Impact of the presence of a mediator on patient violent or uncivil behaviours in emergency departments: a cluster randomised crossover trial.

BACKGROUND AND IMPORTANCE: Several studies reported that violent behaviours were committed by patients against healthcare professionals in emergency departments (EDs). The presence of mediators could prevent or resolve situations of tension. OBJECTIVE: To evaluate whether the presence of mediators in EDs would have an impact on violent behaviours committed by patients or their relatives against healthcare professionals. Design, settings and participants A 6-period cluster randomised crossover trial was performed in 4 EDs during 12 months. Patients aged ≥18 and their relatives were included. INTERVENTION: In order to prevent or resolve situations of tension and conflict, four mediators were recruited.Outcome measure and analysis Using a logistic regression mixed model, the rate of ED visits in which at least one act of violence was committed by a patient or their relatives, reported by healthcare professionals, was compared between the intervention group and the control group. RESULTS: A total of 50 429 ED visits were performed in the mediator intervention group and 50 851 in the control group. The mediators reported 1365 interventions; >50% of the interventions were to answer questions about clinical management or waiting time. In the intervention group, 173 acts of violence were committed during 129 ED visits, and there were 145 acts of violence committed during 106 ED visits in the control group. The rate of ED visits in which at least one act of violence was committed, was 0.26% in the intervention group and 0.21% in the control group (OR = 1.23; 95% CI [0.73-2.09]); on a 4-level seriousness scale, 41.6% of the acts of violence were rated level-1 (acts of incivility or rudeness) in the intervention group and 40.0% in the control group. CONCLUSION: The presence of mediators in the ED was not associated with a reduction in violent or uncivil behaviours committed by patients or their relatives. However, the study highlighted that patients had a major need for information regarding their care; improving communication between patients and healthcare professionals might reduce the violence in EDs. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03139110).

Outcome of patients with cystic fibrosis colonized by Scedosporium and Lomentospora species: A longitudinal cohort study.

Scedosporium and Lomentospora species rank second among the filamentous fungi colonizing the airways of cystic fibrosis (CF) patients. These fungi could be responsible for allergic bronchopulmonary mycosis (ABPM) and bronchitis before lung transplantation and invasive infections after. However, their role in CF lung disease is debated. This study aimed to identify clinical or environmental factors associated with an airway colonization by Scedosporium/Lomentospora species in patients with CF over a period of 7 years. A longitudinal cohort study was conducted from 2008 to 2014 in the CF reference centre in Lyon, France, to compare the characteristics of patients with Scedosporium/Lomentospora colonized and non-colonized patients. During the study period, 283 patients completed the clinical and microbiological follow-up. The analysis revealed that a higher number and duration of hospitalizations, an increased number of courses of parenteral antibiotic therapy, a history of ABPA, and treatment by itraconazole were significantly associated with an airway colonization by Scedosporium/Lomentospora species. The rate of decline of forced expiratory volume in the first second was not statistically different between colonized and non-colonized patients. This study provides evidence that patients colonized by Scedosporium/Lomentospora species require more medical care than non-colonized patients. Additional care could be in part explained by the management of Scedosporium/Lomentospora-related diseases such as ABPM or bronchitis. However, we did not demonstrate a faster rate of decline of respiratory function or body mass index in colonized patients, suggesting, as previously reported, that colonization of the airways by these fungi does not play a significant role in the progression of CF disease.

This prospective study did not demonstrate a faster rate of decline of respiratory function or body mass index in cystic fibrosis (CF) patients colonized by Scedosporium/Lomentospora species compared to non-colonized patients, suggesting that these fungi do not play a significant role in the progression of CF disease.

A Participatory Approach Involving Patients with Cystic Fibrosis and Healthcare Professionals for the Co-Design of an Adherence-Enhancing Intervention Toolkit.

