Cluster-randomized Controlled Study Research Articles

Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation

BackgroundDifficulty obtaining a dermatological consultation is an obstacle to the early diagnosis of melanoma. On the one hand, patients survival depends on the lesion thickness at the time of diagnosis. On the other hand, dermatologists treat many patients with benign lesions. Optimizing patient care pathways is a major concern. The aim of the present study was to assess whether the e-mail transmission of photographs of suspected melanoma lesions between general practitioners (GPs) and dermatologists reduces the time to dermatological consultation for patients whose suspicious skin lesions ultimately require resection.MethodsWe conducted a cluster-randomized controlled study in primary care involving 51 French GPs between April 2017 and August 2019. A total of 250 patients referred to a dermatologist for a suspected melanoma lesion were included GPs were randomized to either the smartphone arm or the usual care arm. In the smartphone arm, the GPs referred patients to the dermatologist by sending 2 photographs of the suspicious lesion using their smartphone. The dermatologist then had to set up an appointment at an appropriate time. In the usual care arm, GPs referred patients to a dermatologist according to their usual practice. The primary outcome was the time to dermatological consultation for patients whose lesion ultimately required resection.Results57 GPs volunteered were randomized (27 to the smartphone arm, and 30 to the usual care arm). A total of 125 patients were included in each arm (mean age: 49.8 years; 53% women) and followed 8 months. Twenty-three dermatologists participated in the study. The time to dermatological consultation for patients whose suspicious skin lesion required resection was 56.5 days in the smartphone arm and 63.7 days in the usual care arm (mean adjusted time reduction: -18.5 days, 95% CI [-74.1;23.5], p = .53).ConclusionsThe e-mail transmission of photographs from GPs to dermatologists did not improve the dermatological management of patients whose suspicious skin lesions ultimately required resection. Further research is needed to validate quality criteria that might be useful for tele-expertise in dermatology.Trial RegistrationRegistered on ClinicalTrials.gov under reference number NCT03137511 (May 2, 2017).

Flipped Classroom: Improved team performance during resuscitation training through interactive pre-course content – a cluster-randomised controlled study

BackgroundResuscitation is a team effort, and it is increasingly acknowledged that team cooperation requires training. Staff shortages in many healthcare systems worldwide, as well as recent pandemic restrictions, limit opportunities for collaborative team training. To address this challenge, a learner-centred approach known as flipped learning has been successfully implemented. This model comprises self-directed, asynchronous pre-course learning, followed by knowledge application and skill training during in-class sessions. The existing evidence supports the effectiveness of this approach for the acquisition of cognitive skills, but it is uncertain whether the flipped classroom model is suitable for the acquisition of team skills. The objective of this study was to determine if a flipped classroom approach, with an online workshop prior to an instructor-led course could improve team performance and key resuscitation variables during classroom training.MethodsA single-centre, cluster-randomised, rater-blinded study was conducted on 114 final year medical students at a University Hospital in Germany. The study randomly assigned students to either the intervention or control group using a computer script. Each team, regardless of group, performed two advanced life support (ALS) scenarios on a simulator. The two groups differed in the order in which they completed the flipped e-learning curriculum. The intervention group started with the e-learning component, and the control group started with an ALS scenario.Simulators were used for recording and analysing resuscitation performance indicators, while professionals assessed team performance as a primary outcome.ResultsThe analysis was conducted on the data of 96 participants in 21 teams, comprising of 11 intervention groups and 10 control groups. The intervention teams achieved higher team performance ratings during the first scenario compared to the control teams (Estimated marginal mean of global rating: 7.5 vs 5.6, p < 0.01; performance score: 4.4 vs 3.8, p < 0.05; global score: 4.4 vs 3.7, p < 0.001). However, these differences were not observed in the second scenario, where both study groups had used the e-learning tool.ConclusionFlipped classroom approaches using learner-paced e-learning prior to hands-on training can improve team performance.Trial registrationGerman Clinical Trials Register (https://drks.de/search/de/trial/DRKS00013096).

