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Clinical Research Directory

Browse clinical research sites, groups, and studies.

26 clinical studies listed.

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Primary Care

Tundra lists 26 Primary Care clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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RECRUITING

NCT07270926

Feasibility Study of a Patient-centered CDS for Recommended Screenings in Primary Care

Primary care professionals (PCPs) are responsible for identifying patients who are eligible for all recommended screenings. Eligibility is difficult, given the number of screenings recommended by the French National Authority for Health (HAS), and the complexity of defining risk groups. When eligibility for one or more screenings is identified, the PCP informs the patient and can help him or her make the decision, considering his or her values and preferences. Lack of information for patients and lack of time for PCPs are the main obstacles to prevention in primary care (PC). Another barrier identified is the lack of opportunity for patients who do not consult their PCP very often, as they are less likely to be approached for preventive interventions due to other more urgent reasons for consultation. A Medical Decision Support System (MDSS) is a software application designed to be a direct aid to clinical decision-making, in which an inference engine matches individual patient characteristics with a computerized knowledge base or machine-learning algorithm to propose a risk assessment or adapted recommendations to the healthcare professional and/or patient. The aim of the ADER-F research program is to support the development and evaluation of a complex intervention centred on the use of a MDSS called "Lianeli". This complex intervention will ultimately contribute to structuring new consultations dedicated to prevention in general practice, by improving the physician's sense of self-efficacy in conducting the shared screening decision, and reducing the patient's decision-making conflict.

Gender: All

Ages: 18 Years - 74 Years

Updated: 2026-04-03

Primary Care
NOT YET RECRUITING

NCT07228065

Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control

The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2026-03-27

Hypertension
Primary Care
NOT YET RECRUITING

NCT07436026

Latin America Network for Primary Palliative Care

Palliative care is the holistic care provided to individuals and their families who experience health related suffering related to life-limiting conditions. Palliative care is practiced by speciality level clinicians and also non-specialists. The term Primary Palliative Care (PPC) refers to the palliative care provided in primary care by primary care staff. In Latin America (LA), palliative care services have shown strong growth over the past two decades, but remain established and integrated in only a few localised areas across the region. Building on the success of the UoE's Global Access to Palliative Care Latin America (GAP - LA) Project led by the Usher Institute and funded by the UK Medical Research Council (grant number MR/V021400/1), primary care has been identified as a natural area for capacity building and strengthening to reduce health related suffering from serious illness and improve end of life care in Latin America. The researchers will collaborate with Pallium Latin America (PLA), a LA association involved in advocacy, education and clinical care in the region. The objectives of this study are: 1. To explore the facilitators and barriers to the implementation of a Latin American contextualised primary palliative care from the perspective of family medicine doctors 2. To list and describe the models in which palliative care is delivered within primary care 3. To define the process and outcome measures which would be meaningful for measurement of primary palliative care A Participatory Action Research (PAR) framework will be employed, combining both qualitative and quantitative components over 24 months. 30 to 50 primary care health professionals across LA will be recruited from the network already established by PLA to become co-researchers in line with the PAR methodology. 1. Online case-based discussion meetings (around 12 every 6 to 8 weeks) and post-meeting survey 2. Online individual semi-structured interviews (20-30) 3. Online co-researcher focus group discussions (3-5) 4. Co-researcher surveys 5. Documentary analysis Online meetings, interviews and focus group discussions will be recorded, translated and transcribed. Transcripts and surveys will be the data for analysis using NVivo, RedCap and MS Excell software.

