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The standard care of hospital or emergency department patients experiencing an acute ischemic stroke includes intravenously administered tissue plasminogen activator (tPA). Mobile stroke units (MSUs) are ambulances equipped with staff and a computed tomographic scanner that can allow for tPA to be administered more quickly. This comparative effectiveness trial examined clinical outcomes in stroke patients who received either an earlier diagnosis and treatment using an MSU or standard triage and transport by Emergency Medical Services (EMS). The sample included multicenter cohorts with randomized deployment weeks and blinded assessment of both trial entry and clinical outcomes.

People experiencing homelessness (PEH) were among the most likely to contract the novel coronavirus disease 2019 (COVID-19). Many PEH utilized high-density public places to satisfy their basic needs (e.g., soup kitchens for sustenance, public libraries for restrooms). This made it difficult for them to limit close contact with others and put them at increased risk of contracting and transmitting COVID-19. Furthermore, it was difficult to follow recommended protective measures--such as handwashing and social distancing--when living in shelters or on the streets.

PEH were at higher risk of COVID-19 related hospitalization and death than the rest of the population. The poor living conditions of PEH accelerated aging, leading them to experience geriatric conditions and medical complications more typical of individuals 10-20 years older. They were also at increased risk of cardiovascular and respiratory disease, HIV/AIDS, and diabetes, all conditions that increase vulnerability to serious COVID-19-related complications and death. These risks were compounded by the fact that PEH also faced significant barriers to accessing quality health care. In the absence of protective action, it was estimated that more than 21,000 PEH would require hospitalization due to COVID-19, more than 7,000 would require critical care, and nearly 3,500 would die.

Consequently, the COVID-19 pandemic made housing and health care for PEH one of the top priorities for the U.S. health care and public health systems. State and local governments across the country used federal relief funds to allocate private hotel rooms as protective shelter for vulnerable PEH. In Los Angeles County (LAC), which contains the largest unsheltered homeless population in the nation, 2,400 PEH were placed in hotels. COVID-19 response plans included accommodating up to 15,000 PEH in hotels who would then be moved to permanent housing in 90 days. This rapid push into housing amid a pandemic necessitated a delicate balance between social distancing and maintaining patients' basic needs, continuity of existing care, and personal and social well-being.

Permanent supportive housing (PSH)--programs that provide immediate access to independent living situations coupled with support services--is the most effective approach for serving PEH. Numerous studies have demonstrated PSH's effectiveness in improving housing retention, quality of life, and HIV outcomes. Though evidence concerning its impact on other health outcomes, health behaviors, and health care utilization is limited, the National Academies of Sciences, Engineering, and Medicine has nonetheless recognized PSH as extremely beneficial for PEH's health. COVID-19 was what this organization termed a "housing-sensitive condition"--one whose transmissibility, course, and medical management are particularly influenced by homelessness. Consequently, the National Alliance to End Homelessness recommended the use of PSH as part of its framework to address COVID-19 and homelessness.

However, significant questions remain about what types of PSH programs can best address COVID-19-related risk and promote patient-centered outcomes at a time of social and community disruption. There are two distinct approaches to implementing PSH: place-based (PB) PSH, or single-site housing placement in a congregate residence with on-site services, and scattered-site (SS) PSH, which uses apartments rented from a private landlord to house clients while providing mobile case management services. The strengths and weaknesses of these two approaches remain largely unknown but may have direct implications for adherence to COVID-19 prevention protocols and other health-related outcomes.

Based on the state of the scientific evidence, the Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial was designed to address three specific aims. The first aim was to quantitatively compare engagement, self-reported PTSD symptom severity (primary outcome), quality of life, and recovery outcomes of primary care patients randomized to initially receive brief psychotherapy (Written Exposure Therapy - WET) or their choice of the three selective serotonin reuptake inhibitors (SSRIs). The second aim was, among patients not responding to initial treatment, to quantitatively compare outcomes of primary care patients randomized to: 1) augment the SSRI with WET, 2) switch from the SSRI to another class of antidepressants (serotonin-norepinephrine reuptake inhibitors - SNRI), or 3) switch from WET to the choice of the three SSRIs. The third specific aim was to quantitatively examine treatment heterogeneity among subgroups of primary care patients receiving pharmacotherapy and psychotherapy, including veterans, women, and those using cannabis.