Is the glass half full or half empty? Examining the impact of Swatch Bharat interventions on sanitation and hygiene in rural Punjab, India

This paper reports the findings of a cluster-randomized control study to assess the impact of India's flagship sanitation program, as implemented in Punjab, that aimed to eliminate the practice of open defecation and improve the awareness and practice of good hygiene across rural Punjab. The study finds that the program interventions specific to the Gram Panchayats (villages) had a modest effect on improving access to toilets and reducing open defecation among households with children in rural Punjab. However, awareness of the importance of handwashing before eating and after defecation among school-going children improved by 8–14 percentage points in treatment arms relative to control, though no significant impact on handwashing practices was observed. Consistent with the problem of implementation failure, the findings indicate the inherent difficulties of implementing bottom-up interventions through a large-scale government program.

Longitudinal associations between food parenting practices and dietary intake in preschool children: The ToyBox Study

IntroductionFood Parenting Practices (FPPs) include the practices parents use in the act of feeding their children, which may further influence their health. ObjectivesTo assess associations between changes in FPPs (permissiveness, food availability, guided choices, water encouragement, rules and limits and the use of food as reward) over 1 year and dietary intake (water, energy-dense/nutrient-poor and nutrient-dense foods) at follow-up in 4- to 6-year-old preschool-aged children. MethodsLongitudinal data from the control group of the ToyBox study, a cluster-randomized controlled intervention study, was used (NCT02116296). Multilevel ordinal logistic regression analyses including FPP as the independent variables and dietary intake as outcome. ResultsNine hundred sixty-four parent-child dyads (50.5% boys and 95.0% mothers) were included. Limited changes on the use of FPPs were observed over time. Nevertheless, in boys, often having F&V at home was associated with higher F&V consumption (OR = 6.92 [1.58; 30.38]), and increasing home availability of F&V was directly associated with higher water consumption (OR = 7.62 [1.63; 35.62]). Also, not having sweets or salty snacks available at home was associated with lower consumption of desserts (OR = 4.34 [1.75; 10.75]). In girls, having F&V availability was associated with higher F&V consumption (OR = 6.72 [1.52; 29.70]) and lower salty snack consumption (OR = 3.26 [1.50; 7.10]) and never having soft drinks at home was associated with lower consumption of sweets (OR = 7.89 [6.32; 9.86]). Also, never being permissive about soft drink consumption was associated with lower soft drink consumption (OR = 4.09 [2.44; 6.85]). ConclusionUsing favorable FPPs and avoiding the negative ones is prospectively associated with healthier dietary intake, especially of F&V, and less intake of soft drinks, desserts, and salty snacks.

Intervention for sleep problems in nursing home residents with dementia: a cluster-randomized study.

To reduce sleep problems in people living with dementia using a multi-component intervention. Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

The effect of a music-based caregiving intervention on pain intensity in nursing home patients with dementia. A cluster-randomized controlled study.

Treatment of chronic pain in patients with dementia is challenging because they have reduced ability to report pain and are particularly vulnerable to side effects of analgesics. Different types of music-based therapy have been recommended and are used as an alternative to analgesics, but the evidence is lacking. Therefore, we performed a cluster-randomized controlled study (RCT) to reduce pain intensity using music-based caregiving (MBC) over 8 weeks in nursing home patients with dementia and chronic pain. We also investigated if the amount of MBC and different chronic pain syndromes would impact on the effect. Of the 645 patients, 498 patients from 36 wards in 12 nursing homes were screened for dementia and pain. Using the Clinical Dementia Rating Scale and the Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (range 0-10), 279 (71% females, 42% severe dementia) nursing home patients were randomized to intervention group (n = 134, 18 wards) or control group (n = 145, 18 wards). The main outcome was change in pain intensity before and after the intervention. The study did not reveal any effect of MBC on pain intensity when compared with the control group (B = -0.15, 95% CI [-0.72 to 0.43]). No significant difference was found within the intervention group analyzing the impact of intervention time (B = 0.73, 95% CI [-0.55 to 2.02]) or chronic primary vs secondary pain syndromes (B = 0.45, 95% CI [-0.05 to 0.96]). Our data from this first RCT on music and pain intensity in patients with dementia and chronic pain did not find an effect of MBC on pain.

Effectiveness and feasibility of an interprofessional training program to improve patient safety-A cluster-randomized controlled pilot study.