Gender: All

Updated: 2026-02-27

Palliative Care
Primary Care
Primary Care Physician
RECRUITING

NCT07019116

Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care

In Rio Grande do Sul, Brazil, the demand for specialty care referrals has increased sharply with the adoption of the electronic regulatory system, especially in rural areas. In 2023 alone, over 79,000 referrals were submitted monthly, totaling 1.7 million annual gatekeeping decisions. Due to workforce limitations, nearly 70% of referrals are authorized automatically, often without clinical validation. This leads to delays for high-risk patients, unnecessary specialist visits, and a growing backlog, currently over 172,000 pending referrals. To address this, an AI algorithm was developed to triage referrals based on urgency and appropriateness. The investigators propose a prospective controlled study with randomized implementation of the AI tool across selected specialty queues in the electronic referral system. The population will consist of referrals from specialties waitlists from municipalities in Rio Grande do Sul. Specialties to be included will be selected by the State Health Department prospectively according to gatekeeping needs. The intervention will be an AI-based triage algorithm. The control will be a standard gatekeeping process. The primary outcome is the proportion of referrals with a final decision (authorized or redirected to primary care) within six months; secondary outcomes include time to decision and appointment, system-level performance metrics. Referrals will be randomly assigned to algorithmic or human gatekeeping with a 1:1 ratio. The algorithm classifies referrals into two groups: not authorized (pending more data or teleconsultation), authorized. Authorization cases are further divided into routine and high-risk referrals to help the manage demand. Each AI prediction provides a probability from 0 to 1 of authorization (or deferring). The implementation threshold is set at 0.8; cases below this level will be classified as low confidence for decision and will not be included. According to the State Health Department's decisions, several referral lines are expected to be selected for the intervention. A sample size 934 (467 per arm) for each included specialty was calculated to detect a 1.2 relative risk for the primary outcome with 90% power and 5% significance.

Gender: All

Updated: 2026-02-20

1 state

Primary Care
Primary Care Patients With Chronic Conditions
RECRUITING

NCT07246837

Diagnostic Stewardship Intervention to Reduce Inappropriate Antibiotic Use for Urinary Tract Infections in Primary Care

Urine culture is the most common microbiological test in the outpatient setting in the United States. Unfortunately, contamination during collection is prevalent and undermines test accuracy, leading to incorrect diagnosis, unnecessary treatment, wasted laboratory resources, and inflated costs. Unnecessary antibiotic treatment increases the risk of developing antimicrobial resistance, one of the most serious threats to patients and public health. The goal of this clinical trial is to test whether a bilingual (English and Spanish) educational intervention, an animated video and pictorial flyer, can reduce urine culture contamination and associated inappropriate antibiotic use in adult patients visiting safety-net primary care clinics. The main questions it aims to answer are: 1. Does providing patients with a bilingual educational intervention reduce urine culture contamination rates? 2. Does the intervention lead to fewer unnecessary urinary antibiotic prescriptions? 3. Does providing patients with a bilingual educational intervention reduce contaminated urinalyses? Researchers will compare patients randomized to receive the educational intervention (video and flyer) to those receiving usual care to see if the intervention improves urine collection accuracy and reduces inappropriate antibiotic use. Participants will watch a short, animated video with step-by-step instructions for proper midstream clean-catch urine (MSCC) collection, receive a pictorial flyer (with stills from the video) reinforcing the instructions, and provide a urine sample for culture. Hypothesis: patients who receive the educational intervention will have: lower urine culture contamination rates (primary outcome), fewer urinary antibiotic prescriptions (secondary outcome), and fewer contaminated urinalyses (secondary outcome). The objectives are to (1) develop educational tools: Create an animated video and pictorial flyer with step-by-step urine collection instructions for women and men, developed through an iterative, stakeholder-engaged process, (2) assess acceptability: Use mixed methods (quantitative surveys and qualitative interviews) to evaluate and refine the tools for usability and cultural/linguistic appropriateness, and (3) test effectiveness: Conduct a randomized controlled trial to assess the intervention's impact on urine contamination rates, antibiotic prescribing, and patient satisfaction.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-13

1 state

Urinary Tract Infection(UTI)
Antimicrobial Stewardship
Primary Care
ENROLLING BY INVITATION

NCT07283055

A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care

The aim of the SINERGIC pilot study is to assess the feasibility in the Swiss context of implementing interprofessional medication reviews between GP and pharmacists, as part of a shared decision-making process with patients. The acceptability and potential effectiveness of such an intervention will also be assessed. This assessment will enable the investigators to take into account the determining factors for setting up a large-scale study to support the sustainable financing of this service in the long term.

