Intervention Phase Research Articles

Application of a Negative Intrauterine Pressure Suction Device for Prophylactic Management of Atonic Postpartum Hemorrhage: A Quality Improvement Study.

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. PPH-preventing interventions need to be prioritized and can be integrated with conventional methods of PPH prevention. The introduction of negative intrauterine pressure using a suction cannula can be one of the cheapest modalities to decrease PPH secondary to uterine atonicity. This method has brought a renaissance to practical obstetrics in low-middle income countries (LMIC), where the cost and availability of uterotonics are major health issues. It was a prospective quality improvement (QI) study conducted in the labor and delivery wards of a tertiary care medical institute and teaching center over the duration of one year. We aimed to assess the decrease in the incidence of atonic PPH with a negative intrauterine pressure suction device (NIPSD) integrated with active management of the third stage of labor (AMTSL) in the prevention of atonic PPH following normal vaginal delivery in low-risk antenatal women. In the initial six months, routine AMTSL was instituted for all consenting women (group 1). In the next six months, NIPSD was integrated with AMTSL (group 2). Data pertaining to the amount of blood loss, the incidence of primary PPH, uterine tone, fall in hemoglobin and hematocrit levels post-delivery, need for blood transfusion, and doctor and patient satisfaction were tabulated for all patients. A total of 1324 consenting women were eligible for enrollment during the study time frame. In the initial six months (baseline period, group 1), 715 participants were subjected to routine AMTSL in the third stage of labor. During the intervention phase (group 2), 609 parturient women were recruited. There was no significant difference in baseline parameters between the two groups. With the introduction of NIPSD to routine AMTSL, there was a significant decrease in the average volume of blood loss during vaginal delivery (group 1 = 389.45+65.42 ml, group 2 = 216.66+34.27 ml; p-value = 0.012). The incidence of atonic PPH was reduced by more than 75% (group 1 = 13 women, group 2 = 3 women; p-value = 0.001) after the introduction of NIPSD complementing routine AMTSL. The introduction of NIPSD has also been instrumental in reducing the cost burden on patient and hospital expenditures. The net benefit of its introduction resulted in a reduction of the overall cost burden of blood transfusions by around 70%. PPH is a public health problem, and measures to reduce PPH must be implemented to decrease this health burden. In countries with low resources, complementing routine AMTSL with NIPSD can be instrumental in decreasing the incidence of PPH. Considering its cost-effectiveness and reusability, LMIC can adopt NIPSD as a routine measure in all vaginal deliveries.

Development of a nurse-led follow-up pathway for patients discharged from cardiology unit: the DIMACC project

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Novartis Background The first year after hospitalisation for Acute Coronary Syndrome (ACS) or Acute Heart Failure (AHF) is the most critical period, with the highest incidence of complications and re-hospitalisations. Multiple epidemiological studies have documented that while hospital mortality in the acute phase has gradually decreased, the mortality trend after discharge remains stable or even increased. These trends may be an expression of inadequate follow-up and poor patient involvement, resulting in poor control of risk factors, and suboptimal adherence to treatments. Aim To present a protocol design for a quality improvement intervention regarding a supported discharge pathway for ACS and AHF patients. Methods The construction of the DIMACC protocol is based on the Plan, Do, Check, Act methodology. Pre-intervention phase: A research project has been developed to introduce a supported discharge pathway from Cardiology wards. The objective and motivation for the change from the existing situation were defined and supported by the theoretical model and international guidelines. Development of the study tools: This phase included the Consensus Conference held with the local institutions, the University delegation, the Head Manager of the District, doctors and nurses, where the actors shared intentions, thus proceeding to their formal approval. Data collection instrument was set. Intervention phase: The group identified strategies to ensure the best possible dissemination of the procedure and the professionals' adherence. A data processing company was involved, which created an online platform to collect the study data. Recruitment within the pilot study started in November 2022. Results The DIMACC project is a PROSPECTIVE OBSERVATIONAL STUDY evaluating the feasibility and performance of a quality improvement intervention on patients discharged from Cardiology following admission for ACS and AHF. The study consists of TWO phases. Phase one aims to implement a structured follow-up in the first year after discharge, with examinations and visits planned according to the severity of the single case. As primary endpoint, there is the achievement of clinical objectives defined on discharge, based on ESC guidelines, improve disease control and reduce the number of admissions to the Emergency dept. and re-hospitalisations. In the second phase, the group plans a series of structured educational interventions held by community nurses care to promote patient engagement and further reduce the elements listed in phase one. In the first two months of the pilot phase, 41 patients were included, with a progressive increase compared to total admissions for ACS or AHF (41% in November and 72% in December). Conclusions This study will generate essential knowledge on CVD patients' experiences and self-empowerment. Findings will be of considerable interest and benefit to many health and care organizations beyond the immediate community of interest.

