Usual Care Practices Research Articles

The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety trial 2 (AESOPS-2): Availability of opioid harm

BackgroundHigh levels of opioid prescribing in the United States has resulted in an alarming trend in opioid-related harms. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to “go low and slow”. We aim to accomplish this by notifying clinicians of harmful patient outcomes, which we expect to increase the mental availability of risks associated with opioid use. MethodsThe trial is multi-site. Random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control). Clinicians in the intervention group receive a letter notifying them of their patient's overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) prescribed in a 6-month period before and after receiving the letter. Additional outcomes are the change in the proportion of patients prescribed at least 50 daily MME and in the proportion of patients referred to medication assisted treatment. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME. DiscussionThe AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering population exposure to these drugs.Trial registration: ClinicalTrials.gov: NCT04758637

Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care

Evidence-based parenting interventions play a crucial role in the sustained reduction of adolescent behavioral health concerns. Guiding Good Choices (GGC) is a 5-session universal anticipatory guidance curriculum for parents of early adolescents that has been shown to reduce substance use, depression symptoms, and delinquent behavior. Although prior research has demonstrated the effectiveness of evidence-based parenting interventions at achieving sustained reductions in adolescent behavioral health concerns, public health impact has been limited by low rates of uptake in community and agency settings. Pediatric primary care is an ideal setting for implementing and scaling parent-focused prevention programs as these settings have a broad reach, and prevention programs implemented within them have the potential to achieve population-level impact. The current investigation, Guiding Good Choices for Health (GGC4H), tests the feasibility and effectiveness of implementing GGC in 3 geographically and socioeconomically diverse large integrated healthcare systems. This pragmatic, cluster randomized clinical trial will compare GGC parenting intervention to usual pediatric primary care practice, and will include approximately 3750 adolescents; n = 1875 GGC intervention and n = 1875 usual care. The study team hypothesizes that adolescents whose parents are randomized into the GGC intervention arm will show reductions in substance use initiation, the study's primary outcomes, and other secondary (e.g., depression symptoms, substance use prevalence) and exploratory outcomes (e.g., health services utilization, anxiety symptoms). The investigative team anticipates that the implementation of GGC within pediatric primary care clinics will successfully fill an unmet need for effective preventive parenting interventions.Trial registration: Clinicaltrials.govNCT04040153

The effectiveness of the role of advanced nurse practitioners compared to physician-led or usual care: A systematic review.

To evaluate the effectiveness of the role of advanced nurse practitioners compared to physicians-led/ usual care (care managed by medical doctors or non-advanced nurse practitioners). Advanced nurse practitioners contribute to the improvement of quality patient care and have substantial potential to optimise the health of people globally. Since the formal recognition of advanced nurse practitioners by the International Council of Nurses, among others, the role has been adopted across most departments and clinical specialties, particularly in high-income countries. Systematic review of primary research evidence. MEDLINE, EMBASE, CINAHL, Cochrane registry, Cochrane trials, and Cochrane EPOC (PDQ Evidence) were searched for randomised controlled trials (RCTs) of patient care and health resource utilisation outcomes associated with advanced nurse practitioners. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The chosen articles were restricted to full-text English language trials published in the last 20 years, incorporating comparators of usual care. Search terms were limited to variations of advanced nurse practitioner role and practice. The eligible studies were bias risk assessed and quality assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Clinical and service outcomes were analysed using narrative synthesis as the marked heterogeneity between studies precluded meta-analysis. Thirteen RCTs were reviewed. All of them were conducted across high-income countries within primary care and hospital settings involving paediatric and adult patients. Five trials were assessed as high quality, and eight were of low to moderate quality. Positive effects were demonstrated for the impact of advanced nurse practitioners on usual care; for indigestion, mean difference [MD] 2.3: 95% CI 1.4, 3.1]), perceptions of health status [ (MD -140.6; 95% CI -184.8, -96.5)], satisfaction levels [ (MD ranged from -8.79; 95% CI -13.59, -3.98 to 0.61; 95% CI -4.84, 6.05)], physical function (1.58 [SD 0.76] v. 1.81 [SD 0.90]), and blood pressure control (systolic [133 [SD 21] v. 135 [SD 19] mmHg p=0.04] and diastolic [77 [SD 10] v. 80 [SD 11] mmHg p=0.007]) were looked at. Positive effects related to service provision included improved patient satisfaction and reductions in waiting times and costs, which significantly favored advanced nurse practitioners (all p<0.05). The evidence of this review supports the positive impact of advanced nurse practitioners on clinical and service-related outcomes: patient satisfaction, waiting times, control of chronic disease, and cost-effectiveness especially when directly compared to medical practitioner-led care and usual care practices - in primary, secondary and specialist care settings involving both adult and pediatric populations.

