Treatment Trials

25 Clinical Trials for Various Conditions

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RECRUITING
Medical Residents Learning Weight Management Counseling Skills
Description

The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are: * How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills. * Evaluate residents' adoption of WMC skills in encounters with their patients * what would be the best way to get residents to adopt the WMC skills Residents in the comparison group will receive a course on obesity and weight management. The residents in the intervention group will have to attend 2 informational sessions and will receive 6 email modules on WMC. Both groups will also take part in 3 assessments over the course of 18 months to see which group has better WMC skills.

COMPLETED
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Description

This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.

Conditions
COMPLETED
Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance
Description

This feasibility study develops methods for larger-scale research, evaluating the acceptability and perceived impact of a group acupuncture and acupressure intervention, as well as suitability of a self-report instrument. During their weekly training program, eleven OB residents at NYU Lutheran Medical Center will receive three sessions of auricular acupuncture therapy. (This resident population was previously anonymously surveyed and all expressed interest in participating in such a study). The Professional Quality of Life Scale (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess participants' acceptance of the intervention as well as applicability of the ProQOL instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals, adverse events, and time taken to complete intervention and surveys.

WITHDRAWN
Ameliorating Work Burnout and Medical Residents
Description

Prior research has demonstrated that during residency years, in particular training to obtain a medical specialty, work burnout is a very prevalent problem. Work burnout is defined as a syndrome of dysfunction in three domains, emotional exhaustion, depersonalization, and a reduced sense of personal accomplishment. (Maslach et. al., 1981). Often, burnout has been associated with poor sleep quality and negative affectivity, such as depression and anxiety. In fact, our preliminary data demonstrate that burnout in medical residents affects sleep quality, and increases negative emotions. Strikingly, burnout in medical residents negatively impacts working performance as well as patient-physician interactions, and hence may affect the quality of health care. However, lacking are studies aimed at understating how work burnout affects cognitive performance and decision making in medical residents. The proposed study will provide essential groundwork in demonstrating the link between burnout and impaired cognitive performance. In addition, the proposed study will demonstrate feasibility for a future trial to test whether an intervention, emWave, integrating a computer based stress management (resilience training), can have a positive impact on residents with high burnout symptoms. The amelioration of psychological risk factors in medical residents may lead to improved physician-patient relationships in the service of improved quality of care.

RECRUITING
Reaching Out to Distressed Medical Residents, Fellows and Faculty
Description

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. The screening and ability to interact online with a clinician anonymously are hypothesized to increase willingness to come for counseling in person. Suicide risk factors are expected to be lower once the distressed medical trainee or faculty member receives treatment.

COMPLETED
Medical Residents Performance: Effect of Simulation-Based Training
Description

I Hypothesis: 1. Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement is superior to general videotape-based training 2. Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical residents, certified in CVC placement, is poor 3. PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal barrier precaution technique during central venous catheter (CVC) placement 4. PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement have good recall after 3 months

Conditions
UNKNOWN
WILD 5 Wellness: A 30-Day Intervention for Residents
Description

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst resident physicians combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

COMPLETED
Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Description

The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are: 1. To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback). 2. To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline. 3. To determine if activity level is associated with change in weight during the residency year. 4. To determine if the average hours of sleep per week is associated with changes in weight and with activity level.

COMPLETED
Developing a Practice-Based Learning and Improvement Quality Improvement (QI) Systems Impact Assessment Questionnaire
Description

The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing needs of physicians in training when it endorsed practice-based learning and improvement (PBLI) -- a competency that is typically omitted from medical curriculum. The goal is to have residents competent to investigate and evaluate their own patient care practices, integrate scientific evidence and be able to improve their practices. Available assessment tools do not adequately address all of the components of PBLI and few assessment tools attempt to capture the residents' ability to develop and implement clinically-based Continuous Quality Improvement (CQI) projects that involve the practice setting. Curriculums without such foci miss the importance of system perspectives and opportunities for interprofessional team development. Our aim is to evaluate preliminary data on the curriculum we developed to address the gaps, to develop an assessment tool, and to provide methods for assessing the sustainability of system projects. The key component of the curriculum is the integration of system quality improvement projects. PBLI curriculum was offered on alternate rotations. Preliminary data is available from 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42). Data includes closed- and open-ended questions designed to assess resident PBLI application skills, the notes and presentation slides for the residents' presentation.

COMPLETED
Optimizing Medical "Teaming" on Resident Based Teams
Description

The main objective of this study is to evaluate the colocalization of internal medicine residents on one clinical inpatient hospital floor for all general medicine block rotations during the 2019-2020 academic year. Specifically, the aims of the study are to determine if co-localization improves familiarity with nursing staff, which in turn, improves team work, psychological safety, patient care and reduces burnout. The investigators' hypothesis is that co-localization will increase familiarity between residents and nurses and result in improved psychological safety, team work and patient outcomes.