Interprofessional healthcare teams are important actors in improving patient safety. To train these teams, an interprofessional training program (IPTP) with two interventions (eLearning and blended learning) was developed to cover key areas of patient safety using innovative adult learning methods. The aims of this study were to pilot test IPTP regarding its effectiveness and feasibility. The trial was registered with DRKS-ID: DRKS00012818. The design of our study included both a pilot investigation of the effectiveness of the two interventions (eLearning and blended learning) and testing their feasibility (effectiveness-implementation hybrid design). For testing the effectiveness, a multi-center cluster-randomized controlled study with a three-arm design [intervention group 1 (IG1): eLearning vs. intervention group 2 (IG2)]: blended learning (eLearning plus interprofessional in-person training) vs. waiting control group (WCG) and three data collection periods (pre-intervention, 12 weeks post-intervention, and 24 weeks follow-up) was conducted in 39 hospital wards. Linear mixed models were used for the data analysis. The feasibility of IPTP was examined in 10 hospital wards (IG1) and in nine hospital wards (IG2) using questionnaires (formative evaluation) and problem-focused interviews with 10% of the participants in the two intervention groups. The collected data were analyzed in a descriptive exploratory manner. Pilot testing of the effectiveness of the two interventions (eLearning and blended learning) showed no consistent differences between groups or a clear pattern in the different outcomes (safety-related behaviors in the fields of teamwork, error management, patient involvement, and subjectively perceived patient safety). Feasibility checks of the interventions showed that participants used eLearning for knowledge activation and self-reflection. However, there were many barriers to participating in eLearning, for example, lack of time or access to computers at the ward. With regard to in-person training, participants stated that the training content sensitized them to patient-safety-related issues in their everyday work, and that awareness of patient safety increased. Although the interventions were judged to be feasible, no consistent effects were observed. A possible explanation is that the duration of training and the recurrence rate may have been insufficient. Another conceivable explanation would be that participants became more sensitive to patient safety-critical situations due to their knowledge acquired through the IPTP; therefore, their assessment post-intervention was more critical than before. In addition, the participants reported high pre-measurement outcomes. Future studies should examine the evidence of the intervention within a confirmatory study after adapting it based on the results obtained.

Effectiveness of community pharmacist-led interventions in osteoarthritis pain management: A cluster-randomized trial

BackgroundCommunity pharmacists contribute in osteoarthritis management via evidence-based pain management services. However, their roles and impacts on osteoarthritis management in low- and middle-income countries have yet to be explored. ObjectiveThis study aims to evaluate the effectiveness of community pharmacist-led educational intervention and medication review among osteoarthritis patients. MethodsA 6-month cluster-randomized controlled study was conducted in 22 community pharmacies of Nepal. Patients clinically diagnosed with osteoarthritis, aged 18 years and above, with a poor knowledge level of osteoarthritis and pain management were enrolled in the study. The intervention groups were educated on osteoarthritis and pain management, and had their medications reviewed while control group received usual care. Primary outcomes evaluated for the study were the change in pain levels, knowledge, and physical functional scores at 3 and 6 months. Repeated analyses of covariance were performed to examine the outcomes. ResultsA total of 158 participants were recruited for the study. The intervention group reported improvements in pain score (mean difference 0.473, 95 % CI 0.047 to 0.900) at 3 months and the end of the study (mean difference 0.469, 95 % CI 0.047 to 0.891) as compared to control. Similarly, improvement in knowledge scores were observed in the intervention group at 3 months (mean difference 5.320, 95 % CI 4.982 to 5.658) and 6 months (mean difference 5.411, 95 % CI 5.086 to 5.735). No differences were observed in other outcomes, including physical functional score, depression, and quality of life. ConclusionCommunity pharmacist-led intervention improved patients’ knowledge of osteoarthritis and pain management. While pain scores improved, physical functional score, depression, and quality of life score remained unchanged. Trial registrationClinicalTrials.gov identifier: NCT05337709.

Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial

BackgroundTuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia.MethodsA cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences.DiscussionThis cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB.Trial registrationClinicalTrials.gov NCT05236452. Registered on July 22, 2022.

The role of qualification and quality management in the prescription of antipsychotics and potentially inappropriate medication (PIM) in nursing home residents in Germany: results of the HIOPP-3-iTBX study.

