Incorporating Research into a Busy Clinical Practice: A Practical Approach.

Treating patients in clinic can be busy and stressful; however, utilization of well-planned strategic workflows that include the proper information for research studies can result in daily prospective data collection that will be subsequently amenable to retrospective analysis.

Implementation strategies for hospital-based probiotic administration in a stepped-wedge cluster randomized trial design for preventing hospital-acquired Clostridioides difficile infection.

BACKGROUND: Clostridioides difficile infection (CDI) is associated with considerable morbidity and mortality in hospitalized patients, especially among older adults. Probiotics have been evaluated to prevent hospital-acquired (HA) CDI in patients who are receiving systemic antibiotics, but the implementation of timely probiotic administration remains a challenge. We evaluated methods for effective probiotic implementation across a large health region as part of a study to assess the real-world effectiveness of a probiotic to prevent HA-CDI (Prevent CDI-55 +). METHODS: We used a stepped-wedge cluster-randomized controlled trial across four acute-care adult hospitals (n = 2,490 beds) to implement the use of the probiotic Bio-K + ® (Lactobacillus acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Laval, Quebec, Canada) in patients 55 years and older receiving systemic antimicrobials. The multifaceted probiotic implementation strategy included electronic clinical decision support, local site champions, and both health care provider and patient educational interventions. Focus groups were conducted during study implementation to identify ongoing barriers and facilitators to probiotic implementation, guiding needed adaptations of the implementation strategy. Focus groups were thematically analyzed using the Theoretical Domains Framework and the Consolidated Framework of Implementation Research. RESULTS: A total of 340 education sessions with over 1,800 key partners and participants occurred before and during implementation in each of the four hospitals. Site champions were identified for each included hospital, and both electronic clinical decision support and printed educational resources were available to health care providers and patients. A total of 15 individuals participated in 2 focus group and 7 interviews. Key barriers identified from the focus groups resulted in adaptation of the electronic clinical decision support and the addition of nursing education related to probiotic administration. As a result of modifying implementation strategies for identified behaviour change barriers, probiotic adherence rates were from 66.7 to 75.8% at 72 h of starting antibiotic therapy across the four participating acute care hospitals. CONCLUSIONS: Use of a barrier-targeted multifaceted approach, including electronic clinical decision support, education, focus groups to guide the adaptation of the implementation plan, and local site champions, resulted in a high probiotic adherence rate in the Prevent CDI-55 + study.

Dosimetrically triggered adaptive radiotherapy for head and neck cancer: Considerations for the implementation of clinical protocols.

PURPOSE: Defining dosimetric rules to automatically detect patients requiring adaptive radiotherapy (ART) is not straightforward, and most centres perform ad-hoc ART with no specific protocol. This study aims to propose and analyse different steps to design a protocol for dosimetrically triggered ART of head and neck (H&N) cancer. As a proof-of-concept, the designed protocol was applied to patients treated in TomoTherapy units, using their available software for daily MVCT image and dose accumulation. METHODS: An initial protocol was designed by a multidisciplinary team, with a set of flagging criteria based only on dose-volume metrics, including two action levels: (1) surveillance (orange flag), and (2) immediate verification (red flag). This protocol was adapted to the clinical needs following an iterative process. First, the protocol was applied to 38 H&N patients with daily imaging. Automatic software generated the daily contours, recomputed the daily dose and flagged the dosimetric differences with respect to the planning dose. Second, these results were compared, by a sensitivity/specificity test, to the answers of a physician. Third, the physician, supported by the multidisciplinary team, performed a self-analysis of the provided answers and translated them into mathematical rules in order to upgrade the protocol. The upgraded protocol was applied to different definitions of the target volume (i.e. deformed CTV + 0, 2 and 4 mm), in order to quantify how the number of flags decreases when reducing the CTV-to-PTV margin. RESULTS: The sensitivity of the initial protocol was very low, specifically for the orange flags. The best values were 0.84 for red and 0.15 for orange flags. After the review and upgrade process, the sensitivity of the upgraded protocol increased to 0.96 for red and 0.84 for orange flags. The number of patients flagged per week with the final (upgraded) protocol decreased in median by 26% and 18% for red and orange flags, respectively, when reducing the CTV-to-PTV margin from 4 to 2 mm. This resulted in only one patient flagged at the last fraction for both red and orange flags. CONCLUSION: Our results demonstrate the value of iterative protocol design with retrospective data, and shows the feasibility of automatically-triggered ART using simple dosimetric rules to mimic the physician's decisions. Using a proper target volume definition is important and influences the flagging rate, particularly when decreasing the CTV-to-PTV margin.

