Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a single-masked prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-stratified telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.

开始日期2024-11-01

申办/合作机构

The Johns Hopkins University

[+2]

NCT06596577 / Not yet recruitingN/AIIT

Improving the Delivery and Equity of Inpatient Palliative Care: a Hybrid Type I Pragmatic Cluster Trial

This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on hospital-free days through 6 months and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.

开始日期2024-11-01

申办/合作机构

University of Pennsylvania

[+1]

NCT06634459 / RecruitingN/AIIT

The POMEGRANATE Trial: a Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse

This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be the number of successful self-managed pessary removal events completed over the six-month time frame. Secondary outcomes will include validated surveys to assess quality of life, adverse events and satisfaction with treatment.
Specific Aims
Aim 1: To compare number of self-management events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 2: To assess successful fitting, number of refitting visits, and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 3: To compare satisfaction with treatment and quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

开始日期2024-10-01

申办/合作机构

MedStar Research Institute

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232

项与 MedStar Research Institute 相关的文献（医药）

2023-06-16·World journal of gastrointestinal endoscopy

Prevalence and clinical risk factors for esophageal candidiasis in non-human immunodeficiency virus patients: A multicenter retrospective case-control study.

Article

作者: Kimchy, Alexandra V ; Sanghavi, Kavya ; Tully, Lindsey ; Ahmad, Akram I ; Lester, Connor ; Jennings, Joseph J

BACKGROUND:

Although esophageal candidiasis (EC) may manifest in immunocompetent individuals, there is a lack of consensus in the current literature about predisposing conditions that increase the risk of infection.

AIM:

To determine the prevalence of EC in patients without human immunodeficiency virus (HIV) and identify risk factors for infection.

METHODS:

We retrospectively reviewed inpatient and outpatient encounters from 5 regional hospitals within the United States (US) from 2015 to 2020. International Classification of Diseases, Ninth and Tenth Revisions were used to identify patients with endoscopic biopsies of the esophagus and EC. Patients with HIV were excluded. Adults with EC were compared to age, gender, and encounter-matched controls without EC. Patient demographics, symptoms, diagnoses, medications, and laboratory data were obtained from chart extraction. Differences in medians for continuous variables were compared using the Kruskal-Wallis test and categorical variables using chi-square analyses. Multivariable logistic regression was used to identify independent risk factors for EC, after adjusting for potential confounding factors.

RESULTS:

Of the 1969 patients who had endoscopic biopsies of the esophagus performed from 2015 to 2020, 295 patients had the diagnosis of EC. 177 of 1969 patients (8.99%) had pathology confirming the diagnosis of EC and were included in the study for data collection and further analysis. In comparison to controls, patients with EC had significantly higher rates of gastroesophageal reflux disease (40.10% vs 27.50%; P = 0.006), prior organ transplant (10.70% vs 2%; P < 0.001), immunosuppressive medication (18.10% vs 8.10%; P = 0.002), proton pump inhibitor (48% vs 30%; P < 0.001), corticosteroid (35% vs 17%; P < 0.001), Tylenol (25.40% vs 16.20%; P = 0.019), and aspirin use (39% vs 27.50%; P = 0.013). On multivariable logistic regression analysis, patients with a prior organ transplant had increased odds of EC (OR = 5.81; P = 0.009), as did patients taking a proton pump inhibitor (OR = 1.66; P = 0.03) or corticosteroids (OR = 2.05; P = 0.007). Patients with gastroesophageal reflux disease or medication use, including immunosuppressive medications, Tylenol, and aspirin, did not have a significantly increased odds of EC.

CONCLUSION:

Prevalence of EC in non-HIV patients was approximately 9% in the US from 2015-2020. Prior organ transplant, proton pump inhibitors, and corticosteroids were identified as independent risk factors for EC.

2023-05-01·Journal of the American College of Cardiology

Screening for Dilated Cardiomyopathy in At-Risk First-Degree Relatives

Article

作者: Jordan, Elizabeth ; Gottlieb, Stephen S ; Hofmeyer, Mark ; Sweitzer, Nancy K ; Lowes, Brian ; Stoller, Douglas ; Pamboukian, Salpy V ; Pan, Stephen ; Haas, Garrie J ; Tang, W H Wilson ; Cao, Jinwen ; Ni, Hanyu ; Shah, Palak ; Judge, Daniel P ; Hershberger, Ray E ; Kransdorf, Evan ; Wang, Jessica ; Smart, Frank ; Kinnamon, Daniel D ; Trachtenberg, Barry H ; Wilcox, Jane E ; Garg, Sonia ; Katz, Stuart ; Wheeler, Matthew T ; Morris, Alanna A ; Huggins, Gordon S ; Owens, Anjali ; Fishbein, Daniel P ; Jimenez, Javier ; Moore, Charles K ; Ewald, Gregory A

BACKGROUND:

Cardiovascular screening is recommended for first-degree relatives (FDRs) of patients with dilated cardiomyopathy (DCM), but the yield of FDR screening is uncertain for DCM patients without known familial DCM, for non-White FDRs, or for DCM partial phenotypes of left ventricular enlargement (LVE) or left ventricular systolic dysfunction (LVSD).