Antibiotics are considered a feasible treatment for appendicitis, yet appendectomy remains the treatment standard in the United States. Previous randomized trials comparing these treatments excluded important subgroups and recruited small sample sizes but questions remain about the applicability of these previous findings. This study conducted the Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) randomized clinical trial to compare antibiotics with appendectomy among adults with appendicitis, including those with appendicolith. Those recruited comprised a diverse population, compared an overall measure of health status as the primary outcome, and included several secondary clinical and patient-reported outcomes, complications, and measures of healthcare utilization.

The Comprehensive Post-Acute Stroke Services (COMPASS) Study is a pragmatic cluster-randomized clinical trial that evaluated the real-world effectiveness of the COMPASS transitional care (COMPASS-TC) model compared to usual care among adult stroke and transient ischemic attack (TIA) patients discharged home between 2016 and 2018. In Phase 1, 40 North Carolina hospital units were randomized 1:1 to the COMPASS-TC intervention or usual care, stratified by stroke patient volume and stroke center certification. In Phase 2, hospitals randomized to usual care crossed over to implement COMPASS-TC, and hospitals randomized to the intervention sustained COMPASS-TC. The intervention was patient-centered and assessed social and functional determinates of health to inform individualized care plans for secondary prevention, recovery, and referrals to services and community-based resources. COMPASS-TC was consistent with Centers for Medicare and Medicaid Services (CMS) TC management reimbursement requirements.

The primary outcome was functional status (Stroke Impact Scale-16; SIS-16) at 90 days; secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, falls, and caregiver strain. Telephone interviewers, blinded to treatment assignment, assessed these outcomes at 90 days.

According to the World Health Organization, palliative care is "an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psycho-social and spiritual." The goal of the study was to generate comparative effectiveness research evidence to support the delivery of coordinated, community-based palliative care that effectively implements care plans consistent with the goals and preferences of older adults with advanced illness and their caregivers.

This study included a pragmatic, two-arm, multi-site randomized controlled trial of older adults (50+ years) with either poor prognosis cancer or end-stage organ failure who were recruited during an emergency department (ED) visit, along with their informal caregivers, to compare nurse-led telephonic case management to facilitated, outpatient specialty palliative care on: 1) quality of life in patients, 2) loneliness, 3) healthcare use in the 12 months following enrollment, 4) symptom burden, 5) caregiver strain, 6) caregiver quality of life, and 7) bereavement.

The BRITE study (Brain Injury Rehabilitation: Improving the Transition Experience) was a six-center, 1:1 randomized controlled pragmatic trial with masked outcome assessment that compared the effectiveness of two established approaches to managing transition from inpatient rehabilitation facility discharge to the next phase of care for individuals with moderate-to-severe traumatic brain injury (TBI). The two established transition methods were (1) a standardized version of existing discharge procedures used at all six sites and (2) a standardized remotely-delivered case management approach that extended beyond the point of discharge, based on the protocol used within the Veteran's Health Administration and enhanced with input from patient and family stakeholders. The sample was stratified by site and discharge location (skilled nursing facility vs. discharge to home/community) based on the relatively lower frequency of discharge to facility (22 percent across all six study sites in 2015) and the expectation of high impact of discharge destination on outcomes. When a caregiver was available for an enrolled patient, they were also approached for consent to be surveyed, with some patients having up to two caregivers enrolled to account for changes in primary caregiver.

The following key outcome domains were assessed: (1) ability of patients to participate in the home and community as independently as possible, (2) health-related quality of life, (3) access to appropriate healthcare and reduced emergent or urgent healthcare, and (4) caregiver outcomes. These outcomes were assessed at 3, 6, 9 and 12 months after discharge from inpatient care. Participants were also given the standard TBI Model Systems follow-up assessment one-year post-injury. Types of medical insurance coverage and satisfaction with healthcare were examined at 6 and 12 months post-discharge.

