Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in India: A Convergent Parallel Mixed Methods Study.

Introduction: A polypill-based implementation strategy has been proposed to increase rates of guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction. This has the potential to improve mortality and morbidity in India and undertreated populations globally. Methods: We conducted a convergent parallel mixed methods study integrating quantitative data from stakeholder surveys using modified implementation science outcome measures and qualitative data from key informant in-depth interviews. Our objective was to explore physician, nurse, pharmacist, and patient perspectives on a HFrEF polypill implementation strategy in India from January 2021 to April 2021. Quantitative and qualitative data were integrated to develop an Implementation Research Logic Model. Results: Among 69 respondents to the stakeholder survey, there was moderate acceptability (mean [SD] 3.8 [1.0]), appropriateness (3.6 [1.0]), and feasibility (3.7 [1.0]) of HFrEF polypill implementation strategy. Participants in the key-informant in-depth interviews (n = 20) highlighted numerous relative advantages of the HFrEF polypill innovation including potential to simplify medication regimens and improve patient adherence. Key relative disadvantages elucidated, include concerns about side effects and interruption of multiple GDMT medications due to polypill discontinuation for side effects or hospitalizations. Based on this data, the proposed implementation strategies in the Implementation Research Logic Model include 1) HFrEF polypills, 2) HFrEF polypill initiation, titration, and maintenance protocols, and 3) HFrEF polypill laboratory monitoring protocols for safety which we postulate will lead to desired clinical and implementation outcomes through multiple mechanisms including increased medication adherence to a single pill. Conclusion: This study demonstrates that a HFrEF polypill-based implementation strategy is considered acceptable, feasible, and appropriate among healthcare providers in India. We identified contextually relevant determinants, strategies, mechanism, and outcomes outlined in an Implementation Research Logic Model to inform future research to improve heart failure care in South Asia.

Fidelity of Enhanced Recovery Protocol Implementation With Assessment of Hospital-Specific Materials.

INTRODUCTION: Variability in implementation of enhanced recovery protocols (ERPs) often reduces the effects of an intervention on clinical outcomes. This study aimed to evaluate hospital-level implementation fidelity to a pediatric gastrointestinal surgery ERP by assessing site-specific implementation materials. METHODS: This document analysis study operationalized implementation fidelity as adherence to the creation of specified materials at each study site. During the 12-mo implementation phase within the stepped-wedge cluster randomized control trial, ENhanced Recovery In CHildren Undergoing Surgery, study sites were provided with materials (e.g., order sets), access to peer-counseling, and given key ERP elements spanning multiple phases of care. Sixteen of the 18 total study sites submitted implementation materials, including 14 anesthesia protocols, 11 order sets, and 16 sets of patient/family education materials. These materials were assessed and graded for fidelity using prespecified criteria. Hospital-level fidelity scores could range from 0 to a maximum score of 18, and were categorized as either high or low, based on whether the score was above or below/equal to the median. Descriptive statistics and Wilcoxon rank sum test were used for analysis. RESULTS: The overall hospital-level median fidelity score for inclusion of ERP elements in the implementation materials was 10.5. The median score was 12.8 at nine high-fidelity sites and was 5.6 at nine low-fidelity sites (P < 0.01). Higher adherence was noted for avoiding prolonged fasting (n = 16/18 hospitals; 89%) and preventing nausea and vomiting (n = 16/18 hospitals; 89%) in anesthesia protocols and/or order sets. Lower adherence was noted for incorporation of minimally invasive surgical techniques (n = 2/18 hospitals, 11%) and of preoperative optimization of medical comorbidities (n = 0/18 hospitals, 0%) in implementation materials. CONCLUSIONS: Despite substantial resources to promote ERP elements, there was wide variation in fidelity for incorporating ERPs into implementation materials among hospital sites. Development of high-fidelity implementation materials for complex ERPs for gastrointestinal surgery in children may require longer than 12 months. Additional implementation strategies, resources, and modification of implementation-focused materials may be needed.

