40 Clinical Trials for Various Conditions
The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. The aims of this study are to: PRIMARY AIM 1. Determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. The primary outcome will be observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale Preoperative Anxiety Scale). SECONDARY AIMS 1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ 2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires 3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.
1. To do formative work with healthcare providers, clinic staff and parents to develop a protocol for a clinic system to routinely collect blood from children at risk of SHS exposure conduct laboratory testing for tobacco toxicants, document exposure in the electronic medical record (EMR) and incorporate the biomarker feedback into a parental smoking treatment plan. 2. To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on provider delivery of tobacco treatment services (primary outcome). 3. To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on parent smoking behavior (participation in smoking cessation treatment, smoking cessation and implementation of smoking restrictions).
The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain. Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function. Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy. Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions. Hypotheses: Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain. Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months. Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy. Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics. Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache. Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function. Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups. Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.
Expanded availability of virtual care encounters in Primary Care provides new opportunities to improve Veterans' outcomes by aligning encounter modalities with their needs and preferences. Yet, Veterans and their Primary Care physicians (PCPs) lack personalized information about the benefits and costs of different Primary Care modalities that is needed to maximize the value of Primary Care encounters. To address this problem, in this study the investigators will use surveys and interviews to identify what Veterans and PCPs perceive to be the benefits and optimal uses of different Primary Care encounter modalities. They will then supplement their existing system for communicating encounter costs to Veterans and PCPs with new interactive messaging about benefits and optimal uses of different encounter modalities. Finally, this novel Advancing Decisions about Virtual Service Encounters (ADViSE) intervention will be optimized through user-centered refinement before evaluating its effects on Veteran-centered outcomes, use of virtual care, and intermediate health outcomes in a randomized controlled trial (RCT).
The purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
The goal of this clinical trial is to test the effects of two suicide prevention interventions for individuals released from jail. The main questions it aims to answer are: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? and Will providing training and resources to behavioral health providers improve re-engagement with healthcare services for patients recently released from jail? Participants will include (1) subscribers of a managed care organization (MCO) and (2) behavioral health providers within the MCO system. Interventions include sending subscribers Caring Contacts letters for 6-months following jail release and providing resources and training to behavioral health providers to target healthcare re-engagement and suicide prevention.
Implicit bias is a form of bias in which a person's automatic and unintentional thoughts of another person or group influence either positively or negatively their behavior or the decisions they make. Studies show that healthcare providers have the same amount of bias as any other person and that it can affect patient care. However, in the emergency room, which is fast-paced and there is a high number of patients, implicit bias may be higher. Therefore, this study will look at emergency care center (ECC) providers' willingness to change their implicit bias behaviors. After, it will provide implicit bias education designed for the ECC to the healthcare providers at SMHCS Sarasota campus and assess whether it improved their willingness to change implicit bias behaviors when compared to the providers in the SMHCS Venice campus who did not receive the education.
This study aims to test the efficacy of an information visualization dashboard on decision-making using a randomized controlled trial with crossover. This study aims to test the efficacy of using an information visualization dashboard on ICU providers' decision-making, efficiency, and performance compared to their institutional EHR through a randomized control trial with crossover.
The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.
The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.
Determine the effectiveness of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit through a randomized controlled trial (RCT).
Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. The study is conducted to develop and test a telephone delivered intervention for the management of OA in Hispanic adults. This study is conducted as a minority supplement to the Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.
The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston/Harris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.
The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.
Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.
This pilot project aims to reduce the prescribing of high-risk medications, such as antipsychotics and benzodiazepines, to hospitalized older adults. To accomplish this, this project consists of two phases. The purpose is to determine whether a novel simulation-based training program reduces prescribing of suboptimal medications for older adults. A 2-arm pilot randomized controlled trial will be conducted to test a simulation-based, principle-driven intervention targeting high-risk prescribing practices versus control.
In the present study, patients will be sent a message shortly after completing a medical procedure that informs or reminds them that they can reach out to Geisinger, and how to do it, if they have any medical issues or concerns. Researchers will assess if such messages make patients more likely to contact Geisinger with post-procedure medical concerns and decrease emergency department utilization.
The purpose of the proposed study is to train mental health providers (MHPs) at lesbian, gay, bisexual, transgender, and queer (LGBTQ) community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT).
This study tests whether changing the relative order of presentation of post acute care skilled nursing facilities (SNFs) in the Repisodic application, i.e., presenting preferred SNFs (P-SNFs) first, increases selection of, and discharges to, P-SNFs and decreases lengths of stay (LoS) for Geisinger patients discharged to SNFs. Along with the order of P-SNFs, the study also assesses whether a short video reviewing the benefits of care coordination in P-SNFs increases patient election to transfer to one.
Emory Spiritual Health has developed a Compassion-Centered Spiritual Health group-based intervention, called CCSH Interventions for Teams, and are enrolling staff and providers into the groups in this randomized study design. The groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total). The investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI- designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to Compassion Centered Spiritual Health Team Intervention (CCSH-TI) or TAU (Treatment as Usual) group. The research objective is to evaluate the feasibility and acceptability of CCSH-TI, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.
The purpose of this study is to assess the impact of a provider counseling training on patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10 Planned Parenthood health centers.
Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the "stage model") and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care.
The purpose of the study is to train New York-based early childhood mental health consultants (ECMHCs) who will apply the Infant-Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD) tool as part of their standard practice. The study will evaluate I-T CHILD-informed early childhood mental health consultation in 100 New York State-licensed family day care and group family day care programs serving infants and toddlers in lower-income neighborhoods
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
Bridging the Gap aims to improve access to effective mental health treatment in a primary care setting through utilization of single session growth mindset interventions for parents and for youths. This project will also utilize focus groups and qualitative interviews to gain feedback on a single session online intervention in a rural pediatric primary care practice.
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time. The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff. Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training. There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.
The goal of this clinical trial is to explore possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can improve health and wellness in health care providers (HCP). The main goals of the study are: * To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and autonomic reactivity (the degree participants physiologically respond). * To investigate whether pre-intervention measures relate to the overall functioning of the HCPs. * To determine the 1-week and 1-month post-intervention effects of the Intervention(s) * To identify individual characteristics that influence the effectiveness of the intervention at the 1-week and 1-month post-intervention assessments. Participants will: * complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation. * complete pre-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples. * participated in the intervention (which involves 4.5 hours; the 1.5-hour classes will be administered over three weeks). Researchers will compare the Intervention Group A to Intervention Groub B to see if the Intervention Group B experiences greater improvements in their health and wellness.
The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children. Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support. Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.