Hospitalization as an opportunity to engage underserved individuals in shared decision-making for lung cancer screening: results from two randomized pilot trials.

PURPOSE: Medicare requires tobacco dependence counseling and shared decision-making (SDM) for lung cancer screening (LCS) reimbursement. We hypothesized that initiating SDM during inpatient tobacco treatment visits would increase LCS among patients with barriers to proactively seeking outpatient preventive care. METHODS: We collected baseline assessments and performed two pilot randomized trials at our safety-net hospital. Pilot 1 tested feasibility, acceptability, and preliminary efficacy of a nurse practitioner initiating SDM for LCS during hospitalization (Inpatient SDM). We collected qualitative data on barriers encountered during Pilot 1. Pilot 2 added a community health worker (CHW) to address barriers to LCS completion (Inpatient SDM + CHW-navigation). For both studies, preliminary efficacy was an intention-to-treat analysis of LCS completion at 3 months between intervention and comparator (furnishing of LCS decision aid only) groups. RESULTS: Baseline assessments showed that patients preferred in-person LCS discussions versus self-reviewing materials; overall 20% had difficulty understanding written information. In Pilot 1, 4% (2/52) in Inpatient SDM versus 2% (1/48, comparator) completed LCS (p = 0.6), despite 89% (89/100) desiring LCS. Primary care providers noted that competing priorities and patient factors (e.g., social barriers to keeping appointments) prevented the intervention from working as intended. In Pilot 2, 50% (5/10) in Inpatient SDM + CHW-navigation versus 9% (1/11, comparator) completed LCS (p < 0.05). Many patients were ineligible due to recent diagnostic chest CT (Pilot 1: 255/659; Pilot 2: 239/527). CONCLUSIONS: Inpatient SDM + CHW-navigation shows promise to improve LCS rates among underserved patients who smoke, but feasibility is limited by recent diagnostic chest CT among inpatients. Implementing CHW-navigation in other clinical settings may facilitate LCS for underserved patients. TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT03276806 (8 September 2017); NCT03793894 (4 January 2019).

Rapid Cycle Evaluation and Adaptation of an Inpatient Tobacco Treatment Service at a U.S. Safety-Net Hospital.

Background: To address disparities in smoking rates, our safety-net hospital implemented an inpatient tobacco treatment intervention: an "opt-out" electronic health record (EHR)-based Best Practice Alert + order-set, which triggers consultation to a Tobacco Treatment Consult (TTC) service for all hospitalized patients who smoke cigarettes. We report on development, implementation, and adaptation of the intervention, informed by a pre-implementation needs assessment and two rapid-cycle evaluations guided by the Consolidated Framework for Implementation Research (CFIR) and Expert Recommendations for Implementing Change (ERIC) compilation. Methods: We identified stakeholders affected by implementation and conducted a local needs assessment starting 6 months-pre-launch. We then conducted two rapid-cycle evaluations during the first 6 months post-implementation. The CFIR informed survey and interview guide development, data collection, assessment of barriers and facilitators, and selection of ERIC strategies to implement and adapt the intervention. Results: Key themes were: (1) Understanding the hospital's priority to improving tobacco performance metrics was critical in gaining leadership buy-in (CFIR Domain: Outer setting; Construct: External Policy and Incentives). (2) CFIR-based rapid-cycle evaluations allowed us to recognize implementation challenges early and select ERIC strategies clustering into 3 broad categories (conducting needs assessment; developing stakeholder relationships; training and educating stakeholders) to make real-time adaptations, creating an acceptable clinical workflow. (3) Minimizing clinician burden allowed the successful implementation of the TTC service. (4) Demonstrating improved 6-month quit rates and tobacco performance metrics were key to sustaining the program. Conclusions: Rapid-cycle evaluations to gather pre-implementation and early-implementation data, focusing on modifiable barriers and facilitators, allowed us to develop and refine the intervention to improve acceptability, adoption, and sustainability, enabling us to improve tobacco performance metrics in a short timeline. Future directions include spreading rapid-cycle evaluations to promote implementation of inpatient tobacco treatment programs to other settings and assessing long-term sustainability and return on investment of these programs.

