Piloting Safety and Stabilization: A Multi-component Trauma Intervention to Improve HIV Viral Suppression, Retention in Care, and Post-traumatic Stress Disorder in a Southern United States HIV Service Organization.

In this observational study, we assessed the extent to which a community-created pilot intervention, providing trauma-informed care for persons with HIV (PWH), affected HIV care retention and viral suppression among PWH attending an HIV Services Organization in the Southern US. PWH with trauma exposure and/or trauma symptoms (N = 166) were offered a screening and referral to treatment (SBIRT) session. Per self-selection, 30 opted-out, 29 received SBIRT-Only, 25 received SBIRT-only but reported receiving other behavioral health care elsewhere, and 82 participated in the Safety and Stabilization (S&S) Intervention. Estimates from multivariable logistic regression analyses indicated S&S Intervention participants had increased retention in HIV care (adjusted odds ratio [aOR] 5.46, 95% CI 1.70-17.50) and viral suppression (aOR 17.74, 95% CI 1.83-172), compared to opt-out participants. Some evidence suggested that PTSD symptoms decreased for intervention participants. A randomized controlled trial is needed to confirm findings.

Sustainability of an Opt-Out Electronic-Health Record-Based Tobacco Treatment Consult Service at a Large Safety-Net Hospital: A 6-Year Analysis.

INTRODUCTION: Our safety-net hospital implemented a hospital-based tobacco treatment intervention in 2016. We previously showed the intervention, an "opt-out" Electronic Health Record (EHR)-based Best Practice Alert (BPA)+ order-set that triggers consultation to an inpatient Tobacco Treatment Consult (TTC) service for all patients who smoke, improves smoking abstinence. We now report on sustainability, 6 years after inception. AIMS AND METHODS: We analyzed data collected between July 2016-June 2022 of patients documented as "currently smoking" in the EHR. Across the 6 years, we used Pearson's correlation analysis to compare Adoption (clinician acceptance of the BPA+ order-set, thus generating consultation to the TTC service); Reach (number of consultations completed by the TTC service); and Effectiveness (receipt of pharmacotherapy orders between patients receiving and not receiving consultations). RESULTS: Among 39 558 adult admissions (July 2016-June 2022) with "currently smoking" status in the EHR for whom the BPA triggered, clinicians accepted the TTC order set on 50.4% (19 932/39 558), though acceptance varied across services (eg, Cardiology [71%] and Obstetrics-Gynecology 12%]). The TTC service consulted on 17% (6779/39 558) of patients due to staffing constraints. Consultations ordered (r = -0.28, p = .59) and completed (r = 0.45, p = .37) remained stable over 6-years. Compared to patients not receiving consultations, patients receiving consultations were more likely to receive pharmacotherapy orders overall (inpatient: 50.8% vs. 35.1%, p < .0001; at discharge: 27.1% vs. 10%, p < .0001) and in each year. CONCLUSIONS: The "opt-out" EHR-based TTC service is sustainable, though many did not receive consultations due to resource constraints. Health care systems should elevate the priority of hospital-based tobacco treatment programs to increase reach to underserved populations. IMPLICATIONS: Our study shows that opt-out approaches that utilize the EHR are a sustainable approach to providing evidence-based tobacco treatment to all hospitalized individuals who smoke, regardless of readiness to stop smoking and clinical condition.

Implementation of an "opt-out" tobacco treatment program in six hospitals in South Carolina.