In the United States, tobacco smoking is associated with significant morbidity and premature mortality for individuals with serious mental illness (SMI) (e.g., schizophrenia, post-traumatic stress disorder, bipolar disorder, major depressive disorder). While many smokers with SMI wish to quit smoking, few are offered advice or treatments with demonstrated effectiveness in reducing tobacco dependence, primarily medication-assisted treatments. The overall aim of this randomized controlled trial was to test the effects of provider education (PE) (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with SMI) and community health worker (CHW) support on the provision and utilization of smoking cessation treatment to those with SMI, and cessation rates for adults with SMI who smoke or use tobacco over a 2-year period. The objectives of this trial were to:

1. Examine whether an intervention combining PE and CHW support would increase prescriber provision of advice and assistance to quit smoking, and improve tobacco cessation rates in smokers with SMI compared to usual care/treatment as usual (TAU) and compared to PE-only treatment
2. Determine the effect of the combined PE+CHW intervention on patient-reported overall health compared to TAU and PE-only treatment

Eligible individuals were recruited from two outpatient psychiatric service providers in the Boston, Massachusetts metropolitan area. Clinics where individuals received services were randomized into either the TAU condition or into the PE condition, where health care providers would receive additional education on first-line medications used to treat tobacco use disorder. Within clinics in the PE arm, individuals were further randomized into the community health worker (CHW) support condition (PE+CHW), where CHWs would assist participants with smoking cessation care access and provide community outreach and education, or no CHW support (PE-only). Enrolled participants (n=1,010) completed surveys on smoking/tobacco use at 3 timepoints: study baseline, 1 year post-randomization, and 2 years post-randomization.

A mixed-methods evaluation of the trial was also conducted post-intervention, using an interactive convergent design. The aims of the evaluation were to identify barriers and facilitators to effective implementation; examine how primary care providers differed by performance and engagement level, and how experiences with the intervention compared across these groups; and identify anticipated barriers to implementing the intervention as discussed by stakeholders. Quantitative outcome and visit data from the trial were used in the evaluation. For the evaluation's qualitative component, interviews were conducted with purposively sampled community health workers, smoker participants, primary care providers, and other stakeholders in policy, payor, and clinical administration. Please note that the qualitative evaluation data are not available for this collection.

Using a pragmatic trial design to limit exclusions, the investigators conducted a 36-month multi-center randomized effectiveness trial to compare the impact of an enhanced usual care (control) intervention, with exercise coaching (exercise), on fragility fractures and serious fall-related injuries (FF/SFRI) in patients with a previous fragility fracture. Specifically, the investigators examined the impact of the intervention on social loneliness, physical function, and bone strength. 1,139 individuals over 65 with a history of fragility fractures and/or osteoporosis were recruited over two years across three regions of Pennsylvania and randomized into either the enhanced usual care control group or exercise with coaching treatment group, where in-person exercise activities were led by trained volunteers.

Dataset (DS) 1 contains the following data used for analysis: participant characteristics at baseline by study group (referred to as Table 5 in the documentation), intervention participant characteristics at baseline based on exercise session type (referred to as Table 6), cumulative incidences of first serious fall-related injury compared by study group (referred to as Figure 3), cumulative incidence for first serious fall-related injury by age, gender, race, and osteoporosis medication (referred to as Table 8 and Figure 4), and cumulative incidence for first series fall-related injury by tertile of average intervention sessions per month (referred to as Figure 5). Other datasets used for analysis are fall injury data (DS2), monthly workout sessions data (DS3), secondary outcomes data (DS4, referred to as Table 7), and adverse events data (DS5, referred to as Table 9). DS6 includes markers designating before and after the start of the COVID-19 pandemic (March 11, 2020), allowing for analyses of participants who experienced fall-related injuries relative to COVID-19.

Datasets labeled "Miscellaneous" were not used in any analysis. These datasets contain extra measures from screening (DS7), baseline assessments (DS8), 4-month check-in visits (DS9), participant's distance to study site (DS10), coaching check-ins for weeks 1-12 (DS11), exercise sessions by month (DS12), adverse events (DS13), and end of study information (DS14).

