Teaching Evidence-Based Practice Competencies to Meet Professional Practice Needs.

BACKGROUND: Evidence-based practice (EBP) is a major concept threaded throughout nursing education, yet competencies are not clearly identified in The Essentials. PURPOSE: Nurse leaders' EBP competency expectations for professional practice were explored to inform competency-based education for students and practicing nurses. A secondary aim explored potential effects of misinformation on EBP. METHODS: Descriptive qualitative inquiry was performed with a focus group of 6 clinical nurse leaders. RESULTS: EBP expectations were identified, discriminating between novice entry level and advanced-level nurses. Participants emphasized asking questions, linking evidence to practice, and acknowledging that evidence changes over time. All advanced-level nurses were expected to apply, lead, and teach EBP. Post pandemic, nurses need to reclaim evidence-based practices, critically appraise evidence, and educate patients and families to address misinformation. CONCLUSIONS: Information learned will inform competency-based EBP education for students and nurses in academic and clinical settings.

Society of Critical Care Medicine Guidelines on Recognizing and Responding to Clinical Deterioration Outside the ICU: 2023.

RATIONALE: Clinical deterioration of patients hospitalized outside the ICU is a source of potentially reversible morbidity and mortality. To address this, some acute care hospitals have implemented systems aimed at detecting and responding to such patients. OBJECTIVES: To provide evidence-based recommendations for hospital clinicians and administrators to optimize recognition and response to clinical deterioration in non-ICU patients. PANEL DESIGN: The 25-member panel included representatives from medicine, nursing, respiratory therapy, pharmacy, patient/family partners, and clinician-methodologists with expertise in developing evidence-based Clinical Practice Guidelines. METHODS: We generated actionable questions using the Population, Intervention, Control, and Outcomes (PICO) format and performed a systematic review of the literature to identify and synthesize the best available evidence. We used the Grading of Recommendations Assessment, Development, and Evaluation Approach to determine certainty in the evidence and to formulate recommendations and good practice statements (GPSs). RESULTS: The panel issued 10 statements on recognizing and responding to non-ICU patients with critical illness. Healthcare personnel and institutions should ensure that all vital sign acquisition is timely and accurate (GPS). We make no recommendation on the use of continuous vital sign monitoring among unselected patients. We suggest focused education for bedside clinicians in signs of clinical deterioration, and we also suggest that patient/family/care partners' concerns be included in decisions to obtain additional opinions and help (both conditional recommendations). We recommend hospital-wide deployment of a rapid response team or medical emergency team (RRT/MET) with explicit activation criteria (strong recommendation). We make no recommendation about RRT/MET professional composition or inclusion of palliative care members on the responding team but suggest that the skill set of responders should include eliciting patients' goals of care (conditional recommendation). Finally, quality improvement processes should be part of a rapid response system. CONCLUSIONS: The panel provided guidance to inform clinicians and administrators on effective processes to improve the care of patients at-risk for developing critical illness outside the ICU.

Executive Summary: Society of Critical Care Medicine Guidelines on Recognizing and Responding to Clinical Deterioration Outside the ICU.

RATIONALE: Clinical deterioration of patients hospitalized outside the ICU is a source of potentially reversible morbidity and mortality. To address this, some acute care facilities have implemented systems aimed at detecting and responding to such patients. OBJECTIVES: To provide evidence-based recommendations for hospital clinicians and administrators to optimize recognition and response to clinical deterioration in non-ICU patients. PANEL DESIGN: The 25-member panel included representatives from medicine, nursing, respiratory therapy, pharmacy, patient/family partners, and clinician-methodologists with expertise in developing evidence-based clinical practice guidelines. METHODS: We generated actionable questions using the Population, Intervention, Control, and Outcomes format and performed a systematic review of the literature to identify and synthesize the best available evidence. We used the Grading of Recommendations Assessment, Development, and Evaluation approach to determine certainty in the evidence and to formulate recommendations and good practice statements (GPSs). RESULTS: The panel issued 10 statements on recognizing and responding to non-ICU patients with critical illness. Healthcare personnel and institutions should ensure that all vital sign acquisition is timely and accurate (GPS). We make no recommendation on the use of continuous vital sign monitoring among "unselected" patients due to the absence of data regarding the benefit and the potential harms of false positive alarms, the risk of alarm fatigue, and cost. We suggest focused education for bedside clinicians in signs of clinical deterioration, and we also suggest that patient/family/care partners' concerns be included in decisions to obtain additional opinions and help (both conditional recommendations). We recommend hospital-wide deployment of a rapid response team or medical emergency team (RRT/MET) with explicit activation criteria (strong recommendation). We make no recommendation about RRT/MET professional composition or inclusion of palliative care members on the responding team but suggest that the skill set of responders should include eliciting patients' goals of care (conditional recommendation). Finally, quality improvement processes should be part of a rapid response system (GPS). CONCLUSIONS: The panel provided guidance to inform clinicians and administrators on effective processes to improve the care of patients at-risk for developing critical illness outside the ICU.

