Clinical Research Directory

Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy

This multicenter pilot study evaluates the feasibility, implementation fidelity, and preliminary effects of the GAP-421 (Personalized Care Management) model for chronic pain management in primary care physiotherapy. The GAP model is a time-limited organizational modality that reconfigures schedules, resources, and professional roles during a defined 6-week window to organize care around the individual patient and their trajectory, formalizing coordination work that previously occurred informally. The study uses a convergent mixed-methods design across three primary care health centers in the Southeast Healthcare District (DASE) of the Community of Madrid, Spain. The quantitative component is a prospective multicenter pre-post case series with 3-month follow-up (n=66 patients, 22 per center). The qualitative component includes semi-structured interviews (n=12) and focus groups (3 groups, n=6 each). Integration occurs through Joint Display, Pillar Integration Process, and a 9-type legitimation framework. The primary outcome is patient-perceived care coordination measured on a 0-10 numerical scale (PREM). Secondary outcomes span five domains: patient-reported outcomes (EQ-5D-5L, Graded Chronic Pain Scale, pain intensity), professional outcomes (coordination burden, role clarity), system sustainability (avoidable re-consultations, emergency department use), implementation fidelity, and feasibility indicators. Results will generate feasibility parameters, intraclass correlation coefficient estimates, and process indicators essential for designing definitive cluster-randomized trials testing organizational interventions in primary care physiotherapy.

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.

Proactive Telemedicine to Improve Healthcare Access and Prevention in Rural Primary Care (PTM)

The study evaluates whether Proactive Telemedicine (PTM) can improve healthcare access for individuals who have not contacted their primary care team for at least one year, compared with face-to-face visits. PTM consists of brief, remote behavioral interventions addressing modifiable risk factors such as tobacco use, alcohol consumption (AUDIT-C: Alcohol Use Disorders Identification Test - Consumption), physical activity (IPAQ: International Physical Activity Questionnaire), and Mediterranean diet adherence (PREDIMED: Prevención con Dieta Mediterránea). PTM follows national preventive protocols including PAPPS (Programa de Actividades Preventivas y de Promoción de la Salud) and uses validated tools such as EuroQol-5D-5L (EQ-5D-5L) to measure healthcare accessibility and quality-of-life outcomes. This randomized non-inferiority trial aims to determine whether PTM is as effective and safe as traditional in-person consultations.

District Health Centre Membership Among Older Adults in Hong Kong

This study is a cluster randomized controlled trial study to evaluate the feasibility, acceptability, and effectiveness of intergenerational home-based and AI-generated digital interventions in improving the proportion of District Health Centre members among older adults in Hong Kong.

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes

This study is being done to investigate strategies that may improve patient's knowledge of type 2 diabetes during reproductive age and improve knowledge and engagement in self-care activities.

Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease

The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention is to integrate a patient-centered advance care planning process into primary care, ultimately helping patients to receive medical care that is aligned with their values. The ENACT Group Visit intervention involves two group discussions about advance care planning with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. This study will compare the ENACT Group Visit intervention to mailed advance care planning materials.

Online Access to Clinical Treatment Notes for Outpatients

This study investigates the feasibility and impact of patient access to clinical notes written by their healthcare providers-a concept known as Open Notes. While international research has already demonstrated positive effects of Open Notes on patient empowerment and treatment outcomes, there is a lack of corresponding evidence for the German healthcare context. The quasi-experimental study therefore combines quantitative and qualitative methods to evaluate the effects of Open Notes on patient-reported outcomes as well as clinical practice. The study is structured into five modules, each addressing specific research questions: Module A - Summative Outcome Evaluation in Patients: Does the use of Open Notes lead to a significant increase in patient-reported outcomes such as empowerment and self-efficacy? Module B - Formative Process Evaluation with Stakeholders: What experiences do patients, relatives and clinicians have with Open Notes and what challenges and barriers arise in their use? Module C - Changes in Clinical Documentation: How do language style and content of clinical notes change when they are shared with patients as Open Notes? Module D - Optimization through Artificial Intelligence: Can clinical notes be processed using artificial intelligence in a way that makes them easier for patients to understand compared to conventional medical documentation? Module E - Integration into National Data Infrastructure: What technical, organizational and legal requirements must be met to successfully integrate Open Notes into the national telematics infrastructure and the electronic health record or routine care? The overall goal is to identify both patient-related outcomes and structural conditions for the sustainable implementation of Open Notes in the German healthcare system. The use of artificial intelligence is intended to further enhance patient-centeredness while reducing the burden on clinical staff.