The primary aim of this randomized clinical trial is to compare the effectiveness of the Specific Carbohydrate Diet (SCD) and the Mediterranean style diet (MSD) in inducing symptomatic and clinical remission in patients with Crohn's disease. Secondary objectives are to compare the effectiveness of the SCD and MSD in reducing mucosal and systemic inflammation, assessed by measuring the concentration of fecal calprotectin (FCP) and C-reactive protein (CRP) respectively; to compare the diets' effectiveness in improving fatigue, pain, and joint symptoms; and to determine the proportion of patients who continue study diets when prepared food is no longer provided without cost and their reasons for discontinuing the diets. The research aims were guided by crowdsourcing patient-generated research priorities; those that received the most support from Patient-Powered Research Network (PPRN) members were related to diet.

Based on the book Breaking the Vicious Cycle (Gottschall 1987), the Specific Carbohydrate Diet (SCD) restricts all but simple carbohydrates. Fresh fruits, vegetables, unprocessed meats, lactose-free cheeses, and certain legumes are permitted; grains, processed foods, canned foods, and milk are not permitted. The Mediterranean style diet (MSD) involves a high intake of olive oil, fruit, nuts, vegetables, and cereals; moderate intake of legumes, fish, seafood, and poultry; and low dairy intake. Red and processed meats, soda drinks, bakery foods, and sweets are not permitted. The MSD was selected as the alternative diet in this trial due to its easier implementation, consistency with U.S. Department of Agriculture and World Health Organization recommendations, and evidence of its role in overall health and specific benefits for Crohn's patients.

A total of 194 adult patients with mild to moderate Crohn's disease were enrolled and randomized into either the SCD (intervention) or MSD (control) diet groups at 33 different sites across the United States. Patients received meal delivery for their assigned diet for six weeks, then were provided instructions and recipes to adhere to the diet on their own for weeks seven through twelve. Outcome measures were taken at baseline, six weeks, and twelve weeks.

Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. PREPARE (PESRAMHIP) is a pragmatic, open-label trial of 1201 randomly assigned African American/Black and Hispanic/Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) plus usual care (intervention) or to continue usual care.

Participants had one in-person visit to consent, randomize and collect baseline data followed by 15 monthly questionnaires. The primary end point of this study was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.

As people age, medical decisions become more complex, including conversations about cancer screening. For patients aged 76-85, the United States Preventive Services Task Force (USPSTF) advises clinicians that decisions about colorectal cancer (CRC) screening should be individualized based on overall health and prior screening history (C recommendation). However, studies find that many older adults are not well-informed about, nor meaningfully engaged in, decisions about whether to continue CRC screening. Shared decision making (SDM) has been shown to improve the quality of decisions about initiating cancer screening but little is known about its effectiveness for decisions about stopping interventions. This study addresses a gap in the understanding of how to support clinicians and older patients in making good decisions about whether to continue CRC screening or not.

The researchers conducted a comparative effectiveness trial that randomly assigned clinicians at participating academic and community practices to one of two different decision support strategies. The first strategy (Registry arm) took a population health management (PHM) approach and used a patient registry to identify and track use of CRC screening among older adults for each clinician. The second strategy enhanced the registry by adding a multi-faceted SDM training program for clinicians (SDM Skills arm). The researchers enrolled patients of participating primary care providers (PCPs), aged 76-85, who are due or overdue for CRC screening, and survey them shortly after an office visit to determine the impact of the two strategies on outcomes of importance to patients. The study randomly assigned about 60 participating PCPs to the SDM skills or Registry arms, and enroll about 500 of their eligible patients.