Change in Patient Enrollment After Site Principal Investigator Turnover in Surgical Clinical Trials.

This cohort study examines the association of principal investigator (PI) turnover with patient enrollment in surgical clinical trials.

Learning from the implementation of a surgical opioid reduction initiative in an integrated health system: a qualitative study among providers and patients.

BACKGROUND: Surgical opioid overprescribing can result in long-term use or misuse. Between July 2018 and March 2019, the multicomponent intervention, Minimizing Opioid Prescribing in Surgery (MOPiS) was implemented in the general surgery clinics of five hospitals and successfully reduced opioid prescribing. To date, various studies have shown a positive outcome of similar reduction initiatives. However, in addition to evaluating the impact on clinical outcomes, it is important to understand the implementation process of an intervention to extend sustainability of interventions and allow for dissemination of the intervention into other contexts. This study aims to evaluate the contextual factors impacting intervention implementation. METHODS: We conducted a qualitative study with semi-structured interviews held with providers and patients of the general surgery clinics of five hospitals of a single health system between March and November of 2019. Interview questions focused on how contextual factors affected implementation of the intervention. We coded interview transcripts deductively, using the Consolidated Framework for Implementation Research (CFIR) to identify the relevant contextual factors. Content analyses were conducted using a constant comparative approach to identify overarching themes. RESULTS: We interviewed 15 clinicians (e.g., surgeons, nurses), 1 quality representative, 1 scheduler, and 28 adult patients and identified 3 key themes. First, we found high variability in the responses of clinicians and patients to the intervention. There was a strong need for intervention components to be locally adaptable, particularly for the format and content of the patient and clinician education materials. Second, surgical pain management should be recognized as a team effort. We identified specific gaps in the engagement of team members, including nurses. We also found that the hierarchical relationships between surgical residents and attendings impacted implementation. Finally, we found that established patient and clinician views on opioid prescribing were an important facilitator to effective implementation. CONCLUSION: Successful implementation of a complex set of opioid reduction interventions in surgery requires locally adaptable elements of the intervention, a team-centric approach, and an understanding of patient and clinician views regarding changes being proposed.

Prevalence and feasibility of assessing the frailty phenotype among hemodialysis patients in a dialysis unit.

BACKGROUND: Frailty increases risk of morbidity and mortality in hemodialysis patients. Frailty assessments could trigger risk reduction interventions if broadly adopted in clinical practice. We aimed to assess the clinical feasibility of frailty assessment among Veteran hemodialysis patients. METHODS: Hemodialysis patients' ≥50 years were recruited from a single dialysis unit between 9/1/2021 and 3/31/2022.Patients who consented underwent a frailty phenotype assessment by clinical staff. Five criteria were assessed: unintentional weight loss, low grip strength, self-reported exhaustion, slow gait speed, and low physical activity. Participants were classified as frail (3-5 points), pre-frail (1-2 points) or non-frail (0 points). Feasibility was determined by the number of eligible participants completing the assessment. RESULTS: Among 82 unique dialysis patients, 45 (52%) completed the assessment, 13 (16%) refused, 18 (23%) were not offered the assessment due to death, transfers, or switch to transplant or peritoneal dialysis, and 6 patients were excluded because they did not meet mobility criteria. Among assessed patients, 40(88%) patients were identified as pre-frail (46.6%) or frail (42.2%). Low grip strength was most common (90%). Those who refused were more likely to have peripheral vascular disease (p = 0.001), low albumin (p = 0.0187), low sodium (p = 0.0422), and ineligible for kidney transplant (p = 0.005). CONCLUSIONS: Just over half of eligible hemodialysis patients completed the frailty assessment suggesting difficulty with broad clinical adoption expectations. Among those assessed, frailty and pre-frailty prevalence was high. Given patients who were not tested were clinically high risk, our reported prevalence likely underestimates true frailty prevalence. Providing frailty reduction interventions to all hemodialysis patients could have high impact for this group.