Nursing home residents (NHR) show high rates of polypharmacy. The HIOPP-3-iTBX study is the first cRCT on medication optimization in nursing homes (NH) in Germany. The intervention did not result in a reduction of PIM and/or antipsychotics. This analysis looks at structure quality in the HIOPP-3-iTBX study participants. Evaluation of structure quality as part of a cluster-randomized controlled intervention study. Structure quality in multiprofessional teams from n = 44 NH (n = 44 NH directors, n = 91 family doctors (FD), and n = 52 pharmacies with n = 62 pharmacists) was assessed using self-designed questionnaires at baseline. Main aspects of the questionnaires related to the qualification of participants, quality management, the medication process and size of the facilities. All completed questionnaires were included. number of PIM/antipsychotics was drawn from the baseline medication analysis in 692 NHR. Data were analyzed by descriptive statistics and mixed model logistic regression. The presence of a nurse with one of the additional qualifications pain nurse or Zertifiziertes Curriculum (Zercur) Geriatrie in the participating NH was associated with a lower risk for the prescription of PIM/antipsychotics. No association between any characteristic in the other participants at baseline was observed. The results support the known role of nursing qualification in the quality and safety of care. Further studies need to look more closely at how use is made of the additional qualifications within the multiprofessional teams. Perspectively, the results can contribute to the development of quality standards in NH in Germany.

What Works for Whom? Evaluating Patterns and Mechanisms of Change Among Bullies, Victims, and Bully-Victims Participating in a School-Based Prevention Program

Abstract The effectiveness and program mechanisms of a whole-school anti-bullying program that builds on the socio-ecological framework were investigated by applying person-oriented methods of data analyses. A longitudinal cluster randomized control study was utilized comprising 1377 adolescents (48.5% girls, Mage = 11.7) who participated in a 1-year whole school anti-bullying program that was implemented in 13 schools and 665 adolescents (45.2% girls, Mage = 11.6) who attended 5 control schools. Student reports were collected at pre- and post-test within a 1-year interval. Applying latent profile analyses (LPA), students who were actively involved in bullying as perpetrators (e.g., bullies), who were the target of bullying (e.g., victims), who were both (e.g., bully-victims), and who were not involved either as perpetrators or victims (e.g., uninvolved) were identified. Latent transition analyses (LTA) investigated transition patterns between bully, victim, bully-victim, and uninvolved subgroups in the control and intervention group before and after the 1-year program implementation. Program effectiveness (e.g., a higher transition probability in the intervention compared to the control group) were found for victims and bully-victims. It was explored whether changes in program mechanisms were differently related to changes in these sub-group memberships in the intervention group. Victims transiting to the uninvolved sub-group increased in help-seeking and anti-bullying norms, while bully-victims transiting to the uninvolved sub-group increased help-seeking, perceived teacher intervention, and anti-bullying norms. It can be concluded that this program works differently for different sub-groups of students and that different mechanisms of change drive changes in different sub-groups of students.

Parental experience of an early developmental surveillance programme for autism within Australian general practice: a qualitative study

ObjectivesImplementing support and services early in the life course has been shown to promote positive developmental outcomes for children at high likelihood of developmental conditions including autism. This study examined...

Co-construct, implement and evaluate an intervention to prevent a sedentary lifestyle in children

Abstract Background In children a sedentary lifestyle is associated with the development of chronic diseases, as well as unfavorable body composition and physical condition, lower levels of self-esteem, sociability, and school results. In Europe 39,8% of children (6-9 years) spend on average more than 2h/day in front of a screen, and 14,6% over 3h/day. In this context, designing and testing effective interventions to decrease sedentary behavior in children is a major public health research gap. The CIPRES intervention aims to reduce sedentary time in school-age children (7-10 years). Methods The CIPRES intervention is co-constructed with key local actors, by using a socio-ecological approach, and theory-based on the transcontextual model. The intervention is evaluated by a cluster-randomized controlled study currently ongoing. The target population is made up of 1000 children from 13 primary schools (in years 4-5) from southeast of France with different levels of social deprivation. Main outcomes are assessed by accelerometer and questionnaires before (T0) and after a six-week intervention (T1) and include sedentary behavior, physical activity (PA) and variables of the transcontextual model. Results Preliminary data were available in 152 children (53 intervention and 99 control). There was no significant difference across the time in sedentary time between intervention and control group (p = 0.11; η2=0,017); however, moderate-to-vigorous physical activity (MVPA) tended to be better in intervention vs control (p = 0.06; η2=0,023). In the intervention group, sedentary time and MVPA were significantly better across the time (p = 0.028 and p = 0.011, respectively) for children having a father with a university diploma as compared to children having a father with a lower education level. Conclusions Preliminary results on a small group of subjects (n = 152) are encouraging and suggest a positive impact of the intervention on children. More results will be available by summer 2022. Key messages • Based on the socio-ecological model, the CIPRES intervention aims to prevent sedentary in school-aged children. • Preliminary data suggests a favorable impact of the intervention on physical activity.