Original Research: Exploring Medication Safety Practices from the Nurse's Perspective.

BACKGROUND: Medication preparation and administration are complex tasks that nurses must perform daily within today's complicated health care environment. Despite more than two decades of efforts to reduce medication errors, it's well known that such errors remain prevalent. Obtaining insight from direct care nurses may clarify where opportunities for improvement exist and guide future efforts to do so. PURPOSE: The study purpose was to explore direct care nurses' perspectives on and experiences with medication safety practices and errors. METHODS: A qualitative descriptive study was conducted among direct care nurses employed across a large health care system. Data were collected using semistructured interview questions with participants in focus groups and one-on-one meetings and were analyzed using qualitative direct content analysis. RESULTS: A total of 21 direct care nurses participated. Four major themes emerged that impact the medication safety practices of and errors by nurses: the care environment, nurse competency, system influences, and the error paradigm. These themes were often interrelated. Most participants depicted chaotic environments, heavy nursing workloads, and distractions and interruptions as increasing the risk of medication errors. Many seemed unsure about what an error was or could be. CONCLUSIONS: The complexity of medication safety practices makes it difficult to implement improvement strategies. Understanding the perspectives and experiences of direct care nurses is imperative to implementing such strategies effectively. Based on the study findings, potential solutions should include actively addressing environmental barriers to safe medication practices, ensuring more robust medication management education and training (including guidance regarding the definition of medication errors and the importance of reporting), and revising policies and procedures with input from direct care nurses.

Comparison of Three Reconstitution Devices: A Simulated Time and Use Study.

The objective of this study was to compare residual volume and time to prepare and reconstitute cefazolin using 3 different reconstitution devices while observing for use errors, participant feedback, and particulate after reconstitution. After demonstrations on the use of each device and practicing twice with each device, participants performed reconstitutions 3 times per device while being timed and observed on device preparation and assembly, mixing the drug with intravenous fluid into vials, and transfer of vial contents into the intravenous bags. Participants completed surveys to assess perceptions on use of each device. Intravenous bags were then hung for 60 minutes and observed for residual fluid and particulate matter. Residual vial volumes ranged from 0.05 mL to 2.6 mL: >0.3 mL in Device 2 (16.7%), Device 1 (55.6%), and Device 3 (81.1%). Most participants (83%) had experience with Device 1. Mean (standard deviation) total time in seconds to reconstitute medication significantly differed between devices (P<0.001): Device 1, 70.98 (15.72), Device 2, 99.11 (14.87), Device 3, 103.7 (18.99). Device assembly took the longest time and significantly differed between devices (P<0.001): Device 1, 18.76 (8.13), Device 2, 36.09 (8.05), and Device 3, 31.21 (7.75). Survey results (60=max score) were significantly different (P<0.001): Device 1, 54.5 (5.3), Device 2, 44 (13.1), Device 3, 37.1 (9.1). Nurses ranked Device 1 the highest (79%) and pharmacy technicians favored Device 2 (60%). No particulates were found (n = 270). Potentially significant residual vial volume was found and use errors were concerning in Device 2 and Device 3, potentially resulting in incomplete medication dosing. Mean times for reconstitution were <104 seconds, with Device 1 being the fastest and most favored.

Exploring Nurses' Attitudes, Skills, and Beliefs of Medication Safety Practices.

