Despite high post-implementation adherence, clinicians may have unresolved questions or concerns regarding use of a protocol to standardize routine daily coordination of the spontaneous awakening trial (SAT) and spontaneous breathing trial (SBT) on ventilated patients. Unresolved questions or concerns may unwittingly curtail practice normalization, impacting practice sustainment when implementation support is withdrawn. The objective of this study was to identify unresolved questions or concerns that may persist following successful implementation of a coordinated SAT/SBT (C-SAT/SBT) protocol. We used an attributed, cross-sectional survey of physicians, advanced practice providers, nurses and respiratory therapists likely to have participated in a C-SAT/SBT in 12 hospitals (15 intensive care units) in Utah and Idaho. We evaluated clinician perceptions of acceptability, including ease of use, usefulness and confidence, along with perceived practice normalization, six months post implementation of a protocol to routinize C-SAT/SBT use. C-SAT/SBT adherence was 83.1

BACKGROUND:Faster delivery of tPA (tissue-type plasminogen activator) results in better health outcomes for eligible patients with stroke. Standardization of stroke protocols in emergency departments (EDs) has been difficult, especially in nonstroke centers. We measured the effectiveness of a centrally led implementation strategy with local site tailoring to sustain adherence to an acute stroke protocol to improve door-to-needle (DTN) times across disparate EDs in a multihospital health system. METHODS:Prospective, type III hybrid effectiveness-implementation cohort study measuring performance at 21 EDs in Utah and Idaho (stroke centers [4]/nonstroke centers [17]) from January 2018 to February 2020 using a nonrandomized stepped-wedge design, monthly repeated site measures and multilevel hierarchical modeling. Each site received the implementation strategies in 1 of 6 steps providing control and intervention data. Co-primary outcomes were percentage of DTN times ≤60 minutes and median DTN time. Secondary outcomes included percentage of door-to-activation of neurological consult times ≤10 minutes and clinical effectiveness outcomes. Results were stratified between stroke and nonstroke centers. RESULTS:A total of 855 474 ED patient encounters occurred with 5325 code stroke activations (median age, 69 [IQR, 56-79] years; 51.8% female patients]. Percentage of door-to-activation times ≤10 minutes increased from 47.5% to 59.9% (adjusted odds ratio, 1.93 [95% CI, 1.40-2.67]). A total of 615 patients received tPA of ≤3 hours from symptom onset (median age, 71 [IQR, 58-80] years; 49.6% female patients). The percentage of DTN times ≤60 minutes increased from 72.5% to 86.1% (adjusted odds ratio, 3.38, [95% CI, 1.47-7.78]; stroke centers (77.4%-90.0%); nonstroke centers [59.3%-72.1%]). Median DTN time declined from 46 to 38 minutes (adjusted median difference, -9.68 [95% CI, -17.17 to -2.20]; stroke centers [41-35 minutes]; nonstroke centers [55-52 minutes]). No differences were observed in clinical effectiveness outcomes. CONCLUSIONS:A centrally led implementation strategy with local site tailoring led to faster delivery of tPA across disparate EDs in a multihospital system with no change in clinical effectiveness outcomes including rates of complication. Disparities in performance persisted between stroke and nonstroke centers.

Fowles, Timothy R. PhD; Knighton, Andrew J. PhD; Carmichael, Harris L. MD; Bledsoe, Joseph MD; Wolfe, Douglas MBA; Srivastava, Rajendu MD, MPH Author Information

