Browsing by Subject "Clinical Protocols"
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Item Impact of National Cancer Institute (NCI)-Mandated Scientific Review on Cancer Clinical Trial Protocol Development(2014-02-04) Ning, Ning; Yan, Jingsheng; Xie, Xian-Jin; Gerber, David E.BACKGROUND: The National Cancer Institute (NCI) requirement that all clinical trials involving cancer patients at NCI-designated cancer centers undergo a scientific protocol review before Institutional Review Board (IRB) review is unique among all medical specialties. Little is known about the impact of scientific review on protocol development. Given heightened interest in the quality and timeliness of oncology clinical trials, we evaluated the scientific review process at an NCI designated center. METHODS: We collected data on all oncology clinical trials that underwent full board review by the UT Southwestern Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. The following data were collected: trial characteristics, PRMC decisions, protocol clarifications and changes requested by PRMC, and subsequent protocol modifications. We analyzed the association between trial characteristics and PRMC protocol modifications using Chi-square testing, Fisher's exact testing, and logistic regression. RESULT: A total of 226 trials were included in our analysis. Of these studies, 23% were institutional (investigator-initiated) trials. Initial PRMC initial decisions were: approved (40%), approved pending response (52%), defer (7%), and disapprove (1%). Across the 226 trials, the PRMC requested 270 changes; total number of requested changes per protocol ranged from 0 (66% of trials) to 17. The number of requested changes per protocol was significantly associated with trial type (mean 0.7 for industry-sponsored versus 3.0 for investigator-initiated; P<0.001) and study year (mean 0.7 in 2009 versus 2.4 in 2013; P=0.03). Forty-nine percent of requested changes applied directly to trial protocols, with the remainder related to consent form (13%) or other documentation (38%). Protocol-related requested changes were as follows: design (53%), intervention (24%), evidence-background-rationale (14%), and population (11%). Compared to those for industry-sponsored trials, PRMC requested changes for investigator-initiated trials were more likely to be implemented (91% versus 83%; P=0.08). A pronounced difference was noted for requested changes related to trial design: among 154 industry-sponsored trials, 28 changes to study design were requested (average 0.2 per trial), and 8 changes (29% of requests) were implemented; among 52 investigator-initiated trials, 39 changes to study design were requested (average 0.8 per trial), and 35 changes (90% of requests) were implemented. CONCLUSION: To our knowledge, this is the first study to evaluate the impact of NCI-mandated scientific protocol review in cancer clinical trial development. While this process appears to have a substantial impact on investigator-initiated trial protocols, effect on industry-sponsored trials is less clear.Item Improving Adherence to an Integrated Spontaneous Awakening and Spontaneous Breathing Trial Protocol(2023-05-01T05:00:00.000Z) Seal, Brayden Christopher; Reed, W. Gary; Bartolome, Sonja; Kershaw, Corey D.BACKGROUND: Integration of nursing-driven spontaneous awakening trial (SAT) and respiratory therapy-driven spontaneous breathing trial (SBT) protocols for patients on mechanical ventilation in the intensive care unit (ICU) is associated with fewer ventilator days, shorter ICU stays, and reduced hospital length-of-stay. However, institutional adherence is often suboptimal due to the complexity and multidisciplinary nature of these integrated protocols. This project aims to describe baseline compliance with our institution's SAT/SBT protocol, identify factors influencing compliance, and increase adherence to the existing SAT/SBT protocol in the ICU to a goal of greater than 95% compliance by August 2023. LOCAL PROBLEM: Data from a retrospective chart review indicated a SAT screen rate of 63.8% and a SBT screen rate of 85%. Therefore, the SAT/SBT protocol adherence at our institution is sub-optimal. METHODS: Initially, we determined baseline adherence rates through a retrospective chart review of SAT and SBT documentation. Specifically, we identified the rates of correctly performed SAT and SBT screenings for all eligible patients and the subsequent rates of correct SAT and SBT performance for patients who passed the appropriate screening. We then sought to identify factors influencing adherence to the SBT/SAT protocol by employing an ethnographic approach, including: (a) process mapping of the integrated SAT/SBT protocol, (b) literature-driven surveys using the Likert scale to assess potential barriers to protocol adherence, (d) informal interviews with nurses and respiratory therapists, and (e) direct observation in the medical ICU. Individual factors identified were organized using the Systems Engineering Initiative for Patient Safety (SEIPS) sociotechnical framework. The SEIPS model allowed for further design of targeted interventions to improve protocol adherence. RESULTS: Factors influencing adherence were identified from survey responses by 63 nurses and 26 respiratory therapists, 30 hours of direct observation, and tabulated comments from surveys and informal interviews. Prominent factors influencing compliance included knowledge of the protocol, protocol variation across intensive care units, accessibility