The impact of an autonomous nurse-led high-flow nasal cannula oxygen protocol on clinical outcomes of infants with bronchiolitis.

OBJECTIVE: To investigate the relationship of the implementation of a nurse-led high-flow nasal cannula oxygen protocol on the clinical outcomes of infants with bronchiolitis in a regional paediatric unit. BACKGROUND: Bronchiolitis is a common lower respiratory illness and is the leading cause for hospitalisation of infants globally. Standard care involves the provision of supportive measures. Historically, supplemental oxygen was provided by low-flow nasal cannula. High-flow nasal cannula oxygen has been increasingly adopted despite limited evidence of its efficacy. METHODS: This study employed non-equivalent, post-implementation only design to explore clinical outcomes of infants with bronchiolitis admitted for high-flow nasal cannula oxygen therapy. The study compared infants in the 24 months before and after the initiation of a high-flow nasal cannula protocol. The primary clinical outcome was length of stay, secondary outcomes included time on high flow, weaning time, escalation of care and time outside of physiological parameters. Implementation strategy evaluation was measured by compliance with applying the protocol, reported as episodes of variance, and duration of variance. The StaRI checklist was selected as the most appropriate reporting guideline. RESULTS: A total of 80 patients were admitted with bronchiolitis and received high-flow nasal cannula oxygen therapy during a 48-month period; 37 patients were prior, and 43 after, the introduction of a nurse-led high-flow nasal cannula protocol. Length of stay was significantly reduced in the post-implementation group compared to the historical control group (83.8 vs. 61.3 h). Time on high flow and weaning time was decreased in the post-implementation group compared to the control group (33.5 vs. 26.7 h and 26 vs.12.25 h, respectively); however, these did not reach statistical significance. There was varied application of the HFNC protocol. CONCLUSIONS: The implementation of a nurse-led high-flow nasal cannula protocol was associated with a reduced length of stay. RELEVANCE TO CLINICAL PRACTICE: This study demonstrated that infants with bronchiolitis that were treated with a nurse-led high-flow nasal cannula (HFNC) therapy protocol had positive effects on clinical outcomes including a shorter length of stay than compared with those with physician-directed care in a regional paediatric unit. A weight-based (2 L/kg) HFNC therapy was safely administered to infants with bronchiolitis in a regional hospital paediatric ward with no paediatric intensive care unit (PICU).

Delayed Repeat Contrast Enema for Treatment of Pediatric Intussusception.