Effect of Raja Yoga Meditation on the Distress and Anxiety Levels of Women with Breast Cancer

Objective: To evaluate the effect of Raja yoga meditation on the level of distress and anxiety in women with breast cancer. Method: A randomized, controlled, clinical trial was carried out in a specialized center between February and December 2019. The patients in the intervention group (n = 25) participated in four group meditation sessions for one month, and the participants in the control group (n = 25) were exposed to an educational activity for the same period and frequency. Cohen’s d was used to evaluate the effect size. Results: A significant reduction in the level of distress and anxiety was found in the intervention group (p &lt; 0.001). The effect of meditation was average in reducing distress, anxiety, depression, and vital signs. There was also an average effect on the increase in saturation of peripheral oxygen (SPO2). Conclusion: The practice of meditation reduced distress and anxiety more effectively than the usual care practices.

LISTEN UP (Locally Integrated Screening and Testing Ear aNd aUral Programme): a feasibility study protocol for a community pharmacy-based ear health intervention

BackgroundEar disease is a major cause of preventable hearing loss and is very common in rural communities, estimated to affect 1.3 million Australians. Rural community pharmacists are well placed to provide improved ear health care to people who are unable to easily access a general practitioner (GP). The purpose of this study is to apply an ear health intervention to the rural community-pharmacy setting in Queensland, Australia, to improve the management of ear disease. The aims are the following: (1) to evaluate the feasibility, potential effectiveness and acceptability of a community pharmacy-based intervention for ear health, (2) to evaluate the use of otoscopy and tympanometry by pharmacists in managing ear complaints in community pharmacy and (3) to evaluate the extended role of rural pharmacists in managing ear complaints, with the potential to expand nationally to improve minor ailment management in rural communities.Methods/designThis is a longitudinal pre- and post-test study of a community-pharmacy-based intervention with a single cohort of up to 200 patients from two rural community pharmacies. Usual care practices pertaining to the management of ear complaints will be recorded prior to the intervention for 8 weeks. The intervention will then be piloted for 6 weeks, followed by a 12 month impact study. Patients aged > 13 years presenting to the pharmacies with an ear complaint will be invited to participate. Trained pharmacists will conduct an examination including a brief history, hearing screening, otoscopy and tympanometry assessments. Patients will be referred to a general practitioner (GP) if required, according to the study protocol. Patients will complete a satisfaction survey and receive a follow-up phone call at 7 days to explore outcomes including prescribed medications and referrals. Pharmacists and GPs will complete pre- and post- intervention interviews. Patient, pharmacist and GP data will be analysed using descriptive statistics and thematic analysis for the qualitative data.DiscussionThis study will demonstrate the implementation of a screening and referring ear health intervention in rural community pharmacy. Feasibility, potential effectiveness and acceptability of the intervention will be assessed.Trial registrationAustralian and New Zealand Clinical Trial Registry Number: ACTRN12620001297910.

Cost-effectiveness of a Smoking Cessation Intervention for Parents in Pediatric Primary Care