OBJECTIVE: Describe the screening, referral, and treatment delivery associated with an opt-out tobacco treatment program (TTP) implemented in six hospitals varying in size, rurality and patient populations. METHODS: Between March 6, 2021 and December 17, 2021, adult patients (≥ 18 years) admitted to six hospitals affiliated with the Medical University of South Carolina were screened for smoking status. The hospitals ranged in size from 82 to 715 beds. Those currently smoking were automatically referred to one of two tobacco treatment options: 1) Enhanced care (EC) where patients could receive a bedside consult by a trained tobacco treatment specialist plus an automated post-discharge follow-up call designed to connect those smoking to the South Carolina Quitline (SCQL); or 2) Basic care (BC) consisting of the post-discharge follow-up call only. An attempt was made to survey patients at 6-weeks after hospitalization to assess smoking status. RESULTS: Smoking prevalence ranged from 14 to 49% across the six hospitals; 6,000 patients were referred to the TTP.The delivery of the bedside consult varied across the hospitals with the lowest in the Charleston hospitals which had the highest caseload of referred patients per specialist. Among patients who received a consult visit during their hospitalization, 50% accepted the consult, 8% opted out, 3% claimed not to be current smokers, and 38% were unavailable at the time of the consult visit. Most of those enrolled in the TTP were long-term daily smokers.Forty-three percent of patients eligible for the automated post-discharge follow-up call answered the call, of those, 61% reported smoking in the past seven days, and of those, 34% accepted the referral to theSCQL. Among the 986 of patients surveyed at 6-weeks after hospitalization quit rates ranged from 20%-30% based on duration of reported cessation and were similar between hospitals and for patients assigned to EC versus BC intervention groups. CONCLUSION: Findings demonstrate the broad reach of an opt-out TTP. Elements of treatment delivery can be improved by addressing patient-to-staffing ratios, improving systems to prescribe stop smoking medications for patients at discharge and linking patients to stop smoking services after hospital discharge.

Patient self-referral patterns in a developing country: characteristics, prevalence, and predictors.

BACKGROUND: Efficient healthcare delivery and access to specialized care rely heavily on a well-established healthcare sector referral system. However, the referral system faces significant challenges in developing nations like Bangladesh. This study aimed to assess self-referral prevalence among patients attending tertiary care hospitals in Bangladesh and identify the associated factors. METHODS: This cross-sectional study was conducted at two tertiary care hospital, involving 822 patients visiting their outpatient or inpatient departments. A semi-structured questionnaire was used for data collection. The patients' mode of referral (self-referral or institutional referral) was considered the outcome variable. RESULTS: Approximately 58% of the participants were unaware of the referral system. Of all, 59% (485 out of 822) of patients visiting tertiary care hospitals were self-referred, while 41% were referred by other healthcare facilities. The primary reasons for self-referral were inadequate treatment (28%), inadequate facilities (23%), critical cases (14%), and lack of expert physicians (8%). In contrast, institutional referrals were mainly attributed to inadequate facilities to treat the patient (53%), inadequate treatment (47%), difficult-to-treat cases (44%), and lack of expert physicians (31%) at the time of referral. The private facilities received a higher proportion of self-referred patients compared to government hospitals (68% vs. 56%, p < 0.001). Among patients attending the study sites through institutional referral, approximately 10% were referred from community clinics, 6% from union sub-centers, 25% from upazila health complexes, 22% from district hospitals, 22% from other tertiary care hospitals, and 42% from private clinics. Patients visiting the outpatient department (adjusted odds ratio [aOR] 3.3, 95% confidence interval [CI] 2.28-4.82, p < 0.001), residing in urban areas (aOR 1.29, 95% CI 1.04-1.64, p = 0.007), belonging to middle- and high-income families (aOR 1.34, 95% CI 1.03-1.62, p = 0.014, and aOR 1.98, 95% CI 1.54-2.46, p = 0.005, respectively), and living within 20 km of healthcare facilities (aOR 3.15, 95% CI 2.24-4.44, p-value < 0.001) exhibited a higher tendency for self-referral to tertiary care facilities. CONCLUSIONS: A considerable number of patients in Bangladesh, particularly those from affluent urban areas and proximity to healthcare facilities, tend to self-refer to tertiary care centers. Inadequacy of facilities in primary care centers significantly influences patients to opt for self-referral.

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients: A Pragmatic Cluster Randomized Trial.

