A randomized controlled trial of a proactive analgesic protocol demonstrates reduced opioid use among hospitalized adults with inflammatory bowel disease.

Most hospitalized patients with inflammatory bowel disease (IBD) experience pain. Despite the known risks associated with opioids in IBD including risk for misuse, overdose, infection, readmission, and even death, opioid use is more prevalent in IBD than any other chronic gastrointestinal condition. Most hospitalized IBD patients receive opioids; however, opioids have not been shown to improve pain during hospitalization. We conducted a randomized controlled trial in hospitalized patients with IBD to evaluate the impact of a proactive opioid-sparing analgesic protocol. Wearable devices measured activity and sleep throughout their hospitalization. Chronic opioid users, post-operative, and pregnant patients were excluded. The primary endpoint was a change in pain scores from admission to discharge. Secondary endpoints included opioid use, functional activity, sleep duration and quality, and length of stay. Of 329 adults with IBD evaluated for eligibility, 33 were enrolled and randomized to the intervention or usual care. Both the intervention and control group demonstrated significant decreases in pain scores from admission to discharge (- 2.6 ± 2.6 vs. - 3.0 ± 3.2). Those randomized to the intervention tended to have lower pain scores than the control group regardless of hospital day (3.02 ± 0.90 vs. 4.29 ± 0.81, p = 0.059), used significantly fewer opioids (daily MME 11.8 ± 15.3 vs. 30.9 ± 42.2, p = 0.027), and had a significantly higher step count by Day 4 (2330 ± 1709 vs. 1050 ± 1214; p = 0.014). There were no differences in sleep duration, sleep quality, readmission, or length-of-stay between the two groups. A proactive analgesic protocol does not result in worsening pain but does significantly reduce opioid-use in hospitalized IBD patients.Clinical trial registration number: NCT03798405 (Registered 10/01/2019).

A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome.

BACKGROUND & AIMS: Gut-directed hypnotherapy (GDH) is effective for treating irritable bowel syndrome (IBS), but access limits its widespread use. We report the first randomized controlled trial comparing the safety and efficacy of a self-administered, digital GDH treatment program with that of digital muscle relaxation (MR) in adults with IBS. METHODS: After a 4-week run-in period, patients were randomized to 12 weeks of treatment with digital GDH (Regulora), or digital MR accessed via a mobile app on a smartphone or tablet. The primary endpoint was abdominal pain response, defined as ≥30% reduction from baseline in average daily abdominal pain intensity in the 4 weeks following treatment. Key secondary outcomes included mean change from baseline in abdominal pain, stool consistency, and stool frequency. RESULTS: Of 378 randomized patients, 362 were treated and included in the efficacy analysis. A similar proportion of the GDH (30.4%) and MR (27.1%) groups met the primary endpoint, with no significant difference between the groups (P = .5352). Significantly more patients treated with GDH than MR were abdominal pain responders during the last 4 weeks of treatment (30.9% vs 21.5%; P = .0232) and over the entire treatment period (29.3% vs 18.8%; P = .0254). Improvements in abdominal pain, stool consistency, and stool frequency were consistent across IBS subtypes. No patients experienced serious adverse events or adverse events leading to study discontinuation. CONCLUSIONS: Treatment with a digital GDH program led to an improvement in abdominal pain and stool symptoms in patients with IBS, supporting a role for this intervention as part of integrated care for IBS. CLINICALTRIALS: gov identifier NCT04133519.

Application of Deep Learning Models to Improve Ulcerative Colitis Endoscopic Disease Activity Scoring Under Multiple Scoring Systems.

BACKGROUND AND AIMS: Lack of clinical validation and inter-observer variability are two limitations of endoscopic assessment and scoring of disease severity in patients with ulcerative colitis [UC]. We developed a deep learning [DL] model to improve, accelerate and automate UC detection, and predict the Mayo Endoscopic Subscore [MES] and the Ulcerative Colitis Endoscopic Index of Severity [UCEIS]. METHODS: A total of 134 prospective videos [1550 030 frames] were collected and those with poor quality were excluded. The frames were labelled by experts based on MES and UCEIS scores. The scored frames were used to create a preprocessing pipeline and train multiple convolutional neural networks [CNNs] with proprietary algorithms in order to filter, detect and assess all frames. These frames served as the input for the DL model, with the output being continuous scores for MES and UCEIS [and its components]. A graphical user interface was developed to support both labelling video sections and displaying the predicted disease severity assessment by the artificial intelligence from endoscopic recordings. RESULTS: Mean absolute error [MAE] and mean bias were used to evaluate the distance of the continuous model's predictions from ground truth, and its possible tendency to over/under-predict were excellent for MES and UCEIS. The quadratic weighted kappa used to compare the inter-rater agreement between experts' labels and the model's predictions showed strong agreement [0.87, 0.88 at frame-level, 0.88, 0.90 at section-level and 0.90, 0.78 at video-level, for MES and UCEIS, respectively]. CONCLUSIONS: We present the first fully automated tool that improves the accuracy of the MES and UCEIS, reduces the time between video collection and review, and improves subsequent quality assurance and scoring.