The development of a safe opioid use agreement for surgical care using a modified Delphi method.

BACKGROUND: Opioids prescribed to treat postsurgical pain have contributed to the ongoing opioid epidemic. While opioid prescribing practices have improved, most patients do not use all their pills and do not safely dispose of leftovers, which creates a risk for unsafe use and diversion. We aimed to generate consensus on the content of a "safe opioid use agreement" for the perioperative settings to improve patients' safe use, storage, and disposal of opioids. METHODS: We conducted a modified three-round Delphi study with clinicians across surgical specialties, quality improvement (QI) experts, and patients. In Round 1, participants completed a survey rating the importance and comprehensibility of 10 items on a 5-point Likert scale and provided comments. In Round 2, a sub-sample of participants attended a focus group to discuss items with the lowest agreement. In Round 3, the survey was repeated with the updated items. Quantitative values from the Likert scale and qualitative responses were summarized. RESULTS: Thirty-six experts (26 clinicians, seven patients/patient advocates, and three QI experts) participated in the study. In Round 1, >75% of respondents rated at least four out of five on the importance of nine items and on the comprehensibility of six items. In Round 2, participants provided feedback on the comprehensibility, formatting, importance, and purpose of the agreement, including a desire for more specificity and patient education. In Round 3, >75% of respondents rated at least four out of five for comprehensibility and importance of all 10 updated item. The final agreement included seven items on safe use, two items on safe storage, and one item on safe disposal. CONCLUSION: The expert panel reached consensus on the importance and comprehensibility of the content for an opioid use agreement and identified additional patient education needs. The agreement should be used as a tool to supplement rather than replace existing, tailored education.

A mixed-method approach to generate and deliver rapid-cycle evaluation feedback: lessons learned from a multicenter implementation trial in pediatric surgery.

BACKGROUND: Rapid-cycle feedback loops provide timely information and actionable feedback to healthcare organizations to accelerate implementation of interventions. We aimed to (1) describe a mixed-method approach for generating and delivering rapid-cycle feedback and (2) explore key lessons learned while implementing an enhanced recovery protocol (ERP) across 18 pediatric surgery centers. METHODS: All centers are members of the Pediatric Surgery Research Collaborative (PedSRC, www.pedsrc.org ), participating in the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) trial. To assess implementation efforts, we conducted a mixed-method sequential explanatory study, administering surveys and follow-up interviews with each center's implementation team 6 and 12 months following implementation. Along with detailed notetaking and iterative discussion within our team, we used these data to generate and deliver a center-specific implementation report card to each center. Report cards used a traffic light approach to quickly visualize implementation status (green = excellent; yellow = needs improvement; red = needs significant improvement) and summarized strengths and opportunities at each timepoint. RESULTS: We identified several benefits, challenges, and practical considerations for assessing implementation and using rapid-cycle feedback among pediatric surgery centers. Regarding potential benefits, this approach enabled us to quickly understand variation in implementation and corresponding needs across centers. It allowed us to efficiently provide actionable feedback to centers about implementation. Engaging consistently with center-specific implementation teams also helped facilitate partnerships between centers and the research team. Regarding potential challenges, research teams must still allocate substantial resources to provide feedback rapidly. Additionally, discussions and consensus are needed across team members about the content of center-specific feedback. Practical considerations include carefully balancing timeliness and comprehensiveness when delivering rapid-cycle feedback. In pediatric surgery, moreover, it is essential to actively engage all key stakeholders (including physicians, nurses, patients, caregivers, etc.) and adopt an iterative, reflexive approach in providing feedback. CONCLUSION: From a methodological perspective, we identified three key lessons: (1) using a rapid, mixed method evaluation approach is feasible in pediatric surgery and (2) can be beneficial, particularly in quickly understanding variation in implementation across centers; however, (3) there is a need to address several methodological challenges and considerations, particularly in balancing the timeliness and comprehensiveness of feedback. TRIAL REGISTRATION: NIH National Library of Medicine Clinical Trials. CLINICALTRIALS: gov Identifier: NCT04060303. Registered August 7, 2019, https://clinicaltrials.gov/ct2/show/NCT04060303.