Importance: Increasing inpatient palliative care delivery is prioritized, but large-scale, experimental evidence of its effectiveness is lacking. Objective: To determine whether ordering palliative care consultation by default for seriously ill hospitalized patients without requiring greater palliative care staffing increased consultations and improved outcomes. Design, Setting, and Participants: A pragmatic, stepped-wedge, cluster randomized trial was conducted among patients 65 years or older with advanced chronic obstructive pulmonary disease, dementia, or kidney failure admitted from March 21, 2016, through November 14, 2018, to 11 US hospitals. Outcome data collection ended on January 31, 2019. Intervention: Ordering palliative care consultation by default for eligible patients, while allowing clinicians to opt-out, was compared with usual care, in which clinicians could choose to order palliative care. Main Outcomes and Measures: The primary outcome was hospital length of stay, with deaths coded as the longest length of stay, and secondary end points included palliative care consult rate, discharge to hospice, do-not-resuscitate orders, and in-hospital mortality. Results: Of 34 239 patients enrolled, 24 065 had lengths of stay of at least 72 hours and were included in the primary analytic sample (10 313 in the default order group and 13 752 in the usual care group; 13 338 [55.4%] women; mean age, 77.9 years). A higher percentage of patients in the default order group received palliative care consultation than in the standard care group (43.9% vs 16.6%; adjusted odds ratio [aOR], 5.17 [95% CI, 4.59-5.81]) and received consultation earlier (mean [SD] of 3.4 [2.6] days after admission vs 4.6 [4.8] days; P < .001). Length of stay did not differ between the default order and usual care groups (percent difference in median length of stay, -0.53% [95% CI, -3.51% to 2.53%]). Patients in the default order group had higher rates of do-not-resuscitate orders at discharge (aOR, 1.40 [95% CI, 1.21-1.63]) and discharge to hospice (aOR, 1.30 [95% CI, 1.07-1.57]) than the usual care group, and similar in-hospital mortality (4.7% vs 4.2%; aOR, 0.86 [95% CI, 0.68-1.08]). Conclusions and Relevance: Default palliative care consult orders did not reduce length of stay for older, hospitalized patients with advanced chronic illnesses, but did improve the rate and timing of consultation and some end-of-life care processes. Trial Registration: ClinicalTrials.gov Identifier: NCT02505035.

Qualitative evaluation of the implementation and future sustainability of an e-referral system for smoking cessation at a US NCI-designated comprehensive cancer center: lessons learned.

BACKGROUND: Promoting smoking cessation is recognized as an essential part of cancer care. Moffitt Cancer Center, supported by the National Cancer Institute Cancer Moonshot Cancer Center Cessation Initiative, developed and implemented an opt-out-based automatic electronic health record (EHR)-mediated referral (e-referral) system for Tobacco Quitline services along with options for local group cessation support and an in-house tobacco treatment specialist. This study evaluated barriers and facilitators for implementation of the e-referral system. METHOD: Steering committee members (N=12) responsible for developing and implementing the new clinical workflow and nurses (N=12) who were expected to use the new e-referral system completed semi-structured interviews. Qualitative thematic content analyses were conducted. RESULTS: Interviewees perceived the e-referral system as an effective strategy for identifying and referring smokers to cessation services. However, barriers were noted including competing demands and perceptions that smoking cessation was a low priority and that some patients were likely to have low motivation to quit smoking. Suggestions to improve future implementation and sustainability included providing regular trainings and e-referral outcome reports and increasing the visibility of the e-referral system within the EHR. CONCLUSION: Initial implementation of the e-referral system was perceived as successful; however, additional implementation strategies are needed to ensure sustainability at both the clinician and system levels. Recommendations for future modifications include providing regular clinician trainings and developing a fully closed-loop system. Implications for cancer survivors Initial implementation of an e-referral system for smoking cessation for cancer patients revealed opportunities to improve the smoking cessation referral process at cancer centers.

Reaching Out to Adolescents at High Risk of HIV Infection in Brazil: Demand Creation Strategies for PrEP and Other HIV Combination Prevention Methods.