Patients treated for metastatic cancer, or cancer that has spread to another part of the body, often have symptoms from cancer and its treatment. They may feel tired, depressed, or nauseated. They may find it hard to do their usual activities. Better symptom tracking may help improve patients' care. For example, symptom tracking could quickly alert doctors when a patient may need a different medicine. In this study, the research team compared use of a weekly electronic symptom tracking system versus usual care for patients with cancer. Patients receiving usual care could report their symptoms to their care team during regular clinic visits. The research team wanted to see if the tracking system helped patients live longer, have better quality of life, or go to the hospital or emergency room less often. The aims of this study were as follows:

1. Determine whether integrating electronic patient-reported outcomes (ePRO) in cancer care improves patient-centered outcomes;
2. Elicit perspectives about benefit burden tradeoffs for integrating patient-reported outcomes into clinical workflow; and
3. Identify barriers, facilitators, and strategies used by practices to integrate patient-reported outcomes into clinical workflow.

A total of 1,191 patients were enrolled from 52 U.S.-based community oncology practices. Randomization into intervention and control conditions occurred at the site level. Data collected as part of this study included patient clinical information; weekly symptom surveys, quality of life surveys, and cancer care surveys completed by patients; feedback on the ePRO intervention from patients, clinical research associates, nurses, and physicians; and symptom alerts sent to nursing staff. Please note that while qualitative data were collected as part of this study, they are not available.

Chronic low back pain is a leading cause of disability and reduced quality of life for nearly 100 million individuals in the United States. Approximately 5 to 10 percent of these individuals are prescribed opioids for treating their chronic low back pain. Limited data exists on the long-term efficacy of opioid treatment while much concern exists regarding the harm they can do to a person. Despite medication treatment patients still suffer from inadequate pain relief, impaired function, and quality of life.

This study sought to compare the long-term effectiveness of two types of alternative therapy approaches - mindfulness based therapy (MBT) and cognitive behavioral therapy (CBT) - for treating chronic low back pain especially those being treated by opioids.

This study addressed whether it is better to expand the scope of collaborative care programs to treat patients with more complex psychiatric disorders or to facilitate successful referrals to specialty mental health care. The primary objective of this study is to compare Telepsychiatry Collaborative Care (TCC) and Telepsychiatry Enhanced Referral (TER) from the patient and provider perspective. The secondary objective is to determine whether patients not engaging and responding to TER, improve with Phone-Psychiatry Enhanced Referral (PER). There are four specific aims.

Aim #1: To quantitatively compare the treatment experience, engagement, self-reported clinical outcomes, and recovery-oriented outcomes of patients initially randomized to TCC and TER.

Aim #2: For the subset of patients randomized to TER who do not engage in treatment and are still symptomatic at 6 months, quantitatively compare treatment experience, treatment engagement, self-reported clinical outcomes and recovery-oriented outcomes of patients randomized to continued-TER or PER.

Aim #3: To gain an in-depth understanding of patients' and providers' treatment experience, qualitatively compare those randomized to TCC, TER and PER.

Aim #4: To examine treatment heterogeneity among subgroups of patients randomized to TCC and TER based on race/ethnicity, age and clinical severity.

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study was a 12-month pragmatic randomized comparative effectiveness trial. The target population was primary care patients (n=820) at ten sites within the United States Department of Veterans Affairs (VA) Health Care System with moderate to severe pain despite treatment with moderate or high-dose long-term opioid treatment (LTOT). The study's primary aim was to compare integrated pain team (IPT) versus pharmacist telecare collaborative management (TCM) for improving pain and reducing opioid use among patients with chronic pain prescribed LTOT. In TCM, a lower-intensity intervention, a clinical pharmacist provides care management, structured symptom monitoring, and pain medication optimization. In IPT, a higher-intensity intervention, an interdisciplinary clinician team delivers care using a multi-modal approach to target biopsychosocial contributors to pain and disability with emphasis on non-drug therapies and behavioral activation sessions.

All participants were randomized to receive either IPT or TCM interventions for 12 months. Common elements of both interventions included individualized pain care and opioid taper recommendations tailored to patient preferences and treatment goals. Outcomes were assessed every three months and the primary time point for comparisons was 12 months. The primary outcome was pain, assessed with the Brief Pain Inventory (BPI) total score, with secondary outcomes as opioid daily dose and quality of life measures.