Role of patient and family engagement in quality improvement for pediatric surgery.

In recent decades, the role of quality improvement (QI) in pediatric surgery has grown substantially. Patient and family engagement can help to maximize the impact of QI by enhancing safety and patient outcomes. Yet, broader, systematic efforts to actively involve patients and families in QI initiatives remain a persistent gap in pediatric surgery. To address this gap, we propose an agenda centered on three key goals for future quality improvement efforts: (1) building partnerships with patients and their families; (2) expanding the use of patient-reported outcomes (PROs) and novel, cross-disciplinary research methods; and (3) engaging patients and families consistently across all stages of pediatric surgical care. Fulfilling this agenda will be essential in shifting our mindset to view QI as a collective that involves patients, families, clinicians, and payers in continuous, system-wide opportunities to evaluate and improve care. Actively listening to and collaborating with patients and families may also help renew our focus on narrowing the gap between current practice and the best possible practice for children undergoing surgery.

Association of Multimodal Pain Control with Patient-Reported Outcomes in Children Undergoing Surgery.

INTRODUCTION: Our aim was to describe practices in multimodal pain management at US children's hospitals and evaluate the association between non-opioid pain management strategies and pediatric patient-reported outcomes (PROs). METHODS: Data were collected as part of the 18-hospital ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) clinical trial. Non-opioid pain management strategies included use of preoperative and postoperative non-opioid analgesics, regional anesthetic blocks, and a biobehavioral intervention. PROs included perioperative nervousness, pain-related functional disability, health-related quality of life (HRQoL). Associations were analyzed using multinomial logistic regression models. RESULTS: Among 186 patients, 62 (33%) received preoperative analgesics, 186 (100%) postoperative analgesics, 81 (44%) regional anesthetic block, and 135 (73%) used a biobehavioral intervention. Patients were less likely to report worsened as compared to stable nervousness following regional anesthetic block (relative risk ratio [RRR]:0.31, 95% confidence interval [CI]:0.11-0.85), use of a biobehavioral technique (RRR:0.26, 95% CI:0.10-0.70), and both in combination (RRR:0.08, 95% CI:0.02-0.34). There were no associations of non-opioid pain control modalities with pain-related functional disability or HRQoL. CONCLUSION: Use of postoperative non-opioid analgesics have been largely adopted, while preoperative non-opioid analgesics and regional anesthetic blocks are used less frequently. Regional anesthetic blocks and biobehavioral interventions may mitigate postoperative nervousness in children. LEVEL OF EVIDENCE: III.

Pediatric Patient and Caregiver Agreement on Perioperative Expectations and Self-Reported Outcomes.

INTRODUCTION: Alignment between pediatric patients and caregiver perspectives on patient-reported outcome (PRO) data is contingent upon context. We aimed to assess agreement between patient and caregiver responses to a series of perioperative domains. METHODS: Agreement between pediatric patients and caregiver responses to preoperative and postoperative surveys about surgery preparedness, perioperative expectations, PRO Measurement Information System (PROMIS) measures for overall health and pain, and reaching milestones gathered as part of an ongoing clinical trial for children undergoing gastrointestinal surgery, was evaluated. Gwet's AC and Spearman's correlation coefficients were calculated, as appropriate, to assess agreement. RESULTS: Of 209 enrolled patients, 65 (31.1%) dyads completed all three surveys and were included. For the domains of education, expectations, and comprehension, patients and caregivers had good agreement with Gwet AC1 with values of 0.80, 0.61, and 0.64, respectively. For milestones, patients and caregivers had very good agreement (Gwet AC1 of 0.95). Milestones measured whether patients achieved certain goals within a prespecified time, including enteral intake (Gwet AC1 0.91 and 0.92 respectively), transition to oral pain medication (Gwet AC1 0.94), ambulation (Gwet AC1 1.00), and return of bowel function (Gwet AC1 0.97). There was moderate to strong agreement between patients and caregivers on PROMIS pain questions (Spearman's correlation: 0.71 preoperatively and 0.51 postoperatively). On PROMIS global health questions, there was strong agreement (0.69 preoperatively and 0.65 postoperatively). CONCLUSIONS: Pediatric patient and caregiver agreement on perioperative survey items ranged from moderate to strong. Caregivers' responses may be acceptable when some patient-level responses are not available.