ACTIVE_NOT_RECRUITING
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Description

Medical students and residents have high rates of mental distress and burnout related to the intellectual and time demands of their training. Research shows that physiological stress on the body can be a result of fatigue and high stress work, and is associated with experiences related to mental distress. Pomegranate is a fruit that is known to contain a variety of antioxidant substances that can reduce physiological stress. This study will look at the potential for pomegranate supplementation to reduce physiological stress and improve well-being in medical students and residents.

ENROLLING_BY_INVITATION
Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents
Description

With increasing awareness about physician fatigue and its effect on patient safety, residency programs are increasingly transitioning to a night float call system. In other industries, multiple night shifts in a row can cause a disruption in the circadian rhythm, sleep debt, shift work disorder, that is related to chronic medical conditions such as obesity and cardiovascular disease. We will evaluate the effect of different call structures on resident activity, sleep and self reported measures of wellness using a commercially available Fitbit device.

COMPLETED
Investigating the Impact of Professional Development Coaching Programs in Residents & Fellows
Description

The goal of the Professional Development Coaching Program is to allow trainees to understand their development over time, find meaning and purpose in their work, and identify their strengths and how to use these to overcome challenges and stressors. Additionally, the program connects trainees with a faculty member who will work with them, grow to know them in-depth over time, and provide meaningful guidance throughout the relationship. There is an additional benefit to the coaches themselves, who are able to connect with other faculty coaches in a rewarding way, that provides faculty development in leadership development and positive psychology, and space to interact with a group of like-minded physicians.

COMPLETED
Discussing Death and Dying: An End of Life Curriculum to Empower Residents
Description

This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.

COMPLETED
Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
Description

In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be: 1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses) 2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses) 3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)

TERMINATED
Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome
Description

The primary objective of the proposed study will be to determine if a multi-modality teaching curriculum utilizing high-fidelity simulation and didactic lecture will result in sustained improvement by internal medicine residents in written knowledge and clinical performance when compared to residents receiving a curriculum utilizing only didactic lecture. The investigators hypothesis is that the addition of high-fidelity simulation to a traditional didactic lecture curriculum will result in sustained and superior written knowledge and practical performance when compared to a group receiving only didactic lecture on the same topic. Specifically, the investigators will be assessing internal medicine resident knowledge and performance in the area of sepsis in the hospitalized patient, and will shape the investigators teaching curriculum around this focus.

COMPLETED
Evaluation of a Resident Curriculum in Firearm Injury Prevention
Description

The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to teach pediatric practitioners how to provide injury prevention anticipatory guidance, emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding the curriculum's effectiveness using a web-based questionnaire which will be administered to pediatric residents prior to, immediately post, and six months following completion of the curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm injury prevention anticipatory guidance.

Conditions
COMPLETED
Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
Description

The purpose of this study is to evaluate the efficacy of individualized performance feedback coupled with an educational module in improving resident performance of the physical and developmental examination component of developmental surveillance of infants at the two month preventive care visit.

COMPLETED
Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents
Description

The purpose of this study is to test whether multi-source feedback, including self-assessment and tailored coaching, improves resident communication skills and professionalism. We hypothesize that residents who are assigned to receive multi-source feedback, in addition to receiving standard feedback, will improve significantly more than residents receiving standard feedback alone, as measured by parent and nurse ratings of specific behaviors over time.

COMPLETED
The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
Description

This study is designed to test the impact of a new curriculum, called Provider Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical residents' cross-cultural knowledge, attitudes, and skills surrounding the care of patients from diverse cultural backgrounds, as well as clinical and patient-reported health outcomes for patients treated by surgical residents undergoing this training.

COMPLETED
IIPE-PRIS Accelerating Safe Signouts
Description

Because communication and handoff failures are a root cause of two-thirds of "sentinel events"- serious, often fatal preventable adverse events in hospitals improving handoffs has been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to improve patient safety. Comparative Effectiveness Research on handoff tools and processes has identified specific strategies to improve handoffs and reduce medical errors: 1) team training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient safety, the investigators are implementing the three inventions above as a Resident Handoff Bundle (RHB) in eight pediatric hospitals in the United States and Canada.

COMPLETED
Implementing a Comprehensive Handoff Program to Improve Patient Safety
Description

The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Conditions
COMPLETED
Evaluating a Physician Opinion Leader Intervention to Increase Utilization of Coaching/Therapy During Residency
Description

Investigators will assess the efficacy of a physician popular opinion leader-led intervention to increase awareness and utilization of existing evidence-based coaching or therapy among post-graduate clinical trainees at Stanford.

COMPLETED
Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
Description

The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

COMPLETED
VITOM Study: A Randomized, Controlled Trial.
Description

This is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video. As data collection only involves survey data collection and satisfaction with an educational experience, and randomization/intervention is only involving use of one type of educational method versus another .