Outcomes at discharge of preterm infants born

Objective: To investigate the incidence and trend of short-term outcomes among preterm infants born <34 weeks' gestation. Methods: A secondary analysis of data from the standardized database established by a multicenter cluster-randomized controlled study "reduction of infection in neonatal intensive care units (NICU) using the evidence-based practice for improving quality (REIN-EPIQ) study". This study was conducted in 25 tertiary NICU. A total of 27 192 infants with gestational age <34 weeks at birth and admitted to NICU within the first 7 days of life from May 2015 to April 2018 were enrolled. Infants with severe congenital malformation were excluded. Descriptive analyses were used to describe the mortality and major morbidities of preterm infants by gestational age groups and different admission year groups. Cochran-Armitage test and Jonckheere-Terpstra test were used to analyze the trend of incidences of mortality and morbidities in 3 study-years. Multiple Logistic regression model was constructed to analyze the differences of outcomes in 3 study-years adjusting for confounders. Results: A total of 27 192 preterm infants were enrolled with gestational age of (31.3±2.0) weeks at birth and weight of (1 617±415) g at birth. Overall, 9.5% (2 594/27 192) of infants were discharged against medical advice, and the overall mortality rate was 10.7% (2 907/27 192). Mortality for infants who received complete care was 4.7% (1 147/24 598), and mortality or any major morbidity was 26.2% (6 452/24 598). The incidences of moderate to severe bronchopulmonary dysplasia, sepsis, severe intraventricular hemorrhage or periventricular leukomalacia, proven necrotizing enterocolitis, and severe retinopathy of prematurity were 16.0% (4 342/27 192), 11.9% (3 225/27 192), 6.8% (1 641/24 206), 3.6% (939/25 762) and 1.5% (214/13 868), respectively. There was a decreasing of the overall mortality (P<0.001) during the 3 years. Also, the incidences for sepsis and severe retinopathy of prematurity both decreased (both P<0.001). However, there were no significant differences in the major morbidity in preterm infants who received complete care during the 3-year study period (P=0.230). After adjusting for confounders, infants admitted during the third study year showed significantly lower risk of overall mortality (adjust OR=0.62, 95%CI 0.55-0.69, P<0.001), mortality or major morbidity, moderate to severe bronchopulmonary dysplasia, sepsis and severe retinopathy of prematurity, compared to those admitted in the first study year (all P<0.05). Conclusions: From 2015 to 2018, the mortality and major morbidities among preterm infants in Chinese NICU decreased, but there is still space for further efforts. Further targeted quality improvement is needed to improve the overall outcome of preterm infants.

Intentional Rounding versus Standard of Care for Patients Hospitalised in Internal Medicine Wards: Results from a Cluster-Randomised Nation-Based Study.

The aim of the study was to explore the effects of Intentional Rounding, a regular-based proactive patient monitoring, on falls and pressure ulcers in internal medicine units. This is a cluster-randomised controlled study, where units were assigned (1:1) to Intentional Rounding (intervention group) or Standard of Care (control group). The primary outcome was the cumulative incidence of falls and new pressure ulcers. These events were considered separately as secondary endpoints, together with the number of bell calls and the evaluation of patient satisfaction. Primary analyses were carried out on the modified intention-to-treat population (hospitalisation of at least 10 days). Recruitment occurred between October 2019 and March 2020, at which time the study was prematurely closed due to the COVID-19 pandemic. Enrolment totalled 1822 patients at 26 sites; 779 patients were included in the modified intention-to-treat analysis. The intervention group had a lower risk of falls (adjusted incidence rate ratio 0.14; 95% confidence interval, 0.02–0.78; p = 0.03). There were no statistical differences in new pressure ulcers or the cumulative incidence of both adverse events. Mean bell calls for each patient were 15.4 ± 24.1 in the intervention group and 13.7 ± 20.5 in the control group (p = 0.38). Additionally, patient satisfaction in the intervention group was almost at the maximum level. Our study supports the usefulness of Intentional Rounding in a complex and vulnerable population such as that hospitalised in internal medicine units.