Effect of a Multifaceted Intervention on the Incidence of Hemodialysis Catheter Dysfunction in a National Stepped-Wedge Cluster Randomized Trial

Effective strategies to prevent hemodialysis (HD) catheter dysfunction are lacking and there is wide variation in practice. In this post hoc analysis of the REDUcing the burden of dialysis Catheter ComplicaTIOns: a national (REDUCCTION) stepped-wedge cluster randomized trial, encompassing 37 Australian nephrology services, 6361 participants, and 9872 catheters, we investigated whether the trial intervention, which promoted a suite of evidence-based practices for HD catheter insertion and management, reduced the incidence of catheter dysfunction, which is defined by catheter removal due to inadequate dialysis blood flow. We also analyzed outcomes among tunneled cuffed catheters and sources of event variability. A total of 873 HD catheters were removed because of dysfunction over 1.12 million catheter days. The raw incidence was 0.91 events per 1000 catheter days during the baseline phase and 0.68 events per 1000 catheter days during the intervention phase. The service-wide incidence of catheter dysfunction was 33% lower during the intervention after adjustment for calendar time (incidence rate ratio= 0.67; 95% confidence interval [CI], 0.50-0.89; P= 0.006). Results were consistent among tunneled cuffed catheters (adjusted incidence rate ratio= 0.68; 95% CI, 0.49-0.94), which accounted for 75% of catheters (n= 7403), 97.4% of catheter exposure time and 88.2% of events (n= 770). Among tunneled catheters that survived for 6 months (21.5% of tunneled catheters), between 2% and 5% of the unexplained variation in the number of catheter dysfunction events was attributable to service-level differences, and 18% to 36% was attributable to patient-level differences. Multifaceted interventions that promote evidence-based catheter care may prevent dysfunction, and patient factors are an important source of variation in events.

Impact of a clinical pharmacist’s intervention on pneumococcal vaccination in a population of at- risk hospitalized patients: The IP-VAC study

ObjectivesThe aim of this study was to evaluate the impact of clinical pharmacist intervention on compliance with pneumococcal vaccination (PV) recommendations in hospitalized patients. MethodsThis was a prospective, single-center, before-and-after study conducted in 2019–2020. Patients had to be over 18 years of age, at risk of pneumococcal infection, and with no PV. No changes were made in the observational phase. During the interventional phase, the clinical pharmacist discussed a prescription for preventive PV and a mention in the discharge letter. A pharmaceutical consultation sensitized the patient to the interest of PV. The clinical pharmacist ensured that a complete vaccination protocol would be carried out by the retail pharmacist within 3 months of hospitalization. ResultsOne hundred and sixty-seven (167) patients were included. In the observational phase, 2.3% of patients received a complete vaccination protocol after discharge from primary care. The rate increased to 63.8% after the clinical pharmacist’s intervention (p < 0.001). Vaccines were prescribed by hospital physicians in 97.5% of cases, while 40% of discharge letters included the indication for PV. ConclusionThe clinical pharmacist’s intervention led to delivery of a complete PV protocol after discharge for over half the patients. This study demonstrated the feasibility of a pharmaceutical intervention to promote PV in hospital activities.