Implementation of Enhanced Recovery Protocols for Gastrointestinal Surgery in Children: Practical Tools From Key Stakeholders.

INTRODUCTION: We explored patient, caregiver, and provider recommendations for development of a tool kit to implement enhanced recovery protocols (ERPs) for pediatric patients undergoing gastrointestinal surgery. ERPs are widely used for adults to decrease hospital length of stay, hospital costs, and complications while hastening patient recovery after surgery. With limited data available for ERPs among pediatric populations informed modification of adult ERPs is needed to facilitate successful implementation for pediatric surgery. METHODS: Using a qualitative research design, semistructured interviews were conducted with hospital-based teams including surgeons, anesthesiologists, gastroenterologists, nursing, and physician assistants. Four in-person focus groups were held at two pediatric hospitals with patients and caregivers. Codes were developed and applied to interview and focus groups transcripts for structural content analysis. Thematic analysis guided by the Active Implementation Framework, included recommendations that informed ERP implementation tool kit development. RESULTS: Key components of the ERP tool kit included the need for a structured and systematic approach, leadership support from key champions, and buy-in from surgical partners and hospital management. Providers identified the need for multimodal educational materials on ERP elements for staff and patients; use of uniform checklists, care sets and an electronic repository to collect outcome data for quality assurance assessment. Patients and caregivers endorsed expansion of the team to include child-life specialists, nutritionists, and patient-parent supporters to help navigate the surgical experience. CONCLUSIONS: This study is the first to leverage key input from patients, caregivers, and providers to identify practical components for an ERP implementation tool kit for children undergoing gastrointestinal surgery.

Nephrology-Palliative Care Collaboration to Promote Outpatient Hemodialysis Goals of Care Conversations.

Background: Goals of care conversations and corresponding life-sustaining treatment (LST) progress notes were completed for only one-fourth of patients on outpatient dialysis despite hospital-wide training with nephrologists at the Edward Hines, Jr. Veterans Affairs Hospital. The purpose of this quality improvement project was to increase completion of LST progress notes and corresponding orders among patients on dialysis through an interdisciplinary nephrology-palliative care collaboration. Observations: The nephrology and palliative care departments began an interdisciplinary collaboration for nephrology to consult palliative care to initiate goals of care conversations and complete LST progress notes with patients on dialysis. A coordinated workflow process was created that included multidisciplinary efforts for patient selection, patient education, and introduction and completion of goals of care conversations for patients on dialysis. Completion rates for LST notes increased from 27% to 81% following the 13-month intervention, with 69 of 85 patients having a documented LST progress note. Conclusions: A collaboration between nephrology and palliative care increased high-quality LST progress note completion. The next steps include expanding these collaborations at other dialysis units and evaluating the impact on patient outcomes.

A qualitative examination of barriers and facilitators of pediatric enhanced recovery protocol implementation among 18 pediatric surgery services.