OBJECTIVES:

This study examined the yield of clinical screening among reportedly unaffected FDRs of DCM patients.

METHODS:

Adult FDRs of DCM patients at 25 sites completed screening echocardiograms and ECGs. Mixed models accounting for site heterogeneity and intrafamilial correlation were used to compare screen-based percentages of DCM, LVSD, or LVE by FDR demographics, cardiovascular risk factors, and proband genetics results.

RESULTS:

A total of 1,365 FDRs were included, with a mean age of 44.8 ± 16.9 years, 27.5% non-Hispanic Black, 9.8% Hispanic, and 61.7% women. Among screened FDRs, 14.1% had new diagnoses of DCM (2.1%), LVSD (3.6%), or LVE (8.4%). The percentage of FDRs with new diagnoses was higher for those aged 45 to 64 years than 18 to 44 years. The age-adjusted percentage of any finding was higher among FDRs with hypertension and obesity but did not differ statistically by race and ethnicity (16.2% for Hispanic, 15.2% for non-Hispanic Black, and 13.1% for non-Hispanic White) or sex (14.6% for women and 12.8% for men). FDRs whose probands carried clinically reportable variants were more likely to be identified with DCM.

CONCLUSIONS:

Cardiovascular screening identified new DCM-related findings among 1 in 7 reportedly unaffected FDRs regardless of race and ethnicity, underscoring the value of clinical screening in all FDRs.

2023-04-25·Circulation

Effectiveness of the Family Heart Talk Communication Tool in Improving Family Member Screening for Dilated Cardiomyopathy: Results of a Randomized Trial

Article

作者: Jordan, Elizabeth ; Gottlieb, Stephen S ; Sweitzer, Nancy K ; Hofmeyer, Mark ; Ni, Hanyu ; Pamboukian, Salpy V ; Pan, Stephen ; Owens, Anjali ; Stoller, Douglas ; Tang, W H Wilson ; Haas, Garrie J ; Aaronson, Keith D ; Burke, Wylie ; Shah, Palak ; Judge, Daniel P ; Kransdorf, Evan ; Wang, Jessica ; Hershberger, Ray E ; Smart, Frank ; Kinnamon, Daniel D ; Morris, Alanna A ; Garg, Sonia ; Wheeler, Matthew T ; Lowes, Brian ; Trachtenberg, Barry H ; Mead, Jonathan O ; Huggins, Gordon S ; Fishbein, Daniel P ; Katz, Stuart ; Ewald, Gregory A ; Jimenez, Javier ; Moore, Charles K ; Wilcox, Jane E

Background::

Managing disease risk among first-degree relatives of probands diagnosed with a heritable disease is central to precision medicine. A critical component is often clinical screening, which is particularly important for conditions like dilated cardiomyopathy (DCM) that remain asymptomatic until severe disease develops. Nonetheless, probands are frequently ill-equipped to disseminate genetic risk information that motivates at-risk relatives to complete recommended clinical screening. An easily implemented remedy for this key issue has been elusive.

Methods::

The DCM Precision Medicine Study developed Family Heart Talk , a booklet designed to help probands with DCM communicate genetic risk and the need for cardiovascular screening to their relatives. The effectiveness of the Family Heart Talk booklet in increasing cardiovascular clinical screening uptake among first-degree relatives was assessed in a multicenter, open-label, cluster-randomized, controlled trial. The primary outcome measured in eligible first-degree relatives was completion of screening initiated within 12 months after proband enrollment. Because probands randomized to the intervention received the booklet at the enrollment visit, eligible first-degree relatives were limited to those who were alive the day after proband enrollment and not enrolled on the same day as the proband.