Use of a Mobile-Assisted Telehealth Regimen to Increase Exercise in Transplant Candidates: A Home-Based Prehabilitation Pilot and Feasibility Trial.

Physical fitness assessed by the Liver Frailty Index (LFI) and 6-minute walk test (6MWT) informs the prognosis of liver transplant candidates, although there are limited data on its reversibility after prehabilitation. On a home-based exercise trial, we aimed to improve LFI and 6MWT and to investigate trial feasibility and intervention adherence. Liver transplant candidates with cirrhosis wore a personal activity tracker and used Exercise and Liver FITness app for 14 weeks, including a 2-week technology acclimation run-in. The 12-week intervention consisted of Exercise and Liver FITness app plus personal activity tracker and 15-/30-minute weekly calls with a physical activity coach aiming to complete ≥2 video-training sessions/week, or ≥500 step/d baseline increase for ≥8 weeks. We defined feasibility as ≥66% of subjects engaging in the intervention phase and adherence as ≥50% subjects meeting training end point. Thirty-one patients (61 ± 7 years, 71% female, model for end-stage liver disease 17 ± 5, ∼33% frail) consented and 21 (68%) started the intervention. In the 15 subjects who completed the study, LFI improved from 3.84 ± 0.71 to 3.47 ± 0.90 ( P = 0.03) and 6MWT from 318 ± 73 to 358 ± 64 m ( P = 0.005). Attrition reasons included death (n = 4) and surgery (n = 2). There was 57% adherence, better for videos than for walking, although daily steps significantly increased (3,508 vs baseline: 1,260) during best performance week. One adverse event was attributed to the intervention. Our clinical trial meaningfully improved LFI by 0.4 and 6MWT by 41 m and met feasibility/adherence goals. In-training daily step increase supported physical self-efficacy and intervention uptake, but maintenance remained a challenge despite counseling.

A Comparative Clinical Study of the Effect of Yoga, Music, and Yoga with Music on Anxiety During Pregnancy

Purpose-stress, anxiety of mother can lead to adverse effects for the expectant mother and the unborn child. The present study investigates whether interventions like yoga,pranayama and classical music can improve anxiety,maternal as well as fetal well-being.&#x0D; Methods- A total of 201 pregnant women took part in this comparative clinical study Symptoms of anxiety were assessed by Hamilton anxiety scale&#x0D; and questionnaires before the intervention phase (from 18-20th weeks of pregnancy) and afterwards (up to labour). Additionally, immediate changes regarding experienced stress and mood from before until after the interventions were explored with questionnaires.&#x0D; Results- Regarding immediate effects, both interventions showed positive effects on the emotional state, symptoms of anxiety). Additionally, the singing group showed a larger reduction in cortisol and a larger improvement in valence than the music group. Looking at more prolonged effects, significant effects on general self-efficacy and perceived closeness to the unborn child were found.&#x0D; Conclusion -In the present study, promising effects of yoga with music and in particular depressive symptoms and on maternal well-being and perceived closeness during pregnancy appeared. Prenatal yoga and music interventions could be an easy to implement and effective addition to improve mood and well-being of the expectant mother and support mother-infant bonding.

Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves.

The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA's effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases. We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi). We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA's compatibility with organizational structures, processes, and priorities of Mozambique's health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds. The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities. ClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

Effects of isoflavone and probiotic intake on calcium transport and bone metabolism biomarkers in female rats.