Eligibility of Patients Referred to Emergency Departments by Their General Practitioners for Care in Walk-in Clinics: A Single-Center Study in Île-de-France

This study aims to find out how many patients sent to the emergency department by their general practitioner could instead be treated in a walk-in clinic. Walk-in clinics provide quick, basic medical care without an appointment and can perform simple tests like blood work and X-rays. By identifying patients who don't need full hospital emergency care, this study hopes to improve patient flow and reduce overcrowding in emergency rooms in the Île-de-France region.

Assessing the Effectiveness of Heat Adaptation Digital Messages From Primary Care Providers to Their Patients on the Change in Behaviour for Heatwave-related Preparedness

Extreme heat events pose a significant health threat in Canada, as demonstrated by the 2021 heat wave that claimed over 600 lives in Western Canada. Most heat-related deaths occur indoors and are preventable. Primary care providers (PCPs), who serve 88% of Canadians, are uniquely positioned to identify and support at-risk individuals. Heat Smart, in alignment with Heat Alert and Response Systems (HARS), aims to bridge the gap between primary care and public health to enhance community resilience and reduce health inequities related to extreme heat events. This randomized control trial in Eastern Ontario will examine whether patients receiving tailored digital health messages from their family physician or nurse practitioner change their behaviour to protect themselves from extreme heat-related illness. The Heat Smart study will: * Assess risk: Analyze electronic medical records and patient surveys to identify vulnerable individuals. * Deliver tailored messages: Send personalized digital guidance via e-mail or text, offering heat safety advice and local resource information in English and French. * Issue early warning alerts: Notify at-risk patients of upcoming heat events, prompting action. * Evaluate impact: Use surveys and health data to measure effectiveness in reducing heat-related health impacts. Short-term outcomes include increased awareness and preparedness among patients about heat-related health risks. Long-term goals involve scaling the intervention across Canada to reduce heat-related illnesses, enhance social connectedness, and decrease healthcare utilization.

Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety

Symptoms of generalized anxiety is common in the general population and is often treated in primary health care. Anger is an emotion that can lead to interpersonal problems but can also be an agent for justice and change. Previous research has shown a link between generalized anxiety and anger but there is a lack of qualitative research investigating how individuals with symptoms of generalized anxiety experience anger. The aim of this research study is to increase knowledge about how anger is experienced in adult patients in primary health care with symptoms of generalized anxiety and about the experiences of health care professionals working with patients with symptoms of generalized anxiety.

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.

Impact of a Community-Based Primary Health Care Project on the Inappropriate Use of Emergency Medical System in Bergamo

The goal of this study is to reduce the inappropriate use of the Emergency Medical System in Bergamo. The main question it aims to answer is: can a Community-Based Primary Health Care Project impact on the use of the Emergency Medical System in Bergamo? Monthly changes in urgent calls to the Emergency Medical System will be analysed.

Report Cards and Feedback for PCCE

As part of UCLA Health's commitment to developing an integrated health system built on a foundation of physician-led, team-based primary care, the Department of Medicine (DOM) implemented a performance-based incentive plan called the Primary Care Clinical Excellence (PCCE) Incentive Plan. The UCLA Health DOM Quality team is leading the implementation and evaluation of this incentive plan across the UCLA Health primary care network, with the primary goal to immediately produce improvements in the quality of primary care. In order to rigorously measure the most efficacious ways to frame and communicate information about the quality improvement (QI) program, the DOM Quality team has partnered with the UCLA Anderson School of Management. Understanding the factors that motivate physicians to deliver high quality primary care will provide pivotal insights into the successful implementation of performance based programs nationwide.

Nursing Practice Environment and Patient Safety in Primary Health Care

The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.

Options for Lowering the Threshold to Brussels Out-of-hours Primary Care Services for Dutch Speaking Citizens

The purpose of this qualitative study is to find out which technological translation tools can be used to improve Dutch-speaking care in all Brussels out-of-hours primary care services.