Effectiveness of an Opt-Out Electronic Heath Record-Based Tobacco Treatment Consult Service at an Urban Safety Net Hospital.

BACKGROUND: To address the burden of tobacco use in underserved populations, our safety net hospital developed a tobacco treatment intervention consisting of an "opt-out" electronic health record-based best practice alert + order set, which triggers consultation to an inpatient tobacco treatment consult (TTC) service for all hospitalized smokers. RESEARCH QUESTION: We sought to understand if the intervention would increase patient-level outcomes (receipt of tobacco treatment during hospitalization and at discharge; 6-month smoking abstinence) and improve hospital-wide performance on tobacco treatment metrics. DESIGN AND METHODS: We conducted two retrospective quasi-experimental analyses to examine effectiveness of the TTC service. Using a pragmatic design and multivariable logistic regression, we compared patient-level outcomes of receipt of nicotine replacement therapy and 6-month quit rates between smokers seen by the service (n = 505) and eligible smokers not seen because of time constraints (n = 680) between July 2016 and December 2016. In addition, we conducted an interrupted time series analysis to examine the effect of the TTC service on hospital-level performance measures, comparing reported Joint Commission measure rates for inpatient (Tob-2) and postdischarge (Tob-3) tobacco treatment preimplementation (January 2015-June 2016) vs postimplementation (July 2016-December 2017) of the intervention. RESULTS: Compared with inpatient smokers not seen by the TTC service, smokers seen by the TTC service had higher odds of receiving nicotine replacement during hospitalization (260 of 505 [51.5%] vs 244 of 680 [35.9%]; adjusted ORs [AOR], 1.93 [95% CI, 1.5-2.45]) and at discharge (164 of 505 [32.5%] vs 84 of 680 [12.4%]; AOR, 3.41 [95% CI, 2.54-4.61]), as well as higher odds of 6-month smoking abstinence (75 of 505 [14.9%] vs 68 of 680 [10%]; AOR, 1.48 [95% CI, 1.03-2.12]). Hospital-wide, the intervention was associated with a change in slope trends for Tob-3 (P < .01), but not for Tob-2. INTERPRETATION: The "opt-out" electronic health record-based TTC service at our large safety net hospital was effective at improving both patient-level outcomes and hospital-level performance metrics, and could be implemented at other safety net hospitals that care for hard-to-reach smokers.

Feasibility, Acceptability, and Adoption of an Inpatient Tobacco Treatment Service at a Safety-Net Hospital: A Mixed-Methods Study.

Rationale: Hospitalization is an opportunity to engage smokers who may not seek tobacco treatment. Our safety-net hospital developed and implemented an inpatient intervention consisting of an "opt-out" electronic health record-based Best Practice Alert (BPA)+order-set, designed to trigger referral to the Tobacco Treatment Consult (TTC) service (a team staffed by tobacco treatment specialists) for all hospitalized smokers, regardless of motivation to quit.Objectives: We performed a sequential explanatory mixed-methods study to evaluate the feasibility, acceptability, and adoption of the TTC service.Methods: Among all admissions of adult "current smokers" between July 2016 and June 2017, we calculated the percentage of patients whose clinicians accepted the order-set (through a simple "order" click), thus generating the TTC referral. We then determined the extent of clinician follow-through of TTC recommendations for prescribing nicotine replacement therapy among 1,651 consecutive smokers seen by the TTC service. Finally, we conducted qualitative interviews with inpatient clinicians (n = 25) to understand their rationale for adoption or nonuse of the TTC intervention, including perceived usefulness, barriers to adoption, and strategies to improve the utility of the service.Results: Clinicians accepted the TTC order-set for 4,100 out of 6,598 "current smokers" (62.1%) for whom the BPA fired, typically after initially deferring the BPA. Rates of acceptance significantly differed across clinical services (range: 8% [obstetrics-gynecology] to 82.2% [cardiology]; P < 0.00001). A chart review showed that 43.5% (719/1,651) of the patients seen by the TTC service desired outpatient nicotine replacement therapy, but only half of these patients (48.8%; 351/719) received a discharge prescription from the inpatient team. Clinicians expressed that they valued the TTC service, but that BPA fatigue, time constraints, competing priorities, and poor communication with the TTC service were barriers to using the service and following recommendations. Clinicians suggested strategies to address barriers to the use of tobacco treatment interventions during hospitalization and after discharge.Conclusions: Implementing a large-scale "opt-out" tobacco treatment service for hospitalized smokers at a safety-net hospital is feasible and acceptable, but suffers from inconsistent adoption due to a variety of clinician barriers. System-level changes are needed to increase uptake and sustain inpatient tobacco treatment interventions to promote smoking cessation.

