Effect of a Co-Located Bridging Recovery Initiative on Hospital Length of Stay Among Patients With Opioid Use Disorder: The BRIDGE Randomized Clinical Trial.

Importance: Co-located bridge clinics aim to facilitate a timely transition to outpatient care for inpatients with opioid use disorder (OUD); however, their effect on hospital length of stay (LOS) and postdischarge outcomes remains unclear. Objective: To evaluate the effect of a co-located bridge clinic on hospital LOS among inpatients with OUD. Design, Setting, and Participants: This parallel-group randomized clinical trial recruited 335 adult inpatients with OUD seen by an addiction consultation service and without an existing outpatient clinician to provide medication for OUD (MOUD) between November 25, 2019, and September 28, 2021, at a tertiary care hospital affiliated with a large academic medical center and its bridge clinic. Intervention: The bridge clinic included enhanced case management before and after hospital discharge, MOUD prescription, and referral to a co-located bridge clinic. Usual care included MOUD prescription and referrals to community health care professionals who provided MOUD. Main Outcomes and Measures: The primary outcome was the index admission LOS. Secondary outcomes, assessed at 16 weeks, were linkage to health care professionals who provided MOUD, MOUD refills, same-center emergency department (ED) and hospital use, recurrent opioid use, quality of life (measured by the Schwartz Outcome Scale-10), overdose, mortality, and cost. Analysis was performed on an intent-to-treat basis. Results: Of 335 participants recruited (167 randomized to the bridge clinic and 168 to usual care), the median age was 38.0 years (IQR, 31.9-45.7 years), and 194 (57.9%) were male. The median LOS did not differ between arms (adjusted odds ratio [AOR], 0.94 [95% CI, 0.65-1.37]; P = .74). At the 16-week follow-up, participants referred to the bridge clinic had fewer hospital-free days (AOR, 0.54 [95% CI, 0.32-0.92]), more readmissions (AOR, 2.17 [95% CI, 1.25-3.76]), and higher care costs (AOR, 2.25 [95% CI, 1.51-3.35]), with no differences in ED visits (AOR, 1.15 [95% CI, 0.68-1.94]) or deaths (AOR, 0.48 [95% CI, 0.08-2.72]) compared with those receiving usual care. Follow-up calls were completed for 88 participants (26.3%). Participants referred to the bridge clinic were more likely to receive linkage to health care professionals who provided MOUD (AOR, 2.37 [95% CI, 1.32-4.26]) and have more MOUD refills (AOR, 6.17 [95% CI, 3.69-10.30]) and less likely to experience an overdose (AOR, 0.11 [95% CI, 0.03-0.41]). Conclusions and Relevance: This randomized clinical trial found that among inpatients with OUD, bridge clinic referrals did not improve hospital LOS. Referrals may improve outpatient metrics but with higher resource use and expenditure. Bending the cost curve may require broader community and regional partnerships. Trial Registration: ClinicalTrials.gov Identifier: NCT04084392.

Effect of Smartphone App-Based Education on Clinician Prescribing Habits in a Learning Health Care System: A Randomized Cluster Crossover Trial.

