Goal #4: Improve clinical research

Informed consent forms are long and complex, making it hard for potential research participants to understand the study.&nbsp; Did you know that&nbsp;<a href="https://www.tuftsctsi.org/about-us-2/our-partners/" target="_blank" rel="noopener noreferrer">investigators from Tufts Clinical and Translational Science Institute (CTSI)-affiliated institutions</a>&nbsp;can now access the&nbsp;<a href="http://www.tuftsctsi.org/KeyInformationChecklist" target="_blank" rel="noopener noreferrer">NEW Key Information Checklist</a>?&nbsp; The&nbsp;<a href="http://www.tuftsctsi.org/KeyInformationChecklist" target="_blank" rel="noopener noreferrer">Informed Consent Key Information Checklist</a>&nbsp;is a new validated and reliable tool that investigators can use to assess how easy informed consent key information is to read, understand, and act on.&nbsp; &nbsp;&nbsp; Specifically, the Key Information Checklist helps research teams:<ul><li>Identify and prioritize essential study information</li><li>Use plain-language principles to improve reading ease</li><li>Promote participant understanding and informed decision-making</li><li>Align informed consent forms with Common Rule and IRB expectations</li></ul>We encourage all investigators and study coordinators to use this checklist when preparing new consent forms or revising existing ones. Need assistance or want to learn more?&nbsp;<a href="https://www.tuftsctsi.org/research-services/regulatory/informed-consent-tools/" target="_blank" rel="noopener noreferrer">Visit our web page</a>&nbsp;and&nbsp;<a href="https://tuftsctsi.my.site.com/s/" target="_blank" rel="noopener noreferrer">submit a service request</a>!

Tufts Clinical and Translational Science Institute

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Tufts University Boston

NEW RESOURCE: Informed Consent Key Information Checklist

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Goal #3: Address health needs of populations

<h2>UI researchers will investigate remote blood pressure monitoring to address a crucial gap in postpartum care.</h2>Researchers with the University of Iowa (UI) Institute for Clinical and Translational Science (ICTS) have launched a three-part project to improve screening and diagnosis of high blood pressure (hypertension) in postpartum women living in rural areas, with the long-term goal of improving treatment of this dangerous condition in this population.&nbsp;Hypertension&nbsp;is a common but underrecognized and undertreated health concern for women following the birth of their child.A <a href="https://journals.lww.com/ogopen/fulltext/2025/06000/prevalence_of_hypertension_in_the_late_postpartum.14.aspx">recent study</a> found that more than 20 weeks after delivery, almost four out of 10 postpartum women had high blood pressure. In addition, women who had elevated blood pressure throughout pregnancy had the highest risk of having stage 1 or 2 hypertension.This study emphasized what researchers with ICTS already knew: postpartum women need hypertension care, and an improved standard of care is necessary for diagnosing, managing, and treating hypertension in these women.&nbsp;When left untreated, hypertension can lead to coronary artery disease, heart failure, stroke, mild cognitive impairment, and more. In pregnant women, high blood pressure can be even more dangerous. It can cause seizures, stroke, temporary kidney failure, liver problems, and blood clotting disorders. Pregnant women with high blood pressure also have a higher risk of needing a C-section in delivery.&nbsp;<h2>Building the path toward better diagnosis and treatment&nbsp;&nbsp;&nbsp;</h2>The multidisciplinary team includes UI researchers and medical providers with expertise in women’s health, preeclampsia, statistical methods, pediatric care, hypertension, and home blood pressure measurements using novel methods. The team includes Philip Polgreen, M.D., Linnea Polgreen, Ph.D., Mark Santillan, M.D., Ph.D., Alberto Segre, Ph.D., Rachel Hoskins, Pharm.D., Shelby Francis, Ph.D., and Joe Cavanaugh, Ph.D.&nbsp;The new project will consist of three phases. Each will focus on postpartum women living in rural areas who have a history of high blood pressure.&nbsp;&nbsp;The first phase, which is currently in progress, will determine which of three methods is the best for remotely collecting blood pressure readings from the women. Participants will be given a blood pressure monitor and assigned a method for providing the data to the research team. Participants will either text their values to the research team, send an image of the values, or use a Bluetooth blood pressure monitor that automatically sends the data to the research team.&nbsp;After the data are collected, the team will move to the second phase, using the data to determine the best frequency for collecting blood pressure readings to ensure timely detection of high blood pressure.&nbsp;These two phases in tandem will help the team develop an effective intervention strategy using remote blood pressure monitoring to ensure postpartum women at risk for hypertension can be diagnosed in a timely fashion and get the care they need to maintain healthy blood pressure.&nbsp;&nbsp;<h2>Meeting new mothers where they are&nbsp;&nbsp;</h2>The team is also using an innovative approach for recruiting participants to the study that meets new mothers where they are. With the help of Hao Tran, M.D., a UI clinical professor of pediatrics, the researchers identified new mothers who matched the participant requirements and visited them while they were in the pediatric clinic for a well-child visit.&nbsp;“Postpartum women often ignore their own health and even ignore their own health care visits, but they regularly bring their children for well-child visits,” Tran shared. This recruitment strategy allows new mothers to participate in the project and take a step towards taking care of their health, without requiring an extra visit to the doctor's office.&nbsp;Overall, the study aims to bridge the gap between birth and long-term care for mothers who may be at risk of developing hypertension in the future.&nbsp;“We are passionate about finding new ways to help these women obtain the care they need,” says Shelby Francis, a member of the research team.

