Clinical Research Directory

Pharmacist Intervention to Reduce Post-Hospitalization Utilization

This is a randomized trial testing a peri- and post-discharge pharmacist-led medication management intervention on post-discharge utilization, including both readmissions and emergency department visits within 30 days of discharge. The intervention incorporates evidence addressing three main areas: medication reconciliation, medication adherence, and polypharmacy. This study uses a pragmatic trial randomized at the patient level and conducted in two large hospitals to achieve the following aims, each of which has been designed using the RE-AIM framework: Aim 1: To test the effect of PHARM-DC on post-discharge utilization among patients most at risk for post-discharge ADEs: recently discharged older adults taking \>10 medications or \>3 high-risk medications using a prospective, randomized, pragmatic multi-site study. Aim 2: To study barriers and facilitators of implementing PHARM-DC using a qualitative study. Aim 3: To analyze the costs of PHARM-DC, including the incremental cost per readmission averted and the net incremental cost from the health system perspective using a time-and-motion study and a cost-effectiveness analysis.

Preemptive Pharmacogenomics Testing Among Geriatric Patients

The primary goal of this study is to conduct pharmacogenomics testing (a type of DNA test) within an aging population and measure the impact of this test on medication selection, dosing, and costs of care.

Population Health Approach to Optimizing Medications in Older Adults

This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.

Prescribing Outcomes of a GP-Targeted Deprescribing Educational Intervention: A Cluster Randomized Trial

Polypharmacy is a common and growing public health concern across healthcare settings worldwide and is associated with an increased risk of inappropriate prescribing and adverse drug events. Deprescribing-defined as the supervised withdrawal of potentially inappropriate medications using structured tools and clinical judgment-has been proposed as a strategy to improve prescribing safety. In Greece, formal initiatives and evidence evaluating deprescribing interventions in primary care remain limited. This study is a cluster randomized controlled trial evaluating the effect of an educational intervention for general practitioners (GPs) on prescribing safety in primary care. Participating GPs are randomized in an approximately 1:1 ratio to an intervention or control arm. GPs in the intervention arm receive structured education and training on medication review and deprescribing, including the use of validated deprescribing tools such as the Beers Criteria. GPs in the control arm provide usual care and do not receive any educational intervention. Patients receiving care from participating GPs are recruited, and prescribing outcomes are assessed at the patient level. The primary outcome is change in prescription medications following the intervention, comparing patients cared for by GPs in the intervention arm versus those cared for by GPs in the control arm.

Telecommunication Technology-based Online Survey

The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. The cohort is built using telecommunication approaches. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics will be assessed. The continuous depersonalized online survey is performed using the original informational resources in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation.

Empowering Patients to Improve Safety in Polymedication

Rationale: In current clinical practice, polypharmacy and patient empowerment are critical yet often overlooked. Polypharmacy, the chronic use of five or more drugs, poses risks such as adverse drug reactions and decreased medication adherence, especially in elderly and multimorbid patients. Despite the interconnected nature of drug-drug and drug-gene pro inter-actions, they are considered separately. Ignoring these interactions can be hazardous, yet clinical trials to investigate them are infeasible due to fast-growing complexity, variability among patients, high costs associated with large-scale studies, and ethical and logistical chal-lenges. Consequently, there is a substantial knowledge gap in managing complex medication regimens in real-life scenarios and providing guidelines to enhance patient empowerment and drug safety. The SafePolyMed project aims to develop a patient-centred framework to define, assess and manage drug-drug, drug-gene and drug-drug-gene interactions. This framework, a web-based medication management centre, will support patients in managing their therapy-related health data, enhancing education and empowerment, and improving patient safety. Objective: To assess the impact of the developed medication management centre on patient empowerment in polypharmacy patients, thereby improving drug safety. Secondary objec-tives are to explore if the tool is able to identify patients at risk for a drug-drug-gene interaction and lower the adverse drug event rate. Study design: The study is a proof of concept study conducted at four institutes located in Germany, Greece, Slovenia and The Netherlands. Polypharmacy patients will use the medi-cation management centre (MMC), which provides curated, patient-specific information about drug interactions and PGx. To assess patient empowerment, patients will receive ques-tionnaires during a 12 week follow-up period. Study population: 120 subjects with polypharmacy (defined as the chronic use of 5 or more drugs) of at least 18 years of age, with a first prescription for one of 10 index drugs. The study will be performed at 4 different sites (Leiden (NL), Patras (GR), Ljubljana (SL), Aachen (DE)) to represent different clinical settings across Europe. Each site will recruit 30 patients. Intervention: The MMC that provides patient centred information on drug-drug interactions and pharmacogenetics affecting personal polytherapy. The MMC will show a selection of high quality publicly available information such as details on different types of medications, includ-ing their uses, side effects and instructions for use, in the language of the patient. This infor-mation is targeted at an individual patient's medication profile to inform patients to better un-derstand and deal with their personal health information, with regard to drug therapy. Patients in the Netherlands, Slovenia and Greece also will receive their PGx profile to further personal-ise the MMC experience. Main study parameters/endpoints: The primary outcome is the sense of empowerment and health literacy for participants before and after use of the MMC. Secondary outcomes include an evaluation of the drug-drug-gene interactions and adverse drug events in the study popula-tions compared to matched historical controls. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Patients are exposed to the regular treatment. In addition, patients will receive questionnaires at baseline, two, and twelve weeks regarding the use and experience of the medication management centre, and a close-out interview at week twelve. In addition, 10ml of blood will be collected during a venipuncture for pharmacogenetic analyses. Benefits include having access to the medication management centre for the duration of the study. Additionally, patients will receive their PGx profile. This can be used to individualize drug treatment, based on the Dutch Pharmacogenetics Working Group (DPWG) guidelines. Overall, minimal risks are expected for subjects as they will receive normal clinical care. In-formation from the MMC will be a curation of existing publicly available data. Any information regarding DDIs and DGIs will be supplemented with a disclaimer that the patient should not adjust their treatment without talking to a healthcare provider.