Results::

Between June 2016 and March 2020, 1241 probands were randomized (1:1) to receive Family Heart Talk (n=621) or not (n=620) within strata defined by site and self-identified race/ethnicity (non-Hispanic Black, non-Hispanic White, or Hispanic). Final analyses included 550 families (n=2230 eligible first-degree relatives) in the Family Heart Talk arm and 561 (n=2416) in the control arm. A higher percentage of eligible first-degree relatives completed screening in the Family Heart Talk arm (19.5% versus 16.0%), and the odds of screening completion among these first-degree relatives were higher in the Family Heart Talk arm after adjustment for proband randomization stratum, sex, and age quartile (odds ratio, 1.30 [1-sided 95% CI, 1.08–∞]). A prespecified subgroup analysis did not find evidence of heterogeneity in the adjusted intervention odds ratio across race/ethnicity strata ( P =0.90).

Conclusions::

Family Heart Talk , a booklet that can be provided to patients with DCM by clinicians with minimal additional time investment, was effective in increasing cardiovascular clinical screening among first-degree relatives of these patients.

Registration::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03037632.

项与 MedStar Research Institute 相关的新闻（医药）

2024-09-27

·drugs

Cognitive Behavioral Therapy Program Aids Insomnia in Breast Cancer Survivors

FRIDAY, Sept. 27, 2024 -- An in-home, voice-activated cognitive behavioral therapy (CBT) program improves insomnia symptoms among breast cancer survivors, according to a study published online Sept. 24 in JAMA Network Open . Claire M. Starling, M.P.H., from the MedStar Health Research Institute in Washington, D.C., and colleagues assessed the efficacy of a CBT-informed, voice-activated, internet-delivered program for improving insomnia symptoms among breast cancer survivors. The analysis included 70 breast cancer survivors with insomnia who were randomly assigned (1:1) to a smart speaker with a voice-interactive CBT-insomnia (CBT-I) program or educational control for six weeks. The researchers found that from baseline to follow-up, Insomnia Severity Index scores changed by a mean of −8.4 points in the intervention group versus −2.6 in the control group. Sleep quality, as assessed by diary data, showed statistically significant improvements in the intervention group versus the control group, as did wake after sleep onset (9.54 minutes), sleep onset latency (8.32 minutes), and sleep efficiency (−0.04 percent). However, there was no improvement in total sleep time. "Future studies should explore potential for scaling in-home sleep programs and increasing application of artificial intelligence and should compare engagement and noninferiority with other effective CBT-I programs," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2024-08-20

·Medical Design and Outsourcing

FDA funds grants for pediatric cardiology devices

NEWS RELEASE: Children’s National Hospital, Additional Ventures offer grants for pediatric cardiology devices Grants totaling $300,000 to be distributed among innovators with medical technology solutions WASHINGTON – The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded by the Food and Drug Administration (FDA), announces today it is partnering with Additional Ventures, a nonprofit foundation focused on accelerating research progress and improving clinical care for individuals born with single ventricle heart defects, to solicit proposals and offer grant funding for the development of pediatric devices specifically evaluated and labeled for children with heart conditions. Children with heart conditions face unique challenges that demand specialized medical devices tailored to their specific physiological needs. There is a significant unmet need for pediatric devices designed to monitor and treat young patients effectively in cardiology, interventional cardiology, cardiac surgery and electrophysiology. Current technologies for pediatric heart patients often fall short because they are typically adapted from adult devices and may not provide the accuracy, safety or comfort required for children. Areas of special interest include remote patient monitoring systems that can track vital signs and heart function in real-time, wearable devices designed for continuous monitoring, and minimally invasive technologies for cardiac procedures. Through this request for proposals, APDI seeks innovative solutions that address these gaps, offering the potential to transform care for children with heart conditions by developing advanced, child-centric devices. “Our commitment to advancing pediatric cardiology is stronger than ever. With the launch of this initiative, we are paving the way for innovative pediatric devices that will transform how we monitor and care for children with heart conditions,” said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National and APDI program director and principal investigator. “This proposal allows us to support projects that show promise in advancing novel devices specifically designed for children and support innovators who need funds for the complex process of bringing new technologies to market.” When approaching device design for this proposal, Dr. Eskandanian adds that innovators should start with a pediatric focus because, if the device works for children, it can be adapted for adults. She notes that developing pediatric device solutions requires an individualized approach with a design that accommodates usability for all age groups. The total award fund of $300,000 will be distributed among innovators with the most promising devices as selected by the judging panel. As part of the collaboration, Additional Ventures and APDI will provide winning companies with support services and technical expertise, including but not limited to regulatory, reimbursement, clinical trials study design and data science services. Interested innovators can learn more and apply for the APDI medical device grant online at innovate4kids.org. The deadline to apply is midnight on September 23, 2024. APDI is one of five nonprofit consortia in the FDA’s Pediatric Device Consortia program that receives funding to provide a platform of services, expertise and grants to support pediatric innovators in bringing medical devices to the market that address the needs of children. Along with Children’s National, APDI members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, Medstar Health Research Institute, OrthoPediatrics Corp. and MedTech Color. Advancements in pediatric medical devices continue to lag significantly behind those of adults, which is why APDI is focused on helping more pediatric medical device innovations achieve commercialization. For more information on APDI, visit innovate4kids.org. About Children’s National Hospital Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger. Today, it is the No. 5 children’s hospital in the nation and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated three times in a row as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. As a nonprofit, Children’s National relies on generous donors to help ensure that every child receives the care they need. For more information, follow us on Facebook, Instagram and LinkedIn. About Additional Ventures Additional Ventures is a purpose-driven organization leveraging evidence-based research and deep subject matter expertise to make an outsized impact. Our relentless optimism powers bold, high-risk innovations to solve some of humanity’s most complex challenges. Our biomedical research work focuses on a rare form of congenital heart defects called single ventricle heart disease. While this field is in its infancy, with limited knowledge of cause, risk, outcomes, or treatments, we are confident that through coordinated strategic and interdisciplinary work, dynamic teaming, and flexible funding, we can illuminate a functional cure for patients and their families. Learn more about our work at additionalventures.org, LinkedIn, or X. The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