Gender: All

Ages: 65 Years - Any

Updated: 2026-02-13

Medication Review
Primary Care
RECRUITING

NCT07314697

Arrival Time Implementation

This is a prospective clinical trial evaluating how behaviorally informed message framing can improve patient on-time arrival for outpatient visits. This trial is being implemented in conjunction with UCLA Health's broader operational quality improvement (QI) efforts to enhance clinic flow and patient experience. The main question it aims to answer is how displaying an explicit arrival time (set to 15 minutes before the scheduled appointment) affects when patients arrive for their appointments, compared to a control condition where only the appointment time is displayed and patients are encouraged to arrive 15 min before the appointment (without an explicit arrival time).

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-10

1 state

Primary Care
NOT YET RECRUITING

NCT07398053

General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients

In Belgium, many adults who have suffered from depression keep using antidepressants on a daily basis for years afterwards, sometimes longer than guidelines recommend. Yet for some people who have been feeling well for a long time, this is no longer necessary, while the continued use of antidepressants can lead to side effects and causes additional costs for the healthcare system. However, reducing the doses of antidepressants or stopping altogether is not always easy. Some patients are afraid that their depression will return, and GPs and pharmacists often find the subject difficult to broach. This is why the GPS-AD study is investigating a new approach in which GPs and pharmacists work more closely together to provide better support to patients. First, the GP invites patients who have been taking antidepressants for a long time for a consultation. Together, they discuss whether tapering of the medication is reasonable and feasible. If they agree to stop the treatment, the GP draws up a tapering plan tailored to the patient. The pharmacist helps monitor this process, offering advice and support to the patient while the doses are gradually reduced. The study will extend over a period of two years and will take place in GP practices throughout Belgium. The new approach based on closer collaboration between GPs and pharmacists will be compared to the current standard of care, to determine whether it helps more long-term users to stop taking antidepressants without experiencing a recurrence of depressive symptoms. The name of the study, GPS-AD (General Practitioner and Pharmacist Support for Antidepressant Discontinuation), refers to the collaboration between GPs and pharmacists in tapering of antidepressants, and also symbolises the support and guidance (the 'GPS') provided to patients and healthcare providers in assessing whether long-term use of antidepressants is still necessary.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-09

Deprescribing
Antidepressant
Depression Disorder
+2
ACTIVE NOT RECRUITING

NCT05412433

Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

Gender: FEMALE

Ages: 15 Years - 65 Years

Updated: 2026-01-26

1 state

HIV Prevention
Primary Care
PrEP
RECRUITING

NCT07362056

Implementing Suicide Prevention Into Primary Care in Nepal

Suicide remains a major contributor to global mortality, with particularly high and persistent rates in low-resourced settings such as South Asia. In Nepal, ongoing integration of mental health services into primary care provides a critical opportunity to strengthen suicide risk assessment and management. Despite the scale-up of mhGAP training for primary care providers (PCPs), gaps remain in the systematic detection, referral, and follow-up of individuals at risk for suicide. There is an urgent need to enhance mhGAP implementation with strategies that address provider workload, stigma, and inequities within the health workforce. Using experience-based co-design principles and RE-AIM this study will assess the feasibility and acceptability of integrating an implementation strategy package to optimize mhGAP suicide prevention delivery in Nepal's decentralized primary healthcare system. This clinical trial leverages deep collaboration with a community advisory board of individuals with lived experience of suicide throughout the trials' design, delivery and analysis. This R34 will generate critical preliminary evidence on the feasibility, acceptability, and implementation of an integrated suicide prevention package within government primary care facilities in Nepal. The findings will inform the design and parameters of a future fully powered effectiveness trial, while aligning with Nepal's national suicide prevention strategy and advancing WHO and NIMH global mental health priorities.

Gender: All

Ages: 18 Years - Any

Updated: 2026-01-23

Suicide
Primary Care
RECRUITING

NCT05091957

Connecting Families

Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.