Rationale: Lung-protective ventilation (LPV) improves outcomes for patients with acute respiratory distress syndrome (ARDS), but adherence remains inadequate. Objectives: To measure the process and clinical impacts of implementation of a science-based intervention to improve LPV adherence for patients with ARDS, in part by increased use of clinical decision support (CDS). Methods: We conducted a type III hybrid implementation/ effectiveness pilot trial enrolling adult patients with ARDS admitted to three hospitals before and after the launch of a multimodal implementation intervention to increase the use of mechanical ventilation CDS and improve LPV adherence. The primary outcome was patients' percentage of time adherent to low tidal volume (<6.5 ml/kg predicted body weight) ventilation (LTVV). Secondary outcomes included adherence to prescribed oxygenation settings, the use of the CDS tool's independent oxygenation and ventilation components, ventilator-free days, and mortality. Analyses employed multivariable regression to compare adjusted pre- versus postintervention outcomes after the exclusion of a postintervention wash-in period. A sensitivity analysis measured process outcomes' level and trend change postintervention using segmented regression. Results: The 446 included patients had a mean age of 60 years, and 43% were female. Demographic and clinical characteristics were similar pre- versus postintervention. The adjusted proportion of adherent time increased postintervention for LTVV (9.2%; 95% confidence interval [CI], 3.8-14.5%) and prescribed oxygenation settings (11.9%; 95% CI, 7.2-16.5%), as did the probability patients spent >90% of ventilated time on LTVV (adjusted odds ratio [aOR] 2.58; 95% CI, 1.64-4.10) and use of ventilation CDS (aOR, 41.3%; 95% CI, 35.9-46.7%) and oxygenation CDS (aOR, 54.3%; 95% CI, 50.9-57.7%). Ventilator-free days (aOR, 1.15; 95% CI, 0.81-1.62) and 28-day mortality (aOR, 0.78; 95% CI, 0.50-1.20) did not change significantly after intervention. Segmented regression analysis supported a causal relationship between the intervention and improved CDS usage but suggested trends before intervention rather than the studied intervention could explain increased LPV adherence after the intervention. Conclusions: In this pilot trial, a multimodal implementation intervention was associated with increased use of ventilator management CDS for patients with ARDS but was not associated with differences in clinical outcomes and may not have independently caused the observed postintervention improvements in LPV adherence.

Intensive care unit (ICU) patients on mechanical ventilation often require sedation and analgesia to improve comfort and decrease pain. Prolonged sedation and analgesia, however, may increase time on mechanical ventilation, risk for ventilator associated pneumonia, and delirium. Coordinated interruptions in sedation [spontaneous awakening trials (SATs)] and spontaneous breathing trials (SBTs) increase ventilator-free days and improve mortality. Coordination of SATs and SBTs is difficult with substantial implementation barriers due to difficult-to-execute sequencing between nurses and respiratory therapists. Telehealth-enabled remote care has the potential to overcome these barriers and improve coordinated SAT and SBT adherence by enabling proactive high-risk patient monitoring, surveillance, and real-time assistance to frontline ICU teams. The telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH) study will determine whether adding a telehealth augmented real-time audit and feedback to a usual supervisor-led audit and feedback intervention will yield higher coordinated SAT and SBT adherence and more ventilator-free days in mechanically ventilated patients than a usual supervisor-led audit and feedback intervention alone in a type II hybrid effectiveness-implementation cluster-randomized clinical trial in 12 Intermountain Health hospitals with 15 ICUs. In the active comparator control group (six hospitals), the only intervention is the usual supervisor-led audit and feedback implementation. The telehealth-enabled support (TEACH) intervention in six hospitals adds real-time identification of patients eligible for a coordinated SAT and SBT and consultative input from telehealth respiratory therapists, nurses, and physicians to the bedside clinicians to promote adherence including real-time assistance with execution. All intubated and mechanically ventilated patients ≥ 16 years of age are eligible for enrollment except for patients who die on the day of intubation or have preexisting brain death. Based on preliminary power analyses, we plan a 36-month intervention period that includes a 90-day run-in period. Estimated enrollment in the final analysis is up to 9900 mechanically ventilated patients over 33 months. The TEACH study will enhance implementation science by providing insight into how a telehealth intervention augmenting a usual audit and feedback implementation may improve adherence to coordinated SAT and SBT and increase ventilator-free days. Clinicaltrials.gov, NCT05141396 , registered 12/02/2021.