Relations among parent-reported physical activity and interoception in children

BackgroundInteroception is the sense of one's internal body and emotional state; it plays a critical role in guiding self-regulatory behaviors. Physical activity (PA) can support interoceptive processes, but limited research has examined the association in children. This study explored the relations among parent-reported PA and several interoceptive domains in children aged 3 – 10 years old. MethodsBaseline data were analyzed from a cluster-randomized controlled study examining a yoga intervention (N = 122). Parents completed a questionnaire that included the Caregiver Questionnaire for Interoceptive Awareness, Second Edition (CQIA-2) and two measures of PA, the PROMIS Parent-Proxy Short Form (PROMIS-PA) and the adapted Burdette Proxy Report (aBPR-PA). Psychometrics of the CQIA-2 subscales were assessed and then used in subsequent analyses to examine the association between PA and interoceptive sensibility. ResultsSeventy percent of the surveys were completed by mothers (30% by fathers), and their children (56% female, Mage = 5.81 ± 1.7 years) were predominately white. Across all children, PA had a significant positive relationship with interoceptive domains related to emotion and physical energy (p < 0.01). Children who met the PROMIS-PA “good” cutoff had a clearer sense of emotion and physical energy (F(2,115) = 4.30, p = 0.016, R2 = 0.070), compared to children who did not. Children's age predicted interoceptive sensibility of illness and toileting needs (F(1,116) = 14.16, p < 0.001, R2 = 0.109). ConclusionChildren with higher PA levels were perceived to have better interoceptive sensibility of emotion and physical energy. Children's age was predictive of interoceptive domains representing the awareness of illness and toileting needs. Future work should consider incorporating direct measures of PA and child-reported interoceptive sensibility. A better understanding of their relationship will likely help guide the design of more effective interventions for health behavior development.

Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial

BackgroundA redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD). Especially in rural areas with limited access to primary care physicians and specialists, these models might improve PwD’s quality of life and well-being. However, such care models are not available in Germany in regular healthcare. This study examines the acceptance, safety, efficacy, and health economic efficiency of an advanced nursing practice model for PwD in the primary care setting in Germany.MethodsInDePendent is a two-arm, multi-center, cluster-randomized controlled intervention study. Inclusion criteria are age ≥70 years, cognitively impaired (DemTect ≤8) or formally diagnosed with dementia, and living in the own home. Patients will be recruited by general practitioners or specialists. Randomization is carried out at the physicians’ level in a ratio of 1:2 (intervention vs. waiting-control group). After study inclusion, all participants will receive a baseline assessment and a follow-up assessment after 6 months. Patients of the intervention group will receive advanced dementia care management for 6 months, carried out by specialized nurses, who will conduct certain tasks, usually carried out by primary care physicians. This includes a standardized assessment of the patients’ unmet needs, the generation and implementation of an individualized care plan to address the patients’ needs in close coordination with the GP. PwD in the waiting-control group will receive routine care for 6 months and subsequently become part of the intervention group. The primary outcome is the number of unmet needs after 6 months measured by the Camberwell Assessment of Need for the Elderly (CANE). The primary analysis after 6 months is carried out using multilevel models and will be based on the intention-to-treat principle. Secondary outcomes are quality of life, caregiver burden, acceptance, and cost-effectiveness. In total, n=465 participants are needed to assess significant differences in the number of unmet needs between the intervention and control groups.DiscussionThe study will provide evidence about the acceptance, efficacy, and cost-effectiveness of an innovative interprofessional concept based on advanced nursing care. Results will contribute to the implementation of such models in the German healthcare system. The goal is to improve the current treatment and care situation for PwD and their caregivers and to expand nursing roles.Trial registrationClinicalTrials.gov NCT04741932. Registered on 2 February 2021.

Effectiveness of a web-based, electronic medical records-integrated patient agenda tool to improve doctor-patient communication in primary care consultations: A pragmatic cluster-randomized controlled trial study