Using baseline data from the PrEP1519 cohort, in this article we aimed to analyze: (i) the effectiveness of demand creation strategies (DCS) to enroll adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW) into an HIV combination prevention study in Brazil; (ii) the predictors of DCS for adolescents' enrollment; and (iii) the factors associated with DCS by comparing online and face-to-face strategies for enrollment. The DCS included peer recruitment (i.e., online and face-to-face) and referrals from health services and non-governmental organizations (NGOs). AMSM and ATGW who agreed to participate in the study could opt to enroll in either PrEP (PrEP arm) or to use other prevention methods (non-PrEP arm). Bivariate and multivariate analyses were conducted and logistic regression odds ratios were estimated. The DCS reached 4529 AMSM and ATGW, the majority of which were derived online (73.8%). Of this total, 935 (20.6%) enrolled to participate (76.6% in PrEP arm and 23.4% in non-PrEP arm). The effectiveness of enrolling adolescents into both arms was greater via direct referrals (235/382 and 84/382, respectively) and face-to-face peer recruitment (139/670 and 35/670, respectively) than online (328/3342). We found that a combination under DCS was required for successful enrollment in PrEP, with online strategies majorly tending to enroll adolescents of a higher socioeconomic status. Our findings reinforce the need for DCS that actively reaches out to all adolescents at the greatest risk for HIV infection, irrespective of their socioeconomic status.

A systematic review of interventions to increase the use of smoking cessation services for women who smoke during pregnancy.

BACKGROUND: Although many pregnant women accept referrals to stop-smoking support, the uptake of appointments often remains low. AIM: The aim was to review the success of interventions to increase the uptake of external stop-smoking appointments following health professional referrals in pregnancy. MATERIALS AND METHODS: Embase, PubMed, Cochrane Central Register of Controlled Trials, Scopus and CINAHL were searched in February 2023 for studies with interventions to increase the uptake rates of external stop-smoking appointments among pregnant women who smoke. Eligible studies included randomised, controlled, cluster-randomised, quasi-randomised, before-and-after, interrupted time series, case-control and cohort studies. Cochrane tools assessing for bias and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. RESULTS: Two before-and-after studies were included, including a combined total of 1996 women who smoked during pregnancy. Both studies had a serious risk of bias, and meta-analysis was not possible due to heterogeneity. One study testing carbon monoxide monitors and opt-out referrals showed increased uptake of external stop-smoking appointments, health professional referrals and smoking cessation rates compared to self-identified smoking status and opt-in referrals. Results were limited in the second study, which used carbon monoxide monitors, urinary cotinine levels and self-disclosed methods to identify the smoking status with opt-out referrals. Only post-intervention data were available on the uptake of appointments to external stop-smoking services. The number of health professional referrals increased, but change in smoking cessation rates was less clear. CONCLUSIONS: There is insufficient evidence to inform practice regarding strategies to increase the uptake of external stop-smoking appointments by women during pregnancy.

FACTORS ASSOCIATED WITH NON-ATTENDANCE TO OUTPATIENT CONSULTATION-LIAISON PSYCHIATRY APPOINTMENTS: A RETROSPECTIVE COHORT STUDY.

BACKGROUND: Non-attendance to outpatient mental health appointments is associated with adverse clinical and financial outcomes. The aim of this study was to investigate the rates of non-attendance to outpatient Consultation-Liaison Psychiatry (CLP) appointments and the factors associated with non-attendance. SUBJECTS AND METHODS: Retrospective cohort study, including two groups of data: 950 initial and 3503 follow-up appointments between 01/01/2015 and 31/12/2019. We employed descriptive statistics, parametric/non-parametric tests and logistic regression analysis. We used a range of environmental, socio-demographic and service-related characteristics as independent parameters and non-attendance as the dependent parameter. RESULTS: Initial and follow-up non-attendance rates were 27.5% and 18.8% respectively. Opting-out text message reminders was associated with both initial and follow-up non-attendance. Higher education was associated with initial non-attendance, whereas lower education with follow-up non-attendance. Other factors associated with non-attendance to initial appointments were: English being the participant's primary communication language, having an appointment with a psychiatrist as opposed to a trained nurse or Cognitive Behavioural Therapist, and longer waiting time. Follow-up non-attendance was also associated with younger age, shorter driving distance and higher income/employment. CONCLUSION: We suggest that improving opt-in rates through a combination of staff and patient education and promotion, improving waiting lists, reducing the stigma associated with seeing a psychiatrist, but also perhaps targeting different socio-economic groups of patients with different strategies should be the focus of policy making to tackle non-attendance. Further research into patient-related and environmental factors, such as day of the week, driving distance, language of primary communication, education, income and employment is warranted in order to design more effective policies and improve engagement with CLP, but also psychiatric services in general.