Initial surgical experience following implementation of lung cancer screening at an urban safety net hospital.

BACKGROUND: Safety net hospitals provide care mostly to low-income, uninsured, and vulnerable populations, in whom delays in cancer screening are established barriers. Socioeconomic barriers might pose important challenges to the success of a lung cancer screening program at a safety net hospital. We aimed to determine screening follow-up compliance, rates of diagnostic and treatment procedures, and the rate of cancer diagnosis in patients classified as category 4 by the Lung CT Screening Reporting and Data System (Lung-RADS 4). METHODS: We conducted a retrospective review of all patients enrolled in our multidisciplinary lung cancer screening program between March 2015 and July 2016. Demographics, smoking status, Lung-RADS score, and number of diagnostic and therapeutic interventions and cancer diagnoses were captured. RESULTS: A total of 554 patients were screened over a 16-month period. The mean patient age was 63 years (range, 47-85 years), and 60% were male. The majority (92%; 512 of 554) were classified as Lung-RADS 1 to 3, and 8% (42 of 554) were classified as Lung-RADS 4. Among the Lung-RADS 4 patients, 98% (41 of 42) completed their recommended follow-up; 29% (12 of 42) underwent a diagnostic procedure, for an overall diagnostic intervention rate of 2% (12 of 554). Eleven of these 12 patients had cancer, and 1 patient had sarcoidosis. The overall rate of surgical resection was 0.9% (5 of 554), and the rate of diagnostic intervention for noncancer diagnosis was 0.1% (1 of 554). CONCLUSIONS: Implementation of a multidisciplinary lung cancer screening program at a safety net hospital is feasible. Compliance with follow-up and interventional recommendations in Lung-RADS 4 patients was high despite anticipated social challenges. Overall diagnostic and surgical resection rates and interventions for noncancer diagnosis were low in our initial experience.

Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients.

OBJECTIVE: This study sought to determine whether aggressive glycemic control (90-120 mg/dL) would result in more optimal clinical outcomes and less morbidity than moderate glycemic control (120-180 mg/dL) in diabetic patients undergoing coronary artery bypass graft (CABG) surgery. SUMMARY OF BACKGROUND DATA: Maintaining serum glucose levels between 120 and 180 mg/dL with continuous insulin infusions decreases morbidity in diabetic patients undergoing CABG surgery. Studies in surgical patients requiring prolonged ventilation suggest that aggressive glycemic control (<120 mg/dL) may improve survival; however, its effect in diabetic CABG patients is unknown. METHODS: Eighty-two diabetic patients undergoing CABG were prospectively randomized to aggressive glycemic control (90-120 mg/dL) or moderate glycemic control (120-180 mg/dL) using continuous intravenous insulin solutions (100 units regular insulin in 100 mL: normal saline) beginning at the induction of anesthesia and continuing for 18 hours after CABG. Primary end points were the incidence of major adverse events (major adverse events = 30-day mortality, myocardial infarction, neurologic events, deep sternal infections, and atrial fibrillation), the level of serum glucose, and the incidence of hypoglycemic events. RESULTS: There were no differences in the incidence of major adverse events between the groups (17 moderate vs 15 aggressive; P = 0.91). Patients with aggressive control had a lower mean glucose at the end of 18 hours of insulin infusion (135 ± 12 mg/dL moderate vs 103 ± 17 mg/dL aggressive; P < 0.0001). Patients with aggressive control had a higher incidence of hypoglycemic events (4 vs 30; P < 0.0001). CONCLUSIONS: In diabetic patients undergoing CABG surgery, aggressive glycemic control increases the incidence of hypoglycemic events and does not result in any significant improvement in clinical outcomes that can be achieved with moderate control. Clinical Trials.gov (ID #NCT00460499).