Importance: Effective methods for engaging clinicians in continuing education for learning-based practice improvement remain unknown. Objective: To determine whether a smartphone-based app using spaced education with retrieval practice is an effective method to increase evidence-based practice. Design, Setting, and Participants: A prospective, unblinded, single-center, crossover randomized clinical trial was conducted at a single academic medical center from January 6 to April 24, 2020. Vanderbilt University Medical Center clinicians prescribing intravenous fluids were invited to participate in this study. Interventions: All clinicians received two 4-week education modules: 1 on prescribing intravenous fluids and 1 on prescribing opioid and nonopioid medications (counterbalancing measure), over a 12-week period. The order of delivery was randomized 1:1 such that 1 group received the fluid management module first, followed by the pain management module after a 4-week break, and the other group received the pain management module first, followed by the fluid management module after a 4-week break. Main Outcomes and Measures: The primary outcome was evidence-based clinician prescribing behavior concerning intravenous fluids in the inpatient setting and pain medication prescribing on discharge from the hospital. Results: A total of 354 participants were enrolled and randomized, with 177 in group 1 (fluid then pain management education) and 177 in group 2 (pain management then fluid education). During the overall study period, 16 868 questions were sent to 349 learners, with 11 783 (70.0%) being opened: 10 885 (92.4%) of those opened were answered and 7175 (65.9%) of those answered were answered correctly. The differences between groups changed significantly over time, indicated by the significant interaction between educational intervention and time (P = .002). Briefly, at baseline evidence-concordant IV fluid ordered 7.2% less frequently in group 1 than group 2 (95% CI, -19.2% to 4.9%). This was reversed after training at 4% higher (95% CI, -8.2% to 16.0%) in group 1 than group 2, a more than doubling in the odds of evidence-concordant ordering (OR, 2.56, 95% CI, 0.80-8.21). Postintervention, all gains had been reversed with less frequent ordering in group 1 than group 2 (-9.5%, 95% CI, -21.6% to 2.7%). There was no measurable change in opioid prescribing behaviors at any time point. Conclusions and Relevance: In this randomized clinical trial, use of smartphone app learning modules resulted in statistically significant short-term improvement in some prescribing behaviors. However, this effect was not sustained over the long-term. Additional research is needed to understand how to sustain improvements in care delivery as a result of continuous professional development at the institutional level. Trial Registration: ClinicalTrials.gov Identifier: NCT03771482.

Assessment of Awake Prone Positioning in Hospitalized Adults With COVID-19: A Nonrandomized Controlled Trial.

Importance: Awake prone positioning may improve hypoxemia among patients with COVID-19, but whether it is associated with improved clinical outcomes remains unknown. Objective: To determine whether the recommendation of awake prone positioning is associated with improved outcomes among patients with COVID-19-related hypoxemia who have not received mechanical ventilation. Design, Setting, and Participants: This pragmatic nonrandomized controlled trial was conducted at 2 academic medical centers (Vanderbilt University Medical Center and NorthShore University HealthSystem) during the COVID-19 pandemic. A total of 501 adult patients with COVID-19-associated hypoxemia who had not received mechanical ventilation were enrolled from May 13 to December 11, 2020. Interventions: Patients were assigned 1:1 to receive either the practitioner-recommended awake prone positioning intervention (intervention group) or usual care (usual care group). Main Outcomes and Measures: Primary outcome analyses were performed using a bayesian proportional odds model with covariate adjustment for clinical severity ranking based on the World Health Organization ordinal outcome scale, which was modified to highlight the worst level of hypoxemia on study day 5. Results: A total of 501 patients (mean [SD] age, 61.0 [15.3] years; 284 [56.7%] were male; and most [417 (83.2%)] were self-reported non-Hispanic or non-Latinx) were included. Baseline severity was comparable between the intervention vs usual care groups, with 170 patients (65.9%) vs 162 patients (66.7%) receiving oxygen via standard low-flow nasal cannula, 71 patients (27.5%) vs 62 patients (25.5%) receiving oxygen via high-flow nasal cannula, and 16 patients (6.2%) vs 19 patients (7.8%) receiving noninvasive positive-pressure ventilation. Nursing observations estimated that patients in the intervention group spent a median of 4.2 hours (IQR, 1.8-6.7 hours) in the prone position per day compared with 0 hours (IQR, 0-0.7 hours) per day in the usual care group. On study day 5, the bayesian posterior probability of the intervention group having worse outcomes than the usual care group on the modified World Health Organization ordinal outcome scale was 0.998 (posterior median adjusted odds ratio [aOR], 1.63; 95% credibility interval [CrI], 1.16-2.31). However, on study days 14 and 28, the posterior probabilities of harm were 0.874 (aOR, 1.29; 95% CrI, 0.84-1.99) and 0.673 (aOR, 1.12; 95% CrI, 0.67-1.86), respectively. Exploratory outcomes (progression to mechanical ventilation, length of stay, and 28-day mortality) did not differ between groups. Conclusions and Relevance: In this nonrandomized controlled trial, prone positioning offered no observed clinical benefit among patients with COVID-19-associated hypoxemia who had not received mechanical ventilation. Moreover, there was substantial evidence of worsened clinical outcomes at study day 5 among patients recommended to receive the awake prone positioning intervention, suggesting potential harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04359797.