An opt-out model for kidney transplant referral: The time has come.

Disparities that affect equity in access to kidney transplantation for patients with kidney failure have been well described. Many robust clinical trials have tested the effectiveness of interventions to reduce disparities and equilibrate access to kidney transplantation. Moreover, policy changes have been enacted to achieve the same aims. Despite these efforts, rates of kidney transplant waitlisting within the first year of end-stage kidney disease have remained unchanged over the past 2 decades, while incident rates of end-stage kidney disease have climbed. Because prior interventions have not durably increased transplant access, disruptive change is clearly needed. The Advancing American Kidney Health Executive Order sets bold goals to transform kidney care for patients and caregivers. In this spirit, we discuss an Opt-Out for Transplant Referral Model as a compelling solution to improve equity in access to kidney transplantation.

Evaluation of a Systems-Based Tobacco Cessation Program Using Bedside Volunteers.

INTRODUCTION: Hospitalization and post-discharge provide an opportune time for tobacco cessation. This study tested the feasibility, uptake, and cessation outcomes of a hospital-based tobacco cessation program, delivered by volunteers to the bedside with post-discharge referral to Quitline services. Patient characteristics associated with Quitline uptake and cessation were assessed. METHODS: Between February and November 2016, trained hospital volunteers approached inpatient tobacco users on six pilot units. Volunteers shared a cessation brochure and used the ASK-ADVISE-CONNECT model to connect ready to quit patients to the Delaware Quitline via fax-referral. Volunteers administered a follow-up survey to all admitted tobacco users via telephone or email at 3-months post-discharge. RESULTS: Of the 743 admitted tobacco users, 531 (72%) were visited by a volunteer, and 97% (531/547) of those approached, accepted the visit. Over one-third (201/531; 38%) were ready to quit and fax-referred to the Quitline, and 36% of those referred accepted Quitline services. At 3 months post-discharge, 37% (135/368) reported not using tobacco in the last 30 days; intent-to-treat cessation rate was 18% (135/743). In a multivariable regression model of Quitline fax-referral completion, receiving nicotine replacement therapy (NRT) during hospitalization was the strongest predictor (odds ratios [OR] = 1.97; 95% confidence interval [CI] = 1.34 to 2.90). In a model of 3-month cessation, receiving Quitline services (OR = 3.21, 95% CI = 1.35 to 7.68) and having coronary artery disease (OR = 2.28; 95% CI = 1.11 to 4.68) were associated with tobacco cessation, but a volunteer visit was not. CONCLUSIONS: An "opt-out" tobacco cessation service using trained volunteers is feasible for connecting patients to Quitline services. IMPLICATIONS: This study demonstrates the feasibility of a systems-based approach to link inpatients to evidence-based treatment for tobacco use. This model used trained bedside volunteers to connect inpatients to a state-funded Quitline after discharge that offers free cessation treatment of telephone coaching and cessation medications. Receiving NRT during hospitalization positively impacted Quitline referral, and engagement with Quitline resources was critical to tobacco abstinence post-discharge. Future work is needed to evaluate the cost-effectiveness and sustainability of this volunteer model.

Predictors of linkage to care for a nontargeted emergency department hepatitis C screening program.

OBJECTIVE: We implemented a nontargeted, opt-out HCV testing and linkage to care (LTC) program in an academic tertiary care emergency department (ED). Despite research showing the critical role of ED-based HCV testing programs, predictors of LTC have not been defined for patients identified through the nontargeted ED testing strategy. In order to optimize health outcomes for patients with HCV, we sought to identify predictors of LTC failure. METHODS: This was a retrospective cohort study of adult patients who were tested for HCV in the ED between August 2015 and September 2018 and were confirmed to have chronic HCV infection through RNA testing. We used logistic regression to assess the relationship between candidate predictors and the primary outcome, LTC failure, which was defined as a patient not being seen by an HCV treating provider after discharge from the ED. RESULTS: Of 53,297 patients tested, 1,674 (3.1%) had HCV on confirmatory testing, and 355 (21%) linked to care. Predictors of LTC failure included younger age (OR 0.96, 95% CI 0.95-0.97), white race (OR 1.65, 95% CI 1.23-2.22), homelessness (OR 1.91, 95% CI 1.19-3.08), substance use (OR 1.77, 95% CI 1.34-2.34), and comorbid psychiatric illness (OR 2.16, 95% CI 1.59-2.94). Patients with significant medical comorbidities (OR 0.57, 95% CI 0.41-0.78) or HIV co-infection (OR 0.11, 95% CI 0.03-0.46) were less likely to experience LTC failure. CONCLUSIONS: One in five HCV-infected patients identified by ED-based nontargeted testing successfully linked to an HCV treating provider. Predictors of LTC failure may guide the development of targeted interventions to improve LTC success.

