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Patient Safety clinical trials

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NCT ID: NCT06269250 Recruiting - Patient Safety Clinical Trials

Acceptance and Perceived Benefits of Digitalization by Medical Assistants

ANDI-MFA
Start date: November 1, 2023
Phase:
Study type: Observational

The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare.

NCT ID: NCT05530187 Recruiting - Patient Safety Clinical Trials

ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors

IePRO
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Immune checkpoint inhibitors (ICIs) can cause immune-related adverse events (IrAEs) throughout and beyond treatment duration. These IrAEs can be varied and difficult to predict, as they can involve almost any organ, regardless of where the primary tumor is located. Treatment modality and individual characteristics appear to influence the frequency and severity of these events, which can become serious without proper monitoring and timely intervention. Generally, patient visits are scheduled at the same intervals in which patients receive treatment, once every two to four weeks. In these large intervals, patients can be surprised by IrAEs without a close schedule visit to their oncology physician. Not only this may negatively influence their overall well-being, their perceived self-efficacy to manage their own condition and their health-related quality of life may be affected as well. Using patient-reported outcomes (PROs) to monitor patient symptoms has become incredibly valuable in describing treatment toxicity, including that of ICIs. PROs are a self-report of the patient's own perceptions of their health status. Using their own words, or by replying to questionnaires, patients can convey symptoms and how these affect their daily life and quality of life. Questionnaires are an example of a PRO measure (PROM), which have increasingly been provided electronically (resulting in electronic PROs or ePROs). The ubiquity of connected electronic devices has enabled long-distance monitoring of symptoms through electronic questionnaires. In patients treated with chemotherapy, studies have shown that using this method to collect symptom data can enable healthcare providers to help patients manage their symptoms remotely. This allows patients to receive timely support from home, that could help prevent serious complications that could entail visits to the emergency department, unscheduled hospitalizations and treatment interruptions. The IePRO study's aim is to test a model of care that uses electronic questionnaires to monitor symptoms that could be related to the use of ICIs. Patients would reply to these questionnaires at least once a week using an electronic web application (on their phone or computer). A team of oncology nurses reviews their replies and calls patients when new symptoms appear or when they worsen. Using a standard triage algorithm, the nurses guide patients on how to proceed: if they should stay home and follow self-care advice, if they should have a second call within the next 24 hours to follow-up on their symptoms, or if they should come to the hospital for an in-person assessment as soon as possible. In this study, it is hypothesized that this model of care could lead to an earlier detection of IrAEs, as well as their improved management by reducing the number of high-severity IrAEs, the number of unscheduled emergency admissions and hospitalizations, as well as decreasing the number of treatment interruptions and of immunosuppressive treatments used to treat IrAEs.

NCT ID: NCT05407129 Recruiting - Patient Safety Clinical Trials

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

I-SHARE
Start date: April 13, 2023
Phase: N/A
Study type: Interventional

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 Spanish and English 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. After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent education and language results. The investigators now propose to conduct an RCT of the intervention in 4 geographically, ethnically, and linguistically diverse hospitals. The specific aims are to: (1) evaluate the effectiveness of the intervention in improving error detection and other safety outcomes, (2) assess the impact of the intervention on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of the intervention. If effective, the intervention will contribute by: (1) increasing patient/family engagement in reporting, especially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to better understand safety problems in a 360-degree manner and design more effective, patient-centered solutions.

NCT ID: NCT04990986 Recruiting - Patient Safety Clinical Trials

Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes

SAME
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The study aims to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods.

NCT ID: NCT04897087 Recruiting - Patient Safety Clinical Trials

Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event

Start date: May 20, 2021
Phase:
Study type: Observational

The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. We are interested in exploring how patient, carer and relative involvement can assist reconciliation, organisational and national learning. Information gained will be used to support the development of national guidance around involving people in a compassionate and caring way and how their experience could help organisational and national learning when things go wrong in health care.

NCT ID: NCT04861025 Recruiting - Aged Clinical Trials

Siderails as a Measure of Physical Restraint. GERBAR Trial

GERBAR
Start date: October 1, 2022
Phase:
Study type: Observational

There is a controversy about if siderails should be considered as a method of physical restraint in older hospitalized patients. This study aims to investigate the opinion of older patients and health professionals about this controversy.

NCT ID: NCT04854278 Recruiting - Patient Safety Clinical Trials

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

Start date: February 19, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT04400669 Recruiting - Patient Safety Clinical Trials

The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.

NCT ID: NCT04176094 Recruiting - Education Clinical Trials

Intensive Care Unit Resident Scheduling Trial

InCURS
Start date: November 18, 2019
Phase: N/A
Study type: Interventional

Many patients, doctors and others worry that tired doctors provide worse patient care, may not learn well and become burnt-out. In response to these concerns, some countries changed their laws to limit work-hours for doctors in training ('residents'). In Canada, most residents work six or seven 24-30h shifts each month. A recent Canadian report ordered by Health Canada said that making good decisions about resident work-hour rules was "significantly limited by quality evidence, especially evidence directly attributable to the Canadian context." Creating this evidence is the main goal of this research. The pilot study in 2 intensive care units(ICU) found that shorter shifts may be worse for patients, and for residents were more tiring than expected but improved wellbeing. Learning was not assessed. Previous studies on resident work-hours report similar findings: conflicting effects for patients, benefits for resident wellbeing, inconsistent and under-studied effects on learning. Overall, these results are not conclusive and confirm the need for a larger study. The current study will provide high-quality Canadian evidence. The investigators will compare two common ICU schedules used in Canada: resident shifts of 16h and 24h. ICU patients are very sick, there is little margin for error: they need doctors who know them well and are thinking clearly. The effects of each schedule on patients and residents will be measured. For patients, mortality rates and harm caused by care in ICU will be studied. For resident education, their learning about managing common illnesses in ICU, to do basic ICU procedures, and communicate with families will be studied. For resident wellbeing measures will include sleepiness, other fatigue symptoms, and burnout. Investigators will study both resident and patient outcomes so that Canadians can understand trade-offs linked to changing schedules. With this knowledge, Canadians can expect safer care for today's patients and better-trained doctors for the patients of tomorrow.

NCT ID: NCT03105713 Recruiting - Surgery Clinical Trials

Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery

PASC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures. A safety checklist for patients to use has been developed and validated for use in surgical patients. In a Stepped Wedge Cluster RCT effects of patients using their own checklists to avoid preventable patient harm are examined. The project will re-use existing health and personal data collected from patient records and patient reported data as outcome measures. A consortium of all relevant stakeholders and users participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The important project partners are information and communications technology companies (Helse-Vest IKT and CheckWare service delivery), general practitioners, and national and international research partners leading in the field of patient safety, implementation science and health economics.