Clinical Research Directory

Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.

Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs. This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics. Goals: 1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis. 2. Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes. 3. To determine a return on investment (ROI) for a software system like RKP.

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.

Improving Hypertension Management Through Preference List Defaults

This study aims to evaluate whether modifying the EPIC preference list to display combination blood pressure (BP) medications at the top and/or adding "(PREFERRED)" to the beginning of the medication listing increases prescribing of these medications. Combination BP medications are aligned with value-based care guidelines and may improve patient adherence and reduce pill burden. Currently, these medications may be under-prescribed in part due to their low visibility in the EPIC prescribing interface.

Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Nurse or pharmacist led GDMT management programs have been shown to effectively increase GDMT rates. The Veterans Healthcare Administration (VHA) has a pharmacist-based HF remote management program that uses an online, real-time, patient dashboard to optimize HF therapy. However, only a minority of VHA patients with recent-onset HF received HF care from pharmacists, with many of the encounters being limited to monitoring and education. Expanding the pharmacist program is a goal, but how to successfully implement this is unclear. The PHARM-HF-2 Project is a multi-site pragmatic randomized quality improvement project that evaluates two different interventions. First, the project evaluates if education and feedback messages increase the frequency of pharmacist HF medication management compared with education alone. Second, the project evaluates if primary care nudges to refer patients with heart failure to pharmacy care increase the frequency of pharmacist HF medication management compared with usual care. PHARM-HF-2 is a cluster randomized project at the level of the clinical site in a stepped wedge design. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to audit and feedback with education in a randomized order. By the end of the project, all sites will be receiving the monthly audit and feedback intervention. The second implementation strategy is nested within the primary strategy among sites randomized to education and feedback. Primary care referral nudges will studied with a two-arm parallel design with randomization at the level of the primary care team (PACT team) with 1:1 allocation stratified by site. This nested evaluation will start four months into the study.

An Evaluation of Epic EHR AI Outpatient Chart Summarization

This is a RCT of 284 outpatient physicians at a large academic health system, randomized 1:1 to an electronic health record (EHR) produced generative AI outpatient chart summarization tool or a usual-care control group. The 90 day study will observe the effects of the tool prior to system-wide roll out of the tool.

British Columbia Prescriber Feedback Program - Antimicrobial Resistance

The goal of this study is to evaluate an educational intervention that aims to reduce the number of unnecessary antibiotics prescribed by family physicians and nurse practitioners in British Columbia, Canada. The intervention materials include a confidential personalized prescribing "portrait" and an evidence-based educational summary (therapeutics letter), accompanied by an introduction letter. The main research questions are: 1. Will the intervention lead to a reduction in the overall number of antibiotics prescriptions started? 2. Will the intervention lead to a reduction in the proportion of antibiotics prescribed that are likely unnecessary, especially prescriptions for upper respiratory tract infections, acute bronchitis, acute sinusitis? Researchers will conduct an intervention study with family physicians and nurse practitioners in British Columbia, Canada. Participant clinicians will be randomly assigned to one of two groups. The Early Group will consist of 80% of the participants and will receive the intervention (prescribing portrait, evidence summary, and introduction letter) at the start of the study. The Delayed Group will consist of 20% of participants and will receive the intervention about nine months later. This study design allows most practitioners to receive the intervention early while still allowing time to compare the two groups to assess the impact. To estimate the impact of the intervention, researchers will use administrative health data to compare the prescribing of the Early Group with prescribing of the Delayed Group.

Enhancing Operational Efficiency in Eye Care Services

Pushpagiri Vitreo Retina Institute (PVRI) based in Secunderabad is a tertiary care eye hospital providing specialty eye care services since 2007. Over 15-20 preplanned surgical/clinical procedures are conducted for patients requiring care on a daily basis. They range from simple cataract surgeries or injections to detailed specialty surgeries including Vitreo-retina, glaucoma, pediatric eye care and muscular conditions of the eye. All procedures are elective procedures and are pre-planned. The current study aims to improve hospital efficiency and reduce the total appointment time for patients. The current study aims to reduce patient overall waiting time by 15-25% by introducing simple patient identification tools to help streamline all planned procedures.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Enhancing Mental and Physical Health of Women Veterans 3.0

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Impact Evaluation of the Therapeutic Initiative's Prescribing Portrait and Therapeutics Letter on Opioid Use by Dentists

The aim of this study is to estimate the impact of providing personalized prescribing data and educational materials on opioid prescribing to dentists in British Columbia, Canada. The main research questions are: 1. What is the impact of an intervention on the use of opioids for dental pain? The intervention includes a personalized prescribing report (a "Portrait"), brief educational summary, and patient education materials; and 2. Does the impact of the intervention increase when dentists are also invited to attend facilitated audit-and-feedback group sessions and to develop a practice improvement plan? Using administrative health data, the prescribing of those in different combinations of materials in the Early Group will be compared to those in the Delayed Group to estimate the impact of the materials on prescribing by the dentists.

Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

The "OR Black box", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures. Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery. This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level. Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.

Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science

The goal of this type of study is to construct the continuous quality promotion project "ICU-NO CRBSI(Catheter-Related Bloodstream Infection , CRBSI)" based on improvement science, and to verify its effect in the prevention of central venous catheter-related bloodstream infection and continuous quality improvement in ICU ( Intensive Care Unit , ICU) through multi-center implementation and two rounds of improvement. The main question\[s\] it aims to answer are: What is the incidence of catheter-related bloodstream infection in the ICU of participating units? How compliant are health care providers in the ICU with evidence-based sensory control practices for the prevention of catheter-associated bloodstream infection? Participants will be provided with the hospital's routine CVC (Central Venous Catheter ,CVC) care practices and CVC quality improvement measures based on evidence-based guidelines What technical and cultural support is needed to implement quality and safety improvement measures?

CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China. A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.

The Impact of Fasting Duration on Quality of Recovery After Cesarean Section

This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting

Utilization Study and Evaluation of Educational Intervention on HbA1c Testing

The aim of this randomized trial is to learn if educational materials and personalized prescribing Portraits change the frequency of ordering HbA1c tests by clinicians in British Columbia, Canada. The main research question: To investigate the overall utilization patterns of HbA1c testing and evaluate the effectiveness of a personalized prescribing Portrait and educational materials to reduce over-utilization of HbA1c tests in diabetes management. Participants are nurse practitioners and family physicians actively practicing in British Columbia. Participants are registered for the online prescribing Portrait program on the Therapeutics Initiative website where they can access their digital prescribing Portraits. Participants were randomized to receive educational materials on the topic of HbA1c testing either in an Early Group (Group 1 or Arm A) or in a Delayed Group (Group 2 or Arm B). Using administrative health data, the ordering of HbA1c tests by those in the Early Group will be compared with those in the Delayed Group to see if the materials influence the frequency of ordering HbA1c tests. Group 3 (Arm C) will be a control group for Groups 1 and 2 and include participants who receive no intervention.

SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients

Elders living with multiple chronic conditions often take many drugs (polypharmacy); some of the drugs may not benefit them or may be harmful. The Canadian Institute for Health Information has reported that about one-quarter of Canadian seniors are prescribed ten or more different drugs each year. Polypharmacy can result in poorer health, reduced quality of life and high healthcare costs. Choosing Wisely Canada and the Canadian Deprescribing Network have suggested wiser uses for the following four Potentially Inappropriate Prescriptions (PIPs): drugs that reduce stomach acid; reduce anxiety and induce sleep; treat agitation; and treat type 2 diabetes but have a high risk of low blood sugar. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Using quality improvement (QI) and supported by Electronic Medical Record (EMR) data, SPIDER will invite family doctors, nurses, pharmacists and front desk staff to participate in Learning Collaboratives and learn from each other. The practice teams will work with a QI Coach to identify areas to improve, develop strategies and implement changes tailored to the local practice context. The objective of this study is to determine whether SPIDER will reduce PIPs for patients 65 years or older who are on ten or more different drugs. The study will also explore patient experience and provider satisfaction with SPIDER and assess the cost of running SPIDER. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a Randomized Controlled Trial (RCT) in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.