Adhesive strips versus subcuticular suture for mediansternotomy wound closure.

BACKGROUND AND AIM: This prospective randomized study was undertaken to compare the use of the 3M™ Steri-Strip™ S Surgical Skin closure system with a running absorbable subcuticular suture technique for skin closure following a mediansternotomy for cardiac surgical procedures. METHODS: Thirty-six patients undergoing a mediansternotomy for a cardiac surgical procedure were prospectively randomized to either Steri-Strip S or subcuticular suture for wound closure. The wounds were evaluated on postoperative days 7 and 21 for erythema, edema, pain, cosmesis, and the time taken to close the incision. RESULTS: Skin closure with Steri-Strip S was faster (5.33 ± 1.32 minutes steri-strips vs. 6.07 ± 0.91 sutures; p = 0.06) and resulted in significantly less erythema and edema, but no difference in pain or cosmesis after seven days. Following 21 days, there was no difference in pain, edema, or cosmesis between the groups. However, patients receiving steri-strips continue to have less erythema. CONCLUSIONS: Both Steri-Strip S and absorbable sutures are effective techniques for skin closure following a mediansternotomy incision for cardiac surgical procedures. Steri-Strip S can decrease the amount of erythema, but results in no significant difference in pain, cosmesis, or edema compared to the traditional subcuticular wound closure technique.

Novel adhesive skin closures improve wound healing following saphenous vein harvesting.

BACKGROUND AND AIMS: New techniques for skin closure that minimize tissue inflammation and avoid foreign material may decrease morbidity following saphenous vein harvesting. The 3M Steri-Strip S surgical skin closure system is a new, noninvasive method of wound closure, which consists of polymeric components coated with a pressure-sensitive skin adhesive. This prospective, randomized study was undertaken to compare the results of the noninvasive skin closure method to the traditional subcuticular skin closure technique on saphenous vein harvest sites. METHODS: Twenty-six patients undergoing coronary artery bypass surgery with saphenous vein harvesting were prospectively randomized to skin closure using 3M Steri-Strip S Surgical Skin Closure System or subcuticular suture closure with a skin sealant. Wounds were evaluated on postoperative days 7 and 2l for erythema, edema, pain, cosmesis, and the time taken to close the incision. RESULTS: Skin closure with 3M Steri-Strip S was significantly faster, resulted in significantly less erythema, edema, and significantly improved cosmesis. CONCLUSIONS: 3M Steri-Strip S Skin Closure improves wound healing of saphenous vein sites, compared to traditional subcuticular skin closure techniques.

Beneficial effects of complement inhibition with soluble complement receptor 1 (TP10) during cardiac surgery: is there a gender difference?

