Dataset Information

Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Non-technical skills (NTS), such as communication and professionalism, contribute to the safe and effective completion of procedures. NTS training has previously been shown to improve surgical performance. Moreover, increases in NTS have been associated with improved clinical endoscopic performance. Despite this evidence, NTS training has not been tested as an intervention in endoscopy. OBJECTIVE:The aim of this study is to evaluate the effectiveness of a simulation-based training (SBT) curriculum of NTS on novice endoscopists' performance of clinical colonoscopy. METHODS:Novice endoscopists were randomized to 2 groups. The control group received 4 hours of interactive didactic sessions on colonoscopy theory and 6 hours of SBT. Hours 5 and 6 of the SBT were integrated scenarios, wherein participants interacted with a standardized patient and nurse, while performing a colonoscopy on the virtual reality (VR) simulator. The NTS (intervention) group received the same teaching sessions but the last hour was focused on NTS teaching. The NTS group also reviewed a checklist of tasks relevant to NTS concepts prior to each integrated scenario case and was provided with dedicated feedback on their NTS performance during the integrated scenario practice. All participants were assessed at baseline, immediately after training, and 4 to 6 weeks post-training. The primary outcome measure is colonoscopy-specific performance in the clinical setting. RESULTS:In total, 42 novice endoscopists completed the study. Data collection and analysis is ongoing. We anticipate completion of all assessments by August 2017. Data analysis, manuscript writing, and subsequent submission for publication is expected to be completed by December 2017. CONCLUSIONS:Results from this study may inform the implementation of NTS training into postgraduate gastrointestinal curricula. NTS curricula may improve attitudes towards patient safety and self-reflection among trainees. Moreover, enhanced NTS may lead to superior clinical performance and outcomes in colonoscopy. TRIAL REGISTRATION:Clinicaltrial.gov NCT02877420; https://www.clinicaltrials.gov/ct2/show/NCT02877420 (Archived by WebCite at http://www.webcitation.org/6rw94ubXX NCT02877420).

SUBMITTER: Khan R

PROVIDER: S-EPMC5562936 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial.

Khan Rishad R Scaffidi Michael A MA Walsh Catharine M CM Lin Peter P Al-Mazroui Ahmed A Chana Barinder B Kalaichandran Ruben R Lee Woojin W Grantcharov Teodor P TP Grover Samir C SC

JMIR research protocols 20170804 8

<h4>Background</h4>Non-technical skills (NTS), such as communication and professionalism, contribute to the safe and effective completion of procedures. NTS training has previously been shown to improve surgical performance. Moreover, increases in NTS have been associated with improved clinical endoscopic performance. Despite this evidence, NTS training has not been tested as an intervention in endoscopy.<h4>Objective</h4>The aim of this study is to evaluate the effectiveness of a simulation-bas ...[more]

PMID: 28778849

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Project description:BackgroundTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that delivers constant, low electrical current resulting in changes to cortical excitability. Prior work suggests it may enhance motor learning giving it the potential to augment surgical technical skill acquisition.ObjectivesThe aim of this study was to test the efficacy of tDCS, coupled with motor skill training, to accelerate laparoscopic skill acquisition in a pre-registered (NCT03083483), double-blind and placebo-controlled study. We hypothesized that relative to sham tDCS, active tDCS would accelerate the development of laparoscopic technical skills, as measured by the Fundamentals of Laparoscopic Surgery (FLS) Peg Transfer task quantitative metrics.MethodsIn this study, sixty subjects (mean age 22.7 years with 42 females) were randomized into sham or active tDCS in either bilateral primary motor cortex (bM1) or supplementary motor area (SMA) electrode configurations. All subjects practiced the FLS Peg Transfer Task during six 20-min training blocks, which were preceded and followed by a single trial pre-test and post-test. The primary outcome was changes in laparoscopic skill performance over time, quantified by group differences in completion time from pre-test to post-test and learning curves developed from a calculated score accounting for errors.ResultsLearning curves calculated over the six 20-min training blocks showed significantly greater improvement in performance for the bM1 group than the sham group (t = 2.07, p = 0.039), with the bM1 group achieving approximately the same amount of improvement in 4 blocks compared to the 6 blocks required of the sham group. The SMA group also showed greater mean improvement than sham, but exhibited more variable learning performance and differences relative to sham were not significant (t = 0.85, p = 0.400). A significant main effect was present for pre-test versus post-test times (F = 133.2, p < 0.001), with lower completion times at post-test, however these did not significantly differ for the training groups.ConclusionLaparoscopic skill training with active bilateral tDCS exhibited significantly greater learning relative to sham. The potential for tDCS to enhance the training of surgical skills, therefore, merits further investigation to determine if these preliminary results may be replicated and extended.