Electronic Health Record Mortality Prediction Model for Targeted Palliative Care Among Hospitalized Medical Patients: a Pilot Quasi-experimental Study.

BACKGROUND: Development of electronic health record (EHR) prediction models to improve palliative care delivery is on the rise, yet the clinical impact of such models has not been evaluated. OBJECTIVE: To assess the clinical impact of triggering palliative care using an EHR prediction model. DESIGN: Pilot prospective before-after study on the general medical wards at an urban academic medical center. PARTICIPANTS: Adults with a predicted probability of 6-month mortality of ≥ 0.3. INTERVENTION: Triggered (with opt-out) palliative care consult on hospital day 2. MAIN MEASURES: Frequencies of consults, advance care planning (ACP) documentation, home palliative care and hospice referrals, code status changes, and pre-consult length of stay (LOS). KEY RESULTS: The control and intervention periods included 8 weeks each and 138 admissions and 134 admissions, respectively. Characteristics between the groups were similar, with a mean (standard deviation) risk of 6-month mortality of 0.5 (0.2). Seventy-seven (57%) triggered consults were accepted by the primary team and 8 consults were requested per usual care during the intervention period. Compared to historical controls, consultation increased by 74% (22 [16%] vs 85 [63%], P < .001), median (interquartile range) pre-consult LOS decreased by 1.4 days (2.6 [1.1, 6.2] vs 1.2 [0.8, 2.7], P = .02), ACP documentation increased by 38% (23 [17%] vs 37 [28%], P = .03), and home palliative care referrals increased by 61% (9 [7%] vs 23 [17%], P = .01). There were no differences between the control and intervention groups in hospice referrals (14 [10] vs 22 [16], P = .13), code status changes (42 [30] vs 39 [29]; P = .81), or consult requests for lower risk (< 0.3) patients (48/1004 [5] vs 33/798 [4]; P = .48). CONCLUSIONS: Targeting hospital-based palliative care using an EHR mortality prediction model is a clinically promising approach to improve the quality of care among seriously ill medical patients. More evidence is needed to determine the generalizability of this approach and its impact on patient- and caregiver-reported outcomes.

Design, implementation, and evaluation of an intervention to improve referral to smoking cessation services in breast cancer patients.

PURPOSE: Smoking is a risk factor for poor outcomes following breast reconstructive surgery. This project aimed to design and implement an intervention to consistently refer all breast cancer patients to tobacco treatment services. METHODS: In formative work, a set of processes for providers to consistently refer patients to a tobacco treatment specialist at the Nicotine Dependence Center (NDC) was designed. Elements included consistent documentation of smoking status, provider advice specific to the benefits of quitting to cancer care, referral to NDC using an "opt-out" strategy that emphasized smoking cessation as a standard part of breast cancer treatment, and reinforcement of the importance of the referral by multiple personnel. The number of referrals to the NDC and number of patients who attended their scheduled NDC appointment were measured before and 1 year after implementation. Qualitative evaluation was performed using semi-structured interviews with participating providers and patients regarding acceptability. RESULTS: The proportion of smoking patients referred to the NDC increased from 29% (22/75) before the intervention to 74% (20/27) afterward. Among those referred, attendance at the consultation increased from 41% (9/22) to 75% (15/20). This occurred despite provider interviews revealing knowledge gaps about the referral process and evidence of provider adaptation to accommodate personal practice. Feasibility and acceptability of the intervention were high. CONCLUSION: These findings suggest that similar referral interventions for all cancer patients should be pursued with the aim of embedding tobacco dependence treatment seamlessly and consistently into the cancer treatment plan of every patient who smokes cigarettes.