BACKGROUND: Medication errors exist within health care systems despite efforts to reduce their incidence. These errors may result in patient harm including morbidity, mortality, and increased health care costs. PURPOSE: The purpose of this study was to explore direct care nurses' attitudes, skills, and beliefs about medication safety practice. METHODS: Researchers conducted a descriptive exploratory study using the Nurses' Attitudes and Skills around Updated Safety Concepts (NASUS) scale and the Nurse Beliefs about Errors Questionnaire (NBEQ). RESULTS: Responses from 191 surveys were analyzed. Of the participants, 70% were bachelor's prepared registered nurses and 88% were female. Results of the NASUS scale revealed the median of means of the Perceived Skills subscale was 79.2 out of 100 and the Attitudes subscale was 65.8 out of 100. The mean of the belief questions related to severity of error was 7.66 out of 10; most participants agreed with reporting of severe errors, reporting errors with moderate or major adverse events, and reporting of incorrect intravenous fluids. CONCLUSIONS: Understanding direct care nurses' attitudes, skills, and beliefs about medication safety practices provides a foundation for development of improvement strategies.

Frame of reference training for content analysis with structured teams (FORT-CAST): A framework for content analysis of open-ended survey questions using multidisciplinary coders.

In the context of a global pandemic, the need for reliable analysis of qualitative data in healthcare has never been more pressing. Open-ended questions are a feasible way for both researchers and organizational stakeholders to gain deeper insight into complex situations when timely research is needed. However, the interpretation of brief, textual responses can prove problematic. Both manual and automated/semiautomated methods of coding qualitative data have been associated with errors and costly temporal delays. Data obtained from the qualitative analysis of open-ended questions have been questioned for lacking robust insights. The present article introduces an innovative, manual, team-based method of analyzing responses to open-ended survey questions. This method was developed and implemented at the outset of the COVID-19 pandemic to understand the needs of nurses and their perceptions of organizational strategies that were implemented to address pandemic-related challenges. This framework utilizes a dedicated project management structure, general purpose software for data collection and analysis, frame-of-reference training designed for an interdisciplinary team of coders, and data analysis procedures that align with qualitative content analysis procedures. In concert, these techniques empower researchd team members with varying backgrounds and disparate levels of experience to provide unique human insights to data analysis procedures, refine the coding process, and support the abstraction of meaningful themes that were used to prioritize organizational strategies and further support nurses as the pandemic progressed.

A 1-minute blood test detects decreased immune function and increased clinical risk in COVID-19 patients.

Upon infection with SARS-CoV-2, the virus that causes COVID-19, most people will develop no or mild symptoms. However, a small percentage of the population will become severely ill, and some will succumb to death. The clinical severity of COVID-19 has a close connection to the dysregulation of the patient's immune functions. We previously developed a simple, nanoparticle-enabled blood test that can determine the humoral immune status in animals. In this study, we applied this new test to analyze the immune function in relation to disease severity in COVID-19 patients. From the testing of 153 COVID-19 patient samples and 142 negative controls, we detected a drastic decrease of humoral immunity in COVID-19 patients who developed moderate to severe symptoms, but not in patients with no or mild symptoms. The new test may be potentially used to monitor the immunity change and predict the clinical risk of patients with COVID-19.

Original Research: Oral Care as Prevention for Nonventilator Hospital-Acquired Pneumonia: A Four-Unit Cluster Randomized Study.

BACKGROUND: Nonventilator hospital-acquired pneumonia (NV-HAP) presents a serious and largely preventable threat to patient safety in U.S. hospitals. There is an emerging body of evidence on the effectiveness of oral care in preventing NV-HAP. PURPOSE: The primary aim of this study was to determine the effectiveness of a universal, standardized oral care protocol in preventing NV-HAP in the acute care setting. The primary outcome measure was NV-HAP incidence per 1,000 patient-days. METHODS: This 12-month study was conducted on four units at an 800-bed tertiary medical center. Patients on one medical and one surgical unit were randomly assigned to receive enhanced oral care (intervention units); patients on another medical and another surgical unit received usual oral care (control units). RESULTS: Total enrollment was 8,709. For the medical control versus intervention units, oral care frequency increased from a mean of 0.95 to 2.25 times per day, and there was a significant 85% reduction in the NV-HAP incidence rate. The odds of developing NV-HAP were 7.1 times higher on the medical control versus intervention units, a significant finding. For the surgical control versus intervention units, oral care frequency increased from a mean of 1.18 to 2.02 times per day, with a 56% reduction in the NV-HAP incidence rate. The odds of developing NV-HAP were 1.6 times higher on the surgical control versus intervention units, although this result did not reach significance. CONCLUSIONS: These findings add to the growing body of evidence that daily oral care as a means of primary source control may have a role in NV-HAP prevention. The implementation of effective strategies to ensure that such care is consistently provided warrants further study. It's not yet known what degree and frequency of oral care are required to effect favorable changes in the oral microbiome during acute care hospitalization.