INTRODUCTION: Ileocolic intussusception is a common cause of pediatric bowel obstruction. Contrast enema is successful in treating the majority of patients, and if initially unsuccessful, approximately one-third may be reduced with repeat enemas. We sought to study protocol implementation for delayed repeat enema in pediatric patients not reduced completely by an initial contrast enema. Our aims were to assess repeat enema success rates and outcome differences in preprotocol and postprotocol patients with respect to (1) intussusception recurrence, (2) surgical intervention and complication rates, and (3) length of stay. MATERIALS AND METHODS: We performed a retrospective review of treatment and clinical outcomes prior to and following protocol implementation for repeat enema for intussusception at two tertiary pediatric referral hospitals. The preprotocol period was defined from 2/2013 to 2/2016, and the postprotocol period was from 8/2016 to 11/2019. RESULTS: There were 112 patients in the preprotocol group, with 74 (66%) having successful reduction following the first enema. Of the 38 patients without successful reduction, 16 (42%) patients underwent repeat enema, and five were successful (31%). The postprotocol group included 122 patients, with 84 (69%) having successful first reduction. Of the 38 patients that failed, 25 patients (66%) underwent repeat enema, of which 13 (52%) were successful. Compared to preprotocol patients, postprotocol patients had significantly more enemas repeated and a trend toward fewer surgical interventions. CONCLUSIONS: Protocol implementation of repeat delayed enemas was significantly associated with an increased rate of repeat enemas at our institutions and reduced need for operative intervention during the index stay.

Life-threatening danger assessments of penetrating injuries in Eastern Danish clinical forensic medicine.

Clinical forensic assessments of injuries' life-threatening danger may have an impact on the legal aftermath following a violent assault. The pursuit of evidence-based guidelines should ensure a user-independent and reproducible forensic practice. However, does it? The aim of this study was to evaluate the forensic life-threatening danger assessments after a protocol implementation in 2016. The evaluation concerned usability and reproducibility of the protocol, and its influence on assessment severity. We analyzed the level of inter- and intra-rater agreement using 169 blinded, prior-protocol cases that were reassessed by two forensic specialists. We compared assessment made the year before and after protocol implementation (n = 262), and the forensic specialists' reassessments with the prior-protocol cases' original assessments (n = 169). Whether to make an assessment, the levels of agreement varied between weak agreement (inter-rater, Κ = 0.43; assessor 1, Κ = 0.57) and strong agreement (assessor 2, Κ = 0.90). Regarding severity, the levels of agreement varied between strong agreement (inter-rater, Κ = 0.87; assessor 1: Κ = 0.90) and almost perfect agreement (assessor 2: Κ = 0.94). The assessments were statistically significant redistributed after the implementation (chi-square test: p < 0.0001). The proportion of cases assessed as having not been in life-threatening danger increased from 9 to 43%, and moderate severity assessments decreased from 55 to 23%. Of the moderate severity assessments, 55% were reassessed as having not been in life-threatening danger. The protocol ensured independent and reproducible assessments when the forensic specialists agreed on making one. The protocol resulted in less severe assessments. Future studies should examine the reliability of the protocol and its consequences for legal aftermaths.

Implementation of Protocolized Care in ARDS Improves Outcomes.

BACKGROUND: Treatments for ARDS that improve patient outcomes include use of lung-protective ventilation, prone ventilation, and conservative fluid management. Implementation of ARDS protocols via educational programs might improve adherence and outcomes. The objective of this study was to investigate the effects of an ARDS protocol implementation on outcomes and adherence with ARDS guidelines. METHODS: This was a single-center, interventional, comparative study before and after protocol implementation. Staff education for the ARDS protocol was implemented between June 2014 and May 2015. A retrospective cohort analysis was conducted during between January 2012 and May 2014 (pre-protocol) and between June 2015 and June 2017 (post-protocol). A total of 450 subjects with ARDS were included. After propensity score matching, 432 subjects were analyzed. Of those, 330 subjects were treated after protocol implementation. RESULTS: The median (interquartile range [IQR]) plateau pressure and tidal volume over the first 3 d decreased significantly after protocol implementation (30.5 [IQR 24.2-33] vs 25.5 [IQR 21.7-30], P = .01 and 7.65 vs 7.4 mL/kg predicted body weight, P = .032, respectively). The percentage of subjects with unsafe tidal volume (> 10 mL/kg predicted body weight) decreased (14.4% vs 5.8%, P = .02). The percentage of subjects with safe plateau pressure (≤ 30 cm H2O) increased (47.4% vs 76.5%, P < .001). PEEP deviation from the ARDSNet PEEP/[Formula: see text] table was significantly lower after the implementation. Mortality at 28 and 90 days improved after implementation (53.9% vs 41.8% and 61.8% vs 48.2%, respectively). Adjusted odds ratios for 28-d and 90-d mortality were 0.47 (95% CI 0.28-0.78) and 0.45 (95% CI 0.27-0.76), respectively. CONCLUSIONS: ARDS protocol implementation was associated with improved survival and rate of adherence.