Sakata, Theadora MD, MPhil; Fowles, Timothy PhD; Knighton, Andrew PhD; Bledsoe, Joseph MD, FACEP; Wolfe, Doug PhD; Srivastava, Rajendu MD, MPH Author Information

Rationale: Routine spontaneous awakening and breathing trial coordination (SAT/SBT) improves outcomes for mechanically ventilated patients, but adherence varies. Understanding barriers to and facilitators of consistent daily use of SAT/SBT (implementation determinants) can guide the development of implementation strategies to increase adherence to these evidence-based interventions. Objectives: We conducted an explanatory, sequential mixed-methods study to measure variation in the routine daily use of SAT/SBT and to identify implementation determinants that might explain variation in SAT/SBT use across 15 intensive care units (ICUs) in urban and rural locations within an integrated, community-based health system. Methods: We described the patient population and measured adherence to daily use of coordinated SAT/SBT from January to June 2021, selecting four sites with varied adherence levels for semistructured field interviews. We conducted key informant interviews with critical care nurses, respiratory therapists, and physicians/advanced practice clinicians (n = 55) from these four sites between October and December 2021 and performed content analysis to identify implementation determinants of SAT/SBT use. Results: The 15 sites had 1,901 ICU admissions receiving invasive mechanical ventilation (IMV) for ⩾24 hours during the measurement period. The mean IMV patient age was 58 years, and the median IMV duration was 5.3 days (interquartile range, 2.5-11.9). Coordinated SAT/SBT adherence (within 2 h) was estimated at 21% systemwide (site range, 9-68%). ICU clinicians were generally familiar with SAT/SBT but varied in their knowledge and beliefs about what constituted an evidence-based SAT/SBT. Clinicians reported that SAT/SBT coordination was difficult in the context of existing ICU workflows, and existing protocols did not explicitly define how coordination should be performed. The lack of an agreed-upon system-level measure for tracking daily use of SAT/SBT led to uncertainty regarding what constituted adherence. The effects of the COVID-19 pandemic increased clinician workloads, impacting performance. Conclusions: Coordinated SAT/SBT adherence varied substantially across 15 ICUs within an integrated, community-based health system. Implementation strategies that address barriers identified by this study, including knowledge deficits, challenges regarding workflow coordination, and the lack of performance measurement, should be tested in future hybrid implementation-effectiveness trials to increase adherence to daily use of coordinated SAT/SBT and minimize harm related to the prolonged use of mechanical ventilation and sedation.

Fowles, Timothy PhD; Knighton, Andrew PhD, CPA; Soria, Natalie MBA; Wolfe, Doug MBA; Srivastava, Rajendu MD, MPH Author Information

Abstract Objective Computer-aided decision tools may speed recognition of acute respiratory distress syndrome (ARDS) and promote consistent, timely treatment using lung-protective ventilation (LPV). This study evaluated implementation and service (process) outcomes with deployment and use of a clinical decision support (CDS) synchronous alert tool associated with existing computerized ventilator protocols and targeted patients with possible ARDS not receiving LPV. Materials and Methods We performed an explanatory mixed methods study from December 2019 to November 2020 to evaluate CDS alert implementation outcomes across 13 intensive care units (ICU) in an integrated healthcare system with >4000 mechanically ventilated patients annually. We utilized quantitative methods to measure service outcomes including CDS alert tool utilization, accuracy, and implementation effectiveness. Attitudes regarding the appropriateness and acceptability of the CDS tool were assessed via an electronic field survey of physicians and advanced practice providers. Results Thirty-eight percent of study encounters had at least one episode of LPV nonadherence. Addition of LPV treatment detection logic prevented an estimated 1812 alert messages (41%) over use of disease detection logic alone. Forty-eight percent of alert recommendations were implemented within 2 h. Alert accuracy was estimated at 63% when compared to gold standard ARDS adjudication, with sensitivity of 85% and positive predictive value of 62%. Fifty-seven percent of survey respondents observed one or more benefits associated with the alert. Conclusion Introduction of a CDS alert tool based upon ARDS risk factors and integrated with computerized ventilator protocol instructions increased visibility to gaps in LPV use and promoted increased adherence to LPV.