Pulmonary Microbiome of Patients Receiving Mechanical Ventilation: Changes Over Time.

BACKGROUND: Interest in the pulmonary microbiome is growing, particularly in patients undergoing mechanical ventilation. OBJECTIVES: To explore the pulmonary microbiome over time in patients undergoing prolonged mechanical ventilation and to evaluate the effect of an oral suctioning intervention on the microbiome. METHODS: This descriptive subanalysis from a clinical trial involved a random sample of 16 participants (7 intervention, 9 control) who received mechanical ventilation for at least 5 days. Five paired oral and tracheal specimens were evaluated for each participant over time. Bacterial DNA from the paired specimens was evaluated using 16S rRNA gene sequencing. Bacterial taxonomy composition, α-diversity (Shannon index), and ß-diversity (Morisita-Horn index) were calculated and compared within and between participants. RESULTS: Participants were predominantly male (69%) and White (63%), with a mean age of 58 years, and underwent mechanical ventilation for a mean of 9.36 days. Abundant bacterial taxa included Prevotella, Staphylococcus, Streptococcus, Stenotrophomonas, and Veillonella. Mean tracheal α-diversity decreased over time for the total group (P = .002) and the control group (P = .02). ß-Diversity was lower (P = .04) in the control group (1.905) than in the intervention group (2.607). CONCLUSIONS: Prolonged mechanical ventilation was associated with changes in the pulmonary microbiome, with the control group having less diversity. The oral suctioning intervention may have reduced oral-tracheal bacterial transmission.

Intravenous Smart Pumps During Actual Clinical Use: A Descriptive Comparison of Primary and Secondary Infusion Practices.

This descriptive observational study was conducted to increase understanding of medication administration practices during actual clinical use between 2 commonly used, different types of intravenous (IV) smart pumps. Compliance with manufacturer-recommended setup requirements for both primary and secondary infusions and secondary medication administration delay was compared between a head-height differential system and a cassette system. A total of 301 medication administration observations were included in this study: 102 (34%) for the linear peristaltic IV smart pump (medical-surgical: N = 51; critical care: N = 51) and 199 (66%) for the cassette pump (medical-surgical: N = 88; critical care: N = 111). Results found a 0% compliance for primary line setup and 84% compliance for secondary line setup and 1 omitted medication due to a closed clamp with the linear peristaltic system. For the cassette system, there are no head-height requirements. Two roller clamps were found to be in the closed position on initiation of the secondary infusion, but the clinician was alerted by an alarm, so no medication delays occurred. These findings support that the current system requirements for flow rate accuracy using head-height differential systems are difficult to achieve consistently at the point of care. There is a need for additional human factor designed technology to replace manual actions to improve the process of care for nurses and the safety of care for patients.

Evaluation of processes, outcomes, and use of midline peripheral catheters for the purpose of blood collection.

HIGHLIGHTS: Results added knowledge on use of midline catheters (MCs) for blood sampling. Using MCs for blood withdrawal resulted in low rates of hemolysis (0.69%). Dwell time was longer in those who had blood drawn from their MC. Nurse practices for blood sampling from MCs varied and learned from other nurses. BACKGROUND: Blood withdrawal from midline catheters (MCs) is done clinically, but no studies were found evaluating outcomes from this procedure, nor were clinical guidelines found. Drawing blood samples from short peripheral catheters is associated with higher hemolysis rates. METHODS: A prospective, observational, mixed methods study was used to evaluate outcomes from using MCs for blood withdrawal. Focus group sessions were held to evaluate nurses' practices for this procedure. RESULTS: Data were collected over 3 months on 397 MCs in 378 patients. Hemolysis rates when the MC was used for blood withdrawal was 0.69% in 1021 tests. More than half had blood specimens drawn through the MC, and the time known for the successful withdrawal was on average 64 ± 85 hours. Mean dwell time for all MCs was 108.5 ± 98 hours, and when MCs were used for blood withdrawal, mean dwell time was 127.19 ± 109.13 hours and for MCs not used for blood withdrawal, 88.34 ± 79.86 hours (P < 0.001). In 338 patients who received therapy through their MC (n = 338), 87% completed intended therapy: 88% with blood withdrawal and 81% without blood withdrawal. Qualitative analysis from focus groups demonstrated wide variation in practice for blood sampling from MCs, and most learned techniques from their preceptors, other nurses, or patients. CONCLUSIONS: Findings indicated that blood withdrawal from one specific type of MC had low rates of hemolysis, increased dwell time, and completion of therapy. More studies are needed to determine best practices for blood sampling through various types of MCs and outcomes.