Promoting patient and nurse safety: testing a behavioural health intervention in a learning healthcare system: results of the DEMEANOR pragmatic, cluster, cross-over trial.

BACKGROUND: Based on clinical staff safety within a learning healthcare system, the purpose of this study was to test an innovative model of care for addressing disruptive behaviour in hospitalised patients to determine whether it should be scaled up at the system level. METHODS: The Disruptive bEhaviour manageMEnt ANd prevention in hospitalised patients using a behaviOuRal (DEMEANOR) intervention team was a pragmatic, cluster, cross-over trial. A behavioural intervention team (BIT) with a psychiatric mental health advanced practice nurse and a social worker, with psychiatrist consultation, switched between units each month and occurrences of disruptive behaviours (eg, documented violence control measures, violence risk) compared. Nursing surveys assessed self-perceived efficacy and comfort managing disruptive patient behaviour. RESULTS: A total of 3800 patients hospitalised on the two units met the criteria for inclusion. Of those, 1841 (48.4%) were exposed to the BIT intervention and 1959 (51.6%) were in the control group. A total of 11 132 individual behavioural issues associated with 203 patient encounters were documented. There were no differences in the use of behavioural interventions, violence risk or injurious behaviour or sitter use between patients exposed to BIT and those in the control group. Tracking these data did rely on nursing documentation of such events. Nurses (82 pre and 48 post) rated BIT as the most beneficial support they received to manage patients exhibiting disruptive, threatening or acting out behaviour. CONCLUSIONS: The BIT intervention was perceived as beneficial by nurses in preparing them to provide care for patients exhibiting disruptive, threatening or acting out behaviour, but documented patient behaviour was not observed to change. TRIAL REGISTRATION NUMBER: NCT03777241.

Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE): study protocol for a randomized controlled trial of a bridge clinic compared with usual care for patients with opioid use disorder.

BACKGROUND: Patients with substance use disorders are overrepresented among general hospital inpatients, and their admissions are associated with longer lengths of stay and increased readmission rates. Amid the national opioid crisis, increased attention has been given to the integration of addiction with routine medical care in order to better engage such patients and minimize fragmentation of care. General hospital addiction consultation services and transitional, hospital-based "bridge" clinics have emerged as potential solutions. We designed the Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE) trial to determine if these clinics are superior to usual care for these patients. METHODS: This single-center, pragmatic, randomized controlled clinical trial is enrolling hospitalized patients with opioid use disorder (OUD) who are initiating medication for OUD (MOUD) in consultation with the addiction consult service. Patients are randomized for referral to a co-located, transitional, multidisciplinary bridge clinic or to usual care, with the assignment probability being determined by clinic capacity. The primary endpoint is hospital length of stay. Secondary endpoints include quality of life, linkage to care, self-reported buprenorphine or naltrexone fills, rate of known recurrent opioid use, readmission rates, and costs. Implementation endpoints include willingness to be referred to the bridge clinic, attendance rates among those referred, and reasons why patients were not eligible for referral. The main analysis will use an intent-to-treat approach with full covariate adjustment. DISCUSSION: This ongoing pragmatic trial will provide evidence on the effectiveness of proactive linkage to a bridge clinic intervention for hospitalized patients with OUD initiating evidence-based pharmacotherapy in consultation with the addiction consult service. TRIAL REGISTRATION: ClinicalTrials.gov NCT04084392 . Registered on 10 September 2019. The study has been approved by the Vanderbilt Institutional Review Board. The current approved protocol is dated version May 12, 2021.

Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial.

Rationale: Respiratory support (noninvasive ventilation or high-flow nasal cannula) applied at the time of extubation has been reported to reduce reintubation rates, but concerns regarding effectiveness have limited uptake into practice.Objectives: To determine if providing postextubation respiratory support to all patients undergoing extubation in a medical ICU would decrease the incidence of reintubation.Methods: We conducted a pragmatic, two-armed, cluster-crossover trial of adults undergoing extubation from invasive mechanical ventilation between October 1, 2017, and March 31, 2019, in the medical ICU of an academic medical center. Patients were assigned to either protocolized postextubation respiratory support (a respiratory therapist-driven protocol in which patients with suspected hypercapnia received noninvasive ventilation and patients without suspected hypercapnia received high-flow nasal cannula) or usual care (postextubation management at the discretion of treating clinicians). The primary outcome was reintubation within 96 hours of extubation.Measurements and Main Results: A total of 751 patients were enrolled. Of the 359 patients assigned to protocolized support, 331 (92.2%) received postextubation respiratory support compared with 66 of 392 patients (16.8%) assigned to usual care, a difference driven by differential use of high-flow nasal cannula (74.7% vs. 2.8%). A total of 57 patients (15.9%) in the protocolized support group experienced reintubation compared with 52 patients (13.3%) in the usual care group (odds ratio, 1.23; 95% confidence interval, 0.82 to 1.84; P = 0.32).Conclusions: Among a broad population of critically ill adults undergoing extubation from invasive mechanical ventilation at an academic medical center, protocolized postextubation respiratory support, primarily characterized by an increase in the use of high-flow nasal cannula, did not prevent reintubation compared with usual care.Clinical trial registered with www.clinicaltrials.gov (NCT0328831).

Learning From What We Do, and Doing What We Learn: A Learning Health Care System in Action.

Different models of learning health systems are emerging. At Vanderbilt University Medical Center, the Learning Health Care System (LHS) Platform was established with the goal of creating generalizable knowledge. This differentiates the LHS Platform from other efforts that have adopted a quality improvement paradigm. By supporting pragmatic trials at the intersection of research, operations, and clinical care, the LHS Platform was designed to yield evidence for advancing content and processes of care through carefully designed, rigorous study. The LHS Platform provides the necessary infrastructure and governance to leverage translational, transdisciplinary team science to inform clinical and operational decision making across the health system. The process transforms a clinical or operational question into a research question amenable to a pragmatic trial. Scientific, technical, procedural, and human infrastructure is maintained for the design and execution of individual LHS projects. This includes experienced pragmatic trialists, project management, data science inclusive of biostatistics and clinical informatics, and regulatory support. Careful attention is paid to stakeholder engagement, including health care providers and the community. Capturing lessons from each new study, the LHS Platform continues to mature with plans to integrate implementation science and to complement clinical and process outcomes with cost and value considerations. The Vanderbilt University Medical Center LHS Platform is now a pillar of the health care system and leads the evolving culture of learning from what we do and doing what we learn.

Embedding Learning in a Learning Health Care System to Improve Clinical Practice.