Calcium is essential for maintaining bone health as it contributes to bone formation, remodeling, strength, and density. This study investigated the effect of isoflavones and probiotics on calcium transporters' gene expression, serum calcium levels, and bone metabolism biomarkers in healthy female rats. Forty-eight female Wistar rats were classified into six groups. Bone metabolism biomarkers (pyridinoline, deoxypyridinoline, parathyroid hormone, and osteocalcin) and serum calcium levels were measured by enzyme-linked immunosorbent assay (ELISA) and atomic absorption spectroscopy (AAS), respectively. Gene expression of calcium transporters (Trpv5 and Trpv6) was evaluated in duodenum and jejunum tissue samples using quantitative polymerase chain reaction (qPCR). Trpv5 and Trpv6, epithelial calcium channels, play a crucial role in calcium transport and homeostasis in the body. The study consisted of a1-week adaptation period for the rats to adjust to the controlled conditions, followed by an 8-week intervention phase. The daidzein and genistein group showed a significant increase in the gene expression of the Trpv6 transporter in the duodenum and a marked decrease in serum pyridinoline levels compared to the control group. The tempeh and soybean groups showed a significant decrease in the gene expression of the Trpv5 calcium transporter in the jejunum. However, no significant influence of the Lactobacillus acidophilus diet on calcium transport and bone metabolism biomarkers was observed in the L. acidophilus group. The correlation analysis showed a significant positive relationship between serum calcium, bone metabolism biomarkers, and calcium transporters. In conclusion, our study demonstrates that the daidzein and genistein diet improves calcium transport in the duodenum and reduces pyridinoline serum concentrations, while tempeh and soybean diets reduce calcium transport in the jejunum. However, the combination of daidzein, genistein, and L. acidophilus did not demonstrate a synergistic effect on calcium transport and bone metabolism, suggesting that further investigations are needed to elucidate their potential interactions.

An overview of facilitators and barriers in the development of eHealth interventions for people of low socioeconomic position: A Delphi study

ObjectiveeHealth interventions can improve the health outcomes of people with a low socioeconomic position (SEP) by promoting healthy lifestyle behaviours. However, developing and implementing these interventions among the target group can be challenging for professionals. To facilitate the uptake of effective interventions, this study aimed to identify the barriers and facilitators anticipated or experienced by professionals in the development, reach, adherence, implementation and evaluation phases of eHealth interventions for people with a low SEP. MethodWe used a Delphi method, consisting of two online questionnaires, to determine the consensus on barriers and facilitators anticipated or experienced during eHealth intervention phases and their importance. Participants provided open-ended responses in the first round and rated statements in the second round. The interquartile range was used to calculate consensus, and the (totally) agree ratings were used to assess importance. ResultsTwenty-seven professionals participated in the first round, and 19 (70.4%) completed the second round. We found a consensus for 34.8% of the 46 items related to highly important rated barriers, such as the lack of involvement of low-SEP people in the development phase, lack of knowledge among professionals about reaching the target group, and lack of knowledge among lower-SEP groups about using eHealth interventions. Additionally, we identified a consensus for 80% of the 60 items related to highly important rated facilitators, such as rewarding people with a low SEP for their involvement in the development phase and connecting eHealth interventions to the everyday lives of lower-SEP groups to enhance reach. ConclusionOur study provides valuable insights into the barriers and facilitators of developing eHealth interventions for people with a low SEP by examining current practices and offering recommendations for future improvements. Strengthening facilitators can help overcome these barriers. To achieve this, we recommend defining the roles of professionals and lower-SEP groups in each phase of eHealth intervention and disseminating this study’s findings to professionals to optimize the impact of eHealth interventions for this group.

Concept of an Intervention for Sustainable Weight Loss in Postmenopausal Women with Overweight-Secondary Analysis of a Randomized Dietary Intervention Study.

The approach of an individual diet has great potential for sustainable weight reduction. Social support, participation and empowerment are also key factors for high motivation and compliance. So, the impact of an individual diet in combination with group sessions on weight loss in postmenopausal women with overweight was investigated. In this reanalysis of a controlled intervention study, postmenopausal women (n = 54; BMI 30.9 ± 3.4 kg/m2; 59 ± 7 years) were recruited receiving an energy restricted diet for 12 weeks, followed by a six-month follow-up phase. The women received 51 individual meal plans based on their habits and were trained in four group sessions. Forty-six women completed the intervention phase, and 29 completed the follow-up. Average weight loss was -5.8 ± 3.0 kg (p < 0.001) after 12 weeks and was still significant at follow-up (-4.9 ± 5.4 kg, p < 0.001). Also, decreases in fat-free mass (-1.1 ± 1.2 kg, p < 0.001) and resting energy expenditure (-1096 ± 439 kJ/24 h, p < 0.001) were observed. The individual nutrition approach with a focus on nutritype in combination with group sessions was effective for long-lasting weight loss in postmenopausal women. An important factor is close individual and group support.

