34 Clinical Trials for Various Conditions
The goal of this multi-site observational cohort study is to link electronic health records (EHR) with novel data sources to examine insurance instability and its association with all-cause and overdose mortality in adult patients who received medications for opioid use disorder (MOUD). The main objectives of the study are: * Objective 1. Perform data linkage of a cohort of patients who received MOUD with the National Death Index using a probabilistic algorithm for matching records to ascertain fact and cause of death relative to treatment and insurance status. * Objective 2: Assess the association of insurance instability and risk of death, including all-cause mortality and drug- and alcohol-related overdose mortality.
We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.
The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.
The investigators are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. The investigators will also compare HINT-S to HINT-A (asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.
With the passage of the American Rescue Plan (ARP) in March 2021, more consumers than ever before are now eligible for $0 -- or $1 per member per month (PMPM) in Marketplaces that include abortion coverage -- health insurance coverage across the ACA Marketplaces. But many individuals may not be aware of the new subsidies, or of their eligibility for Cost-Sharing Reduction (CSR) Silver plans. This project's goal is to examine whether personalized letters and email reminders can increase health insurance enrollment, CSR Silver take-up and $1 PMPM coverage.
This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
This is a test of an existing health insurance education program (HIEP) in the Utah Hispanic community (aged 18-64). The study will evaluate whether the HIEP delivered by Utah Health Policy Project (UHPP) staff improves participants' health insurance and cost-related literacy. Participants will complete a brief baseline survey, be guided through the HIEP by UHPP staff, and complete a brief survey after completing the sessions.
Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors, and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
This study is a US based qualitative PRO research study to document the health insurance literacy as well as the patient experience in Niemann-Pick as it relates to accessing desired care, services and medications for patients. The outcome of this research will be used to inform various other workstreams as NNPDF works to assist families. The core research objectives are to understand the following from Niemann-Pick patients and their families in the US
This is a test of an existing health insurance education program (HIEP) in adolescent and young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate whether the HIEP delivered by patient navigators improves participants' health insurance and cost-related literacy compared to usual navigation care, which does not include education on insurance and medical costs. The study team hypothesizes that: The HIEP will improve participants' health insurance and cost-related literacy compared to usual navigation care. Specifically, that participants in the intervention arm will report greater 1) health insurance and cost literacy, including confidence with provider communication about costs, 2) familiarity with ACA policies, and 3) improvement in financial distress related to medical costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months after meeting with a patient navigator where they may or may not receive the HIEP.
• This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.
The overall purpose of the study is to better understand how the investigators previously developed decision support (DS) tool can help people make decisions about health insurance plans available through the federal exchanges created by the Affordable Care Act (ACA). The investigators will evaluate the DS tool compared to the federal government website. The investigators will also evaluate the feasibility of disseminating this tool. There are two primary aims to be completed in this project: (1) examine the reach and effectiveness of the health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of implementation of the DS tool.
This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability. We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.
This project will assess the impact of various forms of outreach from navigators on Medicaid enrollment. Navigators are professionals who can provide one-on-one assistance with the Medicaid renewal process. The investigators propose to randomize the nature of outreach to households in Wisconsin enrolled in fee-for-service Medicaid who must renew or lose their coverage.
The objective of this study is to evaluate the impact of the value-based formulary on patient out-of-pocket spending and health plan spending as well as the impact of the value-based formulary on medication use, emergency department visits, hospitalizations, and outpatient office visits.
The Centers for Medicare \& Medicaid Services (CMS) approved the renewal of the Healthy Michigan Plan (HMP) Section 1115 Demonstration Waiver on December 21, 2018, for the period January 1, 2019-December 31, 2023. This waiver provides approval for the state to require Medicaid expansion beneficiaries ages 19-62 to complete and report 80 hours per month of community engagement as a condition of eligibility, among other waiver provisions, beginning January 1, 2020. Community engagement activities include employment, education, job training, job search activities, participation in substance use disorder (SUD) treatment, or community service. The State of Michigan will implement a randomized controlled trial (RCT) to evaluate the impact of community engagement requirements on Medicaid enrollment, health insurance coverage, self-reported health status, access to and utilization of health services, earnings, and employment, compared to a control group of HMP enrollees exempted from the community engagement requirement for purposes of the evaluation.
Kentucky HEALTH was an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. In what was initially planned to be a 5-year demonstration, KY HEALTH aimed to modify the traditional Medicaid program to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations. In brief, these included introducing Community Engagement requirements (i.e. work requirements), monthly premiums, MyRewards accounts for dental and vision services, and annual recertification. If beneficiaries failed to complete these requirements, some penalties included suspension and 6-month lockouts from the Medicaid program. The Commonwealth of Kentucky had chosen to implement this program in a randomized fashion, where 10% of the target population was randomly assigned to continue receiving traditional Medicaid while 90% would receive Kentucky HEALTH benefits and be subject to the requirements discussed above. Randomization was conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC also engaged in primary data collection to support the analysis of the project. The University of Pennsylvania team served as the non-partisan, independent evaluators of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis would measure the impact of KY HEALTH compared to traditional Medicaid. Due to ongoing legal challenges and a change in administrations, the implementation of Kentucky HEALTH was delayed and eventually cancelled. On March 27, 2019, the DC District Court Judge concluded that the approvals did not address how the requests would align with Medicaid's core objectives. At that point, data collection was ongoing although Kentucky HEALTH was delayed until further notice. Kentucky's 2019 gubernatorial election took place on November 5th and resulted in the election of a new governor. On December 16, 2019, a termination request was sent to CMS as a notification of the new administration's intention to cancel Kentucky HEALTH. On December 18, 2019, a clarification letter was sent to CMS to notify them that the termination did not apply to the SUD program and NEMT portion (among others) of the waiver. While the Penn team will continue conducting a separate evaluation of the ongoing SUD program, the randomized controlled trial and data collection described in this study will end with the terminated components of the waiver. As a result of the legal challenges, the implementation of Kentucky HEALTH was delayed before being cancelled altogether. The study start and end dates above reflect the beginning of data collection and the termination letter that was sent to CMS, respectively. A total of 9,396 surveys (KHES), 127 beneficiary semi-structured interviews, and 40 provider interviews were conducted.