Implementation of an antenatal late-preterm corticosteroid protocol at a high-volume tertiary care center.

Background: Since publication of the sentinel antenatal late preterm steroids clinical trial, the use of antenatal steroids has become a routine aspect of the management of pregnancies at risk for late preterm delivery. However, in practice, the administration of antenatal corticosteroids in the late preterm period is widely varied across provider and institution, and the process of implementation of this new practice as well as outcomes associated with implementation are not well understood. Objective: The objective was to evaluate institutional adherence to an antenatal late preterm corticosteroid protocol and to assess neonatal outcomes associated with its introduction. Study Design: This is a retrospective cohort study of all women with singleton pregnancies admitted between 34 to 36 5/7 weeks who presented in the year before ("pre-protocol": November 2012 to October 2013) and after implementation ("post-protocol": April 2016 to March 2017). The protocol recommends corticosteroid administration to women 34 to 36 5/7 weeks gestation at risk for preterm birth who have not received prior corticosteroids. Women with fetal anomalies or pregestational or gestational diabetes were excluded from analysis. The frequency with which eligible women received corticosteroids and ineligible women were appropriately excluded (adherence) was calculated on a monthly basis. Neonatal outcomes of interest were hypoglycemia, receipt of dextrose, birth weight, 5 minute Apgar less than 7, receipt of surfactant, respiratory distress syndrome, transient tachypnea of the newborn, neonatal intensive care unit length of stay, intraventricular hemorrhage, necrotizing enterocolitis, culture positive sepsis, bronchopulmonary dysplasia, and death. Bivariable and multivariable analyses were used to compare neonatal outcomes between 1) all women in the post-protocol cohort to those in the pre-protocol cohort and 2) only women who received adherent care in the post-protocol cohort to all women in the pre-protocol cohort. Results: A total of 452 women were included in the pre-protocol cohort and 451 in the post-protocol cohort. The majority of the post-protocol women (N=366, 81.2%) received adherent care. Women in both cohorts were similar with the exception that women in the post-protocol cohort were more likely to be nulliparous (p=0.013). Compared to the pre-protocol period, neonates of women in the post-protocol period had significantly higher odds of hypoglycemia <50 mg/dL in the first 24 hours of life (aOR 1.37, 95% CI 1.05-1.80), without improvements in respiratory outcomes. Results were similar when restricting the analysis to only women in the post-protocol cohort who received care adherent care (glucose <50 mg/dL: aOR 1.52, 95% CI 1.14-2.03). No differences in composite respiratory morbidity or other neonatal outcomes were observed. Conclusion: Uptake of a new institutional protocol for antenatal late preterm corticosteroids was rapid. Compared with historic controls, neonates exposed to antenatal late preterm corticosteroid experienced increased odds of hypoglycemia, without significant improvements in respiratory morbidities.

Intussusception Protocol Implementation: Single-Site Outcomes With Clinician and Family Satisfaction.