BACKGROUND: Enhanced recovery protocols (ERPs) are an evidence-based intervention to optimize post-surgical recovery. Several studies have demonstrated that the use of an ERP for gastrointestinal surgery results in decreased length of stay, shortened time to a regular diet, and fewer administered opioids, while also trending toward lower complication and 30-day readmission rates. Yet, implementation of ERPs in pediatric surgery is lagging compared to adult surgery. The study's purpose was to conduct a theory-guided evaluation of barriers and facilitators to ERP implementation at US hospitals with a pediatric surgery service. METHODS: We conducted semi-structured interviews at 18 hospitals with 48 participants, including pediatric surgeons, anesthesiologists, gastroenterologists, nurses, and physician assistants. Interviews were conducted online, audio-recorded, and transcribed verbatim. To identify barriers and facilitators to ERP implementation, we conducted an analysis using deductive logics based on the five Active Implementation Frameworks (AIFs). RESULTS: Effective practices (usable innovations) were challenged by a lack of compliance to ERP elements, and facilitators were having standardized protocols in place and organization support for implementation. Effective implementation (stages of implementation and implementation drivers) had widespread barriers to implementation across the stages from exploration to full implementation. Barriers included needing dedicated teams for ERP implementation and buy-in from hospital leadership. These items, when present, were strong facilitators of effective implementation, in addition to on-site, checklists, protected time to oversee ERP implementation, and order sets for ERP elements built into the electronic medical record. The enabling context (teams) focused on teams' engagement in ERP implementation and how they collaborated to implement ERPs. Barriers included having surgical team members resistant to change or who were not bought into ERPs in pediatric practice. Facilitators included engaging a multi-disciplinary team and engaging patients and families early in the implementation process. CONCLUSIONS: Barriers to ERP implementation in pediatric surgery highlighted can be addressed through providing guidelines to ERP implementation, team-based support for change management, and protocols for developing an ERP implementation team. Future steps are to apply and evaluate these strategies in a stepped-wedge, cluster randomized trial to increase the implementation of ERPs at these 18 hospitals.

Age- and Sex-Specific Needs for Children Undergoing Inflammatory Bowel Disease Surgery: A Qualitative Study.

INTRODUCTION: The use of enhanced recovery protocols (ERP) is extending to pediatric surgical populations, such as patients with inflammatory bowel diseases (IBDs). Given the variation in age- and sex-specific characteristics of pediatric IBD patients, it is important to understand the unique needs of subgroups, such as male versus female or preadolescent versus older patients, when implementing ERPs. We gathered clinician, patient, and caregiver perspectives on age- and sex-specific needs for children undergoing IBD surgery. METHODS: We used semistructured interviews and focus groups to assess ERP needs and perceived differences in needs between preadolescent (10-13 y), older (14-19 y), male, and female IBD patients. Participants included clinicians, patients who had recent IBD surgery, and patients' caregivers. RESULTS: Forty-eight clinicians, six patients, and eight caregivers participated. Three broad categories of themes emerged: concerns, needs, and experiences related to the (1) surgical care process; (2) continuum of IBD care; and (3) suggestions to make surgical care more patient centered. With regard to surgical care processes, stakeholders reported different communication needs for preadolescent and older children. Key themes about the continuum of IBD care were the need (1) for support from child life specialists and (b) to address young women's health issues. Suggestions to make surgical care more patient centered included providing older children with patient experiences that reflect their perspective as young adults. CONCLUSIONS: The findings highlight the need to adopt a patient-centered approach for ERP use that actively addresses age- and sex-specific factors while engaging patients and caregivers as partners with clinicians to improve surgical care for children with IBD.

A Missing Piece of the Puzzle: Patient and Provider Perspectives on Pain Management Needs and Opioid Prescribing in Inflammatory Bowel Disease Care.