Proliferating cell nuclear antigen mRNA and protein levels were determined in human diploid fibroblasts of different in vitro ages as they progressed through the cell cycle. Cells were analyzed at G0; at various stages of G1, including the G1/S interface; and during S. At all in vitro ages, PCNA message levels were low to undetectable at G0, were evident 8 to 12 h following entrance into G1, peaked at G1/S and declined during S phase. Message levels were 2-3-fold lower in older populations at all stages of the cell cycle tested. PCNA protein increased from G0 through S phase in both age groups with 2-3-fold less being found in older cells. The decline in PCNA mRNA in older populations was not the result of changes in mRNA turnover or transcription. The results suggest that the reduction in PCNA expression is due to an age related alteration in a post-transcriptional regulatory function. The decline in the expression of the PCNA gene would contribute to the inability of older cells to initiate replicative DNA synthesis.

Olsen, Griffin MD; Wolfe, Doug MBA; Hellewell, James MD, MS; Ize-Ludlow, Diego MD; Bledsoe, Joseph MD, FACEP; Srivastava, Rajendu MD, FRCP(C), MPH Author Information

Research ObjectiveThe risk of serious intracranial injury in pediatric patients with minor head trauma (MHT) is less than 5%; most computerized tomography (CT) scans in MHT are normal or contribute little to management, yet expose children to unnecessary radiation. Despite evidence‐based risk classification criteria from the Pediatric Emergency Care Applied Research Network (PECARN) for assessing appropriate CT use during emergency department (ED) visits, barriers persist to replacing unnecessary scans with structured observation. Field readiness assessments at Intermountain Healthcare suggest that physicians often believe they know the risk factors for traumatic brain injury (TBI) but sometimes misremember elements. Information retrieval when delivering ED care can be cumbersome. Many physicians also perceive ordering CT scans is the safest course of action despite a lack of significant symptoms. We theorized that targeting evidence‐based education at the individual scan decision point, coupled with timely performance feedback, would increase cognitive support for assessing risk of clinically‐important TBI (ciTBI), reducing potentially unnecessary scans.Study DesignWe conducted a prospective pre‐post comparison implementation study. The primary implementation strategies were two‐fold. First, we embedded an alert containing an easy‐to‐understand, information‐rich graphic providing current PECARN risk stratification criteria and supporting evidence for classifying ciTBI, along with a risk assessment prompt linked to a CT order. Second, we provided timely feedback on performance and local prompting to educate physicians. Uptake and effectiveness measures included % adherence change in PECARN guidelines and the CT scan rate. Safety was evaluated by counting 48‐hour readmissions with clinical evidence of ciTBI confirmed via chart review. Acceptability, fidelity and feasibility were assessed using qualitative analysis. Statistical analysis was conducted using tests of proportions.Population StudiedApproximately 14,000 pediatric patients presenting with MHT at 22 EDs from January 2019–December 2020 within a single, integrated delivery system including urban, rural and frontier locations and a children's hospital.Principal FindingsYear 1 adherence to PECARN guidelines was 98.7% with a 14% reduction in the CT scan rate for pediatric MHT patients across geographies with no readmissions for ciTBI (Table). Results were sustained in Year 2 despite increased patient acuity in 2020 due to the novel coronavirus pandemic. Subsequent field discussions found good acceptance by physicians noting the alert was relevant, timely and easy to understand. Implementation fidelity was high given routinization of the alert into clinical workflow.ConclusionsCombining local performance feedback with use of an information‐rich text alert was associated with significant improvements in adherence to PECARN guidelines and a reduction in the CT scan order rate for diagnosis of clinically‐important TBI in MHT patients without impacting safety. The routinized nature of the alert was associated with good practice sustainment over multiple years across geographies.Implications for Policy or PracticeSimple, information‐rich text alerts may prove useful as an implementation strategy for updating physicians on changes in evidence‐based triage and risk classification criteria often associated with de‐implementation of legacy clinical practices. Measure Baseline‐Dec2018 Rolling‐6mo Uptake‐Dec2019 Rolling‐12mo Sustainment‐Dec2020 Rolling‐12mo z‐score/p‐value % adherence to PECARN guidelines 95.66% 98.74% 99.32% z = −10.3; p < 0.001 CT scan rate 33% 29% 29% z = 6.0; p < 0.001 48‐hour readmission for ciTBI 0 0 0