Effect of Chronotherapy on Blood Pressure - Time of Intake of Blood Pressure Lowering Drugs

A randomized clinical trials with cross-over design to evaluate changes in blood pressure, renal function (creatinine, estimated glomerular filtration), LDL and HDL-cholesterol after taking antihypertensive drugs in the morning or at bedtime. Blood pressure will be estimated by ambulatory blood pressure measurements. There will be a shift in time of drug intake after 8 weeks for each participant. Approximately 100 individuals aged 40-75 years and on stable anti-hypertensive treatment and blood pressure \<150/95 mm Hg will be recruited. No new drugs will be introduced during the study.

Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial

Urinary incontinence (UI) is a condition with involuntary leakage of urine. UI has a significant impact on health related quality of life, poorer sleep quality and sexual function, reduced participation in social and physical activities and is associated with large health care charge. Non-surgical method is always recommended as first action with a step-by-step care starting from non-invasive to more invasive interventions. Systematic overview shows that available non-surgical treatment options in primary care indicated low results in improving effect. HIFEM® technology is a non-invasive method and studies showed significant result on women with UI. For Swedish healthcare HIFEM® is a new medical technology product to treat UI. However, there is a lack of knowledge about the HIFEM® effect in women seeking primary care. The aim is to evaluate the effect of high-intensity electromagnetic energy (HIFEM®) on pelvic floor muscles, urinary leakage, sexual function, and health-related quality of life in women with urinary leakage in Swedish primary care, as well as to evaluate cost-effectiveness. The intervention included six 30 minutes HIFEM® sessions once a week over six weeks compared with control group. The results are expected to lead to effective non-surgical treatment options that can reach many patients, contribute to improving existing routines and can be a new potential way to support health promotion care in primary care and be a cost-effective investment.

Interprofessional Collaborative Practice in Primary Care: Potentially Avoidable Hospitalization

The World Health Organization supports collaborative practice in primary care, defining it as "when multiple health professionals from different professional backgrounds work together with patients, families, carers and communities to deliver the highest quality of care across settings" (1). Previous research have shown that collaborative practice in primary care improves care pathways, efficiency of care (2,3), job satisfaction among health professionals (4-6), and economic efficiency (3,7). Riverin et al. found a reduction in post-hospitalization mortality with collaborative practice (8). In France, the establishment of primary care teams following the American model of Centered Medical Homes is encouraged. In the Pays de la Loire region, two models exist: A national and a regional model. A major issue for patient care team is the care of seniors (9,10).Hospitalizations can have adverse health effects for this population (11,12). 45% of emergency admissions follow by a hospitalization concern them (13). The hypothesis of the study is that collaborative practice could reduce the global rate of potential avoidable hospitalizations among seniors.

CRP and Lung Ultrasound in Respiratory Evaluation

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists. This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.

Identification of Interpesonal Violence

The goal of this study is to increase primary care professional's ability to identify individuals exposed to intimate partner violence (IPV) in primary health care settings. The main questions it aims to answer are 1. To what extent do the following three interventions contribute to identify potential victims of IPV: (1) the use of a standardized questionnaire that screens exposure to IPV, (2) staff using tailored virtual patients for clinical training on IPV and (3) a combination of interventions 1 and 2? 2. Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV? Participants will be divided to apply one of the three interventions in their health care setting: 1) a standardized questionnaire to patients, 2) virtual patients tailored to health professionals, and 3) a combination of 1 and 2. Pre-and post-measurement of the health professionals identification of patients exposed to IPV will will be used to explore the effect of the interventions. Focus group interviews with the participating health professionals will be a qualitative complement. The participants will be asked about what intervention they experience as the most effective in increasing the ability to identify victims of IPV.

The Effects of Primary Care Behavioral Health in Primary Care in Sweden

The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.

PrimeCog: Primary Care Cognitive Testing

The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated.

Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.

Little research on the health service utilization and the health situation of undocumented pregnant migrants has been performed previously, and it is essential to obtain more information on the services given, and to examine whether residency status is a risk factor in maternal and perinatal health among migrants.This project will give new knowledge on undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The project will present new knowledge by showing trends in undocumented pregnant migrants care seeking compared to general trends among other migrants and Norwegian residents. It will also give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants compared to foreign and Norwegian born women. This approach has not previously been used to study undocumented migrants in Norway, and there are very few similar studies in other European countries. Cause and effect relations are rarely claimed in findings from observational epidemiologic studies, however the information from three different sources (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall picture of the use of primary health care in undocumented pregnant migrants, as well as a comparative assessment of maternal outcomes in this population. The proposed research will also give important knowledge on how to conduct quantitative research in a population that is difficult to reach, and that is not commonly included in research.