The Relationship Between Opioid Use and Healthcare Utilization in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.

BACKGROUND: Pain is commonly experienced by patients with inflammatory bowel disease (IBD). Unfortunately, pain management is a challenge in IBD care, as currently available analgesics are associated with adverse events. Our understanding of the impact of opioid use on healthcare utilization among IBD patients remains limited. METHODS: A systematic search was completed using PubMed, Embase, the Cochrane Library, and Scopus through May of 2020. The exposure of interest was any opioid medication prescribed by a healthcare provider. Outcomes included readmissions rate, hospitalization, hospital length of stay, healthcare costs, emergency department visits, outpatient visits, IBD-related surgeries, and IBD-related medication utilization. Meta-analysis was conducted on study outcomes reported in at least 4 studies using random-effects models to estimate pooled relative risk (RR) and 95% confidence interval (CI). RESULTS: We identified 1969 articles, of which 30 met inclusion criteria. Meta-analysis showed an association between opioid use and longer length of stay (mean difference, 2.25 days; 95% CI, 1.29-3.22), higher likelihood of prior IBD-related surgery (RR, 1.72; 95% CI, 1.32-2.25), and higher rates of biologic use (RR, 1.38; 95% CI, 1.13-1.68) but no difference in 30-day readmissions (RR, 1.17; 95% CI, 0.86-1.61), immunomodulator use (RR, 1.13; 95% CI, 0.89-1.44), or corticosteroid use (RR, 1.36; 95% CI, 0.88-2.10) in patients with IBD. On systematic review, opioid use was associated with increased hospitalizations, healthcare costs, emergency department visits, outpatient visits, and polypharmacy. DISCUSSION: Opioids use among patients with IBD is associated with increased healthcare utilization. Nonopioid alternatives are needed to reduce burden on the healthcare system and improve patient outcomes.

Pain control in inflammatory bowel disease presents a challenge due to the potential for adverse effects of opioids in this population. This systematic review and meta-analysis demonstrates that opioid use in inflammatory bowel disease is associated with increased healthcare utilization.

A Care Coordination Intervention Improves Symptoms But Not Charges in High-Risk Patients With Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD) is associated with substantial symptom burden, variability in clinical outcomes, and high direct costs. We sought to determine if a care coordination-based strategy was effective at improving patient symptom burden and reducing healthcare costs for patients with IBD in the top quintile of predicted healthcare utilization and costs. METHODS: We performed a randomized controlled trial to evaluate the efficacy of a patient-tailored multicomponent care coordination intervention composed of proactive symptom monitoring and care coordinator-triggered algorithms. Enrolled patients with IBD were randomized to usual care or to our care coordination intervention over a 9-month period (April 2019 to January 2020). Primary outcomes included change in patient symptom scores throughout the intervention and IBD-related charges at 12 months. RESULTS: Eligible IBD patients in the top quintile for predicted healthcare utilization and expenditures were identified. A total of 205 patients were enrolled and randomized to our intervention (n = 100) or to usual care (n = 105). Patients in the care coordinator arm demonstrated an improvement in symptoms scores compared with usual care (coefficient, -0.68, 95% confidence interval, -1.18 to -0.18; P = .008) without a significant difference in median annual IBD-related healthcare charges ($10,094 vs $9080; P = .322). CONCLUSIONS: In this first randomized controlled trial of a patient-tailored care coordination intervention, composed of proactive symptom monitoring and care coordinator-triggered algorithms, we observed an improvement in patient symptom scores but not in healthcare charges. Care coordination programs may represent an effective value-based approach to improve symptoms scores without added direct costs in a subgroup of high-risk patients with IBD. (ClinicalTrials.gov, Number: NCT04796571).

Integrated Care for Irritable Bowel Syndrome: The Future Is Now.

Irritable bowel syndrome (IBS) is a common symptom-based condition of heterogeneous pathogenesis and clinical phenotype. This heterogeneity and multidimensional nature creates significant diagnostic and treatment challenges. Recent evidence has documented the benefits of diet and behavioral interventions. These nonmedical strategies are causing a shift from the traditional care model to a multidisciplinary care model. Recent evidence suggests that collaborative, team-based integrated care leads to better clinical outcomes and reduced cost per cure compared with traditional care. Although it is growing increasingly clear that integrated care offers significant benefits to IBS patients, widespread dissemination will require solutions to structural, cultural, and financial barriers.

Impact of an Online Gastrointestinal Symptom History Taker on Physician Documentation and Charting Time: Pragmatic Controlled Trial.

