36 Clinical Trials for Various Conditions
The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men's engagement in preventive healthcare. The main questions it aims to answer are: Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons. Researchers will compare three arms (one that receives an offer of vaccines at bedside in the birthing clinic, one that receives an information flyer about the importance of preventive care in addition to the offer of vaccines and a third one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside) to see if there is a difference in vaccine uptake and engagement in healthcare Participants will complete two survey and one interview.
This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the United States. Study subjects must meet a set of inclusion and exclusion criteria. Potential subjects arriving at the study sites will be evaluated for enrollment. It is the Principal Investigator's (PI) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. Recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (HCP) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (IRB) or ethics committee (EC) when applicable.
It is widely accepted that prevention is far more impactful than curative medicine and must be included in primary care. In a previous pilot study, we evaluated passive video preventive lifestyle education in the emergency department. The current study is a randomized prospective trial assessing the practicality and impact of a brief interactive educational video intervention to patients during primary care clinic visits.
The goal of this study is to improve the use of preventive health services by implementing a multilevel intervention to stimulate Annual Wellness Visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 24 primary care practices over 24 months. Every 3 months, 6 practices will receive the intervention. Electronic health record (EHR) data extractions will be used to collect outcomes in a population cohort of patients. Semi-structured interviews will be conducted with clinicians/staff and patients to assess intervention implementation. The investigators hypothesize that the implementation will increase AWV visit use and consequently, use of preventive health services.
This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.
The goal of this study is to improve the use of preventive health services by implementing the AWV Practice Redesign Toolkit to stimulate AWV visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 16 small-to-mid-size primary care practices (at the practice level) with clinicians and staff. Eight practices will participate in the main clinical trial, and 8 in a replication study. The main clinical trial (with community-based practices) and replication study (with Federally Qualified Health Center practices) will be conducted simultaneously. Electronic health record (EHR) data extractions will be used to collect outcomes in a population cohort of patients. Semi-structured interviews will be conducted with clinicians/staff and patients to assess intervention implementation. The investigators hypothesize that the toolkit implementation will increase AWV visit use and consequently, use of preventive health services.
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.
The goal of this pilot clinical trial is to determine feasibility and explore whether immediate versus delayed patient financial incentives improve patient engagement with self-monitoring of blood pressure in patients with uncontrolled hypertension at Louisiana federally qualified health centers (FQHCs). The main questions it aims to answer are: * Do patients randomized to receive financial incentives on a weekly basis during the study (immediate) have better adherence to blood pressure self-monitoring compared to patients randomized to receive financial incentives at the end of the study (delayed)? * Do patients randomized to immediate financial incentives have better blood pressure control compared to patients randomized to delayed incentives? Participants will: * attend a baseline visit to measure blood pressure, respond to a baseline survey, and receive remote patient monitoring devices and instructions to take home with them (home blood pressure monitor, wrist-worn sensor to track sleep activity, and associated apps) * receive a random allocation to one of two groups: control condition (receive cash incentives at the end of the study for measuring blood pressure as instructed) or intervention condition (receive weekly cash incentives throughout the study for measuring blood pressure as instructed) * use remote patient monitoring devices during a two month study period, receive weekly reports on adherence to blood pressure monitoring, and receive weekly financial incentives (intervention condition only) * attend one follow-up visit at 2 months to measure their blood pressure, complete a follow-up survey, return the remote patient monitoring devices, and receive financial incentives for blood pressure monitoring (control condition only) Researchers will compare the immediate and delayed incentive groups to see if there are differences in blood pressure monitoring adherence rates and blood pressure control.
The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are: * Do patient financial incentives for completing colorectal cancer screening increase screening completion? * Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots? Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment. Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups.
The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.