BACKGROUND: The objective of this study was to evaluate clinical outcomes, costs, and clinician and parent satisfaction after implementation of a protocol to discharge patients from the emergency department (ED) after successful reduction of uncomplicated ileocolic intussusception. MATERIALS AND METHODS: In March 2017, an intussusception management protocol was implemented for children presenting with ultrasound findings of ileocolic intussusception. Those meeting inclusion criteria were observed after successful radiological reduction in the ED and discharged after 6 h with resolution of symptoms. Retrospective chart review was completed for cases before and after protocol implementation for clinical outcomes and costs. Clinicians and parents were surveyed to assess overall satisfaction. RESULTS: Charts were reviewed before (42 encounters, 37 patients) and after (30 encounters, 23 patients) protocol implementation. After implementation, admission rates decreased from 95% (40/42) to 23% (7/30; P < 0.001) and antibiotic use was eliminated (91% to 0%, P < 0.001). There was no difference in recurrence rates (17% versus 23%, P = 0.44). Median total length of stay decreased from 18.87 to 9.52 h (P < 0.001), whereas median ED length of stay increased from 4.37 to 9.87 h (P < 0.001). In addition, there was an overall hospital cost saving of over $2000 ($9595 ± 3424 to $7465 ± 3723; P = 0.009) per encounter. Clinicians and parents were overall satisfied with the protocol and parents showed no changes in patient satisfaction with protocol implementation. CONCLUSIONS: An intussusception protocol can facilitate early discharge from the ED and improve patient care without increased risk of recurrence. Additional benefits include decreased hospital- and patient-related costs, elimination of antibiotic use, and parent as well as clinician satisfaction.

Oncologists and Breaking Bad News-From the Informed Patients' Point of View. The Evaluation of the SPIKES Protocol Implementation.

The way that bad news is disclosed to a cancer patient has a crucial impact on physician-patient cooperation and trust. Consensus-based guidelines provide widely accepted tools for disclosing unfavorable information. In oncology, the most popular one is called the SPIKES protocol. A 17-question survey was administered to a group of 226 patients with cancer (mean age 59.6 years) in order to determine a level of SPIKES implementation during first cancer disclosure. In our assessment, the patients felt that the highest compliance with the SPIKES protocol was with Setting up (70.6%), Knowledge (72.8%), and Emotions (75.3%). The lowest was with the Perception (27.7%), Invitation (30.4%), and Strategy & Summary (56.9%) parts. There could be improvement with each aspect of the protocol, but especially in Perception, Invitation, and Strategy & Summary. The latter is really important and must be done better. Older patients felt the doctors' language was more comprehensible (r = 0.17; p = 0.011). Patients' satisfaction of their knowledge about the disease and follow-up, regarded as an endpoint, was insufficient. Privacy was important in improving results (p < 0.01). In practice, the SPIKES protocol is implemented in a satisfactory standard, but it can be improved in each area, especially in Perception, Invitation, and Summary. It is suggested that more training should be done in undergraduate and graduate medical education and the effectiveness of the disclosure continue to be evaluated and improved.

Early Results of Fecal Microbial Transplantation Protocol Implementation at a Community-based University Hospital.