Project description:BackgroundProblems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6-13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST.ObjectivesThe primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children's Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response.MethodsThis is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6-13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value.PerspectivesThis study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST.Trial registrationClinicalTrials.gov NCT03160378 . Registered on May 19, 2017.

Project description:PurposeTo compare the effectiveness, in comparison to a control group (C), of module-based training (MBT) and traditional learning (TL) as a means of acquiring arthroscopic skills on an arthroscopic surgery simulator.MethodsThirty health sciences students with no previous arthroscopy experience were recruited and randomized into 1 of 3 groups: MBT, TL, or C (1:1:1 ratio). Participants in MBT were required to independently practice on a VirtaMed ArthroS simulator (VirtaMed AG, Zurich, Switzerland) for a minimum of 2 hours per week, whereas TL received one-on-one coaching by a senior orthopaedic resident for 15 minutes per week. The control group received no training. All groups were assessed at baseline and at 4 weeks based on objective measures generated by the surgical simulator (procedure time, camera path length, meniscus cutting score, detailed visualization, safety score and total score), and subjective ratings scales (Objective Assessment of Arthroscopic Skill [OAAS] global assessment form, and Competency-Based Assessment form).ResultsParticipants in the MBT group trained on average 113 min/week whereas the TL group trained on average 24 min/week. Three-way repeated-measures analysis of variance showed significant group by time interactions for procedure time (P = .006), camera path length (P = .008), safety score (P = .013), total score (P = .003), OAAS form (P < .001), and Competency-Based Assessment form (P < .001). MBT group was superior to C group for procedure time (P = .02), camera path length (P = .003), total score (P = .004), and OAAS form (P = .021), but there were no significant post-hoc differences between MBT and TL groups, or TL and C groups after Bonferroni correction. Total practice time explained 37.5% of the final simulator total score variance.ConclusionsKnee arthroscopy simulation training with self-learning modules can improve skills in areas such as procedure time, camera path length, and total score in untrained participants compared with a control group.Clinical relevanceModule-based simulation training provides additional training time and improves technical skills in naive health science students. It is hoped that this effect can be preserved and applied to junior resident developing in a busy residency program.

Project description:BACKGROUND:African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA. METHODS/DESIGN:This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System. DISCUSSION:This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.

Project description:Individuals who are not engaged in treatment are commonly overlooked in the design of intervention trials targeting suicidal populations as a result of recruitment methodology that requires individuals to be referred from their current provider. In fact, research suggests that the majority of individuals who die by suicide have not been in contact with mental health services in the year before their death.A randomized controlled trial of two brief, one-session interventions for adults who are not engaged in mental health treatment. Inclusion criteria include 1) 18 years or older, 2) experiencing suicidal ideation in the past week, 3) have not received mental health treatment in the month prior to screening, 4) living within commuting distance to the research office, and 5) willing to consent to recording and assessment. Exclusion criteria are 1) non-English speaking and 2) significant cognitive impairment. Recruitment takes place in the community via flyers, radio, and online advertisements. Interested individuals are screened via telephone and those who are eligible attend a one-time in-person assessment and intervention appointment. During this appointment, they are randomized to a single-session intervention in which they are presented with either dialectical behavior therapy skills or supportive discussion and instruction in relaxation. Following the in-person appointment, participants complete three follow-up interviews via telephone at one-week, four-weeks, and twelve-weeks post-intervention. The primary outcomes are suicidal ideation, emotion dysregulation, and skills use. Secondary outcomes include depression, anxiety, self-efficacy, and treatment utilization. Exploratory outcomes are suicidal and intentionally self-injurious behaviors. Intent-to-treat analyses will be conducted on primary and secondary outcomes.Suicidal individuals who are not engaged in mental health treatment are an understudied and significantly at-risk group for death by suicide. A better understanding of this population, targeted efforts to recruit and engage these individuals, and developing effective interventions for this group are critical areas for investigation in the field that this trial seeks to address.Clinicaltrials.gov identifier: NCT02236325 ; Date of registration: 05-Sept-2014.

Project description:BackgroundFor patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning.MethodsThis RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings.DiscussionThis trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer.Trial registrationThis study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.

Project description:BackgroundTo ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only.MethodsThis study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training.DiscussionTo our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes.Trial registrationClinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Dataset Information

Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial.

Publications

Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial.

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