Clinical Research Directory

Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention was developed to prevent psychological elder abuse (EA) and promote high-quality caregiving by lowering relationship strain and developing CG resourcefulness. The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to persons living with dementia and to describe how the intervention may work to reduce psychological EA.

Effect of a Respectful Maternity Care-Based Action Plan in Postpartum Care on Maternal and Neonatal Outcomes

This study will examine whether a Respectful Maternity Care-based action plan can improve the quality of postpartum care and maternal and newborn outcomes. Nurses and midwives will receive a three-day interactive training about respectful, evidence-based postpartum care. After training, a unit-level action plan will be implemented, including supportive visits, educational materials, and feedback meetings. Women receiving routine postpartum care before the intervention will be compared with women receiving care after implementation. Outcomes will include respectful maternity care experiences, maternal satisfaction, exclusive breastfeeding at 6-8 weeks, maternal mental health, mother-infant bonding, and postpartum complications. The goal of this study is to promote respectful, high-quality postpartum care and improve the health and well-being of mothers and newborns.

Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Training and Support Programme on Data-driven Quality Development for Swiss Long-Term Care Facilities (NIP-Q-UPGRADE Subaim 2.6)

Since 2019, long-term care facilities (LTCFs) in Switzerland have been required by the Federal Insurance Law (KVG, Art. 59a) to report data for the calculation and public reporting of medical quality indicators (MQIs) in four clinical domains: polypharmacy, pain, malnutrition, and physical restraints. This data serves both for monitoring care quality at the national level through public reporting and for internal quality development. Contextual analysis showed that various quality development methods are already known and used in Swiss LTCFs. However, significant challenges remain: limited resources, time constraints, and restricted access to MQI data hinder effective use. Facilities reported a greater need for support in using MQI data. They also expressed interest in peer networking, structured support for applying quality methods (such as Plan Do Check Act cycles (PDCA)), and practical tools such as training, best-practice examples, and additional resources. Residents and relatives also expressed a strong interest in being more involved in decision-making and care quality discussions. The overall aim of the current study is to test a quality development training programme that supports LTCFs in using MQI data for continuous data-driven care quality development. The study is structured into three thematic areas: 1. MQI Results Literacy - Supporting LTCFs in interpreting MQI reports and benchmarks. 2. Impactful Actions - Supporting LTCFs to translate MQI results into concrete quality development actions using PDCA cycles. 3. Sparking Culture - Integrating data-driven quality development into everyday practice and fostering a culture of continuous development, with a strong emphasis on strengthening the involvement of residents, relatives, and leadership. The study follows a train-the-trainer strategy. Trainers instructed by the NIP-Q-UPGRADE research team provide structured training and coaching to Quality Leaders and management representatives of LTCFs. Quality Leaders then support their co-workers in quality development. The training programme consists of online and in-person trainings, training materials, practical tools, a website, guided tasks for facilities, and an email helpdesk for ongoing support. Study outcomes: This sub-study of the NIP-Q-UPGRADE programme aims to assess the acceptability, feasibility, fidelity, and costs related to the training programme, both at the facility level and at the trainer level.

Comprehensive Care Community and Culture Study

This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients at increased risk of hospitalization experience fewer hospitalization if those patients are offered care in: 1) ACCT, where patients receive care from different physicians in the hospital and the clinic settings and have access to nurse and social worker care coordination services, 2) CCP where patients receive care from one physician in the inpatient and outpatient settings or 3) C4P which adds screening of unmet social needs, community health worker support and arts and culture programming to CCP. The study will determine how these programs affect patient activation and engagement in care, satisfaction with care, general health and mental health, and goal attainment.

Parental Well-being After Childbirth in Switzerland

Improving maternal and child health is a global priority, with increasing emphasis on ensuring women and their families not only survive but also thrive after childbirth. While high-income countries like Switzerland provide strong antenatal and intrapartum care, the quality of postnatal care often lags behind, despite the critical physical, mental, and social needs of the postpartum period. Studies indicate high rates of mental distress, physical pain, and sexual discomfort among mothers, alongside a lack of research on the well-being of co-parents. The main question this cohort study aims to answer is: how do the health and well-being of mothers and co-parents evolve during the first year after childbirth? Participants will complete four online questionnaires: the first within the first few days after birth, followed by additional assessments at 2, 6, and 12 months postpartum. This comprehensive approach seeks to inform policy and improve evidence-based postnatal care practices, benefiting approximately 80,000 families annually in Switzerland.

Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII)

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness

currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. The project aims to examine trends in patient-reported outcomes (PROMs), including symptoms, quality of life, and distress, in multimorbid hospitalized patients from admission to 30 days post-discharge. It will also investigate whether PROMs at discharge are linked to the risk of readmission or emergency visits and explore how these outcomes differ in patients who receive low-value care. Additionally, the project will assess the relationship between patient-reported experiences (PREMs) and the provision of low-value care during the hospital stay.