Gender: All

Ages: 1 Day - 3 Years

Updated: 2026-01-13

1 state

Poverty
Primary Care
Intervention
ENROLLING BY INVITATION

NCT07294573

Maternal Health Assessment in Pediatric Care

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

Gender: FEMALE

Ages: 18 Years - Any

Updated: 2026-01-07

Postpartum Care
Primary Care
Mental Health
+2
RECRUITING

NCT06853626

One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care

Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin. In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria. In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires. This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.

Gender: All

Ages: 18 Years - Any

Updated: 2025-12-10

1 state

Acute Myocardial Infarction (AMI)
Chest Pain
Acute Coronary Syndromes (ACS)
+5
RECRUITING

NCT07130487

Project CARE: CAncer Risk Evaluation

The purpose of Project CARE (cancer risk assessment and evaluation) research study is to explore the acceptance and feasibility of a study-initiated proactive outreach and digital care delivery model for conducting hereditary cancer risk assessment in primary care settings and facilitating genetic risk evaluation for patients flagged as high risk. Potential participants will be recruited from Rutgers Health primary care sites (family practice and general internal medicine). EPIC will be used to identify all potential participants and they will be invited to participate in the study. Consented participants will be provided a link via email, and or text message to engage with a Relational Agent (RA, chatbot), through the patient portal for cancer risk assessment and genetic education. Those identified as high risk will be offered genetic counseling and testing. The research questions the study aims to answer are: 1. What percent of patients who completed the RA are identified as high risk? 2. What percent of patients who engaged with the risk assessment were identified as high risk? 3. What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?

Gender: All

Ages: 18 Years - 70 Years

Updated: 2025-11-25

1 state

Primary Care
RECRUITING

NCT07237919

Improving the Accuracy of Artificial Intelligence Triage in Primary Care

WHY ARE WE DOING THIS? When patients contact their GP practice, the first step is to work out what kind of help they need and how quickly it's needed. This is called 'triage' and is important for patient safety. Artificial Intelligence (AI) can help make triage faster. While AI is already being used in the NHS, we don't know how accurate it is or if it treats all patients fairly. WHAT WILL WE DO? We will collect anonymised data from patients that use an AI triage system called Patchs in GP practices in England. The project will last four years. We will analyse the data in four steps: 1. Look at data from GP practices using Patchs without AI triage to see how they currently triage patients and what problems they face. 2. Use data from GP practices using Patchs (both with AI on and off) to make the AI triage more accurate. 3. Check data from GP practices using Patchs with AI triage off to measure how well the updated AI system works. 4. Give the improved AI triage system to GP practices already using AI. At each step, we will check whether patients from different backgrounds are treated fairly. HOW WILL WE ANALYSE THE DATA? We will use statistical methods to compare the triage decisions made by the AI with those made by clinical staff. This analysis will also be used to check that the AI works fairly for patients from different backgrounds. WHAT DIFFERENCE WILL WE MAKE? Our research will show the problems with triage and explain how an improved AI system could help patients get the care they need more quickly.

Gender: All

Updated: 2025-11-20

Primary Care
Artificial Intelligence (AI)
RECRUITING

NCT07031817

Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility. The main research questions are : * Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ? * How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ? Participants will : * Provide a blood sample for biomarker analysis using the investigational diagnostic device. * Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI). * Share sociodemographic and clinical data relevant to psychiatric evaluation.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2025-10-07

Bipolar Disorder (BD)
Major Depressive Episode (MDE)
Primary Care
+1
RECRUITING

NCT07039253

Pilot Trial of Clinic-based Dating Violence Prevention Program for Adolescents and Caregivers

ETHR V 2.0 pilot trial is a one-arm, multi-site pilot trial to assess the acceptability and feasibility of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care.