BACKGROUND: TP10, a potent inhibitor of complement activation during cardiopulmonary bypass (CPB) has been shown to significantly reduce the incidence of death and myocardial infarction (MI) in high-risk male patients undergoing cardiac surgery. However, the effect of TP10 in females was undefined because of the limited number of females studied. To examine the possibility of a gender effect, this phase 2 multi-center trial was undertaken to determine whether TP10 would also limit ischemic damage in a larger sample size of high-risk females undergoing cardiac surgery on cardiopulmonary bypass (CPB). METHODS AND RESULTS: This prospective, double-blind, placebo-controlled, multi-center trial involved 297 high-risk (urgent surgery, CABG + Valve, reoperations, ejection fraction <30%) female patients randomized to receive a 5 mg/kg dose of TP10 (n=150) or placebo (n=147) as a 30-minute intravenous infusion before surgery. The primary end point was the incidence of death or MI at 28 days after surgery. Complement activation was assessed by levels of CH50 and SC5b-9 during and after CPB. TP10 was well tolerated and there were no differences in the safety profiles of the 2 groups. Although TP10 effectively suppressed complement activation (at 2 hours after CPB CH50 (mean+SD % change from baseline) 50+/-17% placebo versus 4+/-14% TP10; P=0.0001; SC5b-9 (ng/mL) 917+/-1067 placebo versus 204+/-79 TP10; P=0.0001), there was no difference in the primary end point between the groups (17% placebo versus 21% TP10; P=0.2550). CONCLUSIONS: The benefits of TP10 appear to be gender-related. and mechanisms other than complement activation may be responsible for myocardial injury in high-risk female patients during cardiac surgery on CPB.

Soluble human complement receptor 1 limits ischemic damage in cardiac surgery patients at high risk requiring cardiopulmonary bypass.

BACKGROUND: This study was undertaken to determine whether soluble human complement receptor type 1 (TP10), a potent inhibitor of complement activation, would reduce morbidity and mortality in high-risk patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). METHODS: This was a randomized multicenter, prospective, placebo-controlled, double-blind study in which 564 high-risk patients undergoing cardiac surgery on CPB received an intravenous bolus of TP10 (1, 3, 5, 10 mg/kg) or placebo immediately before CPB. The primary endpoint was the composite events of death, myocardial infarction (MI), prolonged (> or =24 hours) intra-aortic balloon pump support (IABP), and prolonged intubation. RESULTS: TP10 significantly inhibited complement activity after 10 to 15 minutes of CPB and this inhibition persisted for 3 days postoperatively. However, there was no difference in the primary endpoint between the 2 groups (33.7% placebo versus 31.4% TP10; P=0.31). The primary composite endpoint was, however, reduced in all male TP10 patients by 30% (P=0.025). TP10 reduced the incidence of death or MI in males by 36% (P=0.026), the incidence of death or MI in CABG males by 43% (P=0.043) and the need for prolonged IABP support in male CABG and valve patients by 100% (P=0.019). There was, however, no improvement seen in female TP10 patients. There were no significant differences in adverse events between the groups. CONCLUSIONS: TP10 effectively inhibits complement activation during CPB; however, this was not associated with an improvement in the primary endpoint of the study. Nevertheless, TP10 did significantly decrease the incidence of mortality and MI in male patients.

Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events.

BACKGROUND: This study sought to determine whether tight glycemic control with a modified glucose-insulin-potassium (GIK) solution in diabetic coronary artery bypass graft (CABG) patients would improve perioperative outcomes. METHODS AND RESULTS: One hundred forty-one diabetic patients undergoing CABG were prospectively randomized to tight glycemic control (serum glucose, 125 to 200 mg/dL) with GIK or standard therapy (serum glucose <250 mg/dL) using intermittent subcutaneous insulin beginning before anesthesia and continuing for 12 hours after surgery. GIK patients had lower serum glucose levels (138+/-4 versus 260+/-6 mg/dL; P<0.0001), a lower incidence of atrial fibrillation (16.6% versus 42%; P=0.0017), and a shorter postoperative length of stay (6.5+/-0.1 versus 9.2+/-0.3 days; P=0.003). GIK patients also showed a survival advantage over the initial 2 years after surgery (P=0.04) and decreased episodes of recurrent ischemia (5% versus 19%; P=0.01) and developed fewer recurrent wound infections (1% versus 10%, P=0.03). CONCLUSIONS: Tight glycemic control with GIK in diabetic CABG patients improves perioperative outcomes, enhances survival, and decreases the incidence of ischemic events and wound complications.