Analytics were used to measure uptake over the first two years following the 2018 relaunch and promotion of CATT for medical professionals. Medical and healthcare professionals who had completed the CATT from the time of the relaunch on June 11, 2018, to July 31, 2019, were invited via e-mail to participate in the survey-based QA/QI assessment. Both quantitative and qualitative data were collected. Results Year 1 saw 8,072 pageviews for the CATT for medical professionals landing page, increasing to 9,382 in Year 2. Eighty-nine medical and healthcare professionals who had completed the CATT for medical professionals participated in the QA/QI assessment. Results showed that 85% of respondents reported learning new information about concussion; 73% reported changing the way they diagnose, treat, or manage concussion; and 71% reported recommending the CATT to colleagues. Qualitative data also indicated highly favourable opinions and experiences. Conclusions The CATT for medical professionals has demonstrated promise as a tool to promote knowledge translation practice and help fill the gap in concussion training and knowledge reported by medical and healthcare professionals.

Epidemiological and Accounting Analysis of Ground Ambulance Whole Blood Transfusion.

In October 2017, the American Association of Blood Bankers (AABB; Bethesda, Maryland USA) approved a petition to allow low-titer group O whole blood as a standard product without the need for a waiver. Around that time, a few Texas, USA-based Emergency Medical Services (EMS) systems incorporated whole blood into their ground ambulances. The purpose of this project was to describe the epidemiology of ground ambulance patients that received a prehospital whole blood transfusion. The secondary aim of this project was to report an accounting analysis of these ground ambulance prehospital whole blood programs. The dataset came from the Harris County Emergency Service District 48 Fire Department (HCESD 48; Harris County, Texas USA) and San Antonio Fire Department (SAFD; San Antonio, Texas USA) whole blood Quality Assurance/Quality Improvement (QA/QI) databases from September 2017 through December 2018. The primary outcome of this study was the prehospital transfusion indication. The secondary outcome was the projected cost per life saved during the first 10years of the prehospital whole blood initiative. Of 58 consecutive prehospital whole blood administrations, the team included all 58 cases. Hemorrhagic shock from a non-traumatic etiology accounted for 46.5% (95% CI, 34.3%-59.2%) of prehospital whole blood recipients. In the non-traumatic hemorrhagic shock cohort, gastrointestinal hemorrhage was the underlying etiology of hemorrhagic shock in 66.7% (95% CI, 47.8%-81.4%) of prehospital whole blood transfusion recipients. The projected average cost to save a life in Year 10 was US$5,136.51 for the combined cohort, US$4,512.69 for HCESD 48, and US$5,243.72 for SAFD EMS. This retrospective analysis of ground ambulance patients that receive prehospital whole blood transfusion found that non-traumatic etiology accounted for 46.5% (95% CI, 34.3%-59.2%) of prehospital whole blood recipients. Additionally, the accounting analysis suggests that by Year 10 of a ground ambulance whole blood transfusion program, the average cost to save a life will be approximately US$5,136.51.

Dispatcher Identification of Out-of-Hospital Cardiac Arrest and Neurologically Intact Survival: A Retrospective Cohort Study.

To date, there are no published data on the association of patient-centered outcomes and accurate public-safety answering point (PSAP) dispatch in an American population. The goal of this study is to determine if PSAP dispatcher recognition of out-of-hospital cardiac arrest (OHCA) is associated with neurologically intact survival to hospital discharge. This retrospective cohort study is an analysis of prospectively collected Quality Assurance/Quality Improvement (QA/QI) data from the San Antonio Fire Department (SAFD; San Antonio, Texas USA) OHCA registry from January 2013 through December 2015. Exclusion criteria were: Emergency Medical Services (EMS)-witnessed arrest, traumatic arrest, age <18 years old, no dispatch type recorded, and missing outcome data. The primary exposure was dispatcher recognition of cardiac arrest. The primary outcome was neurologically intact survival (defined as Cerebral Performance Category [CPC] 1 or 2) to hospital discharge. The secondary outcomes were: bystander cardiopulmonary resuscitation (CPR), automated external defibrillator (AED) use, and prehospital return of spontaneous return of circulation (ROSC). Of 3,469 consecutive OHCA cases, 2,569 cases were included in this analysis. The PSAP dispatched 1,964/2,569 (76.4%) of confirmed OHCA cases correctly. The PSAP dispatched 605/2,569 (23.6%) of confirmed OHCA cases as another chief complaint. Neurologically intact survival to hospital discharge occurred in 99/1,964 (5.0%) of the recognized cardiac arrest group and 28/605 (4.6%) of the unrecognized cardiac arrest group (OR = 1.09; 95% CI, 0.71-1.70). Bystander CPR occurred in 975/1,964 (49.6%) of the recognized cardiac arrest group versus 138/605 (22.8%) of the unrecognized cardiac arrest group (OR = 3.34; 95% CI, 2.70-4.11). This study found no association between PSAP dispatcher identification of OHCA and neurologically intact survival to hospital discharge. Dispatcher identification of OHCA remains an important, but not singularly decisive link in the OHCA chain of survival.