of the protocol, ease of documentation in the electronic medical record (EMR), and the exclusion of nurses and respiratory therapists in physician-led ICU rounds. CONCLUSION: Data from a retrospective chart review and ethnographic investigation of SAT/SBT protocols indicated sub-optimal adherence. Further investigation into the specific factors influencing adherence allowed us to propose specific interventions to improve performance. Such future interventions will include: (a) EMR redesign using feedback obtained in our investigation to improve accessibility and allow reliable surveillance of protocol adherence, (b) enhanced, standardized multidisciplinary ICU rounds, (c) protocol education sessions, (d) continuous monitoring of protocol metrics with intermittent feedback provided to staff, and (e) a Quality Assurance and Performance Improvement Workgroup dedicated to regular engagement of key stakeholders for process improvement.Item Improving Protocol Adherence in Central Line Placements(2022-05-01T05:00:00.000Z) Roy, Mathews Francis; Goff, Kristina L.; Yager, Ashley; Reed, W. GaryBACKGROUND: The placement of central lines is a very common exercise in medicine. Central lines are required for everything from acute trauma scenarios to long term cancer treatments. However, this ubiquitous procedure has several morbid complications that are not uncommon. Possible complications include infection, catheter misplacement, arterial puncture, hematoma, pneumothorax, and death[1]. Not only are the complications severe they are also quite prevalent with a complication rate of 15 to 25 percent[2]. LOCAL PROBLEM: Due to a concern for the rates of central line infections across campuses at the University of Texas Southwestern Medical Center (UTSW) there was a project underway to create a standardized central line placement protocol for all departments in the system. This protocol was taught to all incoming residents on a simulation session day. However, because a significant period of time can pass between central line training and the clinical practice of placing central lines, the rate of resident retention and adherence to the standardized procedure for central line placement is unknown. This report describes the results of a QI experiment meant to reduce the rate of catheter associated blood stream infections and ensure better resident protocol adherence at UTSW medical center using checklists and visual aids to ensure implementation of the standardized protocols. METHODS: The study was split into three phases. The first phase examined the baseline knowledge of UTSW residents regarding the placement of central lines and found the nursing position regarding possible interventions. The residents were interviewed regarding the standardized UTSW protocol and asked to detail the steps of placing a central line. The results were used to analyses areas of weakness in protocol adherence. Based on the results of the interviews, a checklist and visual aid were created highlighting key steps to ensure the adherence to the protocol. In phase two, to evaluate the feasibility of incorporating a checklist and CVA into the original CVC insertion methodology, a simulated pilot was conducted, and a survey was completed by the participants to determine how staff perceived the use of these new tools. In phase three after analyzing the ability to integrate the checklist and visual aid in a simulated setting, the utility of using a checklist to improve CVC insertions was tested by conducting a pilot study on real patients. During the pilot, CVCs placed in the ICU were observed by a medical student with the bedside nurse's participation and real time completion of the checklist RESULTS: Phase 1: It was found that there were significant variations in the average adherence between departments and training years. On average, post graduate year (PGY)3s did better than PGY2s. Furthermore, it was found that 50% of missed steps were caused by only 8 out 36 questions and 75% of mistakes were caused by just 15 out of 36 questions. Phase 2: Simulated pilot Survey results showed that all participants felt that their team successfully followed the standardized placement method. The participants also said that the implemented huddle helped to create teamwork and organization, and that it could easily be incorporated into the normal workflow. Phase 3: In-practice pilot All trial participants were asked for feedback regarding the perceived benefit of the process. Results were very positive with most participants saying that they thought that the new workflow was helpful and easy to implement. Analysis of the completed checklists show that participants were able to complete the forms without issue ensuring that complete adherence to the standardized protocol was possible. CONCLUSIONS: By interviewing residents to understand areas of difficulties and going through a multistep approach to ensure safety and efficacy of interventions, this project provides insight into the possible gaps in resident procedure adherences and retention of the UTSW protocol. It then also provides an intervention that strengthen the memory of the preforming physician and a layer of oversight to ensure that even if a mistake is made it is quickly corrected. The general concepts of simulation trials prior to clinical application and utilization of a checklist and cognitive visual aid can be applied not only to central lines at UTSW, but to many different procedures across multiple hospital systems.