Effect of intensive training and education of health care workers on the maintenance bundle of venous access devices in critically ill patients at a tertiary care academic hospital

The maintenance bundle of care for all venous access devices (peripheral intravenous catheters, PIVC; central venous catheters, CVCs; hemodialysis ports) is important to prevent secondary sepsis in critically ill patients. This quality improvement project analyzed the effect of intensive training and education of health care workers (HCWs) on maintenance bundles for venous access devices. The study period comprising of preintervention phase (3-months) included 25 random visits to the intensive care unit for point observations regarding maintenance of all venous access devices in-situ in all intensive care unit patients on the day of the visit. The observations were categorized as appropriate or inappropriate practices based on American Society of Anesthesiologists (ASA) guidelines for CVC 2020, INICC guidelines for PIVC 2017, and Australian Commission on Safety and Quality in Health Care (ACQHCS) for PIVC and hemodialysis ports, December 2019. While the intervention phase (1-month) comprised intensive training and education of HCWs, postintervention phase 3 (3-months) included similar visits and point observations as during the preintervention phase. The maintenance of PIVC improved significantly in terms of the condition of site (from 82.7% appropriate observations to 97.8%, P<.05); condition of connectors (45.7%-56.8%, P<.05), and any attached unused IV sets (90.5%-98.56%, P<.05). For CVC, there was significant improvement in condition of insertion site (66%-94%, P<.01); condition of connectors (0%-44.37%, P<.01); fixation (91%-99.3%, P<.05); any attached unused IV sets (38.9%-97.3%, P<.01) and knowledge of HCW (96.52%-100%, P=.05). For hemodialysis ports, no significant improvement was observed. Intensive training and education of HCWs led to significant improvement in the maintenance bundle of care for PIVC and CVC.

Frequent upregulation of HER2 protein in hormone-receptor-positive HER2-negative breast cancer after short-term neoadjuvant endocrine therapy.

Endocrine resistant metastatic disease develops in ~ 20-25% of hormone-receptor-positive (HR+) breast cancer (BC) patients despite endocrine therapy (ET) use. Upregulation of HER family receptor tyrosine kinases (RTKs) represent escape mechanisms in response to ET in some HR+ tumors. Short-term neoadjuvant ET (NET) offers the opportunity to identify early endocrine escape mechanisms initiated in individual tumors. This was a single arm, interventional phase II clinical trial evaluating 4weeks (± 1week) of NET in patients with early-stage HR+/HER2-negative (HER2-) BC. The primary objective was to assess NET-induced changes in HER1-4 proteins by immunohistochemistry (IHC) score. Protein upregulation was defined as an increase of ≥ 1 in IHC score following NET. Thirty-seven patients with cT1-T3, cN0, HR+/HER2- BC were enrolled. In 35 patients with evaluable tumor HER protein after NET, HER2 was upregulated in 48.6% (17/35; p = 0.025), with HER2-positive status (IHC 3+ or FISH-amplified) detected in three patients at surgery, who were recommended adjuvant trastuzumab-based therapy. Downregulation of HER3 and/or HER4 protein was detected in 54.2% of tumors, whereas HER1 protein remained low and unchanged in all cases. While no significant volumetric reduction was detected radiographically after short-term NET, significant reduction in tumor proliferation rates were observed. No significant associations were identified between any clinicopathologic covariates and changes in HER1-4 protein expression on multivariable analysis. Short-term NET frequently and preferentially upregulates HER2 over other HER family RTKs in early-stage HR+/HER2- BC and may be a promising strategy to identify tumors that utilize HER2 as an early endocrine escape pathway. Trial registration number: NCT03219476.

Drug Utilization Evaluation and Impact of Pharmacist Interventions on Optimization of Piperacillin/Tazobactam Use: A Retrospective Analysis and Prospective Audit.