Role Development, Implementation and Evaluation of Nurse Practitioners

Hospitals face new challenges in providing sustainable high quality care as the prevalence of chronic conditions, multimorbidity and the complexity of care increases. The high burden on healthcare teams, the growing costs and the increasing scarcity in healthcare providers (HCPs) result in unmet needs of patients and their families and a high workload on HCPs. Worldwide there is growing recognition that new care models integrating nurse practitioners (NPs) in interdisciplinary teams could contribute to respond to these challenges. ANP is defined as an "advanced practice nurse (APN) who integrates clinical skills associated with nursing and medicine in order to assess, diagnose and manage patients in primary healthcare settings and acute care populations as well as ongoing care for populations with chronic illness". Despite the proven benefits of integrating NPs in interdisciplinary teams, the introduction of NPs in Belgium is at an early stage. Advanced practice nurses, including NPs, are formally recognized in Belgium since 2019, but there is still no legal framework in which additional rights or agreements compared to other nursing groups are defined. Given the early stage of introduction, little is known about the development, implementation and impact of NPs in the Belgian health care context. Insights in implementation processes and the effectiveness of NP roles at different levels can inform healthcare managers and policy makers for future (nation-wide) implementation in a hospital setting. The overall objective of this longitudinal pre-post mixed methods study is to develop, implement and evaluate the integration of the role of NPs in four different departments in a Belgian university hospital.

The Right Care, for the Right Patient, at the Right Time, by the Right Provider: A Value-based Comparison of the Management of Ambulatory Patients With Acute Health Concerns in walk-in Clinics, Primary Care Physician Practices and Emergency Departments

INTRODUCTION Whereas low-acuity ambulatory patients have been cited as a source of emergency department (ED) overuse or misuse, it is argued that patient evaluation in the ED may end up being more cost-effective. The COVID-19 pandemic has complicated the debate by shifting primary care practices (PCP) and walk-in clinics (WIC) towards telemedicine, a consultation modality presumed to be more efficient under the circumstances. OBJECTIVES To compare, from patient and healthcare system perspectives, the value of the care received in person or by telemedicine in EDs, WICs and PCPs by ambulatory patients presenting with one the following complaints: 1) Acute diarrheas; 2) Sore throat; 3) Nasal congestion; 4) Increased or purulent nasal discharge; 5) Earache or ear discharge; 6) Shortness of breath; 7) Cough; 8) Increased or purulent sputum; 9) Muscle aches; 10) Anosmia; 11) Dysgeusia; 12) Burning urine; 13) Urinary frequency and urgency; 14) Dysuria; 15) Limb traumatic injury; 16) Cervical, thoracic or lumbar back pain; and 17) Fever METHODS The investigators shall perform a multicenter prospective cohort study in Québec and Ontario. In phase 1, a time-driven activity-based costing method will be applied at each of 14 study sites. This method uses time as a cost driver to allocate direct costs (e.g. medication), consumable expenditures (e.g. needles, office supplies), overhead (e.g. building maintenance) and physician charges to patient care. The cost of a care episode thus will be proportional to the time spent receiving the care. At the end of this phase, a list of care process costs (e.g. triage, virtual medical assessment) will be generated and used to calculate the cost of each consultation during phase 2, in which a prospective cohort of patients will be monitored in order to compare the care received in EDs, WICs and PCPs. Research assistants will recruit eligible participants during the initial in-person or virtual visit. They will complete the collection using local medical records and provincial databases. Participants will be contacted by phone for follow-up questionnaires 1-3 and 8-14 days after their visit. Patients shall be aged 18 years and over, ambulatory throughout the care episode and have one of the targeted presenting complaints mentioned above. The estimated sample size is 3,906 patients. The primary outcome measurement for comparing the three types of care setting will be patient-reported outcome scores. The secondary outcome measurements will be: 1) patient-reported experience scores; 2) mean costs borne wholly by patients; 3) the proportion of return visits to any site 3 and 7 days after the initial visit; 4) the mean cost of care; 5) the incidences of mortality, hospital admissions and placement in intensive care within 30 days following the initial visit; 6) adherence to practice guidelines. Multilevel generalized linear models will be used to compare the care setting types and an overlap weights approach will be applied to adjust for confounding due to age, sex, gender, ethnicity, comorbidities, registration with a family physician, socioeconomic status and perceived severity of illness. EXPERTISE This research project brings together a strong team with expertise in emergency and primary care, pneumonology, performance assessment, biostatistics, health economics, patient-oriented research, knowledge translation, administration and policymaking. IMPORTANCE The endpoint of our program will be for policymakers, patients and care providers to be able to determine the most appropriate care setting for the management of ambulatory emergency conditions, based on the value of care associated with each alternative.