2024-07-30

·PRNewswire

RLDatix and MedStar Health Partner to Improve Patient Safety Using Artificial Intelligence

The partnership will focus on researching patient safety incidents through AI data extraction tools to enable safer healthcare. CHICAGO, July 30, 2024 /PRNewswire/ -- RLDatix, the leading global provider of connected healthcare operations software and services, announced its new partnership with Medstar Health, the largest healthcare provider in the mid-Atlantic region, to utilize sophisticated AI tools for data extraction to augment patient safety event analysis. The partnership will accelerate collaboration across healthcare organizations to address patient safety concerns. Data extraction tools, powered by MedStar Health's AI algorithms, will be leveraged with the RLDatix risk management solutions to accelerate research for safety and care delivery best practices. RLDatix scientists will be able to help risk customers facilitate data analysis from thousands of patient safety event reports in seconds with a simple search. "RLDatix believes that prioritizing patient safety requires industry collaboration to proactively design safety into care delivery processes, instead of designing processes around existing systems with poor safety design," said Jeff Surges, RLDatix CEO. "Through our partnership with MedStar Health, we will provide our RLDatix learning communities with the information they need to address the root causes of safety incidents and develop improvements to make their care processes safer." By leveraging AI, organizations will be able to extract data in seconds, search specific incidents and find both high-level rates and trends with increased specificity. This will reduce analytical burden and provide organizations with more time, resources and insights to uncover previously unforeseen risk factors affecting patient safety. "This technology breaks the mold of healthcare systems tackling patient safety on their own," said Raj Ratwani, PhD, Vice President of Scientific Affairs at MedStar Health. "Working with RLDatix means organizations across the country can partner to help protect patients." RLDatix and MedStar Health's research agreement initiates a collaborative opportunity for the healthcare industry to work together and share best practices in designing safety into the care delivery process. About RLDatix RLDatix is on a mission to improve healthcare by enabling a world where patients receive the best and safest care possible. Trusted by thousands of clients around the world, our connected healthcare operations platform combines software and trusted services to empower organizations with critical data insights across risk, safety, compliance, provider lifecycle and workforce management. Our user-centric approach provides a holistic, real-time view of healthcare operations, connecting disparate information across the enterprise – thus giving organizational leadership the contextualized data they need to make better-informed decisions. Visit rldatix.com to learn more. About MedStar Health At MedStar Health, we use the best of our minds and the best of our hearts to serve our patients, those who care for them, and our communities. Our 30,000 associates and 4,700 affiliated physicians are committed to living this promise through our core SPIRIT values—Service, Patient first, Integrity, Respect, Innovation, and Teamwork—across our more than 300 locations including 10 hospitals, ambulatory, and urgent care centers. As the medical education and clinical partner of Georgetown University, MedStar Health is training future physician leaders to care for the whole person and is advancing care through the MedStar Health Research Institute. From our telemedicine and urgent care services to the region's largest home health agency, we're committed to providing high-quality health care that's also easy and convenient for our patients. At MedStar Health—It's how we treat people. Learn more at MedStarHealth.org. Media Contact: Matter Communications for RLDatix [email protected] SOURCE RLDatix

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