Parental smoking adversely affects parents' and children's health. There are effective interventions delivered in pediatric settings to help parents quit smoking. The cost-effectiveness of this type of intervention is not known. To evaluate the cost-effectiveness of a parental smoking cessation intervention, the Clinical Effort Against Secondhand Smoke Exposure (CEASE) program, delivered in pediatric primary care, compared with usual care from a health care organization's perspective. This economic evaluation used data on intervention costs and parental smoking cessation collected prospectively as part of the CEASE randomized clinical trial. Data were collected at pediatric offices in 5 US states from April 2015 to October 2017. Participants included parents of children attending 10 pediatric primary care practices (5 control, 5 intervention). Data analysis was performed from October 2019 to August 2020. The trial compared CEASE (practice training and support to address family tobacco use) vs usual care. The overall cost and incremental cost per quit of the CEASE intervention were calculated using microcosting methods. CEASE effectiveness was estimated using 2 trial outcomes measures assessed in repeated cross-sections: (1) change in smoking prevalence assessed by parental report for intervention vs usual care practices at 2 weeks after program initiation (baseline) and at 2-year follow-up and (2) changes in the proportion of smokers who achieved cotinine-confirmed smoking cessation in the previous 2 years at baseline vs follow-up. Monte Carlo analyses were used to provide 95% CIs. The study included a total of 3054 participants (1523 at baseline and 1531 at follow-up); 2163 (70.8%) were aged 25 to 44 years old, and 2481 (81.2%) were women. Over 2 years, the total cost of implementing and sustaining CEASE across 5 intervention practices was $115 778. The incremental cost per quit for CEASE compared with usual care was $1132 (95% CI, $653-$3603), according to the change in parent-reported smoking prevalence, and $762 (95% CI, $418-$2883), according to cotinine-confirmed cessation. CEASE was cost-effective at a willingness-to-pay threshold of $2000 per quit in 88.0% of simulations based on the parent-reported smoking prevalence and 94.6% of simulations based on cotinine-confirmed smoking cessation measures. These findings suggest that the CEASE intervention was associated with an incremental cost per quit that compared favorably with those of other clinical smoking cessation interventions. CEASE is inexpensive to initiate and maintain in the clinical pediatric setting, suggesting that it has the potential for a high impact on population health.

Reducing Emergency Department Visits Among Patients With Diabetes by Embedding Clinical Pharmacists in the Primary Care Teams.

Pharmacists are effective at improving control of cardiovascular risk factors, but it less clear whether these improvements translate into less emergency department (ED) use and fewer hospitalizations. The UCMyRx program embed pharmacists in primary care. The objective of this study was to examine if the integration of pharmacists into primary care was associated with lower ED and hospital use for patients with diabetes. This was a quasi-experimental study with a comparator group. The analytic sample included patients with diabetes with uncontrolled cardiovascular risk factors (A1C >9%, blood pressure >140/90 mm Hg, low-density lipoprotein-cholesterol >130 mg/dL) who had 1 or more visits in either a UCMyRx (648 patients, 14 practices) or usual care practice (1944 patients, 14 practices). Our outcomes were ED and hospitalization rates as measured before and after the consultations between UCMyRx and usual care. Our predictor variable was the pharmacist consultation. Poisson generalized estimating equations model was used to estimate the adjusted predicted change in utilization before and after the pharmacist consultation. The Average Treatment Effect on the Treated was estimated. In models adjusted, the adjusted mean predicted number of emergency department visits/month during the year before the consultation was 0.09 among UCMyRx patients. During the year after initiating the care with the pharmacists, this rate decreased to an adjusted mean monthly rate of 0.07, with an Average Treatment Effect on the Treated=0.021 (P=0.035), a predicted reduction of 21% in emergency department visits associated with the clinical pharmacist consults. There was a nonsignificant predicted 3.2% reduction in hospitalizations over time for patients in the UCMyRx program. Clinical pharmacists are an important addition to clinical care teams in primary care practices and significantly decreased utilization of the ED among patients with poorly controlled diabetes.

Randomised controlled trial to assess the effectiveness of apnoeic oxygenation in adults using low-flow or high-flow nasal cannula with head side elevation versus usual care to prevent desaturation during endotracheal intubation in the emergency department (ApOxED): study protocol

IntroductionApnoeic oxygenation is a process of delivering continuous oxygen through nasal cannula during direct laryngoscopy. The oxygen that is delivered through these nasal cannulas is either low flow or high...

An absolute risk-guided approach to cardiovascular risk management within a chest pain clinic: the ARCPAC randomized trial

Abstract Background The majority of patients attending chest pain clinics are found not to have a cardiac cause of their symptoms, but have a high burden of cardiovascular risk factors that may be opportunistically addressed. Absolute risk calculators are recommended to guide risk factor management, although it is uncertain to what extent these calculations may assist with patient engagement in risk factor modification. Purpose We sought to determine the usefulness of a proactive, absolute risk-based approach, to guide opportunistic cardiovascular risk factor management within a chest pain clinic. Methods This was a prospective, open-label, blinded-endpoint study in 192 enhanced risk (estimated 5-year risk ≥8%, based on Australian Absolute Risk Calculator) patients presenting to a tertiary hospital chest pain clinic. Patients were randomized to best practice usual care, or intervention with development of a proactive cardiovascular risk management strategy framed around a discussion of the individual's absolute risk. Patients found to have a cardiac cause of symptoms were excluded as they constitute a secondary prevention population. Primary outcome was 5-year absolute cardiovascular risk score at minimum 12 months follow up. Secondary outcomes were individual modifiable risk factors (lipid profile, blood pressure, smoking status). Results 192 people entered the study; 100 in the intervention arm and 92 in usual care. There was no statistical difference between the two groups' baseline sociodemographic and clinical variables. The intervention group showed greater reduction in 5-year absolute risk scores (difference −2.77; p&amp;lt;0.001), and more favourable individual risk factors, although only smoking status and LDL cholesterol reached statistical significance (table). Conclusion An absolute risk-guided proactive risk factor management strategy employed opportunistically in a chest pain clinic significantly improves 5-year cardiovascular risk scores. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Tasmanian Community Fund