INTRODUCTION: Clostridium difficile (CD) is a serious and increasingly prevalent healthcare-associated infection. The pathogenesis of CD infection (CDI) involves the acquisition of CD with a concurrent disruption of the native gut flora. Antibiotics are a major risk although other contributing factors have also been identified. Clinical management combines discontinuation of the offending antibiotic, initiation of CD-specific antibiotic therapy, probiotic agent use, fecal microbiota transplantation (FMT), and surgery as the "last resort" option. The aim of this study is to review short-term clinical results following the implementation of FMT protocol (FMTP) at our community-based university hospital. METHODS: After obtaining Institutional Review Board and Infection Control Committee approvals, we implemented an institution-wide FMTP for patients diagnosed with CDI. Prospective tracking of all patients receiving FMT between July 1, 2015, and February 1, 2017, was conducted using REDCap™ electronic data capture system. According to the FMTP, indications for FMT included (a) three or more CDI recurrences, (b) two or more hospital admissions with severe CDI, or (c) first episode of complicated CDI (CCDI). Risk factors for initial infection and for treatment failure were assessed. Patients were followed for at least 3 months to monitor for cure/failure, relapse, and side effects. Frozen 250 mL FMT samples were acquired from OpenBiome (Somerville, MA, USA). After 4 h of thawing, the liquid suspension was applied using colonoscopy, beginning with terminal ileum and proceeding distally toward mid-transverse colon. Monitored clinical parameters included disease severity (Hines VA CDI Severity Score or HVCSS), concomitant medications, number of FMT treatments, non-FMT therapies, cure rates, and mortality. Descriptive statistics were utilized to outline the study results. RESULTS: A total of 35 patients (mean age 58.5 years, 69% female) were analyzed, with FMT-attributable primary cure achieved in 30/35 (86%) cases. Within this subgroup, 2/30 (6.7%) patients recurred and were subsequently cured with long-term oral vancomycin. Among five primary FMT failures (14% total sample), 3 (60%) achieved medical cure with long-term oral vancomycin therapy and 2 (40%) required colectomy. For the seven patients who either failed FMT or recurred, long-term vancomycin therapy was curative in all but two cases. For patients with severe CDI (HVCSS ≥3), primary and overall cure rates were 6/10 (60%) and 8/10 (80%), respectively. Patients with CCDI (n = 4) had higher HVCSS (4 vs. 3) and a mortality of 25%. Characteristics of patients who failed initial FMT included older age (70 vs. 57 years), female sex (80% vs. 67%), severe CDI (80% vs. 13%), and active opioid use during the initial infection (60% vs. 37%) and at the time of FMT (60% vs. 27%). The most commonly reported side effect of FMT was loose stools. CONCLUSIONS: This pilot study supports the efficacy and safety of FMT administration for CDI in the setting of a community-based university hospital. Following FMTP implementation, primary (86%) and overall (94%) nonsurgical cure rates were similar to those reported in other studies. The potential role of opioids as a modulator of CDI warrants further clinical investigation.

Evaluation of a simulation-based curriculum for implementing a new clinical protocol.

OBJECTIVE: To evaluate the implementation of a new clinical protocol utilizing on-unit simulation for team training. METHODS: A prospective observational study was performed at the obstetrics unit of Von Voightlander Women's Hospital, Michigan, USA, between October 1, 2012 to April 30, 2013. All members of the labor and delivery team were eligible for participation. Traditional education methods and in-situ multi-disciplinary simulations were used to educate labor and delivery staff. Following each simulation, participants responded to a survey regarding their experience. To evaluate the effect of the interventions, paging content was analyzed for mandated elements and adherence to operating room entry-time tracking was examined. RESULTS: In total, 51 unique individuals participated in 12 simulations during a 6-month period. Simulation was perceived as a valuable activity and paging content improved. Following the intervention, the inclusion of a goal time for reaching the operation room increased from 7% to 61% of pages and the proportion of patients entering to operating room within 10 minutes of the stated goal increased from 67% to 85%. CONCLUSION: The training program was well received, and the accuracy of the communication and the goal set for reaching the operating room improved.

Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials.

BACKGROUND: Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. PURPOSE: In this study, we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as to identify potential correlates of prolonged development and implementation. METHODS: We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by National Institutes of Health's HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/IV). We also examined several potential correlates to prolonged development and implementation intervals. RESULTS: Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2½ years) and implementation times (>3 years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. LIMITATIONS: The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects present for a specific study phase may have been masked by combining protocols into phase groupings. Presence of informative censoring, such as withdrawal of some protocols from development if they began showing signs of lost interest among investigators, complicates interpretation of Kaplan-Meier estimates. Because this study constitutes a retrospective examination over an extended period of time, it does not allow for the precise identification of relative factors impacting timing. CONCLUSION: Delays not only increase the time and cost to complete clinical trials but they also diminish their usefulness by failing to answer research questions in time. We believe that research analyzing the time spent traversing defined intervals across the clinical trial protocol development and implementation continuum can stimulate business process analyses and re-engineering efforts that could lead to reductions in the time from clinical trial concept to results, thereby accelerating progress in clinical research.