Preventive care for adolescents is vitally important for maximizing their health and well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive needs of adolescents as demonstrated by poor health outcomes for this population. In this grant application, the investigators propose to expand an existing computer decision support system (CDSS) into the investigators adolescent primary care practices for the purpose of implementing a comprehensive, and developmentally appropriate, screening and physician decision support process. Prior work completed by the investigators research group has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines. The investigators seek to positively impact the effectiveness of preventative primary care visits by applying this previous success to the investigators adolescent practice. The investigators hypothesize that the implementation of developmentally appropriate universal screening practices, using tablet technology, and enhanced physician decision support regarding clinically relevant guidelines for all annual adolescent preventive care visits will result in better health outcomes, including higher rates of adherence to physician recommendations and improved patient functioning. The specific research aims of this proposal are: Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years and tailored evidence-based clinical decision support for physicians. Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of specific mental and physical health problems and treatment outcomes in an adolescent primary health care setting. Adolescent primary care issues of interest for this project include sexually transmitted infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The investigators expect this project to improve the health outcomes of adolescents, guide future efforts to implement universal screening and CDSS in a variety of primary care settings, and provide additional evidence to support broad-based electronic screening and computerized decision support for use in preventive care as a method for improving adolescent health.
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
The purpose of this research is to design and test a new model for delivery of well-child care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators used an innovative expert panel and community advisory board process to develop this new model for the delivery of WCC to low-income families in partnership with our partner community pediatric practices. The new model of care utilizes a trained health educator, or "Parent Coach" at every well-visit from 0-3 years of age. The Parent Coach provides a range of services, including health education and guidance, developmental screening, and psychosocial screening and services. The Parent Coach works with the Primary Care Physician to ensure that the family's needs are met for that well-visit. As a part of this new model for well-child care, the parent also uses a web-based tool to help prioritize needs for the visit and complete any necessary pre-visit screening. Parents receive additional education and guidance from a text message service and have access to the Parent Coach outside of the visit. The randomized controlled trial (RCT) of this new model of care will include 250 families who will be enrolled at participating clinics if the child is under 1 year of age. Parents will receive the intervention for 12 months and will complete surveys to collect data on their experiences of care. Our hypothesis is that this new model of care will be more patient-centered and more effective in providing recommended preventive care services than usual care, and that it will be a sustainable and feasible model for the partner practices.
This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.
Physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. This study will test the hypothesis that an electronic medical record enhanced with geographic information systems can improved physician counseling for physical activity, dental services, and academic support services by identifying services that are near the patient's residential address and informing MD's of such info at the point of care.
Americans only receive 50% of indicated preventive services. We hypothesize that an interactive preventive health record (IPHR) will increase the delivery of recommended screening tests, immunizations, and counseling. The IPHR will function as a highly sophisticated personal health record for prevention, linking patients directly to their health information in the electronic record of their primary care physician. The functions of the IPHR will extend beyond those of personal health records by providing tailored recommendations, links to educational resources and decision aids, and patient and clinician reminders. Year one will focus on updating and refining an existing IPHR prototype. The second and third year, through a randomized controlled trial, will examine the effectiveness of the IPHR. Outcomes will include (1) whether the IPHR increases the delivery of recommended preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR increases shared decision-making and improves clinician-patient communication. The study will take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network (ACORN) that utilize a common electronic medical record (EMR). A randomly selected sample of 5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a one-to-one ratio to receive a request from their clinician to use the IPHR (intervention group) or receive "usual" preventive care (control group). A Preventive Services Survey, which uses standardized questions to evaluate the delivery of preventive care, will be mailed to 4,500 patients and the CAHPS Clinician \& Group Survey will be mailed to 1,000 patients. Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months post-intervention. Delivery of preventive care will be measured by the Preventive Services Survey and EMR data, while shared decision-making and clinician-patient communication will be measured by the CAHPS survey. The change from baseline to 6 and 18 months post-intervention for the control and intervention groups will be compared.
The purpose of this study is to determine whether "video doctor" programs can effectively deliver preventive health messages to women of reproductive age while they wait to be seen in urgent care settings. In this study, the specific hypotheses being tested are: 1) is the video doctor program effective in improving women's knowledge about emergency contraception, and 2) is the video doctor program effective in improving women's knowledge about the importance of folate.