Background: Recent data have shown high rates of opioid misuse among inflammatory bowel disease (IBD) patients. We conducted a qualitative study to explore IBD patient and provider perceptions and experiences with pain management and opioid prescribing. Methods: We conducted a focus group with IBD patients and semistructured interviews with IBD-focused physicians and nurses. We used an inductive approach for analysis and the constant comparison method to develop and refine codes and identify prominent themes. We analyzed interview and focus group data concurrently to triangulate themes. Results: Nine patients and 10 providers participated. We grouped themes into 3 categories: (1) current practices to manage pain; (2) perceived pain management challenges; and (3) suggestions to optimize pain management. In the first category (current practices), both patients and providers reported building long-term patient-provider relationships and the importance of exploring nonpharmacologic pain management strategies. Patients reported proactively trying remedies infrequently recommended by IBD providers. In the second category (pain management challenges), patients and providers reported concerns about opioid use and having limited options to treat pain safely. Patients discussed chronic pain and having few solutions to manage it. In the third category, providers shared suggestions for improvement such as increasing use of nonpharmacologic pain management strategies and enhancing care coordination. Conclusions: Despite some common themes between the 2 groups, we identified some pain management needs (eg, addressing chronic pain) that matter to patients but were seldom discussed by IBD providers. Addressing these areas of potential disconnect is essential to optimize pain management safety in IBD care.

Opioid-related emergency department visits and hospitalizations among patients with chronic gastrointestinal symptoms and disorders dually enrolled in the Department of Veterans Affairs and Medicare Part D.

PURPOSE: We examined the prevalence of, and factors associated with, serious opioid-related adverse drug events (ORADEs) that led to an emergency department (ED) visit or hospitalization among patients with chronic gastrointestinal (GI) symptoms and disorders dually enrolled in the Department of Veterans Affairs (VA) and Medicare Part D. METHODS: In this retrospective cohort study, we used linked national patient-level data (April 1, 2011, to October 31, 2014) from the VA and Centers for Medicare and Medicaid Services to identify serious ORADEs among dually enrolled veterans with a chronic GI symptom or disorder. Outcome measures included serious ORADEs, defined as an ED visit attributed to an ORADE or a hospitalization where the principal or secondary reason for admission involved an opioid. We used multiple logistic regression models to determine factors independently associated with a serious ORADE. RESULTS: We identified 3,430 veterans who had a chronic GI symptom or disorder; were dually enrolled in the VA and Medicare Part D; and had a serious ORADE that led to an ED visit, hospitalization, or both. The period prevalence of having a serious ORADE was 2.4% overall and 4.4% among veterans with chronic opioid use (≥90 consecutive days). Veterans with serious ORADEs were more likely to be less than 40 years old, male, white, and to have chronic abdominal pain, functional GI disorders, chronic pancreatitis, or Crohn's disease. They were also more likely to have used opioids chronically and at higher daily doses. CONCLUSION: There may be a considerable burden of serious ORADEs among patients with chronic GI symptoms and disorders. Future quality improvement efforts should target this vulnerable population.

Characteristics of Opioid Prescriptions to Veterans With Chronic Gastrointestinal Symptoms and Disorders Dually Enrolled in the Department of Veterans Affairs and Medicare Part D.

INTRODUCTION: Gastrointestinal (GI) symptoms and disorders affect an increasingly large group of veterans. Opioid use may be rising in this population, but this is concerning from a patient safety perspective, given the risk of dependence and lack of evidence supporting opioid use to manage chronic pain. We examined the characteristics of opioid prescriptions and factors associated with chronic opioid use among chronic GI patients dually enrolled in the DVA and Medicare Part D. MATERIALS AND METHODS: In this retrospective cohort study, we used linked, national patient-level data (from April 1, 2011, to December 31, 2014) from the VA and Centers for Medicare & Medicaid Services to identify chronic GI patients and observe opioid use. Veterans who had a chronic GI symptom or disorder were dually enrolled in VA and Part D and received ≥1 opioid prescription dispensed through the VA, Part D, or both. Chronic GI symptoms and disorders included chronic abdominal pain, chronic pancreatitis, inflammatory bowel diseases, and functional GI disorders. Key outcome measures were outpatient opioid prescription dispensing overall and chronic opioid use, defined as ≥90 consecutive days of opioid receipt over 12 months. We described patient characteristics and opioid use measures using descriptive statistics. Using multiple logistic regression modeling, we generated adjusted odds ratios and 95% CIs to determine variables independently associated with chronic opioid use. The final model included variables outlined in the literature and our conceptual framework. RESULTS: We identified 141,805 veterans who had a chronic GI symptom or disorder, were dually enrolled in VA and Part D, and received ≥1 opioid prescription dispensed from the VA, Part D, or both. Twenty-six percent received opioids from the VA only, 69% received opioids from Medicare Part D only, and 5% were "dual users," receiving opioids through both VA and Part D. Compared to veterans who received opioids from the VA or Part D only, dual users had a greater likelihood of potentially unsafe opioid use outcomes, including greater number of days on opioids, higher daily doses, and higher odds of chronic use. CONCLUSIONS: Chronic GI patients in the VA may be frequent users of opioids and may have a unique set of risk factors for unsafe opioid use. Careful monitoring of opioid use among chronic GI patients may help to begin risk stratifying this group. and develop tailored approaches to minimize chronic use. The findings underscore potential nuances within the opioid epidemic and suggest that components of the VA's Opioid Safety Initiative may need to be adapted around veterans at a higher risk of opioid-related adverse events.

