Clinical Research Directory

Clinician Motivational Interviewing Training Evaluation

The goal of this study is to evaluate the impact of motivational interviewing (MI) training for Geisinger clinicians on their patients' health outcomes. Clinicians will be randomly assigned to attend or not attend mandated MI training, which will be provided at one of several sessions offered beginning in August 2026. Randomization will be stratified by department to ensure participant balance and that participating departments maintain necessary staffing levels during the training period. The study will assess whether there is a significant increase in patients' positive health behaviors and outcomes, as reflected in an index measure of multiple outcomes that may reasonably be facilitated by MI training: vaccinations and health screenings as reflected in electronic health record care gaps. Smoking cessation and other lifestyle modifications, preventive medication adherence, and behavioral health use may also be examined as part of an overall measure of MI impact. For each clinician assigned to the study, all patients they see in the 90-day period following the (would-be) date of that clinician's training will be identified and enrolled in the study. Outcome timeframes will then be relative to each unique patient's first encounter following (would-be) training.

Assistive Device Rental/Purchase, LTC Service Use, and Caregiver Burden in Taiwan

The goal of this observational study is to examine the associations between assistive device approval and acquisition modality (rental or purchase), long-term care service utilization, and family caregiver burden among individuals receiving long-term care services in Taiwan. The study will use de-identified nationwide long-term care administrative data from 2021 to 2022. The main questions it aims to answer are: 1. What individual, disability-related, socioeconomic, residential, and caregiving factors are associated with assistive device approval, the number and type of approved devices, and rental or purchase modality? 2. Are assistive device approval and utilization patterns associated with the use of formal long-term care services and with family caregiver burden?

Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies

Hearing loss is a major public health concern due to its negative association with emotional well-being, cognition, and physical ailments, such as diabetes. Access to audiologists and otolaryngologists in many regions across the US is poor or extremely limited. Rural populations are older, less educated, and have lower household incomes compared to populations in metropolitan areas. Also, with increasing age adults experience greater rates of hearing loss. Fortunately, the 2022 FDA Final Rule for Over-the-Counter Hearing Aids (OTC HAs) could revolutionize assess to hearing aids and hearing healthcare by allowing adults with perceived mild-to-moderate hearing loss to purchase these devices over the counter, without medical clearance or care from an audiologist. Pharmacies located in rural areas now have the option to provide OTC HAs, something previously not possible. Currently, however, there are no established guidelines for effective provision of these devices in pharmacies located in rural communities. Educating pharmacy technicians to provide basic hearing healthcare related to OTC HAs use could address a critical need and create a new care delivery model to ensure sustainable, long-term access to hearing healthcare. The long-term goal of this study is to create a sustainable interprofessional collaborative between audiologists and pharmacists for the development of a hearing healthcare model that improves access and affordability of care in rural regions across the country. The specific aims are to 1) Determine an effective approach for educating pharmacy technicians for the provision of OTC HAs in rural community pharmacies, and 2) Identify satisfaction of care provided by pharmacy technicians and initial performance with OTC HAs in adults with hearing loss living in rural communities. A stepped wedged clinical trial design will be used to study the effectiveness of a comprehensive educational training program for pharmacy technicians. Technicians from rural Alabama and Mississippi, placed within four different clusters, will participate in a multimodal training program for the purpose of developing basic clinical skills to assist adults with perceived mild-to-moderate hearing loss. Additionally, adults with hearing loss who receive clinical services from trained pharmacy technicians will be asked to report on the care they received and benefit from their OTC HAs. The central hypotheses are a) that pharmacy technician training will result in greater understanding of hearing healthcare concepts compared to no training, and b) the training will lead to successful provision of basic hearing healthcare to adults with hearing loss in rural communities. The expected outcome of this project will be the establishment of a multimodal education program, leveraging the increased access of OTC HAs, to support those with hearing loss in rural pharmacies across the county. The ability of pharmacy technicians to provide this support will dramatically increase the availability of hearing services in rural communities, which will positively impact the quality of life for those with hearing loss.

Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)

The goal of this study is to implement Opioid Use Disorder Quality Measurement and Management (OUD-QM2) strategy by the Office of Addiction Services and Supports (OASAS) to drive change and improve treatment practices. Through a concurrent mixed methods approach that iteratively examines quantitative and qualitative data to inform the process, the investigators will examine the effects of the strategy on stakeholders-PWUD/patients, families, and providers-and outcomes. This comprehensive approach will allow for a "global" view of the perceived effects of the OUD-QM2 strategy for all stakeholders while allowing us to use administrative data to test the effects of the strategy on patient outcomes. Through qualitative interviews and focus groups conducted in years 1, 3, and 5 of the phase, the investigators will derive information from stakeholders about their perceptions and use of the quality measures. Through surveys conducted with all clinics, the investigators will elicit data on changes in provider use of quality measures, clinical practice, and use of measures for incentive-based contracting. Finally, the investigators will conduct a stepped wedge trial to examine the effects of performance coaching that guides clinics on use of the quality measures for clinical practice improvement. The trial will also benefit from a treatment as usual (TAU) condition of clinics not participating in the trial to examine secular trends in patient outcomes across the period of the OASAS QM2 strategy rollout. The overall aim is to build and test a science-based OUD-QM2 strategy for person-centered treatment.

Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects

This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects

Voice Assistant for Outpatient Neurology Visits

Documentation duties account for a substantial portion of an outpatient physician's working time and reduce time available for direct patient interaction. Voice assistants based on automatic speech recognition and large language models are being developed to automate medical documentation across clinical specialties. However, such ambient AI-based services have not been systematically validated in Russian-language outpatient neurology practice integrated with a regional electronic health record platform. This pilot, multicenter, prospective, before-after study evaluated the feasibility and preliminary effectiveness of a voice assistant Service designed to automatically pre-fill the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS). The Service implements a pipeline of streaming speech-to-text transcription, two-speaker diarization, and large language model-based mapping of the dialogue between the physician and the patient onto the fields of the standardized neurology examination protocol. Five neurologists at five outpatient clinics in Moscow participated. The study comprised three stages: (1) baseline timing of consultations without the Service; (2) timing of consultations with the Service after a two-week adaptation period, with parallel evaluation of transcription and pre-fill quality and of physician and patient satisfaction; and (3) statistical analysis. Three hundred twenty consultations were timed (160 per stage). A stratified random sample of 30 audio-recording / generated-protocol pairs was used to evaluate Service quality; free-text fields were rated on a 5-domain Likert questionnaire and on a 10-point visual analogue scale, and binary fields were rated dichotomously to derive sensitivity, specificity, accuracy, Jaccard index, and false-positive rate. Patient satisfaction was assessed by the modified Patient Satisfaction Questionnaire 8 (PSQ-8); physician feedback was assessed by a custom questionnaire (including the Net Promoter Score) and by semi-structured in-depth interviews with thematic analysis using grounded theory. The primary outcomes were the change between stages in (a) the time of focused physician attention to the patient and (b) the time spent filling and editing the protocol. Secondary outcomes addressed total consultation time, transcription quality (Word Error Rate), expert-rated quality of pre-filled fields, patient satisfaction, and physician satisfaction. The study was conducted under the framework of the Moscow Healthcare Department experiment on the use of digital innovation technologies in health care (Order No. 153 of 21 February 2025), and was approved by the local independent ethics committee.

Using Anonymous Data From A Digital Tool for Medical History-Taking To Improve Healthcare Services

This study aims to understand how people use a mobile app that helps them record their symptoms before going to the doctor. Patients use the app on a tablet or other digital device. The app guides patients through a series of structured questions tailored to their symptoms. The data collected is then transferred to the practice's electronic record and is available to the treating doctor before and during the consultation. In this project, anonymized usage data will be analyzed to contribute to the further development of the tool and to provide valuable insights for health services research.

Perceptions of Key Domains of Home-Based Palliative Care Among Healthcare Professionals (MULTIPAL)

This observational cross-sectional study evaluates and compares healthcare professionals' perceptions of key domains of home-based palliative care. Using an anonymous online survey and multicriteria decision analysis (MCDA) methods, the study explores perceived importance, strategic prioritization, and self-assessed performance across five core palliative care domains. The study is conducted across Hospital-at-Home units throughout the Valencian Community (Spain).

Implementation Pilot of Preoperative CGA Before Major Surgery

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.

Experiences of Early Postnatal Discharge Home as Perceived by Mothers and Healthcare Professionals

In recent years, the average length of stay in maternity units has decreased, leading to the development of early postnatal discharge home (EPDH) programs. Postnatal follow-up is a major public health issue, as it supports the physical and psychological well-being of mothers and newborns, helps parents adjust to their new roles, and promotes health prevention and education. International studies show that mothers expect longer and more comprehensive follow-up, particularly regarding child development, sexuality, contraception, and returning to work. In France, EPDH has existed since the early 2000s and is offered to low-risk mothers and newborns shortly after birth, with two or three follow-up visits at home or in healthcare facilities. As these programs are expected to expand, there is a need to better understand the experiences and needs of both mothers and healthcare professionals. This qualitative study, conducted in the Val-de-Marne department, aims to explore how they experience early discharge at individual, organizational, and medical levels. It seeks to identify the factors that contribute to positive or negative postnatal experiences and to compare local findings with existing international research.

Care Pathways and Disparities in Care for Older Patients With Cancer: Typology, Determinants and Effect on Prognosis ( PASSAGE )

More than half of new cases of cancer in Europe in 2022 occurred in people aged over 70. In addition to cancer, the majority of older people have one or more illnesses that may interact with the treatment decision, cancer progression, tolerance and efficacy of treatments, quality of life, care pathway and survival. Furthermore, cancer treatments are most often evaluated in middle-aged subjects without severe disease, so the real-life management of older patients is often empirical. The general objective of the PASSAGE project is to assess the hospital care pathways of older patients with cancer treated at AP-HP by evaluating key elements of these pathways from both geriatric and therapeutic perspectives. Characterizing these care trajectories will help identify the most vulnerable patient profiles and potential disparities in access to care, with the goal of optimizing the management of elderly patients with cancer. The aims of this research are 1) to provide a better description of trends in the management of older cancer patients in routine clinical practice, and 2) to assess the impact of frailty, multimorbidity and the management of these patients on the prognosis of the disease.

A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone

This is a three arm cluster randomized control trial to determine if proactive community case management (ProCCM) conducted over a short period of time improves care-seeking indicators for febrile illnesses in children in hard to reach (HTR) areas of Sierra Leone compared to integrated community case management (iCCM). The three arms include: 1. Optimized standard of care for CCM plus ProCCM - ProCCM will be implemented for two months near the start of the transmission season, and the existing program will be supplemented to ensure that HTR CHWs have all commodities needed for malaria testing and treatment and are adequately trained on SBCC messages to ensure activities are implemented as designed. 2. Optimized standard of care- as in arm 1 without ProCCM 3. Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.