Testing a Smart Medication Dispenser (Mobili®) to Help People With Chronic Conditions Take Their Medicine

Medication adherence is one of the biggest challenges faced by healthcare systems, especially among people with multiple chronic diseases who take several medications daily. Studies show that up to half of patients do not take their medication as prescribed, which can compromise treatment effectiveness, increase complications, and lead to waste of healthcare resources. In this context, several solutions have been developed to help patients organize their therapy, such as dose administration aids (DAAs) used in pharmacies. However, many of these systems are manual, inflexible, or difficult to use. This study is part of the MobiMAd@PT project, which will evaluate Mobili®, a portable digital medication dispenser developed in Norway. Mobili® allows patients to automatically receive the right medication at the right time and comes with a real-time monitoring system, enabling healthcare professionals to detect missed doses and provide timely support. The main goal of this study is to assess the effectiveness of Mobili® in improving medication adherence among patients with polypharmacy in Portugal and to understand whether this type of technology can be useful and applicable in the context of Portuguese community pharmacies. Your participation will contribute to the development of new ways to manage health at home, with the support of pharmacists and technology.

Evaluation of the Impact of a Collaboration Between Hospital and Community Pharmacists at Hospital Discharge

The aim of this study is to evaluate the impact of an enhanced collaboration between a hospital pharmacist and a community pharmacist during hospital discharge. For patients taking multiple medications, hospitalization often involves numerous changes to their treatment regimen. For community pharmacies, discharge prescriptions are often complex, and they sometimes lack the information that pharmacists need to deliver the treatment as safely as possible. As a result, there is a risk of medication errors, and a risk for patients. We aim to evaluate the benefits of this collaboration for adult patients admitted to the internal medicine ward of a regional hospital who are taking seven or more drugs and are being discharged to home. The main question it aims to answer is : Does the enhanced collaboration reduce the number of drug-related problems encountered by community pharmacists with discharge prescriptions ? Researchers will compare patients when a hospital pharmacist is involved during the discharge process and when he or she is not involved, which corresponds to normal care. The hospital pharmacist will not perform the intervention directly on the patient, but only with the community pharmacy. Once they agree to participate in the study, patients will only have to go to their usual community pharmacy after discharge and accept that the hospital transmits medical information to their usual pharmacy.

Less Is More: Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple

The goal of this cluster randomized controlled trial is to compare transitional multidisciplinary pharmacotherapeutic care (TMPC) with usual care in patients aged 70 years or older with polypharmacy, admitted to the hospital via the emergency department for longer than 24 hours and that have an elevated risk of drug related readmissions. The primary aims of the study are: * To assess whether TMPC leads to a decrease in number of DRreAs compared to usual care during the first 30 days after index hospitalisation. * To assess whether TMPC is cost-effective Participants will receive TMPC in hospitals allocated to the intervention. TMPC will be executed by a pharmacotherapeutic team, it consists of the following four elements: * pharmacotherapeutic analysis * transitional multidisciplinary discussion * pharmacotherapeutic care interview and discussion with the patient * discharge note with the pharmacotherapeutic care plan Researchers will compare TMPC with usual care to assess the effect and cost-effectiveness of TMPC.

The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment

To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage.

Improving Medication Management in World Trade Center Responders

By 2030, the majority of World Trade Center (WTC) rescue and recovery workers (responders) will be aged 65 and over and at risk for aging-related conditions and consequences including the concurrent use of five or more medications (i.e., polypharmacy). The purpose of this research study is to investigate an educational approach targeting polypharmacy through de-prescribing unnecessary and burdensome medications via the support of informed discussions between WTC responders and their prescribing physicians.

Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults

The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are: 1. The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge 2. The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.

Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment. The main questions this trial aims to answer are: Aim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects. Aim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.