(1) Background: Piperacillin/tazobactam is a broad-spectrum antimicrobial encompassing most Gram-positive and Gram-negative aerobic and anaerobic bacteria. The inappropriate use of such broad-spectrum antibiotics is an important contributor to the rising rates of antimicrobial drug resistance worldwide. Drug utilization evaluation studies and pharmacists' interventions are vital to assess, develop, and promote the rational use of antibiotics. This drug utilization study aimed to evaluate the current utilization practice of piperacillin/tazobactam in a hospital setting and assess the impact of pharmacist intervention in improving its appropriate use. (2) Methodology: In this study, we used a retrospective cohort and a prospective cohort, a cross-sectional, observational method. It included a retrospective (Cycle A/pre-intervention-CycA) phase followed by an educational interventional phase conducted by the pharmacists. During the 2 months of educational intervention, pharmacists used several methods, including workshops, lectures, oral presentations, and the development and reinforcement of clinical pathways to promote the judicious use of piperacillin/tazobactam. This was followed by a prospective (Cycle B/post-intervention-CycB) phase to improve piperacillin/tazobactam usage appropriateness. The appropriateness criteria for this drug utilization evaluation were established based on antimicrobial guidelines, the published literature, the institutional antibiogram, consultation from the antimicrobial stewardship committee, and the product monograph (Tazocin). The appropriateness of CycA and CycB patients was compared using the measurable elements, including indication and dose based on renal function, timely order for cultures, de-escalation, and use of extended infusion protocol. (3) Results: The study population comprised 100 patients in both CycA and CycB. The mean age of the patients was 66.28 ± 16.15 and 67.35 ± 17.98, and the ratios of men to women were found to be 49:51 and 61:39 in CycA and CycB, respectively. It was observed that inappropriate usage was high in CycA patients, and the appropriateness was improved in CycB patients. A total of 31% of inappropriate empirical broad-spectrum use was found in CycA, and it was reduced to 12% in CycB patients. The transition of appropriateness was observed in all measurable criteria, which includes the optimized dose according to the renal function (CycA = 49% to CycB = 94%), timely bacterial culture orders (CycA = 47% to CycB = 74%), prompt de-escalation (CycA = 31% to CycB = 53%), and adherence to extended infusion institutional guidelines (CycA = 34% to CycB = 86%). (4) Conclusions: The study highlighted important aspects of inappropriate piperacillin/tazobactam use. This can be considerably improved by proper education and timely interventions based on the pharmacists' vigilant approach. The study results emphasized the need for surveillance of piperacillin/tazobactam usage by conducting similar drug utilization evaluations and practice to improve quality and safety in healthcare organizations globally.

Implementation of a case formulation to reduce restrictive interventions on a psychiatric intensive care unit: quasi-experimental single case evaluation.

Despite the use of case formulation being encouraged for in-patient psychiatric care, there have been no previous examples and evaluations of this type of work on a psychiatric intensive care unit (PICU). To evaluate whether a schema-informed formulation with a patient diagnosed with emotionally unstable personality disorder (EUPD), autism spectrum disorder (ASD) and mild learning difficulties was effective in reducing the use of restrictive interventions. A biphasic n = 1 quasi-experimental design with an 8-week baseline versus an 8-week intervention phase. The restrictive outcomes measured were use of physical restraint, seclusion, and intramuscular rapid tranquilisation. The formulation was developed through eight one-to-one sessions during the baseline period, and was implemented via six one-to-one sessions during the intervention phase and discussion at the ward reflective practice group. The intervention encouraged better communication of schema modes from the patient and for staff to then respond with bespoke mode support. Incidents involving need for seclusion, restraint and rapid tranquilisation extinguished. The need for making access to psychological input a routine aspect of the care in PICUs and the necessity for developing a methodologically more robust evidence base for psychological interventions on these wards.