A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial

BackgroundTransitioning care from hospital to home is associated with risks of adverse events and poor continuity of care. These transitions are even more challenging when new approaches to care, such as palliative care, are introduced before discharge. Family caregivers (FCGs) are expected to navigate these transitions while also managing care. In addition to extensive caregiving responsibilities, FCGs often have their own health needs that can inhibit their ability to provide care. Those living in rural areas have even fewer resources to meet their self-care and caregiving needs. The purpose of this study is to test the efficacy and cost-effectiveness of an intervention to improve FCGs’ health and well-being. The intervention uses video visits to teach, guide, and counsel FCGs in rural areas during hospital-to-home transitions. The intervention is based on evidence of transitional and palliative care principles, which are individualized to improve continuity of care, provide caregiver support, enhance knowledge and skills, and attend to caregivers’ health needs. It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost. We describe the rationale for targeting rural caregivers, the methods for the study and intervention, and the analysis plan to test the intervention’s effect.MethodsThe study uses a randomized controlled trial design, with FCGs assigned to the control condition or the caregiver intervention by computer-generated lists. The intervention period continues for 8 weeks after care recipients are discharged from the hospital. Data are collected at baseline, 2 weeks, 8 weeks, and 6 months. Time and monetary costs from a societal perspective are captured monthly.DiscussionThis study addresses 2 independent yet interrelated health care foci—transitional care and palliative care—by testing an intervention to extend palliative care practice and improve transition management for caregivers of seriously ill patients in rural areas. The comprehensive cost assessment will quantify the commitment and financial burden of FCGs.Trial registrationClinicalTrials.gov NCT03339271. Registered on 13 November 2017.Protocol version: 11.

Relationship-based care model in paediatrics: A randomized controlled trial to implement the parents' perception of the quality of nursing care.

To evaluate whether the application of the Relationship-based care model as a new treatment, called "Take 5min", affects the level of anxiety, depression, and perceived quality of nursing care of parents of paediatric patients and the work satisfaction of the nursing staff. Single-blind randomized controlled trial. The trial was performed from February-July 2016. The trial was conducted with one intervention (N=101) and one control group (N=90). Nurses applied the treatment named "Take 5 Minutes", which consisted of dedicating some short time (from 5 to 10min) to the relationship with the parents using specifically designed communication strategies. The primary outcome was the evaluation of anxiety and depression of parents; the secondary was the parent perceived quality of nursing care. In the experimental group, participants had a lower level of anxiety and depression and highlighted that the effect of the "Take 5 Minutes" was proportional to the initial seriousness of parents' anxiety and depression. Higher scores for the perception of the quality of care were given from the parents of the experimental group. The "Take 5 Minutes" treatment offered to parents of paediatric patients demonstrated significant improvements in terms of their anxiety, depression, and perceived quality of nursing care. Caregivers of paediatric patients are subject to psychological disorders such as depression and anxiety. The communication by the nursing community is of fundamental importance in the management of anxiety and depression in the caregivers of hospitalized patients. Caregivers who received the "Take 5 Minutes" treatment demonstrated a significant decrease in anxiety and depression compared with the control group caregivers. The perceived level of quality of nursing care showed a significant increase in the group of caregivers who received the T5M treatment. The RBC model does not require extra costs for health organizations and can be applied during the usual practice of care. Practices such as T5M could become part of paediatric patient care guidelines and nurses should be trained to apply them. Padua Research: ID No. 10,034; ClinicalTrials.gov: ID No. NCT04199429.

Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial

ObjectiveTo investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.DesignCluster randomised controlled trial.Setting47 intention-to-screen and 49 usual care primary care practices in...