Plastic surgery telehealth consultation expedites Emergency Department treatment

Plastic surgery is a field that is particularly amenable to a telehealth milieu, as visual exam and radiographs guide proper diagnosis and management. The goals of this study were to evaluate telehealth feedback executed through an iPad app for plastic surgery-related consultations. A Quality Assurance/Quality Improvement (QA/QI) study was conducted over a 1-month period during which patients with hand injuries, facial injuries, or acute wounds presenting to the Emergency Department (ED) of a level-one trauma centre and university hospital were monitored. The study utilized a commercial iPad application through which up to four images and a brief history could be sent to a remote Plastic Surgery Educator (PSE) for evaluation. The PSE would respond with best practice information, references and videos to assist ED point-of-care providers. During the 1-month period of this study, there were 42 ED consultations for plastic surgical conditions. There was a highly significant difference in overall mean response time between consultants and PSEs (48.3 minutes vs. 8.9 minutes respectively, p < 0.001). The agreement between PSEs and consultants regarding patient assessment and care was 85.7% for in-person consultations and 100% for phone consultations. In four cases of telephone consultations, the ED providers placed splints incorrectly on hand-injured patients. Our results show that telehealth consultations to a remote plastic surgeon based on digital images and a brief history were able to produce timely and accurate responses in an emergency care facility. This design may have significant impact in rural areas, underserved populations, or regions abroad.

Quality assurance and quality improvement in national HIV prevention policies in Europe

Improving the quality of HIV prevention activities to become more effective is a key objective of HIV policies. Quality Assurance/Quality Improvement (QA/QI) are management tools that systematically assess and improve the factors that determine the success of interventions. Quality Action, an EU co-funded project across 25 European countries, has promoted the use of 5 tools in HIV prevention using a combination of tool development, training workshops, supported applications, evidence review and policy advocacy.

Research Priorities Regarding Multimodal Peripheral Nerve Blocks for Postoperative Analgesia and Anesthesia Based on Hospital Quality Data Extracted from Over 1,300 Cases (2011–2014): Table 1

The use of additives with local anesthetics for peripheral nerve blocks has received considerable attention [1] due to the patient-centered goals of prolonging analgesic duration and possibly reducing local anesthetic-related toxicity. Applying such additives to single-injection nerve blocks also has the potential to reduce overhead [2] and disposables [3] costs, when compared with the costs related to continuous perineural infusions. Furthermore, recent research has elucidated in vivo animal sciatic nerve safety of the preservative-free combination of clonidine, buprenorphine, and dexamethasone (CBD) with the local anesthetic bupivacaine (BPV) [4]. Ropivacaine–CBD was previously demonstrated to be no more neurotoxic than plain ropivacaine to cultured primary sensory neurons harvested from rat dorsal root ganglia in vitro [5]. In our institution (Veterans Affairs Pittsburgh Healthcare System [VAPHS]), the lead author was in charged with creating a regional anesthesia (RA) and analgesia program for patients eligible for peripheral nerve blocks. For this new program, hospital administration was unable to budget resources for a perineural catheter-based acute pain service. Instead, the Medical Executive Board approved the lead author's recommendation to routinely use BPV–CBD off-label. These single-injection nerve block procedures are typically placed before surgery to provide postoperative analgesia and intraoperative anesthesia when feasible, and thus avoiding general endotracheal anesthesia (GETA). The Medical Executive Board tasked the lead author with per-patient quality assurance/quality improvement (QA/QI) data collection to evaluate comparative effectiveness (against historical controls) and outcomes (block duration and rebound pain [6,7], perineural complications, etc.). In accordance with Veterans Health Administration Handbook 1058.05, this manuscript was processed for authentication of nonresearch status of the activities prior to submission to this journal. Our institutional review board declared these clinical operations as “not research” at the time of program initiation (mid-2011) and annually since then during required reviews. The objective is to describe the patient outcomes …

Inappropriate Helicopter Emergency Medical Services Transports: Results of a National Cohort Utilization Review