High-Dose Opioid Use Among Veterans with Unexplained Gastrointestinal Symptoms Versus Structural Gastrointestinal Diagnoses.

BACKGROUND: In a cohort of Veterans dually enrolled in the Department of Veterans Affairs (VA) and Medicare Part D, we sought to describe high-dose daily opioid use among Veterans with unexplained gastrointestinal (GI) symptoms and structural GI diagnoses and examine factors associated with high-dose use. METHODS: We used linked national patient-level data from the VA and Centers for Medicare and Medicaid Services (CMS). We grouped patients into 3 subsets: those with unexplained GI symptoms (e.g., chronic abdominal pain); structural GI diagnoses (e.g., chronic pancreatitis); and those with a concurrent unexplained GI symptom and structural GI diagnosis. High-dose daily opioid use levels were examined as a binary variable [≥ 100 morphine milligram equivalents (MME)/day] and as an ordinal variable (50-99 MME/day, 100-119 MME/day, or ≥ 120 MME/day). RESULTS: We identified 141,805 chronic GI patients dually enrolled in VA and Part D. High-dose opioid use was present in 11% of Veterans with unexplained GI symptoms, 10% of Veterans with structural GI diagnoses, and 15% of Veterans in the concurrent GI group. Compared to Veterans with only an unexplained GI symptom or structural diagnosis, concurrent GI patients were more likely to have higher daily opioid doses, more opioid days ≥ 100 MME, and higher risk of chronic use. Factors associated with high-dose use included opioid receipt from both VA and Part D, younger age, and benzodiazepine use. CONCLUSIONS: A significant subset of chronic GI patients in the VA are high-dose opioid users. Efforts are needed to reduce high-dose use among Veterans with concurrent GI symptoms and diagnoses.

Patient Understanding of "Flare" and "Remission" of Inflammatory Bowel Disease.

Patients with inflammatory bowel disease have adopted medical jargon terms of "flare" and "remission," but what they mean by these terms is ill-defined and may have implications for nurse-patient communication and treatment expectancy. The aim of this study was to elicit patients' understanding of "flare" and "remission." Individuals with self-reported inflammatory bowel disease were recruited through social media. A web-based survey, with closed and open-ended questions, was administered. Conventional content analysis was used to evaluate respondents' perceptions of jargon terms. A word cloud was generated to augment analysis by visualization of word use frequency. A majority of the 34 respondents had a symptom-focused understanding and described these terms as alternating states. Various symptoms were understood to signify "flare," which was largely attributed to lifestyle factors. Corroborated by the word cloud, there was rare mention of inflammation or tissue damage. This study demonstrates that an understanding of "flare" and "remission" by patients with inflammatory bowel disease is largely symptom-based. The role of inflammation, medication failure, and targets of inflammatory bowel disease treatment beyond symptom control are not currently well known to patients with inflammatory bowel disease. To create a shared understanding of symptoms and treatment goals between the patient and the nurse, patient education on emerging expectations of inflammatory bowel disease care should be prioritized.