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

BACKGROUND: Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, reporting acceptability of the system changes to staff, as well as aids and hindrances to implementation and normalization of this complex intervention. METHODS: Process evaluation was used to complement an effectiveness study. Interviews with maternity and smoking cessation services staff and observations of training were undertaken. Normalization Process Theory (NPT) was used to frame the interview guides and analysis. NPT is an empirically-derived theory, developed by sociologists, that uses four concepts to understand the process of routinising new practices. RESULTS: Staff interviews took place across eight National Health Service trusts at a time of widespread restructuring in smoking cessation services. Principally interviewees worked in maternity (n = 63) and smoking cessation services (n = 35). Five main themes, identified inductively, influenced the implementation: 1) initial preparedness of the organisations; 2) staff training; 3) managing partnership working; 4) resources; 5) review and planning for sustainability. CONCLUSIONS: NPT was used to show that the babyClear© package was acceptable to staff in a range of organisations. Illustrated in Themes 1, 2 & 3, staff welcomed ways to approach pregnant women about their smoking, without damaging their professional relationship with them. Predicated on producing individual behaviour change in women, the intervention does this largely through reorganising and standardising healthcare systems that are required to implement best practice guidelines. Changing organisational systems requires belief and commitment from staff, so that they set up and maintain practical adjustments to their practice and are reflective about adapting themselves and the work context as new challenges are encountered. The ongoing challenge is to identify and maintain the elements of the intervention package which are essential for its effectiveness and how to tailor them to local circumstances and resources without compromising its core ingredients.

Examining predictors and outcomes of fertility consults among children, adolescents, and young adults with cancer.

Infertility has a negative impact on quality of life among cancer survivors. Studies show establishing a fertility team results in improved patient satisfaction. A review of electronic medical records was performed to examine predictors of fertility referrals, interventions, and the impact of an opt-out consult mechanism. Findings show many patients, particularly those that are younger, are still not receiving fertility counseling despite the presence of a fertility team. Notably, patients were 3.6 times more likely to receive a consult after the opt-out. Strategies are needed to improve access to fertility related care, particularly in groups where consults are underutilized.

Evaluation of a complex healthcare intervention to increase smoking cessation in pregnant women: interrupted time series analysis with economic evaluation.

OBJECTIVES: To evaluate the effectiveness of a complex intervention to improve referral and treatment of pregnant smokers in routine practice, and to assess the incremental costs to the National Health Service (NHS) per additional woman quitting smoking. DESIGN: Interrupted time series analysis of routine data before and after introducing the intervention, within-study economic evaluation. SETTING: Eight acute NHS hospital trusts and 12 local authority areas in North East England. PARTICIPANTS: 37 726 records of singleton delivery including 10 594 to mothers classified as smoking during pregnancy. INTERVENTIONS: A package of measures implemented in trusts and smoking cessation services, aimed at increasing the proportion of pregnant smokers quitting during pregnancy, comprising skills training for healthcare and smoking cessation staff; universal carbon monoxide monitoring with routine opt-out referral for smoking cessation support; provision of carbon monoxide monitors and supporting materials; and an explicit referral pathway and follow-up protocol. MAIN OUTCOME MEASURES: Referrals to smoking cessation services; probability of quitting smoking during pregnancy; additional costs to health services; incremental cost per additional woman quitting. RESULTS: After introduction of the intervention, the referral rate increased more than twofold (incidence rate ratio=2.47, 95% CI 2.16 to 2.81) and the probability of quitting by delivery increased (adjusted OR=1.81, 95% CI 1.54 to 2.12). The additional cost per delivery was £31 and the incremental cost per additional quit was £952; 31 pregnant women needed to be treated for each additional quitter. CONCLUSIONS: The implementation of a system-wide complex healthcare intervention was associated with significant increase in rates of quitting by delivery.

Opt-in or opt-out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis.

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt-in policy, and enhance it with 'required transplant referral' in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt-in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt-in, opt-out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt-in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical-level barriers identified in our empirical study, we propose a contextually sensitive option for "enabling" soft opt-in through "required transplant referral". We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.