Effect evaluation of a tele-neurologic intervention in primary care in a rural area in Germany—the NeTKoH study protocol of a stepped-wedge cluster randomized trial

BackgroundNeurological disorders account for a large and increasing proportion of the global burden of disease. Therefore, it is important to strengthen the management of neurologic care, particularly in rural areas. The use of tele-neurology in primary care in rural areas is internationally considered to have the potential to increase access to health care services and improve the quality of care in these underserved areas. NeTKoH aims to address the existing knowledge gap regarding the effects of a tele-neurologic intervention in primary care under real-world conditions in a rural area in Germany.MethodsNeTKoH is a cluster-randomized controlled trial with a stepped-wedge design involving 33 outpatient general practitioner’s (GP) offices (clusters) in a rural area in Northeast Germany. During 11 predetermined steps, all clusters are randomized before they cross over into groups from the control to the intervention arm. The targeted sample size is 1,089 patients with neurologic symptoms that are continuously being recruited. In the intervention arm, tele-neurologic consultations will be provided via a face-to-face video conferencing system with a neurologic expert at a university hospital. The control arm will receive usual care. The primary outcome is the proportion of neurologic problems being solved at the GP’s office. Secondary outcomes will comprise hospital stays and days, time until neurologic specialist appointments and diagnostics, patients’ health status and quality of life, outpatient and inpatient referrals.A concurrent observational study, together with a process, implementation, and health economic evaluation, will also be conducted.DiscussionUsing a stepped-wedge cluster design in a real-life situation can help with logistic challenges and enhance the motivation of the participating GPs, as all, at some point, will be in the intervention phase. With the additional implementation evaluation pertaining to external validity, an observational study, and a health economic evaluation, NeTKoH will be able to provide an extensive evaluation for health policy decision-makers regarding the uptake into standard care.Trial registrationGerman Clinical Trials Register (DRKS00024492). Date registered: September 28, 2021. Date and protocol version: June 2023, version 1.

The effect of Real-Time feedback and incentives on speeding behaviors using Telematics: A randomized controlled trial

Speeding behaviour of drivers is highly correlated to their tangible consequence. Therefore, this study aimed to evaluate the effectiveness of telematics-based feedback and financial incentives in reducing speeding behaviors through a randomized controlled field trial. This randomized controlled trial included four groups of (1) control, (2) information-only, (3) gain-of-reward, and (4) loss-of-reward. While drivers of the control group were unobtrusively monitored using telematics devices, drivers of the information-only group received real-time, weekly, and monthly feedback via text message. In both groups with financial incentives, in addition to receiving feedback, drivers could receive payments at the end of each month based on observed speeding. The primary outcome was the distance traveled at speeds more than 10% (S10 + ) above the posted speed limit as a proportion of the total traveled distance. A total of 397 male taxi drivers consented to participate in the study. After the stratified randomization, the mean age of the participant was 46.0 (95% Confidence Interval: 43.8 to 48.2), 47.0 (44.7 to 49.3), 46.1 (43.7 to 48.5), and 48.8 (46.5 to 51.1) years for the control, the information-only, the gain-of-reward, and the loss-of-reward groups, respectively. The mean S10 + rate per 100 km was 0.9 (0.5 to 1.2) for the control, 0.8 (0.4 to 1.1) for the information-only, 0.7 (0.3 to 1.1) for the gain-of-reward, and 1.3 (0.4 to 2.2) for the loss-of-reward group at the start of intervention. During the intervention phase, the loss-of-reward group with 0.6 (0.5 to 0.7) had the lowest mean of S10 + rate, followed by the gain-of-reward group with 0.8 (0.7 to 0.8). The loss-of-reward and gain-of-reward groups were the most influenced groups by the intervention, with 38.0% (13.2 to 55.7; p-value < 0.01) and 29.4% (2.0 to 49.2; p-value = 0.04) less S10 + rate than the control group, respectively. It was figured out that providing information regarding drivers' behavior without appropriating motives or penalties would have a minuscule impact.In addition, the group of drivers who were treated with instant punishment was the most influenced group by the intervention.