BackgroundDoctors may struggle to identify patient agendas during busy primary care consultations. Therefore, an online patient agenda tool (the Values in Shared Interactions Tool- VISIT) was developed which allowed patients to enter their agenda items pre-consultation for doctors to view on their electronic medical records (EMR). This study aimed to measure the impact of this EMR-integrated website on patient satisfaction, number of agenda items discussed and consultation time. MethodsAn unblinded cluster-randomized controlled trial was conducted in a university-based primary care clinic between June-October 2019. Twenty-five family medicine trainees were randomized into using the VISIT tool (intervention) and usual care (control). Descriptive analysis showed significant differences between arms for age, occupation and mobile device proficiency scores. These were entered as covariates in trial analyses. Primary outcome was mean self-reported patient satisfaction score using the Healthcare Provider-Patient Communication (HCPPC) questionnaire, secondary outcomes were mean agenda items per consultation and mean consultation time. ResultsThe intervention arm had 12 doctors and 109 patients; the control arm had 13 doctors and 137 patients. Participation rates were 25.5% for intervention vs 53.6% for control. There was no difference between arms for patient satisfaction scores (133.3, 95% CI: 130.67–135.88 intervention vs 134.0, 95% CI: 131.76–136.29 control, P =.680) and consultation duration (15.83 min, 95% CI: 13.66–17.99 intervention vs 15.45 min, 95% CI: 13.57–17.34 control, P =.805). Mean number of agenda items discussed was higher in the intervention arm (2.25 items, 95% CI: 2.06–2.44 intervention vs 1.94 items, CI 95%: 1.78–2.11, P =.024). ConclusionsIntegrating patient agendas into the EMR did not affect patient satisfaction compared to usual care but was associated with a slightly increased number of agenda items without an increase in consultation time. This shows it may be useful for a busy primary care setting with multiple comorbidities and short consultation times.

Evaluating Health Education Module on Hand, Food, and Mouth Diseases Among Preschoolers in Malacca, Malaysia.

This study aims to improve parents' perceptions of susceptibility, severity, benefits, and barriers to children's handwashing practice by utilizing the Health Belief Model. In Alor Gajah, Melaka, a parallel cluster-randomized controlled study was conducted over 26 months. Parents who agreed to participate completed pre-test (t0) questionnaires. Data analysis used IBM SPSS version 25. The descriptive analysis described the baseline data pre-intervention. Chi-square and T-test or Mann-Whitney U test for non-parametric analysis assessed baseline data comparability between intervention and control groups. Generalized Estimating Equation (GEE) analyzed between and within-group comparison of the outcomes, and multivariate analysis determined the effectiveness of the intervention with clustered data. The individual participation rate was 86%. Parents who followed up immediately had higher perceived susceptibility, perceived severity, and perceived barriers (p < 0.001). Each unit increment in parents' practice score was 0.02-unit higher preschool children's hand hygiene practice score (p = 0.045). The intervention effectively improved parents' perceived susceptibility and benefits at immediate follow-up compared to baseline. However, there were no significant intervention effects on parents' perceived severity and barriers and preschool children's handwashing practices. The follow-up time significantly affected each outcome. There were significant covariates as the outcome predictors in this study, besides intervention groups and follow-up time. Parents' knowledge and age of the youngest child were significant predictors of parents' perceived susceptibility, besides parents' knowledge and perceived susceptibility being the predictors of parents' practice score. As a result, parents, teachers, and communities can implement this intervention in other schools with susceptible children.

Prescription Appropriateness of Drugs for Peptic Ulcer and Gastro-Esophageal Reflux Disease: Baseline Assessment in the LAPTOP-PPI Cluster Randomized Trial.

Background: Drugs for peptic ulcer and gastro-esophageal reflux disease (GERD) are among the most widely prescribed, frequently without appropriate indications. This represents an important issue, as it leads to risk of adverse events for patients and unnecessary costs for National Health Service. Aim: To assess the prescription appropriateness of drugs for GERD, in the frame of the “Evaluation of the effectiveness of a Low-cost informative intervention to improve the Appropriate PrescripTiOn of Proton PumP Inhibitors in older people in primary care: a cluster-randomized controlled study” (LAPTOP-PPI) (Clinicaltrial.gov: NCT04637750). Methods: The appropriateness of drug prescription was assessed on data collected in administrative databases, by integrating information on concomitant medications, outpatient medical and laboratory procedures and hospital discharge diagnoses, according to the reimbursement criteria provided by the Italian Medicine Agency. We analyzed data of community-dwelling people aged 65 years and over, living in the areas of Bergamo (Northern Italy) and Caserta (Southern Italy), from July 1 to 31 December 2019. Results: Among 380,218 patients, 175,342 (46.1%) received at least one prescription of drugs for GERD. All in all, we found that only 41.2% of patients received appropriate prescriptions. Conclusion: Given the potential risk of adverse drug reactions, especially in older people, educational interventions should be prompted for physicians, in order to improve the quality of prescription of drugs for GERD and, in turn, avoid unfavorable health outcomes and unnecessary costs.