University of Iowa Institute for Clinical and Translational Science

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University of Iowa

Researchers with the University of Iowa (UI) Institute for Clinical and Translational Science (ICTS) have launched a three-part project to improve screening and diagnosis of high blood pressure (hypertension) in postpartum women living in rural areas, with the long-term goal of improving treatment of this dangerous condition in this population.

ICTS Team Works To Advance Postpartum Hypertension Care For Rural Populations

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The hepatitis C virus (HCV) is a significant cause of liver disease, yet many people who are infected remain asymptomatic for years. While effective treatments can cure the infection, fewer than one in three diagnosed patients in Los Angeles County complete their care.&nbsp;Project HCV Connect is targeting the problem by training University of Southern California (USC) healthcare students as caseworkers. These students reach out to infected individuals and connect or reconnect them with healthcare providers.&nbsp;“Our caseworkers call patients and tell them, ‘You have hepatitis C, it’s treatable, and we can offer some options,’” said Chrysovalantis Stafylis, M.D., M.P.H., first author and a senior research associate at the Keck School of Medicine of USC. “Patients are guided to connect with their primary care doctor—or if they don’t have one, caseworkers can link them to community clinics or telemedicine partners&nbsp;who can provide treatment.”&nbsp;The overarching goal of Project HCV Connect is to build a scalable public health infrastructure across the county to close treatment gaps and support the elimination of hepatitis C.&nbsp;Project HCV Connect was partially supported by a multidisciplinary grant from the Southern California Clinical and Translational Science Institute (SC CTSI). The project is a collaborative effort between the Los Angeles County Department of Public Health (LACDPH) and USC. It leverages public health case reports and caseworker interviews to pinpoint barriers and support systems related to hepatitis C testing, treatment initiation, and completion.&nbsp;The team is led by principal investigator and lead author Jeffrey Klausner, M.D., M.P.H., Clinical Professor of Medicine, Infectious Diseases, Population, and Public Health Sciences at the Keck School of Medicine at USC. They published a project report in the Journal of Public Health Management &amp; Practice.&nbsp;The authors noted that some patients infected with HCV grapple with substance use, mental illness, or homelessness. Without caseworkers to track and encourage individuals to seek care, many patients fall through the cracks in a broken system. For instance, positive HCV test results are reported to public health registries. But registries are generally passive collectors of information and lack the resources to follow up with infected individuals who still need treatment.&nbsp;The project recruits USC students from medicine, public health, global health, and health promotion programs to work as caseworkers. “We are leveraging a very underutilized workforce that wants real-life work experience, and this helps prepare the next generation of public health workers,” Stafylis said. “One of the lessons of the COVID pandemic is that we can train students on important public health tasks.”&nbsp;Caseworkers ask HCV patients about their insurance status and any obstacles in starting or completing treatment. Patients are informed that current HCV regimens are relatively easy to manage, typically consisting of 8 to 12 weeks of oral treatment with limited monitoring. The HIPAA-trained caseworkers also help schedule appointments with healthcare providers. If patients lack regular providers, they connect patients with partnering treatment programs. Three months after the initial contact, caseworkers follow up with calls to further support patients and update their treatment status in the HCV project management database.&nbsp;An SC CTSI-funded sub-study of Project HCV Connect found that infected people in their 30s and early 40s were nearly three times more likely to finish hepatitis C treatment than those in their late teens and 20s. Younger adults may be less informed about the disease and more likely to be dealing with active substance use and other life pressures, according to co-author Stafylis. The sub-study appeared in BMC Infectious Diseases.&nbsp;Patients tested and treated by liver or infectious disease specialists were almost twice as likely to complete treatment as those seen only in primary care. Specialists have greater familiarity with hepatitis C and have more time and support to help manage the disease. The authors noted that expanding primary care physicians’ capacity to treat hepatitis C directly, rather than just testing and referring, could significantly improve treatment completion.&nbsp;Another SC CTSI-funded sub-study was led by&nbsp;Daniel Soto, Ed.D., M.P.H., Assistant Professor at the Keck School of Medicine of USC and Director of the Center for Population Health. Soto and his team are completing in-depth interviews with patients, providers, and community navigators (promotores de salud) to understand why some people with hepatitis C start and complete treatment, and why others never do.&nbsp;“If we’re serious about making Los Angeles County hepatitis C–free, we have to look beyond the lab results and listen to people’s lived realities—how they move through clinics, jails, families and neighborhoods—and then design interventions that meet them where they are,” Soto said.

Southern California Clinical and Translational Science Institute

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University of Southern California

An SC CTSI-funded public health project could begin to break down barriers and help keep people with hepatitis C virus from falling through the cracks.

SC CTSI-funded Research is Closing the Hepatitis C Treatment Gap in Los Angeles

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NEW RESOURCE: Informed Consent Key Information Checklist