Olsen, Griffin MD; Knighton, Andrew PhD, CPA; Vilendrer, Stacie MD, MBA, MSHP; Taylor, Nicholas Kenji MD; Ho, Vy-Thuy MD; Thomas, Samuel MD; Carmichael, Harris MD, MSHP; Brunisholz, Kimberly PhD, MST; Wolfe, Doug MBA; Allen, Lauren MAS; Belnap, Tom MS; Asch, Steven MD, MPH; Srivastava, Rajendu MD, MPH, FRCP(C)Author Information

Olsen, Griffin MD; Quam, Jill BA; Wolfe, Doug MBA; Soria, Natalie MBA; West, Milli MBA; Gibbons, Steve MS; Province, Wing MD, MBA; Brunisholz, Kimberly D. PhD, MST; Belnap, Tom MS; Knighton, Andrew J. PhD, CPA; Allen, Lauren MAS; Pollard, Matt MD, MBOE; Woodruff, Mike MD; Srivastava, Rajendu MD, FRCP(C), MPH Author Information

Meier, Jeremy D. MD; Knighton, Andrew J. PhD, CPA; Coon, Eric MD, MS; Wolfe, Doug MBA; Brunisholz, Kimberly PhD; Allen, Lauren MAS; Allen, Todd L. MD; Menge, Kim RN; Richards, Nathan G. MD; Srivastava, Rajendu MD, MPH, FRCP(C) Author Information

Abstract Background Lung-protective ventilation (LPV) improves outcomes for patients with acute respiratory distress syndrome (ARDS) through the administration of low tidal volumes (≤ 6.5 ml/kg predicted body weight [PBW]) with co-titration of positive end-expiratory pressure and fraction of inspired oxygen. Many patients with ARDS, however, are not managed with LPV. The purpose of this study was to understand the implementation barriers and facilitators to the use of LPV and a computerized LPV clinical decision support (CDS) tool in intensive care units (ICUs) in preparation for a pilot hybrid implementation-effectiveness clinical trial. Methods We performed an explanatory sequential mixed methods study from June 2018 to March 2019 to evaluate the variation in LPV adherence across 17 ICUs in an integrated healthcare system with > 4000 mechanically ventilated patients annually. We analyzed 47 key informant interviews of ICU physicians, respiratory therapists (RTs), and nurses in 3 of the ICUs using a qualitative content analysis paradigm to investigate site variation as defined by adherence level (low, medium, high) and to identify barriers and facilitators to LPV and LPV CDS tool use. Results Forty-two percent of patients had an initial set tidal volume of ≤ 6.5 ml/kg PBW during the measurement period (site range 21–80%). LPV CDS tool use was 28% (site range 6–91%). This study’s main findings revealed multi-factorial facilitators and barriers to use that varied by ICU site adherence level. The primary facilitator was that LPV and the LPV CDS tool could be used on all mechanically ventilated patients. Barriers included a persistent gap between clinician attitudes regarding the use of LPV and actual use, the perceived loss of autonomy associated with using a computerized protocol, the nature of physician-RT interaction in ventilation management, and the lack of clear organization measures of success. Conclusions Variation in adherence to LPV persists in ICUs within a healthcare delivery system that was an early adopter of LPV. Potentially promising strategies to increase adherence to LPV and the LPV CDS tool for ARDS patients include initiating low tidal ventilation on all mechanically ventilated patients, establishing and measuring adherence measures, and focused education addressing the physician-RT interaction. These strategies represent a blueprint for a future hybrid implementation-effectiveness trial.

Allen, Lauren MAS; Knighton, Andrew J. PhD, CPA; Brunisholz, Kimberly D. PhD, MST; Wolfe, Doug MBA; Kean, Jacob PhD; Belnap, Thomas W. MS; Grissom, Colin MD; Srivastava, Raj MD, FRPC(C), MPH Author Information