Gender: All

Ages: 12 Years - Any

Updated: 2025-09-04

1 state

Dating Violence
Parent
Primary Care
NOT YET RECRUITING

NCT07145528

Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care

Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences. Objectives: Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population. Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic, intrinsic or environmental criteria Type of study: multicenter comparative cross-sectional study Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers) Study description: Cross-sectional, multicenter study. The patients will be included consecutively over a one-year period at the time of their visit to the inclusion center. Primary endpoint: score obtained for each of the 4 axes on the ad hoc psychosocial skills assessment test. Number of subjects: 600 patients (60 in each group) Inclusion criteria * Patients aged 18 and over, * Patients with chronic pain lasting at least 6 months, * Patients with alcohol dependence, * Patients victims of intra-family violence, * Patients who commit intra-family violence, * Patients followed in primary care and not presenting any of the 4 previous items, Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history. Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.

Gender: All

Ages: 18 Years - Any

Updated: 2025-08-28

Social Skills
Primary Care
ACTIVE NOT RECRUITING

NCT04961762

Navigator Program for Homeless Adults

Individuals experiencing homelessness often have complex health and social needs. This population also faces disproportionate systemic barriers to accessing health care services and social supports, such as not having primary care providers, needing to meet other competing priorities, and difficulties affording medications. These barriers contribute to discontinuities in care, poor health outcomes, and high acute healthcare utilization after hospitalization among this population. This randomized controlled trial aims to evaluate the effect of a case management intervention (the Navigator program) for individuals experiencing homelessness who have been admitted to hospital for medical conditions. This study will examine outcomes over a 180-day period after hospital discharge, including follow-up with primary care providers, acute healthcare utilization, quality of care transitions, and overall health.

Gender: All

Ages: 18 Years - Any

Updated: 2025-08-01

1 state

Homeless Persons
Case Management
Primary Care
+1
RECRUITING

NCT06856733

Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care

The goal of this clinical trial is to reduce inappropriate long term opioid treatment (LTOT) and to optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centred and team-based approach. The main question it aims to answer is: What are the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care? Researchers will compare a new person-centred and team-based approach to usual care to see if pain interference is lower. Participants will receive a person-centred team-based treatment consisting of: * Phase 1 (investigation and assessment, week 1-3): A medication review, pain analysis and other assessments through separate visits to a pharmacist, general practitioner, physiotherapist, psychologist and care manager * Phase 2 (treatment plan, week 3-4): A team consultations with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made based. * Phase 3 (treatment and follow-up, week 4-24): Implementation of the individualized rehabilitation plan with frequent follow-up contacts (1 per 1-3 weeks) by phone with the care manager.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2025-04-30

Chronic Pain
Chronic Pain Management
Primary Care
ACTIVE NOT RECRUITING

NCT06873243

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.

Gender: All

Ages: 18 Years - Any

Updated: 2025-03-12

1 state

Hypertension
Diabetes
Kidney Disease
+3
RECRUITING

NCT06852326

Designing a Tailored Primary Care Intervention to Manage the Burden of Caring for Patients Living with Alzheimer's Disease (or a Related Dementia)

The design of the intervention is an ongoing process which will consist of two phases: a determination of the intervention using the Delphi-modified consensus method and an assessment of its acceptability, as described in the methodological recommendations of the Medical Research Council Guidance.

Gender: All

Ages: 18 Years - Any

Updated: 2025-02-28

Primary Care
Alzheimer Disease
NOT YET RECRUITING

NCT06678906

Physical Inactivity and Sedentary Behavior: Screening and Intervention in Ambulatory Primary Care

Physical inactivity and sedentary behaviors are among the leading modifiable risk factors for chronic diseases. In France, despite the national Sport Health strategy, awareness campaigns physical inactivity and sedentary behavior worsened between 2005 and 2015. Primary healthcare professionals, including general practitioners and physiotherapists already involved in tertiary prevention, can act for primary and secondary prevention.

Gender: All

Ages: 18 Years - Any

Updated: 2025-02-10

Primary Care
NOT YET RECRUITING

NCT06580756

Problematic Use and Addiction in Primary Care

The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption. Other primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders. The hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers. The overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.

Gender: All

Ages: 18 Years - Any

Updated: 2024-12-09

Addiction Disorders
Primary Care