In May 2023, Covered California, California's ACA marketplace, implemented its automatic enrollment program for individuals losing Medicaid coverage, as defined by Senate Bill 260. If individuals are found eligible for subsidized marketplace coverage, individuals will be automatically enrolled in the lowest cost silver plan available to them, but individuals must still take action to confirm their plan or pay their first month's premium. To identify whether the phone outreach is the effective outreach strategy to increase take-up in this population, Covered California implemented this intervention. The results of this evaluation will inform operational and budgeting decisions.
The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.
The overall goal of the study is to better understand how communication strategies can help people make decisions about health insurance plans. This study aims to: * (Aim 1) Examine currently uninsured individuals' understanding of terminology and details of health insurance plans; * (Aim 2) Apply three recommended strategies for communicating information about health insurance plans; * (Aim 3) Test the effects of these strategies in a randomized experiment.
This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions, such as hypertension and diabetes. The multi-level intervention includes clinic-level practice facilitation and patient-level digital health coaching.
This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.
In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.
In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes. Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care. In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four months and less likely to report non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than those receiving usual care. Findings will provide evidence about the effectiveness of strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.
This study evaluates the impact of a large-scale, national expansion of Medicaid on hypertension incidence, screening, treatment, and management. Social Determinants of Health will be assessed as moderators, and comparing states that did versus states that did not expand Medicaid will also be evaluated.
The objective of this randomized trial is to evaluate the effect of providing full prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins, beta-blockers, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers to patients recently discharged from hospital after acute myocardial infarction.
In March 2021, President Biden signed into law the American Rescue Plan Act of 2021 (ARP), a landmark federal economic relief and stimulus package designed to provide support to Americans hit by the economic recession brought about by the COVID-19 global pandemic. The law provides increased federal premium tax credits (PTC), and ensures that consumers will pay no more than 8.5 percent of household income on health insurance premiums in 2021 and 2022, if enrolled through an Affordable Care Act marketplace like Covered California. The ARP also provides additional PTC and cost-sharing reduction (CSR) benefits to eligible marketplace enrollees who report receiving unemployment insurance benefits (UIB) for at least one week in 2021. Under the law, for 2021 only, Covered California consumers will have their household income level treated as if it were at 138.1 percent of the federal poverty level (FPL), regardless of their projected annual income, which will make them eligible for a Silver 94 plan, and which offers the greatest value on cost-sharing benefits. But in order to access those cost-sharing benefits, households must be in silver tier plans, but over 40,000 were not. This project's goal is to assess the effects of an informational email on plan switching into Cost Sharing Reduction Silver plans and downstream healthcare utilization. The project's research design is a randomized intervention among approximately 42,500 enrolled households with an email address in non-silver tier plans. The investigators randomly assigned to either two informational emails or to a no email control group. The investigators then collected administrative data to examine plan switching behavior and healthcare utilization among households in the study.
This randomized research trial studies the Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in increasing cancer screening and prevention care in uninsured patients at community health centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage, leading to improved cancer screening and prevention rates in community health care settings, and general recommended preventive care.
This study will explore ways in which employee benefits may be designed to improve people's health, through examining the viewpoints and preferences of low-income people. A person's health is affected not only by being able to receive health care but also by several factors such as income and education. People with lower incomes have been found to be not as healthy as those with higher incomes. While the governments of many countries in the Organization for Economic Cooperation and Development are currently working on public policy to address this topic, the likelihood is small that the United States, given its market-based economy, will do the same. However, owing to the heavy reliance in the United States on employer-sponsored health insurance, it would be useful to explore the possibility of insuring some of the measures that people can take to improve their health, and to do that through employee benefit packages. Solutions might include extended unemployment insurance, more education, job training, exercise programs, help for housing, disability insurance, and extra retirement benefits. Adults who have a minimum of a sixth-grade reading level, have low incomes, are English speaking may be eligible for this study. For recruitment, 400 people who live and work in the Washington, D.C, area will be invited to participate, and about12 people will take part in each session. Unless people in the study participate during working hours, they will each be paid $75 at the conclusion of the session. The study consists of one phase, in which participants will engage in a group exercise that lasts for approximately 2-1/2 hours. During that time, participants will have the chance to say what employee benefits they would choose, if the opportunity arose, to improve their health. They will first make those choices by themselves and then make choices along with other people in the group. While group members talk, the discussion will be recorded on a tape recorder. Participants will be asked to give information about themselves and their opinions but will not be asked for any information that identifies them personally, except for data needed to pay participants with a paycheck. They will also get to use a computer and will be shown how to use it, if necessary. If videotaping or photographs are done during the exercise, the investigators of the study will ask for separate signed permission to do so. Participants will be asked to respect the privacy of others in the group and to not discuss the opinions of others after leaving the session.
The objective of the project is to understand how best to help mid-size employers adopt evidence-based chronic disease prevention practices that improve employee health behaviors.