Background. Medical transport using helicopter emergency medical services (HEMS) has rapidly proliferated over the past decade. Because of issues of cost and safety, appropriate utilization is of increasing concern. Objective. This study sought to describe the medical appropriateness of HEMS transports, using established guidelines, in a large national patient cohort. Methods. A review was performed of all flights designated as inappropriate by a large national air medical company, Air Evac EMS Inc. (which operates Air Evac Lifeteam [AEL]), for the period from January 1, 2009, through December 31, 2009. Every flight was reviewed initially through a resource utilization process as well as a utilization review process. Medical appropriateness review criteria were derived from the Medicare Benefit Policy Manual and industry guidelines outlined by the Commission on Accreditation of Medical Transport Systems (CAMTS), Air Medical Physicians Association (AMPA) position papers, the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) Guidelines for Field Triage, and published clinical peer-reviewed articles, as well as previous interactions with Medicare contractors and reimbursement appeal decisions. Higher scrutiny was given to flights of <30 or >100 miles. Records indicating a possible inappropriate flight (i.e., review criteria were not satisfied, but special circumstances existed) were further reviewed by a senior quality assurance/quality improvement (QA/QI) nurse and/or senior medical director and were categorized. Results. During the study period, 27,697 flights were completed and reviewed, with 582 (2.1%) flights identified for further review by a senior QA/QI nurse and/or senior medical director. Of those, 367 (1.3%) were determined to be medically inappropriate flights. Inappropriate flights were most often on-scene flights (59.9%), were most often for adult patients (92.9%; median age 56.9 years; 25–75% interquartile range 42–75 years), and most often represented medical diagnoses (57.8%). Conclusions. Based on established criteria, only 1.3% of total flights were determined to be inappropriate. This large national cohort demonstrated compliance with current industry standards.

P03-14 Development of a tool to improve screening rates for cardiometabolic risk factors associated with mental illness

Major mental illness is associated with premature mortality, primarily from cardiovascular disease. Modifiable risk factors include obesity, smoking, hyperglycemia, dyslipidemia and hypertension, all prevalent in this population, and commonly underrecognized and undertreated. Public health guidelines for screening and interventions to lower risk have reduced cardiovascular mortality in the general population, but these improvements have not extended to mentally ill populations. Recent recommendations to screen in this population have come from psychiatric professional groups, and in relation to regulatory warnings on potential adverse drug effects. However, recent studies suggest low levels of monitoring, both pre- and post-guidelines and warnings.Public health interest is now directed at improving screening in this population. One of the barriers to increasing screening is limited awareness among mental health professionals of the details of existing public health guidelines that define specific risk thresholds, diagnostic values and treatment targets for adiposity, blood pressure, plasma glucose and plasma lipids levels. Quality assurance/quality improvement (QA/QI) tools to facilitate screening include data collection forms that educate about risk parameters and organize patient data in a manner that helps to track risk over time.This presentation will describe a specific QA/QI tool for screening and monitoring cardiometabolic risk in the mentally ill, based on published guidelines from the European Association for the Study of Diabetes (EASD) and the European Society for Cardiology (ESC). Cardiometabolic screening, along with treatment approaches and interventions to reduce risk, offers an established public health approach to lower morbidity and mortality in vulnerable populations.

American College of Surgeons trauma quality indicators: an analysis of outcome in a statewide trauma registry.

Quality assurance/quality improvement (QA-QI) is a priority for maintaining the highest standards of care in trauma systems. To be an effective tool for system review, the QA-QI indicators should identify patients with higher rates of morbidity and mortality from injury. While the American College of Surgeons (ACS) and the Joint Commission on Accreditation of Health Care Operations have identified certain audit filters within the trauma system, there are few data to substantiate the value of these audit filters for trauma care. The purpose of this study was to analyze the ability of the ACS trauma indicators to predict adverse patient outcome following injury requiring review. The study population consisted of 44,019 patients from the North Carolina State Trauma Registry from 1987 to 1992. Of the 22 audit filters nine were available for analysis. Mortality rate, length of stay, and total charges were used as measures of outcome. The hypotheses tested were that patients who met the indicator criteria would have higher mortality rates and worse outcomes than the non-indicator group. Student's t test and Chi-square analysis were used to test the differences between the group which met the criteria for the indicator and those without. Of the nine audit filters tested, only three were found to have significantly worse outcomes than their non-indicator comparison group: gunshot wound to the abdomen with non-surgical management, femur fracture without fixation, and complications from pulmonary embolism-deep vein thrombosis-decubitus ulcer (p < 0.05). Contrary to expectations, four of the audit filters, coma without intubation, laparotomy > 2 hours, transfer > 6 hours, and admission to non-surgical service, actually had significantly better outcomes than their non-indicator counterpart. Scene time > 20 minutes, laparotomy > 2 hours after arrival, and craniotomy > 4 hours after arrival may be indicators of patients at risk for morbidity. This study demonstrates that several ACS clinical indicators, as currently written, are not useful in identifying patients at higher risk for poor outcome. The indicators need further definition to be of value in the quality review process. Specifically, the study suggests that audit filters should be data driven and based upon analyses of large populations of injured patients and their outcomes to be valid QA-QI tools.