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.

Holistic Integration for Healthy Longevity and Aging in Place

Background: Taiwan is experiencing rapid population aging, with a growing prevalence of chronic diseases and functional impairments among older adults. Existing Integrated Care for Older People (ICOPE) programs focus primarily on screening but lack sufficient follow-up and intervention. In response, the HI-HOPE Project was developed to establish a community-based, multidisciplinary intervention model to enhance intrinsic capacity and promote healthy aging in rural elderly populations. Survey and Screening: The study will be conducted in 30 community centers across Yunlin County, targeting older adults aged ≥55 years. Participants will undergo biannual screenings over two years, assessing cognitive function, depression, mobility, vitality (nutrition), hearing, vision, osteoporosis, polypharmacy, urological health, and social participation \& welfare. Intervention: Participants will be randomly assigned to either: HI-HOPE Integrated Care Group: On-Site Community Interventions: Exercise training, mindfulness, social activities, oral and swallowing rehabilitation, hearing and vision training. Telehealth \& Remote Education: Digital health monitoring, remote consultations, and health education. Referral Services: Access to specialized medical care, transportation assistance, and follow-up support. Control Group: Standard community care services without additional structured interventions. Outcome Measures: Primary outcomes include changes in intrinsic capacity of functional health metrics, including abnormalities of I-COPE components (mobility, cognitive status, depression, hearing, vision, vitality) . Secondary outcomes assess quality of life, activities of daily living, hospitalization, emergency visits, falls, and mortality rates over two years. Significance: This project integrates digital health technologies, interdisciplinary care, and community-based interventions to improve elderly health outcomes. The findings will guide the future scalability of integrated aging care models in Taiwan and beyond.

Reduction of Polypharmacy in Elderly People With Multiple Diseases

Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.

The Critical Care Recovery Program: Use of a Structured Clinic Visit to Reduce Adverse Drug Events in ICU Survivors

Background and Objective: Intensive Care Units (ICUs) save lives, but many ICU survivors face ongoing health issues, including adverse drug events (ADEs) from medications started during their hospital stay. These ADEs lead to emergency department visits and hospital admissions. Our project aims to improve the health of ICU survivors by creating a clinic that focuses on managing post-ICU health. The clinic will track and address medical issues that arise after ICU discharge and focus on deprescribing, or safely stopping, medications that may no longer be needed or could be harmful. Project Plan: The clinic will be set up within the CARES clinic at VGH. Patients will be enrolled when they leave the ICU and will have follow up visits after hospital discharge. During these visits, the team will review each patient's medications and develop a personalized plan to reduce or stop unnecessary medications. We will also monitor patients for any new health issues that arise and provide eduction to patients and caregivers about managing their health. Research and Evaluation: We will collect and analyze data on patient health outcomes, including the incidence of ADEs, hospital reeadmissions, and emergency department visits. We hope to show that patients who receive follow up care have better health outcomes and use fewer healthcare resources than a historical cohort. This data will help us demonstrate the cost-effectiveness of the clinic and support the need for expanding ICU follow up programs in British Columbia. Long-term goals: We plan to establish a post-ICU care working group and expand the clinic model to other hospitals. Over the long term, we hope to standardize post-ICU care across BC, ensuring that all ICU survivors have access to comprehensive follow up care. This project will also lay the groundwork for future research on deprescribing medications for ICU related complications, which tend to improve or resolve once critical illness has resolved. The CCRP clinic will provide a setting to conduct clinical deprescription trials to establish whether long-term treatment of these complications is necessary. Conclusion: Establishing a post-ICU discharge follow up clinic with a focus on deprescription has the potential to improve the long-term health and quality of life for ICU survivors. By reducing unnecessary medications, we can prevent complications, reduce hospital readmissions and demonstrate the value of comprehensive post-ICU follow up care.

Prioritising Patient Medication Review: Hospitals Reaching Out

To examine the effect of a cross-sectoral medication review intervention to admitted multi-morbid, polypharmacy patients aged 65+ at SHS in two settings; an acute admission unit (typical admission time \< 48 hours) and a medical outpatient setting (patients routinely visits for follow-up, diagnosis or treatment, but do require a bed or overnight care).

Effectiveness of PGx Testing

The purpose of this study is to determine the clinical and economic effectiveness of a pharmacogenomic (PGx) approach to prescribing medications in patients with high-risk polypharmacy in an integrated healthcare delivery system. Investigators hypothesize that patients who receive the RightMed® PGx test from OneOme, LLC with subsequent counseling of their prescribers by a study pharmacist, as needed, on the appropriateness of their prescribed medications will experience lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care.

Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine

Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.

Evaluation of Medication Management Service

Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects: * To evaluate the perception and satisfaction of patients on MMS service * To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems * To identify and categorize the types of drug-related problems identified during MMS * To evaluate the cost-effectiveness of implementing MMS in community pharmacies MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS.

Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.