The Effect of Implementing Bar-Code Medication Administration in an Emergency Department on Medication Administration Errors and Nursing Satisfaction.

INTRODUCTION: Bar-code medication administration has been shown to reduce medication errors in inpatient settings with limited studies on its use in emergency departments. In addition, no studies have evaluated nursing satisfaction with implementing bar-code medication administration in an emergency department. This study was designed to determine the impact of implementing bar-code medication administration in an emergency department on medication errors and nursing satisfaction. METHODS: This is a before-and-after study, with no control group, of a bar-code medication administration intervention conducted in a community hospital emergency department. Direct observation was used to compare medication error rates before and 3 months after implementing bar-code medication administration. The Medication Administration System-Nurses Assessment of Satisfaction survey was used to assess the impact on nursing satisfaction before and 1 month after bar-code medication administration implementation. RESULTS: A total of 676 medication administrations were observed in the period before bar-code medication administration implementation and 656 after. The medication administration error rate preimplementation was 2.96% with "wrong dose" errors being the most common. After bar-code medication administration implementation, the medication administration error rate fell to 0.76%, a relative reduction of 74.2% (Fisher exact P < 0.01). The average (SD) Medication Administration System-Nurses Assessment of Satisfaction score preimplementation was 2.60 (0.75) and improved to 2.29 (0.66) (t = 2.00, P = 0.05) 1 month post implementation. DISCUSSION: Implementing bar-code medication administration in a community emergency department was associated with a decrease in medication administration errors and an improvement in Medication Administration System-Nurses Assessment of Satisfaction scores. The results of this study suggest a benefit of bar-code medication administration in reducing medication administration errors and improved nursing satisfaction in the emergency department.

Evaluation of the Use of Open Versus Closed Short Peripheral Catheters on Catheter Dwell Time.

Short peripheral catheters (SPCs) vary by design and materials. The investigators conducted a before-and-after study comparing catheter dwell time and complications with open and closed system SPCs. Many SPCs in the study were saline locks. Results showed that the closed system SPCs had a significantly longer dwell time than open system SPCs. Complications overall were few and not different between groups. Nurse survey ratings were more positive for reduced blood spillage and materials with the closed system SPC but favored the open system SPC for ease of use when handling the catheter and venipuncture. The most common reason for discontinuing the catheter was for patient discharge.

Impact of Bundled Care on Outcomes Following Elective Primary Total Hip or Total Knee Arthroplasty.

BACKGROUND: Standardized approaches to care and care pathways for patients with joint replacement have been shown to decrease length of stay (LOS), improve patient participation in education, decrease patient anxiety while improving perception of care, and lead to overall efficiency and improved care and outcomes. PURPOSE: The purpose of this study was to determine whether implementation of a standardized bundle approach to care influenced the outcomes after total hip or total knee arthroplasty (THA or TKA). METHODS: A retrospective, quasi-experimental before- and after-design study was used to evaluate the impact of the intervention. Two hospitals implemented a standardized bundle of care for patients undergoing THA or TKA that included preoperative patient education, day of surgery mobilization, and a total joint group physical therapy session (Full Bundle). Data analyses were completed on a convenience sample of 2,200 patients who underwent THA or TKA. Outcomes data measured were LOS, discharge disposition, costs, and readmission rate. RESULTS: Patients receiving the Full Bundle had significant reduction in LOS of roughly 1 day (OR = 1.687, 95% CI [1.578, 1.797]) versus group not receiving all elements (OR = 2.706; 95% CI [2.623, 2.789]). Full Bundle patients were 6 times more likely to be discharged home compared with the Partial Bundle group (OR = 6.01, 95% CI [4.01, 9.03]). Full Bundle group had significantly lower total direct costs, F(1) = 4.06, p = .046, partial η = 0.003. There were no differences in readmission rates between the 2 groups. CONCLUSION: Patients who had all elements of the THA/TKA bundle had the best outcomes. By improving efficiencies of care through the use of the bundle, the 2 hospitals positively impacted the care and outcomes of THA and TKA patients.

Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial.

AIMS: To evaluate a deep oropharyngeal suction intervention (NO-ASPIRATE) in intubated patients on microaspiration, ventilator-associated events and clinical outcomes. DESIGN: Prospective, two-group, single-blind, randomized clinical trial. METHODS: The study was conducted between 2014 - 2017 in 513 participants enroled within 24 hr of intubation and randomized into NO-ASPIRATE or usual care groups. Standard oral care was provided to all participants every 4 hr and deep oropharyngeal suctioning was added to the NO-ASPIRATE group. Oral and tracheal specimens were obtained to quantify α-amylase as an aspiration biomarker. RESULTS: Data were analysed for 410 study completers enrolled at least 36 hr: NO-ASPIRATE (N = 206) and usual care (N = 204). Percent of tracheal specimens positive for α-amylase, mean tracheal α-amylase levels over time and ventilator-associated events were not different between groups. The NO-ASPIRATE group had a shorter hospital length of stay and a subgroup with moderate aspiration at baseline had significantly lower α-amylase levels across time. CONCLUSION: Hospital length of stay was shorter in the NO-ASPIRATE group and a subgroup of intervention participants had lower α-amylase across time. Delivery of standardized oral care to all participants may have been an intervention itself and possibly associated with the lack of significant findings for most outcomes. IMPACT: This trial compared usual care to oral care with a deep suctioning intervention on microaspiration and ventilator-associated events, as this has not been systematically studied. Further research on the usefulness of α-amylase as an aspiration biomarker and the role of oral suctioning, especially for certain populations, is indicated. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02284178.

Nursing oral suction intervention to reduce aspiration and ventilator events (NO-ASPIRATE): A randomized clinical trial.

AIM: The primary aim of this study is to compare an oropharyngeal suction intervention versus usual care on microaspiration in intubated patients. Secondary aims are to evaluate the intervention on ventilator-associated condition rates, time to occurrence and compare tracheal-oral α-amylase ratios between groups. DESIGN: Prospective randomized clinical trial. METHODS: The study received funding from the National Institutes of Health in February 2014 and Institutional Review Board approval in July 2013. Over 4 years, a convenience sample of 600 orally intubated, ventilated adult patients will be enrolled within 24 hr of intubation. The target sample is 400 participants randomized to the two groups. The intervention involves enhanced suctioning of the mouth and oropharynx every 4 hr, while the usual care group receives a sham suctioning. The research team will deliver usual oral care to all patients every 4 hr and collect oral and tracheal specimens every 12 hr, to quantify α-amylase levels to detect aspiration of oral secretions. Study completers must be enrolled at least 36 hr (baseline and three paired samples). Outcomes include α-amylase levels, percent of positive specimens, ventilator-associated conditions, length of stay, ventilator hours, and discharge disposition. DISCUSSION: Enrolment has closed, and data analysis has begun. Subgroup analyses emerged, contributing to future research knowledge. IMPACT: Standardized interventions have reduced but do not address all risk factors associated with ventilator-associated conditions. This study provides the potential to reduce microaspiration and associated sequelae in critically ill, intubated patients.

Collecting Nursing Research Data 24 Hours a Day: Challenges, Lessons, and Recommendations.

BACKGROUND: Research on many routine nursing interventions requires data collection around the clock each day (24/7). Strategies for implementing and coordinating a study 24/7 are not discussed in the literature, and best practices are needed. OBJECTIVE: To identify strategies incorporated into implementing a nursing intervention trial 24/7, including key lessons learned. METHODS: Strategies to facilitate implementation of a clinical trial of a nursing intervention with patients undergoing mechanical ventilation are shared. Challenges and changes for future studies also are discussed. RESULTS: Adequate planning, including a detailed operations manual, guides study implementation. Staffing is the most challenging and costly part of a study but is essential to a study's success. Other important strategies include communication among the study personnel and with collaborators and direct care staff. An electronic method of recording study-related data also is essential. CONCLUSIONS: A nursing clinical trial that requires interventions on a 24/7 basis can be done with thorough planning, staffing, and continuous quality improvement activities.