Heart failure (HF) patients with supportive caregivers have better physical health, emotional health, and quality of life. But caregivers have an increased risk of caregivers' own worsening health and often feel a sense of burden related to caregiving. However, caregivers receive very little support to balance caring for the patient with caring for themselves. Therefore, this research will provide a program for caregivers of advanced heart failure patients to build on the caregiver's strengths, sense of purpose, and set goals for healthy lifestyle changes. The investigators believe that caregivers who receive the program will have better quality of life, less sense of burden, and a healthier lifestyle.
The purpose of this study is to evaluate the impact of integrating ambulatory computerized physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety and quality domains in the ambulatory setting, including: a) medication monitoring, b) preventive care and chronic disease management, and c) test result follow-up. In addition we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis. We hypothesize that the value of ACPOE integrated with advanced CSDSS lies in improved medication safety and guideline compliance, but also improved efficiencies for the provider and the health-care system.
The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.
The investigators overall goal is to develop, implement, test, and disseminate an intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older who participate in annual influenza vaccination campaigns. The investigators hypothesis is that the FLU-FIT Program will be an effective method to increase colorectal cancer screening rates at Kaiser Permanente.
This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.
This is a study to better understand the nature and extent of adverse drug events (ADEs), defined as injuries due to prescription medications, in primary care. We will study whether PatientSite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.
This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid expansions on access to and utilization of community health center (CHC) services. Building on the investigators prior work that developed a robust community-based research infrastructure within the OCHIN community health information network, the investigator will utilize linked electronic health record data from the OCHIN network of \>400 CHC clinics in 8 states that expanded Medicaid coverage and 8 states that did not expand.
Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Indeed, while many systems currently take a "case-management" approach to identify and address clinical care issues for high risk patients, no systems to our knowledge apply a risk-based approach that accounts both for adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific patient will ignore a reminder letter and would therefore benefit from direct phone or in person contact). The investigators propose to directly test the hypothesis that implementing a health IT platform that 1) provides novel risk-based decision support using data derived from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of his or her patient panel will result in more effective and more efficient population-based primary care. The investigators will test this hypothesis in a practice-randomized clinical trial of preventive cancer screening within our primary care Practice-Based Research Network (PBRN).
The goal of this pilot randomized controlled trial is to determine whether a 6-month behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security among postpartum low-income Medicaid or uninsured women identified as having very low or low food security in the past 12 months. We hypothesize that a behavioral health intervention applying a multisectoral nurturing care navigation approach facilitating access to health, nutrition, early learning, responsive care, and security and safety resources is likely to decrease levels of maternal-child food insecurity. The main question it aims to answer is: * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security? Outcome 1: Improve levels of food security * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase knowledge to navigate barriers across the four pillars of food insecurity? Outcome 2: Increase knowledge across the four pillars of food insecurity * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase self-efficacy to secure and sustain enrollment with community nurturing care services? Outcome 3: Increase self-efficacy to secure and sustain enrollment with community nurturing care services Researchers will compare levels of food security among those receiving a navigation behavioral health intervention (consisted of 1:1 tailored navigation session and an educational workbook) compared to those receiving an educational workbook with messages across the four pillars of food insecurity (standard of care). Participants will: * Engage in intense weekly navigation 1:1 tailored session for 3 months * Engage in follow up monthly navigation 1:1 tailored session for 3 months * Participate in evaluation calls with a research assistant at enrollment, 3, 6, 12 months
The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are: 1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process? 2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will 1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history 2. Have the opportunity to opt-out of clinician-ordered HIV testing 3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment.
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role ("Parent's Coach") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by families in low-income communities, and decreases reliance on the clinician as the primary provider of WCC services. The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino, Medicaid-insured populations. The aims of this study are to (1) Adapt the PARENT intervention to meet the needs of a diverse, largely Black population of underserved families, (2) Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services, emergency department utilization, and parent experiences of care, (3) Determine whether the effectiveness of adapted PARENT differs by family-level factors, (4) Explore parents' experiences in receiving adapted PARENT, (5) Examine the economic impact of adapted PARENT from the parent stakeholder perspective, (6) Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective, and (7) Examine the economic impact of adapted PARENT on healthcare utilization, from the perspectives of parents and families. This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model.
This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures.
This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.