Promoting Physical Activity and Executive Functions Among Children: A Cluster Randomized Controlled Trial of an After-School Program in Australia.

The aim of this study was to examine the efficacy of an embedded after-school intervention, on promoting physical activity and academic achievement in primary-school-aged children. This 6-month, 2-arm cluster randomized controlled trial involved 4 after-school centers. Two centers were randomly assigned to the intervention, which involved training the center staff on and implementing structured physical activity (team sports and physical activity sessions for 75min) and academic enrichment activities (45min). The activities were implemented 3 afternoons per week for 2.5hours. The control centers continued their usual after-school care practice. After-school physical activity (accelerometry) and executive functions (working memory, inhibition, and cognitive flexibility) were assessed pre- and postintervention. A total of 60 children were assessed (7.7 [1.8]y; 50% girls) preintervention and postintervention (77% retention rate). Children in the intervention centers spent significantly more time in moderate to vigorous physical activity (adjusted difference = 2.4%; 95% confidence interval, 0.6 to 4.2; P = .026) and scored higher on cognitive flexibility (adjusted difference = 1.9 units; 95% confidence interval, 0.9 to 3.0; P = .009). About 92% of the intervention sessions were implemented. The participation rates varied between 51% and 94%. This after-school intervention was successful at increasing moderate to vigorous physical activity and enhancing cognitive flexibility in children. As the intervention was implemented by the center staff and local university students, further testing for effectiveness and scalability in a larger trial is required.

Considerations for development of pharmacy support models for COVID-19 alternate care sites.

PurposeGuidance on alternate care site planning based on the experience of a health-system pharmacy department in preparing for an expected surge in coronavirus disease 2019 (COVID-19) cases is provided.SummaryIn disaster response situations such as the COVID-19 pandemic, healthcare institutions may be compelled to transition to a contingency care model in which staffing and supply levels are no longer consistent with daily practice norms and, while usual patient care practices are maintained, establishment of alternate care sites (eg, a convention center) may be necessitated by high patient volumes. Available resources to assist hospitals and health systems in alternate care site planning include online guidance posted within the COVID-19 resources section of the US Army Corps of Engineers website, which provides recommended medication and supply lists; and the Federal Healthcare Resilience Task Force’s alternate care site toolkit, a comprehensive resource for all aspects of alternate care site planning, including pharmacy services. Important pharmacy planning issues include security and storage of drugs, state board of pharmacy and Drug Enforcement Administration licensing considerations, and staff credentialing, education, and training. Key medication management issues to be addressed in alternate site care planning include logistical challenges of supply chain maintenance, optimal workflow for compounded sterile preparations (eg, on-site preparation vs off-site preparation and delivery from a nearby hospital), and infusion pump availability and suitability to patient acuity levels.ConclusionPlanning for and operation of alternate care sites in disaster response situations should include involvement of pharmacists in key decision-making processes at the earliest planning stages.

Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network

IntroductionPrimary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational...

Improving primary care identification of familial breast cancer risk using proactive invitation and decision support

Family history of breast cancer is a key risk factor, accounting for up to 10% of cancers. We evaluated the proactive assessment of familial breast cancer (FBC) risk in primary care. Eligible women (30 to 60 years) were recruited from eight English general practices. Practices were trained on FBC risk assessment. In four randomly-assigned practices, women were invited to complete a validated, postal family history questionnaire, which practice staff inputted into decision support software to determine cancer risk. Those with increased risk were offered specialist referral. Usual care was observed in the other four practices. In intervention practices, 1127/7012 women (16.1%) returned family history questionnaires, comprising 1105 (98%) self-reported white ethnicity and 446 (39.6%) educated to University undergraduate or equivalent qualification, with 119 (10.6%) identified at increased breast cancer risk and offered referral. Sixty-seven (56%) women recommended referral were less than 50 years old. From 66 women attending specialists, 26 (39.4%) were confirmed to have high risk and recommended annual surveillance (40–60 years) and surgical prevention; while 30 (45.5%) were confirmed at moderate risk, with 19 offered annual surveillance (40–50 years). The remaining 10 (15.2%) managed in primary care. None were recommended chemoprevention. In usual care practices, only ten women consulted with concerns about breast cancer family history. This study demonstrated proactive risk assessment in primary care enables accurate identification of women, including many younger women, at increased risk of breast cancer. To improve generalisability across the population, more active methods of engagement need to be explored.Trial registration: CRUK Clinical Trials Database 11779.