Purpose: Cystic fibrosis (CF) is an inherited life-shortening disease involving a significant treatment burden. Few interventions have been proven effective in improving adherence, and of these fewer have been adopted for implementation. Patient participation in research is increasingly desired in developing relevant health care services. A participatory approach was implemented in an adult CF center to co-design an adherence-enhancing intervention toolkit. We aimed to report on the participatory process and the results regarding the co-designed intervention. Patients and Methods: Two focus group sessions and four working sessions were conducted at 4-week intervals with three healthcare professionals (HCP; physician, nurse, physiotherapist), eight patients, and two researchers (sociologist, public health pharmacist). The two initial focus group sessions were dedicated to the collection of narratives about CF treatment experiences to identify drivers of adherence. The next four working sessions were dedicated to the reflection on solutions that could alleviate the difficulties identified and be used in current clinical practice. The researchers observed during all sessions the interactions between participants, group dynamics, and process of implementation of the collective reflection. Results: The process facilitated an active participation of patients and HCP, who contributed equally to the intervention development. The co-design adherence-enhancing intervention toolkit consisted in a self-questionnaire to be completed by patients before the medical consultation and used as a communication support during the consultation, plus a toolkit of solutions to be proposed by the HCP for each barrier identified by patients, and to be followed up during the next consultation. Conclusion: This study demonstrated that a participatory approach involving CF patients and HCP lead to the development of an adherence-enhancing intervention toolkit, using a 6-session format; the benefits of the co-designed intervention on the medication adherence have yet to be tested in a multicenter, open-label study in 3 centers in France.

Parental experience of parent-mediated intervention for children with ASD: A systematic review and qualitative evidence synthesis.

LAY ABSTRACT: The effectiveness of parent-mediated interventions in the field of autism spectrum disorder is well documented but information on the experience of parents involved in parent-mediated interventions is limited.This study is the first synthesis of evidence concerning the experience of parents involved in parent-mediated interventions. It synthesizes the voice of 345 parents across the world into four general themes: barriers to implementation and logistical issues, feeling overwhelmed and stressed (a need for support), facilitators of implementation, and empowerment in the parent and improvement in the child.The findings of our study provide evidence that parent-mediated interventions should be adapted to the needs of each family. Specific care and support should be offered to parents in addition to parent-mediated interventions. Our study, however, highlights which outcomes are important to parents and should be considered in future studies.

Impact of a nurse education programme on oral feeding in a neonatal unit.

BACKGROUND: Premature neonates often experience feeding difficulties during their hospital stay, and evidence-based interventions have been shown to improve feeding outcomes. AIM: This study investigated whether an infant-cue based nurse educational feeding bundle accelerates the achievement of independent oral feeding in neonates in a neonatal intensive care unit. STUDY DESIGN: A quality improvement study with a pre, during and post intervention test design. All premature neonates admitted to the unit were eligible. The feeding programme included a four-month nurse training module and nurse coaching. RESULTS: A hundred and twenty-five nurses or nurse assistants attended the programme and 706 neonates were included. The median time to independent oral feeding (IOF) was 40, 36 and 37 days, respectively, for pre, during and post intervention. The reduction in time to IOF observed during the post-intervention period compared with the baseline period was significant (HR = 1.32, CI 95%: 1.01-1.74). No difference was noted in the length of hospital stay between the three study periods. CONCLUSIONS: An infant-cue based nurse educational feeding bundle can promote earlier achievement of IOF in preterm neonates. RELEVANCE TO CLINICAL PRACTICE: This quality improvement study demonstrates the impact that a nurse-driven intervention in neonatal care can have on improving practice. Feeding interventions involve the early introduction of oral feeding, non-nutritive sucking (NNS), and oral motor stimulation, and should be individualized for each neonate. These individualized feeding interventions applied by all nurses and assistant nurses, can facilitate the achievement of earlier independent oral feeding in preterm infants and should be included in neonatal critical care nurse education programs.

Feelings of Trust and of Safety Are Related Facets of the Patient's Experience in Surgery: A Descriptive Qualitative Study in 80 Patients.