Developing a Learning Health System for Primary Care in Thailand

Research question: Can a Learning Health System (LHS) approach improve delivery of care and reduce inequalities in outcomes for people with hypertension and related non-communicable diseases (NCDs) compared to routine care in primary care settings in Thailand? Background: NCDs account for 74% of all deaths in Thailand. Electronic health record data is used in Thailand to monitor how well whole regions deliver care, but is not directly available to healthcare teams in an actionable format which allows them to identify individuals in need of earlier, or more active management. LHS' are an effective framework for empowering healthcare teams to drive quality improvement (QI), reduce inequalities, and translate electronic health record data into actionable clinical insight. Aims and objectives: We will conduct a stratified cluster randomized controlled trial to compare the LHS approach to routine care in two Thai provinces. We will randomize 16 primary care units to the intervention over three phases: targeting management of people with hypertension in phase 1, type 2 diabetes in phase 2 and chronic kidney disease (CKD) in phase 3. In each phase, we will: 1. Co-design a LHS with healthcare teams, policymakers, researchers and the public 2. Train healthcare and analytic teams to deliver the LHS and establish local champions to support it 3. Trial the LHS approach for 12 months 4. Compare performance between intervention and control practices and evaluate the benefits and costs of implementing the LHS 5. Identify provider and patient barriers and facilitators to inform long-term QI for NCDs Methods: We will create four strata of primary care units according to practice size and case-mix. Within each stratum, we will randomize four practices to the intervention arm. In each of the three phases of the intervention, we will hold a series of stakeholder workshops to co-design quality improvement pathways, training materials, and computerised decision support tools (Aim 1); We will train multidisciplinary healthcare, analytic and research teams to implement the LHS and establish clinical and community champions to support it (Aim 2); We will trial the LHS for 12 months. Monthly data on key metrics will be used to monitor progress and iterate the LHS based on data analytics and shared learning across healthcare teams (Aim 3). We will conduct formal statistical comparisons between intervention and control arms, undertake health economic and mixed-methods realist evaluations to understand what works in promoting change and associated costs and benefits. (Aims 4 \& 5). Timeline: Trial setup (months 0-6), Hypertension (months 3-21), Diabetes (months 15-33), CKD (months 24-45), Evaluation (months 24-48) Impact and dissemination: Results will be disseminated via publication in high-impact journals, conference presentations, stakeholder meetings, and the media. We will co-produce locally relevant educational materials and clinical guidelines. Impact will include the generation of longitudinal epidemiological data on management and outcomes of NCDs, including factors which facilitate continuous QI, and associated costs and benefits. The decision support tools, training resources, and economic evaluative frameworks will be made freely available by the Thai Ministry of Health and the regional WHO office. Capacity building will ensure the next generation of clinical, community, and research leaders promulgate this way of working across the region.

Use and Opinions of Care Home Medicines Audit Tools

To describe the barriers and facilitators experienced by residents, health and social care staff, commissioners and regulators when managing medicines within care homes.

National Emergency Bariatric Surgery Audit

The goal of this observational study is to investigate the incidence, management, and outcomes of complications following bariatric surgery in patients in the United Kingdom. The main questions it aims to answer are: * What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK? * What are the current practices for managing these complications, and how do they impact patient outcomes? Participants will: Be identified from hospitals treating patients presenting with complications following bariatric surgery. Have their data collected regarding demographics, surgical history, complications, treatments, and outcomes. Researchers will compare different management strategies and their impact on patient outcomes, with the aim of identifying best practices to improve emergency bariatric care and factors leading to patients attending as an emergency.

Impact Evaluation of the Therapeutic Initiative's Type 2 Diabetes in Older Adults Portrait and Therapeutics Letter

The goal of this randomized trial is to learn if educational materials and personalized prescribing portraits change how clinicians in British Columbia (BC), Canada treat older adults with type 2 diabetes (T2DM). The main question the investigators aim to answer is: • Did a personalized prescribing portrait and therapeutics letter lead to a change in the number of older adults prescribed sulfonylureas or insulin when they have glycated hemoglobin (A1C) levels below 7%, compared to usual care. Study participants are nurse practitioners and family physicians actively practicing in BC, Canada. Participants registered on the project website, Portrait Online, to receive their digital prescribing portraits. Participants were randomized to either receive educational materials in the Early Group or in the Delayed Group. Using administrative health data, the prescribing of those in the Early Group will be compared to those in the Delayed Group to see if the materials influenced their prescribing.

Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care. Primary Objective: Compare postoperative hospital stay between the rapid recovery group and the usual care group. Secondary Objectives: Assess morbidity and mortality between both groups. Evaluate patient satisfaction using validated tools. Analyze incremental costs associated with both approaches. Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method). Evaluate adherence to rapid recovery protocol metrics by healthcare teams. Measure changes in patient safety culture among healthcare professionals. Hypothesis: The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP). This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.

To a Sustainable Quality Policy

The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. In this study protocol, a monocentric mixed-method quasi-experimental study will be used to assess the impact of a rapid-cycle quality indicator feedback mechanism on both patients and professionals.