¿Disponemos de un protocolo "ideal" en la intubación con fibrobroncoscopio en el paciente con vía aérea difícil anticipada? Revisión

La intubación con fibrobroncoscopio en el paciente despierto supone una buena opción para aquellos pacientes con vía aérea difícil conocida que se van a someter a una intervención quirúrgica programada, lo cual permite al anestesiólogo responsable idear un plan de acción para evitar un desenlace no deseado. Son muchos los protocolos que se aplican para ello, pero, la mayoría de las veces, obedecen a la experiencia de cada anestesiólogo y a los resultados obtenidos con su aplicación en la práctica asistencial habitual. Este artículo es la primera revisión sistemática de ensayos clínicos aleatorizados que se centran en este abordaje. Para ello, se seleccionó principalmente información de cuatro áreas de trabajo: premedicación, sedación, anestesia local y uso de dispositivos y técnicas auxiliares que faciliten la intubación en el paciente despierto. La conclusión final a la que llegan los autores de este artículo es la existencia de gran heterogeneidad en lo que a estos aspectos se refiere, sin que ninguno de los protocolos haya demostrado superioridad en seguridad y eficacia. ABSTRACT Do we have an "ideal" protocol in the intubation with fibrobronchoscope in the patient with difficult anticipated airway?: A review. Intubation with fibrobronchoscope in the awake patient is a good option form patient with a known difficult airway who are going to undergo a scheduled surgical intervention, which allows the responsable anesthesiologist to devise a plan of action to prevent an unwanted outcome. There are many protocols that are applied for this but most of the time are due to the experience of each anesthesiologist and the results obtained with application in the usual care practice. This article is the first systematic review or randomized clinical trials focusing on this approach. Information was mainly selected from four areas of work: premedication, sedation, local anesthesia and the use of devices and auxiliary techniques to facilitate intubation in the awake patient. The authors find a great heterogeneity as far as these aspects are concerned, without any of the protocols having demonstrated superiority in safety and efficacy.

Economic evaluation of a multimodal intervention in pre-frail and frail older people with diabetes mellitus: the MID-FRAIL project

ABSTRACT Background: The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality adjusted life years (QALYs) in different European countries. Methods: The MID-FRAIL study was a cluster randomized multicentre trial conducted in seven European countries. A cost-utility analysis was carried out based on this study, conducted from the perspective of the health care system with a time horizon of one year. Univariate and probabilistic analysis were carried out to test the robustness of the results. Results: The cost estimation showed the offsetting health effect of the intervention program on total health care costs. The mean annual health care costs were 25% higher among patients in usual care. The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice. Conclusions: The MID-FRAIL intervention program showed to be the dominant option in comparison with usual care practice. It saved costs to the health care system and achieved worthwhile health gains. This finding should encourage its implementation, at least, in the trial participant countries.

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial

BackgroundSupervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.MethodsThis multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1–5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.DiscussionThe SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.Trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.

Peer-Led Education Expedites Deprescribing Proton Pump Inhibitors for Appropriate Veterans

Costly proton pump inhibitors have been widely prescribed since the 1990s for prevention and treatment of ulcers and gastroesophageal reflux disease. Evidence published since 2012 demonstrates risks associated with taking proton pump inhibitors for longer than 8 weeks. Primary care providers mostly deprescribe proton pump inhibitors for persons not meeting criteria for long-term use. Many patients resist discontinuation.A 3-month evidence-based practice education project was conducted by a nurse practitioner to improve primary care provider peer deprescribing successes with appropriate patients in an outpatient California-based veteran primary care clinic. Fifteen primary care providers were pretested about usual care practices between 2 comparable clinics. Five primary care providers at the smaller clinic location were educated about long-term proton pump inhibitor use risks and introduced to 3 evidence-based practice guidelines using tapering techniques with follow-up care.A Canadian 2017 evidence-based practice proton pump inhibitor deprescribing guideline was proposed for translation into practice. Primary care providers voted to pilot this guideline, dependent upon nursing support. Primary care providers denied frustration with usual care practices, even as all were willing to try an evidence-based practice change between pre- and post-test surveys. Support for peer-led evidence-based practice on-site coaching increased from 87% to 100%. Tapering behavior increased from 67% to 100%, expediting improved long-term medication cessation.