BACKGROUND: A potential benefit of electronic health records (EHRs) is that they could potentially save clinician time and improve documentation by auto-generating the history of present illness (HPI) in partnership with patients prior to the clinic visit. We developed an online patient portal called AEGIS (Automated Evaluation of Gastrointestinal [GI] Symptoms) that systematically collects patient GI symptom information and then transforms the data into a narrative HPI that is available for physicians to review in the EHR prior to seeing the patient. OBJECTIVE: This study aimed to compare whether use of an online GI symptom history taker called AEGIS improves physician-centric outcomes vs usual care. METHODS: We conducted a pragmatic controlled trial among adults aged ≥18 years scheduled for a new patient visit at 4 GI clinics at an academic medical center. Patients who completed AEGIS were matched with controls in the intervention period who did not complete AEGIS as well as controls who underwent usual care in the pre-intervention period. Of note, the pre-intervention control group was formed as it was not subject to contamination bias, unlike for post-intervention controls. We then compared the following outcomes among groups: (1) documentation of alarm symptoms, (2) documentation of family history of GI malignancy, (3) number of follow-up visits in a 6-month period, (4) number of tests ordered in a 6-month period, and (5) charting time (difference between appointment time and time the encounter was closed). Multivariable regression models were used to adjust for potential confounding. RESULTS: Of the 774 patients who were invited to complete AEGIS, 116 (15.0%) finished it prior to their visit. The 116 AEGIS patients were then matched with 343 and 102 controls in the pre- and post-intervention periods, respectively. There were no statistically significant differences among the groups for documentation of alarm symptoms and GI cancer family history, number of follow-up visits and ordered tests, or charting time (all P>.05). CONCLUSIONS: Use of a validated online HPI-generation portal did not improve physician documentation or reduce workload. Given universal adoption of EHRs, further research examining how to optimally leverage patient portals for improving outcomes are needed.

Pain in Inflammatory Bowel Disease Is Not Improved During Hospitalization: The Impact of Opioids on Pain and Healthcare Utilization.

BACKGROUND: Most patients with IBD experience pain, especially during acute disease exacerbations. Opioid use continues to be more prevalent in IBD than any other chronic gastrointestinal condition, and the majority of IBD patients consume narcotics during hospitalization despite the risks of infection and death. METHODS: We performed a retrospective review of 57 subjects aimed at quantifying pain and opiate consumption for IBD-related admissions over a 3-month period. For each patient, the average and maximum of each day's pain scores were used to measure changes in pain from admission to discharge using mixed model regression, with opiate use as a time-dependent covariate. RESULTS: The daily average pain score over the entire hospitalization was 4.23 ± 2.09, and the maximum pain score was 8.28 ± 1.75. Among opioid users (n = 51), the daily average pain score was 4.65 ± 2.16 and the maximum pain score was 7.53 ± 2.56. Across all cases from admission to discharge, there was less than a 1-point change in daily average pain (- 0.96 ± 2.03, p = 0.0009), and no change in maximum pain (- 0.89 ± 3.59, p = 0.0671). Opioid users, a subset of the overall cohort, had a similar less than one-point drop in daily average pain (- 0.94 ± - 0.29, p = 0.0024) and no change in daily maximum pain scores (- 0.81 ± - 0.47, p = 0.0914). Patients on average used 20 ± 25 mg morphine equivalents per day. Opioid-naïve patients used similar doses to those who used opioids prior to admission (PTA). Almost half of all cases (47%) were discharged with an opioid prescription, the majority (71%) of whom were not on opioids PTA. CONCLUSIONS: Pain in IBD is not well controlled through hospitalization, with less than a 1-point change from admission to discharge, despite significant opioid consumption. Alternative analgesic methods should be explored, given the significant impact of narcotics on long-term outcomes including mortality and quality of life.

Quality indicators in inflammatory bowel disease.

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a chronic, debilitating, and expensive condition affecting millions of people globally. There is significant variation in the quality of care for patients with IBD across North America, Europe, and Asia; this variation suggests poor quality of care due to overuse, underuse, or misuse of health services and disparity of outcomes. Several initiatives have been developed to reduce variation in care delivery and improve processes of care, patient outcomes, and reduced healthcare costs. These initiatives include the development of quality indicator sets to standardize care across organizations, and learning health systems to enable data sharing between doctors and patients, and sharing of best practices among providers. These programs have been variably successful in improving patient outcomes and reducing healthcare utilization. Further studies are needed to demonstrate the long-term impact and applicability of these efforts in different geographic areas around the world, as regional variations in patient populations, societal preferences, and costs should inform local quality improvement efforts.

Quality Improvement Initiatives in Inflammatory Bowel Disease.

PURPOSE OF REVIEW: This article serves as an overview of several quality improvement initiatives in inflammatory bowel disease (IBD). RECENT FINDINGS: IBD is associated with significant variation in care, suggesting poor quality of care. There have been several efforts to improve the quality of care for patients with IBD. Quality improvement (QI) initiatives in IBD are intended to be patient-centric, improve outcomes for individuals and populations, and reduce costs-all consistent with "the triple aim" put forth by the Institute for Healthcare Improvement (IHI). Current QI initiatives include the development of quality measure sets to standardize processes and outcomes, learning health systems to foster collaborative improvement, and patient-centered medical homes specific to patients with IBD in shared risk models of care. Some of these programs have demonstrated early success in improving patient outcomes, reducing costs, improving patient satisfaction, and facilitating patient engagement. However, further studies are needed to evaluate and compare the effects of these programs over time on clinical outcomes in order to demonstrate long-term value and sustainability.