OBJECTIVE: Few studies to date have explored the question of the safety of a hospital stay from the patient's point of view. The aim of this study was to describe patients' own perspectives on the safety of the surgical care they received. A qualitative study was conducted based on interviews. METHODS: Semidirected interviews were conducted by a sociologist with adult patients admitted for hospitalization in 2 orthopedic and in 2 digestive surgery wards in 4 hospitals. RESULTS: Eighty interviews were transcribed and analyzed. The patients surveyed averaged 61.7 years old (SD, 16.0 y). Forty-eight percent were men (n = 38). The issue of the safety of care, as defined by professionals, is little apprehended by patients. In their view, sense of safety was related to the trust in the surgeon, which is a requisite condition for a sense of security and is based on interactions with the surgeon and on their communication style. Sense of safety was also related to the preoperative consultation, in which the procedure is explained and illustrated and to a postoperative encounter with a person who participated in the operation. CONCLUSIONS: Patients' sense of safety is linked to the amount of trust they have in their surgeons. New strategies to improve language practices and surgeon-patient interaction should be developed, along with organizational improvement guaranteeing that participants of the surgery debrief with the patient.The study has been registered at ClinicalTrials.gov (identifier: NCT02820545).

A Positive Impact of an Observational Study on Breastfeeding Rates in Two Neonatal Intensive Care Units.

We aimed to investigate whether the participation in an observational study on breastfeeding (Doal) modified breastfeeding outcomes in enrolling neonatal intensive care units (NICUs). This bi-centric before-and-after study included neonates who were admitted during a 4-month period before and a 4-month period after the implementation of Doal. Breastfeeding intention and breastfeeding rates at discharge were compared between the two periods. The association between inclusion in Doal and breastfeeding at discharge was assessed among the infants fulfilling the inclusion criteria of Doal. The present study included 655 neonates. After adjustments, both breastfeeding (aOR 1.21, 95%CI [1.1; 1.4], p = 0.001) and exclusive breastfeeding (aOR 1.8, 95%CI [1.4; 2.3], p < 0.001) at discharge increased in the period after. Breastfeeding intention was higher in one center in the period after (79%) compared to before (59%, p = 0.019). Compared to the period before, neonates who were not included in Doal in the period after had a lower chance to be breastfed at discharge, whereas those included were more frequently exclusively breastfed. The participation in an observational study on breastfeeding was associated with an increase in breastfeeding outcomes in enrolling neonatal intensive care units (NICUs). Patients who are not included deserve attention as they are at risk to be disadvantaged regarding breastfeeding success.

HOMA indices as screening tests for cystic fibrosis-related diabetes.

BACKGROUND: We assessed the diagnostic performances of homeostasis model assessment indices (HOMA) of ß-cell function (HOMA-%ß) and of insulin resistance (HOMA-IR) for cystic fibrosis related diabetes (CFRD) screening. METHODS: Data were collected from a prospective cohort of 228 patients with CF (117 adults and 111 children). Fasting insulin and glucose levels were measured to calculate HOMA-%ß and HOMA-IR. HOMA-%ß <100 indicated insulin secretion deficiency and HOMA-IR >1 insulin resistance. Both were used to calculate sensitivity, specificity, and positive and negative predictive values (PPV and NPV). Two-hour oral glucose tolerance tests (2h-OGTT) defined CFRD. Analyses were conducted separately for children and adults. Performances of HOMA-%ß and HOMA-IR were calculated at inclusion, for each year of follow-up and for pooled data over the follow-up period. RESULTS: Sensitivity, specificity, NPV and PPV were respectively: 88%, 45%, 98% and 11% for HOMA-%ß and 42%, 48%, 91% and 6% for HOMA-IR in the pooled data of children; and 83%, 18%, 90% and 10% for HOMA-%ß, and 39%, 80%, 92% and 18% for HOMA-IR in the pooled data of adults. Combining HOMA-%ß and HOMA-IR did not improve performances. CONCLUSION: Within both age groups, HOMA-%ß <100 provided good sensitivity and NPV. HOMA-IR >1 had low sensitivity. Calculation of the HOMA-%ß could be an interesting first-line screening approach to exclude CFRD and thus avoid unnecessary OGTT in patients for whom value is ≥100. However, HOMA-%ß<100 does not support the diagnosis of CFRD and should be complemented by OGTT.

VETCOSED study: efficacy of compressive garments for patients with hypermobile Ehlers-Danlos syndrome on shoulder stability and muscles strength.