Evaluation of a Dedicated Tobacco Cessation Support Service for Thoracic Cancer Center Patients.

CONTEXT: Cancer patients' continued tobacco use results in poorer therapeutic outcomes including decreased quality of life and survival. OBJECTIVE: To assess reach and impact of a free, opt-out, telephone-based tobacco cessation program for thoracic cancer center patients. DESIGN: Observational study. SETTING: Comprehensive Cancer Center in Western New York. PARTICIPANTS: Current or recent (within past 30 days) tobacco-using thoracic cancer center patients referred to a tobacco cessation support service between October 2010 and October 2012 at a Comprehensive Cancer Center (n = 942/1313 referrals were eligible for cessation support). INTERVENTION: A free, opt-out, telephone-based cessation service that was implemented as standard of care. Cessation specialists had patient-guided conversations that assessed readiness to quit; methods used in the past provided cessation strategies and worked to set up a quit date. There was an average of 35.9 days between referral and first contact. MAIN OUTCOME MEASURES: Program reach (referral and participation rates) and impact (as self-reported cessation outcomes measured twice after referral). RESULTS: Of 942 patients, 730 (77.5%) referred to and called by a tobacco cessation service participated in at least 1 cessation support call, of which 440 of 730 (60.3%) were called for follow-up and 89.5% (394/440) participated. In total, 20.2% (69/342) of current smokers at referral reported at least 7-day abstinence at follow-up. Among current smokers at referral and first contact, being married (odds ratio [OR] = 2.05; 95% confidence interval [CI], 1.01-4.18) and having a lower Eastern Cooperative Oncology Group (ECOG) performance score (OR = 4.05; 95% CI, 1.58-10.39) were associated with quitting at follow-up, after controlling for demographic, clinical, and health behavior characteristics. CONCLUSIONS: Our results demonstrate that 78% of thoracic cancer center patients, if contacted, participated at least once in this cessation support service; for current smokers at referral and first contact, being married and having a lower ECOG performance score were associated with self-reported quitting at follow-up. Other organizations may find our results useful while implementing a systematic way to identify tobacco-using patients as part of routine care and to improve available cessation support services.

'Opt-out' referrals after identifying pregnant smokers using exhaled air carbon monoxide: impact on engagement with smoking cessation support.

BACKGROUND: In the UK, free smoking cessation support is available to pregnant women; only a minority accesses this. 'Opt-out' referrals to stop smoking services (SSS) are recommended by UK guidelines. These involve identifying pregnant smokers using exhaled carbon monoxide (CO) and referring them for support unless they object. METHODS: To assess the impact of 'opt-out' referrals for pregnant smokers on SSS uptake and effectiveness, we conducted a 'before-after' service development evaluation. In the 6-month 'before' period, there was a routine 'opt-in' referral system for self-reported smokers at antenatal 'booking' appointments. In the 6-month 'after' period, additional 'opt-out' referrals were introduced at the 12-week ultrasound appointments; women with CO≥4 ppm were referred to, and outcome data were collected from, local SSS. RESULTS: Approximately 2300 women attended antenatal care in each period. Before the implementation, 536 (23.4%) women reported smoking at 'booking' and 290 (12.7%) were referred to SSS. After the implementation, 524 (22.9%) women reported smoking at 'booking', an additional 156 smokers (6.8%) were identified via the 'opt-out' referrals and, in total, 421 (18.4%) were referred to SSS. Over twice as many women set a quit date with the SSS after 'opt-out' referrals were implemented (121 (5.3%, 95% CI 4.4% to 6.3%) compared to 57 (2.5%, 95% CI 1.9% to 3.2%) before implementation) and reported being abstinent 4 weeks later (93 (4.1%, 95% CI 3.3% to 4.9%) compared to 46 (2.0%, 1.5% to 2.7%) before implementation). CONCLUSIONS: In a hospital with an 'opt-in' referral system, adding CO screening with 'opt-out' referrals as women attended ultrasound examinations doubled the numbers of pregnant smokers setting quit dates and reporting smoking cessation.