Ketogenic diet in relapsing multiple sclerosis: Patient perceptions, post-trial diet adherence & outcomes

Ketogenic diets (KDs) are safe and tolerable in people with multiple sclerosis (MS). While many patient-reported and clinical benefits are noted, the sustainability of these diets outside of a clinical trial is unknown. Evaluate patient perceptions of the KD following intervention, determine the degree of adherence to KDs post-trial, and examine what factors increase the likelihood of KD continuation following the structured diet intervention trial. Sixty-five subjects with relapsing MS previously enrolled into a 6-month prospective, intention-to-treat KD intervention. Following the 6-month trial, subjects were asked to return for a 3-month post-study follow-up, at which time patient reported outcomes, dietary recall, clinical outcome measures, and laboratory values were repeated. In addition, subjects completed a survey to evaluate sustained and attenuated benefits following completion of the intervention phase of the trial. Fifty-two subjects (81%) returned for the 3-month post-KD intervention visit. Twenty-one percent reported continued adherence to a strict KD and an additional 37% reported adhering to a liberalized, less restrictive form of the KD. Those subjects with greater reductions in body mass index (BMI) and fatigue at 6-months on-diet were more likely to continue on KD following trial completion. Using intention-to-treat analysis, patient-reported and clinical outcomes at 3-months post-trial remained significantly improved from baseline (pre-KD), though the degree of improvement was slightly attenuated relative to outcomes at 6-months on KD. Regardless of diet type following the KD intervention, dietary patterns shifted toward greater protein and polyunsaturated fats and less carbohydrate/added sugar consumption. Following the 6-month KD intervention study, the majority of subjects elected to continue on KD, though many pursued a more liberal limit for carbohydrate restriction. Those who experienced a greater reduction in BMI or fatigue were more likely to continue with strict KD. The 6-month KD intervention induced persistent changes to dietary habits in the months following study completion. Registered on Clinicaltrials.gov under registration number NCT03718247, posted on Oct 24, 2018. First patient enrollment date: Nov 1, 2018. Link: https://clinicaltrials.gov/ct2/show/NCT03718247?term=NCT03718247&amp;draw=2&amp;rank=1.

Dental and nursing collaboration in oral healthcare research in palliative care inpatient settings.

Collaboration between palliative care nurses and oral health professionals has been frequently recommended to ensure optimal oral healthcare. However, the importance of this collaboration to the success of evidence-based protocols, involving oral healthcare interventions in the inpatient palliative care setting, is less discussed. Feasibility requires consideration during the planning, intervention and implementation phases of any clinical trial; all of which typically rely on good collaboration with nursing staff. Therefore, it is imperative that nursing staff appreciate the need for oral healthcare at the end of a person's life. Nursing and dental collaboration is critical to the feasibility of running research trials in this group and can help overcome some of the logistical and ethical challenges in this vulnerable population.

Early recognition and management of maternal sepsis in Pakistan: a feasibility study of the implementation of FAST-M intervention

ObjectiveMaternal sepsis is the third leading cause of maternal mortality globally. WHO and collaborators developed a care bundle called FAST-M (Fluids, Antibiotics, Source identification and treatment, Transfer and Monitoring) for...

Encourage reflective and self-assessment processes through the automatic processing of personalized feedback

Technologies in training processes by radically modifying the relationship with (and between) knowledge, have determined the need to experiment with new methodological approaches to innovate didactic action, respond to subjective training needs, satisfy the ever increasing requests coming from the job market. In this paper, we want to deepen a particular action of this process, preliminary to the implementation phase of each training intervention. We refer to the needs analysis (NA) aimed at identifying training needs and requirements of the participants with respect to which to organize and modulate the contents and the didactic action. In the opinion of the author, already the NA, if accompanied by specific actions, can constitute an intentionally structured moment to enhance the effectiveness of training feedback in a diagnostic and self-assessment function and in this work we will describe an automated system designed and developed specifically for this purpose. To examine the application opportunities and to show the potential of the automated system, an experience will be presented that involved students attending the specialization course for educational support activities for pupils with disabilities held at the University of Salerno in the A.Y. 2022/2023.