PURPOSE: to assess the effect of wearing a compressive short-sleeve jacket on shoulder stability and rotator muscles in adult patients with a hypermobile subtype of Ehlers-Danlos syndrome. MATERIALS AND METHODS: a quasi-experimental study with "Pre/Post" design (4 weeks with versus 4 weeks without), open, conducted on a national cohort. Shoulder rotators were assessed with an isokinetic device at 180°/s and 90°/s; frequency of shoulder stability defects, pain (Visual Analogical Scale), and satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology) were reported. RESULTS: 36 patients (35 women), mean age 37.9 years, wore jackets for a meanly 7.8 h/day. >70% were satisfied with the effect on arthralgia, instability, or function. QUEST results were high (m = 4.1, SD = 0.7). After jacket wear, the power of external rotators at 180°/s was significantly increased (+1.29 W, CI95%: 0.31; 2.28; p = 0.0318). At 90°/s, no significant difference was found, either on power or strength. The on-off effect highlights a significant difference in external and internal rotators power, whatever the speed. The occurrence of subluxation (p = 0.0140) and dislocations (p = 0.0163) decreased. Pain decreased from 3.5/10 to 2.5/10, without significance (p = 0.0964). CONCLUSION: compressive CICATREX SED® jackets are well supported by patients, impact the power of external rotators at high speed (180°/s), and improve joint stability.IMPLICATIONS FOR REHABILITATIONCompressive garments made to measure are beneficial to patients with hypermobile Ehlers-Danlos syndrome.Compressive CICATREX SED® jackets clearly improve shoulder stability and help to promote muscle power in shoulder external rotators during high-speed movements.One month of jacket wearing seems to bring no lasting effect on shoulder-rotator power, so the jacket needs to be kept on for the benefits to be maintained.

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial.

BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS: Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p <  0.001 and aOR = 11.0, CI95 [4.6-26.4], p <  0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).

Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol.

INTRODUCTION: Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas. METHODS AND ANALYSIS: This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18-36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect. ETHICS AND DISSEMINATION: This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04244721.

Impact of 1h oral glucose tolerance test on the clinical status of adult cystic fibrosis patients over a 4-year period.

OBJECTIVE: To report the clinical profile associated with G60 and I60 over a 4-year prospective observational period in 2 large cohorts of adult patients with CF. METHODS: 319 patients were included (210 Canadian and 119 French) and classified according to their inclusion G60 (≥ or < 11.1 mmol/L) and the median inclusion I60 (≥ or < 24 mU/I). Forced expiratory volume in 1 second (FEV1), body mass index (BMI) were collected on OGTT days. Linear mixed regression models were used to assess the effect of G60 and I60. RESULTS: High G60 was not associated to a lower FEV1 at inclusion and the follow-up decline was not higher in the high G60 group (Coefficient [95% CI]: -3.4 [-7.4;0.6], p = 0.0995.). There was no significant association between BMI and G60. Patients with high I60 tended to have a higher mean BMI (+0.5 kg/m2 [0.0 to 1.1], p = 0.05) but no interaction over time was observed. CONCLUSIONS: High G60 is not associated with a lower lung function at inclusion nor its decline over a 4-year follow-up. High I60 is slightly associated to a higher weight at inclusion, but not with BMI evolution over time in adult patients.

Women's dissatisfaction with inappropriate behavior by health care workers during childbirth care in France: A survey study.

BACKGROUND: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. METHODS: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self-reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self-reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision-making, or deficient consideration of pain). RESULTS: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94-7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57-12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision-making. CONCLUSIONS: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.

Strategies used by emergency care professionals to handle interpersonal difficulties with patients: a qualitative study.

OBJECTIVES: Identify the strategies implemented by emergency care professionals when facing tension and interpersonal violence from patients and their friends and family. DESIGN: Descriptive qualitative study based on 38 semidirective interviews. PARTICIPANTS: Doctors, nurses, nursing assistants and administrative staff. SETTING: Four emergency departments (EDs) from three French university hospitals. RESULTS: According to the medical professionals interviewed, the difficulties that they encounter with patients or their accompanying family members can be explained by a lack of understanding of the functioning of EDs, by a general increase in individualistic behaviours leading to a lack of civility or by deviant behaviours (related to toxic substance abuse or mental illness). While managing deviant behaviours may sometimes require a collective intervention, ED staff also implement what are essentially individual communication strategies (with the use of rational explanation, seduction and empathy), confrontation or flight to deal with interpersonal difficulties. CONCLUSIONS: Strategies used by staff members tend to be individualised for the most part, and some, such as confrontational or escape strategies, may not be adapted to all situations. In the face of difficulties between staff and patients, mediators, specialised in resolving conflict, could entrust some cases to professionals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03139110).

Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial.

BACKGROUND: Narrow-band imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect esophageal squamous cell carcinoma (SCC) but its specificity, which appears higher than that of Lugol chromoendoscopy in expert centers, remains to be established in general practice. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy in the detection of esophageal SCC and high grade dysplasia (HGD) in current general practice (including tertiary care centers, local hospitals, and private clinics). METHODS: This prospective randomized multicenter trial included consecutive patients with previous or current SCC of the upper aerodigestive tract who were scheduled for gastroscopy. Patients were randomly allocated to either the Lugol or NBI group. In the Lugol group, examination with white light and Lugol chromoendoscopy were successively performed. In the NBI group, NBI examination was performed after white-light endoscopy. We compared the diagnostic characteristics of NBI and Lugol chromoendoscopy in a per-patient analysis. RESULTS: 334 patients with history of SCC were included and analyzed (intention-to-treat) from 15 French institutions between March 2011 and December 2015. In per-patient analysis, sensitivity, specificity, positive and negative likelihood values were 100 %, 66.0 %, 21.2 %, and 100 %, respectively, for Lugol chromoendoscopy vs. 100 %, 79.9 %, 37.5 %, and 100 %, respectively, for NBI. Specificity was greater with NBI than with Lugol (P = 0.002). CONCLUSIONS: As previously demonstrated in expert centers, NBI was more specific than Lugol in current gastroenterology practice for the detection of early SCC, but combined approaches with both NBI and Lugol could improve the detection of squamous neoplasia.

Human Papilloma Virus Vaccination Among Female Patients Attending French Pediatric Cystic Fibrosis Centers.

STUDY OBJECTIVE: To describe human papilloma virus (HPV) vaccination practice among adolescent girls with cystic fibrosis (CF) and to identify reasons for non-vaccination. DESIGN: Cross-sectional multicentric study. SETTING AND PARTICIPANTS: Girls aged 9-17 years, attending 7 French pediatric CF centers, and their accompanying adult. INTERVENTIONS: Administration of a self-report questionnaire. MAIN OUTCOME MEASURES: The proportion of girls having received or receiving HPV vaccination, compliance with the vaccination schedule, factors associated with vaccination, and reasons for vaccination and for non-vaccination. RESULTS: A total of 113 girls and 104 accompanying adults participated. The mean age was 13.6 years (standard deviation 2.5; range 9-17). A total of 34 (30.9%) patients reported having received HPV vaccination. Among the 34 girls aged 15 years or older, 15 (44.1%) were vaccinated. Most patients (58.8%) started vaccination between 11 and 14 years of age (mean age 13.9). Most vaccine prescriptions (67.6%) were made by a CF center health care provider. Factors associated with vaccination were older age (odds ratio [OR] = 1.27, 95% confidence interval [CI] = 1.01-1.6, P = .037 for each year older), previous vaccination by the accompanying parent of one of their children for hepatitis B (OR = 8.01, 95% CI = 0.96-67.02), P = .055), and parental influence on decision-making (OR = 2.77, 95% CI = 0.97-7.95, P = .058). Health care providers' positive advice and fear of HPV-related disease were the main reasons given to justify vaccination decisions. Insufficient knowledge and concerns about potential side effects were the main barriers. CONCLUSION: HPV vaccination remains insufficient among girls with CF. CF health care providers may play a crucial role in HPV vaccination acceptance, and their sensitization to cervical cancer prevention is mandatory.

A Nurse-Led Bridging Program to Reduce 30-Day Readmissions of Older Patients Discharged From Acute Care Units.