PROBLEM: In an ideal learning health care system (LHS), clinicians learn from what they do and do what they learn, closing the evidence-to-practice gap. In operationalizing an LHS, great strides have been made in knowledge generation. Yet, considerable challenges remain to the broad uptake of identified best practices. To bridge the gap from generating actionable knowledge to applying that knowledge in clinical practice, and ultimately to improving outcomes, new information must be disseminated to and implemented by frontline clinicians. To date, the dissemination of this knowledge through traditional avenues has not achieved meaningful practice change quickly. APPROACH: Vanderbilt University Medical Center (VUMC) developed QuizTime, a smartphone application learning platform, to provide a mechanism for embedding workplace-based clinician learning in the LHS. QuizTime leverages spaced education and retrieval-based practice to facilitate practice change. Beginning in January 2020, clinician-researchers and educators at VUMC designed a randomized, controlled trial to test whether the QuizTime learning system influenced clinician behavior in the context of recent evidence supporting the use of balanced crystalloids rather than saline for intravenous fluid management and new regulations around opioid prescribing. OUTCOMES: Whether spaced education and retrieval-based practice influence clinician behavior and patient outcomes at the VUMC system level will be tested using the data currently being collected. NEXT STEPS: These findings will inform future directions for developing and deploying learning approaches at scale in an LHS, with the goal of closing the evidence-to-practice gap.

The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial.

BACKGROUND: Disruptive behavior in hospitalized patients has become a priority area of safety concern for clinical staff, and also has consequences for patient management and hospital course. Proactive screening and intervention of patients with behavioral comorbidities has been reported to reduce disruptive behavior in some settings, but it has not been studied in a rigorous way. METHODS: The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted. Each month, the behavioral intervention team, comprising a psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA. The team proactively screens patients upon admission, utilizing a protocol which includes a comprehensive chart review and, if indicated, a brief interview, seeking to identify those patients who possess risk factors indicative of either a potential psychological barrier to their own clinical progress or a potential risk for exhibiting disruptive, aggressive, or self-injurious behavior during their hospitalization. Once identified, the team provides interventions aimed at mitigating these risks, educates and supports the patient care teams (nurses, physicians, and others), and assists non-psychiatric staff in the management of patients who require behavioral healthcare. Patients who are both admitted to and discharged from either unit are included in the study. Anticipated enrollment is approximately 1790 patients. The two primary outcomes are (1) a composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior. Secondary outcomes include patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention. DISCUSSION: This ongoing trial will provide evidence on the real-world effectiveness of a proactive behavioral intervention to prevent disruptive, threatening, or acting out events in adult hospitalized patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03777241. Registered on 14 December 2018.

COMPASS: A Pilot Trial of an Early Palliative Care Intervention for Patients With End-Stage Liver Disease.

CONTEXT: Palliative care interventions have shown promise in improving quality of life and reducing health-care utilization among patients with chronic organ failure. OBJECTIVES: To evaluate the effect of a palliative care intervention for adults with end-stage liver disease. METHODS: A randomized controlled trial of patients with end-stage liver disease admitted to the hepatology service at a tertiary referral center whose attending hepatologist indicated they would not be surprised if the patient died in the following year on a standardized questionnaire was performed. Control group patients received usual care. Intervention group patients received inpatient specialist palliative care consultations and outpatient phone follow-up by a palliative care nurse. The primary outcome was time until first readmission. Secondary outcomes included days alive outside the hospital, referral to hospice care, death, readmissions, patient quality of life, depression, anxiety, and quality of end-of-life care over 6 months. RESULTS: The trial stopped early because of difficulties in accruing patients. Of 293 eligible patients, only 63 patients were enrolled, 31 in the intervention group and 32 in the control group. This pace of enrollment was only 25% of what the study had planned, and so it was deemed infeasible to complete. Despite stopping early, intervention group patients had a lower hazard of readmission (hazard ratio: 0.36, 95% confidence interval: 0.16-0.83, P = 0.017) and greater odds of having more days alive outside the hospital than control group patients (odds ratio: 3.97, 95% confidence interval: 1.14-13.84, P = 0.030). No other statistically significant differences were observed. CONCLUSION: Logistical obstacles hindered completion of the trial as originally designed. Nevertheless, a preemptive palliative care intervention resulted in increased time to first readmission and more days alive outside the hospital in the first six months after study entry.