OBJECTIVES: Older hospitalized patients are at high risk of early readmissions, requiring the implementation of enhanced coordinated transition programs on discharge. The objective of this study was to evaluate the impact of a nurse-led transition bridging program on the rate of unscheduled readmissions of older patients within 30 days from discharge from geriatric acute care units. DESIGN: A stepped-wedge cluster randomized trial. SETTING AND PARTICIPANTS: Seven hundred five patients aged ≥75 years hospitalized in one of 10 acute geriatric units, with at least 2 readmission risk-screening criteria (derived from the Triage Risk Screening Tool), were included from July 2015 to August 2016. METHODS: The intervention condition consisted in a nurse-led hospital-to-home bridging program with 4 weeks postdischarge follow-up (2 home visits and 2 telephone calls). Unscheduled hospital readmission or emergency department (ED) visits were compared in intervention and control condition within 30 days from discharge. RESULTS: The rate of 30-day readmission or ED visit was 15.5% in the intervention condition vs 17.6% in the control condition [hazard ratio stratified on clusters: 0.61 (upper limit unilateral 95% confidence interval = 1.11), P = .09]. Rate of presence of professional caregivers was increased in the intervention condition (P < .001). CONCLUSIONS AND IMPLICATIONS: Although the intervention resulted in an increase in the rate of implementation of a package of care at the 4-week of follow-up, we could not demonstrate a reduction in the rate of 30-day readmissions or ED visits of older patients at risk of readmission. These findings support the evaluation of this type of program on the longer term.

Effect of one-year lumacaftor-ivacaftor treatment on glucose tolerance abnormalities in cystic fibrosis patients.

OBJECTIVES: To investigate the effects of 1-year lumacaftor-ivacaftor treatment on abnormalities in glucose tolerance (AGT) in Phe508del homozygous cystic fibrosis (CF) patients. METHODS: Untreated CF patients with glucose intolerance or newly diagnosed diabetes were included in a prospective, observational study. After 1-year lumacaftor-ivacaftor treatment, AGT were evaluated by using oral glucose tolerance test. RESULTS: Forty patients participated. 78% of patients had glucose intolerance and 22% diabetes at baseline. After one-year treatment, 50% of patients had normal glucose tolerance, 40% glucose intolerance, and 10% diabetes (p <0.001). The two-hour OGTT glycemia decreased from 171 (153-197) to 139 (117-162) mg/dL (p <0.001). 57.5% (n = 23) of patients improved their glucose tolerance with a significant decrease in both 1-hour (p<0.01) and 2-hour (p<0.001) OGTT glycemia. CONCLUSION: Improvements in AGT were observed following 1-year lumacaftor-ivacaftor treatment. Larger studies are needed to comprehensively assess CF transmembrane conductance regulator (CFTR) modulators.

Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. METHODS AND ANALYSIS: Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup. ETHICS AND DISSEMINATION: French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. TRIAL REGISTRATION NUMBER: NCT03156946.

Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial).

BACKGROUND: Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18 years of age, and therefore, patients initially followed in paediatric departments are then transferred to adult departments. This paediatric-adult care transition is a period with an increased risk of discontinuity of care and subsequent morbidity and mortality. During this period, the patient will have to manage new interlocutors and places of care, and personal issues related to the period of adolescence. To take into consideration all these aspects, an interesting approach is to use the whole system approach to the patient, as presented in the biopsychosocial approach. The aim of this trial is to evaluate the impact of the proposed biopsychosocial paediatric-adult transition programme. METHODS: The DREPADO study is a multicentre randomised control trial comparing a control group (Arm A) to an interventional group with a paediatric-adult transition programme based on a biopsychosocial approach (Arm B). To be included, patients should have the SS, SC, or Sß form of sickle cell disease and be aged between 16 and 17 years. The randomisation in a 1:1 ratio assigns to Arm A or B. The primary outcome is the number of hospital admissions and emergencies for complications in the index hospital, in the 2 years after the first consultation in the adult department of care. Secondary outcomes consider the quality of life, but also include coping skills such as sense of self-efficacy and disease knowledge. To provide patient and parent knowledge and coping skills, the transition programme is composed of three axes: educational, psychological, and social, conducted individually and in groups. DISCUSSION: By providing self-care knowledge and coping skills related to SCD and therapeutics, helping empower patientsin relation to pain management and emotions, and facilitating the relationship to oneself, others, and care in Arm B of the DREPADO study, we believe that the morbidity and mortality of patients with SCD may be reduced after the proposed paediatric-adult transition programme. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03786549; registered on 17 December 2018; https://clinicaltrials.gov/.